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 In this section:

                COVID-19 Emergency Use Authorizations for Medical Devices

COVID-19 Emergency Use Authorizations for Medical Devices

                        Blood Purification Devices EUAs
          Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
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          Emergency Use Authorizations for Medical Devices
          COVID-19 Emergency Use Authorizations for Medical Devices
          EUA Authorized Serology Test PerformanceCOVID-19 Emergency Use Authorizations for Medical Devices EUA Authorized Serology Test Performance
  
  	
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Serology tests detect the presence of antibodies in the blood from the body’s adaptive immune response to an infection, like COVID-19. They do not detect the virus itself. In the early days of an infection when the body's adaptive immune response is still building, antibodies may not be detected. This limits the test's effectiveness for diagnosing current COVID-19 and is one reason serology tests should not be used to diagnose or exclude acute COVID-19 infection. Serology tests play a role in the fight against COVID-19 by helping health care professionals identify individuals who may have developed an adaptive immune response to SARS-CoV-2. However, to use serology tests properly, it is important to understand their performance characteristics and limitations. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as which antibodies may indicate a level of protection that would prevent or reduce the severity of infection or re-infection as well as the duration for which this protection may last.

The performance of these tests is described by their "sensitivity," or their ability to identify those with antibodies to SARS-CoV-2 (true positive rate), and their "specificity," or their ability to identify those without antibodies to SARS-CoV-2 (true negative rate). A test's sensitivity can be estimated by determining whether or not it is able to detect antibodies in blood samples from patients who have been confirmed to have COVID-19 with a nucleic acid amplification test, or NAAT. In some validation studies of these tests, like the one the FDA is conducting in partnership with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA), the samples used, in addition to coming from patients confirmed to have COVID-19 by a NAAT, may also be confirmed to have antibodies present using other serology tests. A test's specificity can be estimated by testing large numbers of samples collected and frozen before SARS-CoV-2 is known to have circulated to demonstrate that the test does not produce positive results in response to the presence of other causes of a respiratory infection, such as other coronaviruses.

These estimates of sensitivity and specificity are just that: estimates. They include 95% confidence intervals, which are the range of estimates we are about 95% sure a test's sensitivity and specificity will fall within given how many samples were used in the performance validation. The more samples used to validate a test, the smaller the confidence interval becomes, meaning that we can be more confident in the estimates of sensitivity and specificity provided.

Tests are also described by their Positive and Negative Predictive values (PPV and NPV). These measures are calculated using a test's sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called "prevalence" in these calculations). Every test returns some false positive and false negative results. The PPV and NPV help those who are interpreting these tests understand, given how prevalent individuals with antibodies are in a population, how likely it is that a person who receives a positive result from a test truly does have antibodies to SARS-CoV-2 and how likely it is that a person who receives a negative result from a test truly does not have antibodies to SARS-CoV-2. The PPV and NPV of a test depend heavily on the prevalence of what that test is intended to detect. Because all tests will return some false positive and some false negative results, including tests that detect antibodies to SARS-CoV-2, broad use of the tests, when not appropriately informed by other relevant information, such as clinical history or diagnostic test results, could identify too many false-positive individuals.

**The prevalence of SARS-CoV-2 antibody positive individuals varies across the United States, and prevalence is changing as the virus infects more individuals and as more individuals are vaccinated.** In low prevalence populations, the result of a single antibody test is not likely to be sufficiently accurate to make an informed decision regarding whether or not an individual has had a prior infection or truly has antibodies to the virus. A second test, typically one assessing for the presence of antibodies to a different viral protein, generally would be needed to increase the accuracy of the overall testing results.

Methodology

For this page, the FDA has summarized the expected performance of the tests it has authorized based on the information the FDA reviewed when deciding whether or not to grant these tests an Emergency Use Authorization and with prevalence assumptions ranging from 5% to 50% for PPV and NPV calculations. For tests that had multiple validation studies or where the tests showed variable performance in samples collected at different times after symptom onset, the FDA analysts selected the results they considered to be most representative of expected test performance. This is an incomplete representation of the performance of these tests. **Always refer to the complete instructions for use to put these estimates into the proper context** and to understand how to use and interpret these tests. The FDA is also providing a calculator that will allow users to see the estimated performance of a single test or two independent tests based on their performance characteristics and the estimated prevalence of SARS-CoV-2 antibodies in the target population.

Test Performance

Abbott AdviseDx SARS-CoV-2 IgG II (Alinity)

**Developer:** Abbott Laboratories Inc.**Test:** AdviseDx SARS-CoV-2 IgG II (Alinity)**Technology:** Semi-quantitative High Throughput CMIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			98.1% (51/52)
			(89.9%; 99.7%)IgG
			Specificity (NPA)
			99.6% (2000/2008)
			(99.2%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			92.8% (95% CI: 85.8%; 96.3%)
			99.9% (95% CI: 99.5%; 100%)10.0%
			96.5% (95% CI: 92.7%; 98.2%)
			99.8% (95% CI: 98.9%; 100%)20.0%
			98.4% (95% CI: 96.6%; 99.2%)
			99.5% (95% CI: 97.5%; 99.9%)30.0%
			99.1% (95% CI: 98.0%; 99.5%)
			99.2% (95% CI: 95.8%; 99.9%)40.0%
			99.4% (95% CI: 98.7%; 99.7%)
			98.7% (95% CI: 93.6%; 99.8%)50.0%
			99.6% (95% CI: 99.1%; 99.8%)
			98.1% (95% CI: 90.7%; 99.7%)60.0%
			99.7% (95% CI: 99.4%; 99.9%)
			97.2% (95% CI: 86.7%; 99.5%)70.0%
			99.8% (95% CI: 99.6%; 99.9%)
			95.7% (95% CI: 80.8%; 99.2%)80.0%
			99.9% (95% CI: 99.8%; 99.9%)
			92.8% (95% CI: 71.0%; 98.7%)90.0%
			100% (95% CI: 99.9%; 100%)
			85.2% (95% CI: 52.1%; 97.0%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseAbbott AdviseDx SARS-CoV-2 IgG II (Architect)

**Developer:** Abbott Laboratories Inc.**Test:** AdviseDx SARS-CoV-2 IgG II (Architect)**Technology:** Semi-quantitative High Throughput CMIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			98.1% (52/53)
			(90.1%; 99.7%)IgG
			Specificity (NPA)
			99.6% (1999/2008)
			(99.2%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			92.0% (95% CI: 84.8%; 95.7%)
			99.9% (95% CI: 99.5%; 100%)10.0%
			96.1% (95% CI: 92.2%; 97.9%)
			99.8% (95% CI: 98.9%; 100%)20.0%
			98.2% (95% CI: 96.4%; 99.1%)
			99.5% (95% CI: 97.6%; 99.9%)30.0%
			98.9% (95% CI: 97.8%; 99.5%)
			99.2% (95% CI: 95.9%; 99.9%)40.0%
			99.3% (95% CI: 98.6%; 99.6%)
			98.8% (95% CI: 93.7%; 99.8%)50.0%
			99.5% (95% CI: 99.1%; 99.8%)
			98.1% (95% CI: 90.9%; 99.7%)60.0%
			99.7% (95% CI: 99.4%; 99.8%)
			97.2% (95% CI: 86.9%; 99.5%)70.0%
			99.8% (95% CI: 99.6%; 99.9%)
			95.8% (95% CI: 81.0%; 99.2%)80.0%
			99.9% (95% CI: 99.8%; 99.9%)
			93.0% (95% CI: 71.4%; 98.7%)90.0%
			99.9% (95% CI: 99.9%; 100%)
			85.4% (95% CI: 52.6%; 97.1%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseAbbott Alinity i SARS-CoV-2 IgG

**Developer:** Abbott**Test:** Alinity i SARS-CoV-2 IgG**Technology:** High Throughput CMIA**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (34/34)
			(89.9%; 100%)IgG
			Specificity (NPA)
			99.0% (99/100)
			(94.6%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			84.0% (95% CI: 46.5%; 96.8%)
			100% (95% CI: 99.4%; 100%)10.0%
			91.7% (95% CI: 64.7%; 98.4%)
			100% (95% CI: 98.8%; 100%)20.0%
			96.2% (95% CI: 80.5%; 99.3%)
			100% (95% CI: 97.4%; 100%)30.0%
			97.7% (95% CI: 87.6%; 99.6%)
			100% (95% CI: 95.6%; 100%)40.0%
			98.5% (95% CI: 91.7%; 99.7%)
			100% (95% CI: 93.3%; 100%)50.0%
			99.0% (95% CI: 94.3%; 99.8%)
			100% (95% CI: 90.3%; 100%)60.0%
			99.3% (95% CI: 96.1%; 99.9%)
			100% (95% CI: 86.1%; 100%)70.0%
			99.6% (95% CI: 97.5%; 99.9%)
			100% (95% CI: 80.0%; 100%)80.0%
			99.8% (95% CI: 98.5%; 100%)
			100% (95% CI: 70.0%; 100%)90.0%
			99.9% (95% CI: 99.3%; 100%)
			100% (95% CI: 50.9%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseAbbott ARCHITECT SARS-CoV-2 IgG

**Developer:** Abbott**Test:** ARCHITECT SARS-CoV-2 IgG**Technology:** High Throughput CMIA**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (88/88)
			(95.8%; 100%)IgG
			Specificity (NPA)
			99.6% (1066/1070)
			(99.0%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			93.4% (95% CI: 84.0%; 97.3%)
			100% (95% CI: 99.8%; 100%)10.0%
			96.7% (95% CI: 91.8%; 98.7%)
			100% (95% CI: 99.5%; 100%)20.0%
			98.5% (95% CI: 96.2%; 99.4%)
			100% (95% CI: 99.0%; 100%)30.0%
			99.1% (95% CI: 97.7%; 99.7%)
			100% (95% CI: 98.2%; 100%)40.0%
			99.4% (95% CI: 98.5%; 99.8%)
			100% (95% CI: 97.3%; 100%)50.0%
			99.6% (95% CI: 99.0%; 99.9%)
			100% (95% CI: 95.9%; 100%)60.0%
			99.8% (95% CI: 99.3%; 99.9%)
			100% (95% CI: 94.0%; 100%)70.0%
			99.8% (95% CI: 99.6%; 99.9%)
			100% (95% CI: 91.0%; 100%)80.0%
			99.9% (95% CI: 99.8%; 100%)
			100% (95% CI: 85.6%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 72.5%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	CDC's Evaluation Report
	CDC's Evaluation DataAbbott Laboratories AdviseDx SARS-CoV-2 IgM (Alinity i)

**Developer:** Abbott Laboratories Inc.**Test:** AdviseDx SARS-CoV-2 IgM (Alinity i)**Technology:** High Throughput CMIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			95.0% (38/40)
			(83.5%; 98.6%)IgM
			Specificity (NPA)
			99.6% (2972/2985)
			(99.3%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			92.0% (95% CI: 85.5%; 95.3%)
			99.7% (95% CI: 99.1%; 99.9%)10.0%
			96.0% (95% CI: 92.6%; 97.7%)
			99.4% (95% CI: 98.2%; 99.8%)20.0%
			98.2% (95% CI: 96.6%; 99.0%)
			98.8% (95% CI: 96.0%; 99.7%)30.0%
			98.9% (95% CI: 98.0%; 99.4%)
			97.9% (95% CI: 93.3%; 99.4%)40.0%
			99.3% (95% CI: 98.7%; 99.6%)
			96.8% (95% CI: 90.0%; 99.1%)50.0%
			99.5% (95% CI: 99.1%; 99.7%)
			95.2% (95% CI: 85.7%; 98.6%)60.0%
			99.7% (95% CI: 99.4%; 99.8%)
			93.0% (95% CI: 80.0%; 98.0%)70.0%
			99.8% (95% CI: 99.6%; 99.9%)
			89.5% (95% CI: 72.0%; 96.9%)80.0%
			99.9% (95% CI: 99.8%; 99.9%)
			83.3% (95% CI: 60.1%; 94.8%)90.0%
			99.9% (95% CI: 99.9%; 100%)
			68.9% (95% CI: 40.1%; 88.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseAbbott Laboratories AdviseDx SARS-CoV-2 IgM (Architect)

**Developer:** Abbott Laboratories Inc.**Test:** AdviseDx SARS-CoV-2 IgM (Architect)**Technology:** High Throughput CMIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			95.0% (38/40)
			(83.5%; 98.6%)IgM
			Specificity (NPA)
			99.6% (2952/2965)
			(99.3%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			91.9% (95% CI: 85.4%; 95.3%)
			99.7% (95% CI: 99.1%; 99.9%)10.0%
			96.0% (95% CI: 92.5%; 97.7%)
			99.4% (95% CI: 98.2%; 99.8%)20.0%
			98.2% (95% CI: 96.5%; 99.0%)
			98.8% (95% CI: 96.0%; 99.7%)30.0%
			98.9% (95% CI: 98.0%; 99.4%)
			97.9% (95% CI: 93.3%; 99.4%)40.0%
			99.3% (95% CI: 98.7%; 99.6%)
			96.8% (95% CI: 90.0%; 99.1%)50.0%
			99.5% (95% CI: 99.1%; 99.7%)
			95.2% (95% CI: 85.7%; 98.6%)60.0%
			99.7% (95% CI: 99.4%; 99.8%)
			93.0% (95% CI: 80.0%; 98.0%)70.0%
			99.8% (95% CI: 99.6%; 99.9%)
			89.5% (95% CI: 72.0%; 96.9%)80.0%
			99.9% (95% CI: 99.8%; 99.9%)
			83.3% (95% CI: 60.1%; 94.8%)90.0%
			99.9% (95% CI: 99.9%; 100%)
			68.9% (95% CI: 40.1%; 88.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseAccess Bio CareStart COVID-19 IgM/IgG

**Developer:** Access Bio, Inc.**Test:** CareStart COVID-19 IgM/IgG**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			89.1% (57/64)
			(79.1%; 94.6%)IgM
			Specificity
			99.5% (181/182)
			(97.0%; 99.9%)IgG
			Sensitivity
			96.9% (62/64)
			(89.3%; 99.1%)IgG
			Specificity
			99.5% (181/182)
			(97.0%; 99.9%)Combined
			Sensitivity
			98.4% (63/64)
			(91.7%; 99.7%)Combined
			Specificity
			98.9% (180/182)
			(96.1%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			82.5% (95% CI: 55.2%; 94.6%)
			99.9% (95% CI: 99.5%; 100%)10.0%
			90.9% (95% CI: 72.2%; 97.4%)
			99.8% (95% CI: 99.0%; 100%)20.0%
			95.7% (95% CI: 85.4%; 98.8%)
			99.6% (95% CI: 97.9%; 99.9%)30.0%
			97.5% (95% CI: 90.9%; 99.3%)
			99.3% (95% CI: 96.4%; 99.9%)40.0%
			98.4% (95% CI: 94.0%; 99.5%)
			99.0% (95% CI: 94.5%; 99.8%)50.0%
			98.9% (95% CI: 95.9%; 99.7%)
			98.4% (95% CI: 92.0%; 99.7%)60.0%
			99.3% (95% CI: 97.2%; 99.8%)
			97.7% (95% CI: 88.5%; 99.6%)70.0%
			99.5% (95% CI: 98.2%; 99.9%)
			96.4% (95% CI: 83.2%; 99.4%)80.0%
			99.7% (95% CI: 98.9%; 99.9%)
			94.1% (95% CI: 74.2%; 98.9%)90.0%
			99.9% (95% CI: 99.5%; 100%)
			87.6% (95% CI: 56.2%; 97.6%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataAccess Bio, Inc. CareStart EZ COVID-19 IgM/IgG

**Developer:** Access Bio, Inc.**Test:** CareStart EZ COVID-19 IgM/IgG**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			86.7% (26/30)
			(70.3%; 94.7%)IgM
			Specificity
			100% (80/80)
			(95.4%; 100%)IgG
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)IgG
			Specificity
			100% (80/80)
			(95.4%; 100%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			100% (80/80)
			(95.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 50.5%; 100%)
			100% (95% CI: 99.4%; 100%)10.0%
			100% (95% CI: 68.3%; 100%)
			100% (95% CI: 98.7%; 100%)20.0%
			100% (95% CI: 82.9%; 100%)
			100% (95% CI: 97.1%; 100%)30.0%
			100% (95% CI: 89.2%; 100%)
			100% (95% CI: 95.2%; 100%)40.0%
			100% (95% CI: 92.8%; 100%)
			100% (95% CI: 92.7%; 100%)50.0%
			100% (95% CI: 95.1%; 100%)
			100% (95% CI: 89.4%; 100%)60.0%
			100% (95% CI: 96.7%; 100%)
			100% (95% CI: 84.9%; 100%)70.0%
			100% (95% CI: 97.8%; 100%)
			100% (95% CI: 78.3%; 100%)80.0%
			100% (95% CI: 98.7%; 100%)
			100% (95% CI: 67.8%; 100%)90.0%
			100% (95% CI: 99.4%; 100%)
			100% (95% CI: 48.3%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataACON Laboratories ACON SARS-CoV-2 IgG/IgM Rapid Test

**Developer:** ACON Laboratories, Inc.**Test:** ACON SARS-CoV-2 IgG/IgM Rapid Test**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)IgM
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)IgG
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgG
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			96.2% (77/80)
			(89.5%; 98.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			58.4% (95% CI: 30.9%; 80.4%)
			100% (95% CI: 99.3%; 100%)10.0%
			74.8% (95% CI: 48.5%; 89.7%)
			100% (95% CI: 98.6%; 100%)20.0%
			87.0% (95% CI: 67.9%; 95.1%)
			100% (95% CI: 96.9%; 100%)30.0%
			92.0% (95% CI: 78.4%; 97.1%)
			100% (95% CI: 94.8%; 100%)40.0%
			94.7% (95% CI: 85.0%; 98.1%)
			100% (95% CI: 92.2%; 100%)50.0%
			96.4% (95% CI: 89.5%; 98.7%)
			100% (95% CI: 88.8%; 100%)60.0%
			97.6% (95% CI: 92.7%; 99.2%)
			100% (95% CI: 84.0%; 100%)70.0%
			98.4% (95% CI: 95.2%; 99.5%)
			100% (95% CI: 77.2%; 100%)80.0%
			99.1% (95% CI: 97.1%; 99.7%)
			100% (95% CI: 66.4%; 100%)90.0%
			99.6% (95% CI: 98.7%; 99.9%)
			100% (95% CI: 46.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataADVAITE RapCov Rapid COVID-19 Test

**Developer:** ADVAITE, Inc.**Test:** RapCov Rapid COVID-19 Test**Technology:** Lateral Flow**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			90.0% (27/30)
			(74.4%; 96.5%)IgG
			Specificity (NPA)
			95.2% (99/104)
			(89.2%; 97.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			49.6% (95% CI: 26.7%; 71.1%)
			99.5% (95% CI: 98.5%; 99.8%)10.0%
			67.5% (95% CI: 43.4%; 83.8%)
			98.8% (95% CI: 96.9%; 99.6%)20.0%
			82.4% (95% CI: 63.3%; 92.1%)
			97.4% (95% CI: 93.3%; 99.1%)30.0%
			88.9% (95% CI: 74.8%; 95.2%)
			95.7% (95% CI: 89.0%; 98.5%)40.0%
			92.6% (95% CI: 82.2%; 96.9%)
			93.5% (95% CI: 83.9%; 97.7%)50.0%
			94.9% (95% CI: 87.4%; 97.9%)
			90.5% (95% CI: 77.7%; 96.6%)60.0%
			96.6% (95% CI: 91.2%; 98.6%)
			86.4% (95% CI: 69.9%; 95.0%)70.0%
			97.8% (95% CI: 94.2%; 99.1%)
			80.3% (95% CI: 59.9%; 92.4%)80.0%
			98.7% (95% CI: 96.5%; 99.5%)
			70.4% (95% CI: 46.5%; 87.6%)90.0%
			99.4% (95% CI: 98.4%; 99.8%)
			51.4% (95% CI: 27.9%; 75.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (Combined)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (Combined)Assure Tech. Assure COVID-19 IgG/IgM Rapid Test Device

**Developer:** Assure Tech. (Hangzhou Co., Ltd)**Test:** Assure COVID-19 IgG/IgM Rapid Test Device**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgM
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)IgG
			Sensitivity
			90.0% (27/30)
			(74.4%; 96.5%)IgG
			Specificity
			100% (80/80)
			(95.4%; 100%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			80.8% (95% CI: 40.9%; 96.0%)
			100% (95% CI: 99.4%; 100%)10.0%
			89.9% (95% CI: 59.4%; 98.1%)
			100% (95% CI: 98.7%; 100%)20.0%
			95.2% (95% CI: 76.7%; 99.1%)
			100% (95% CI: 97.0%; 100%)30.0%
			97.2% (95% CI: 84.9%; 99.5%)
			100% (95% CI: 95.0%; 100%)40.0%
			98.2% (95% CI: 89.8%; 99.7%)
			100% (95% CI: 92.5%; 100%)50.0%
			98.8% (95% CI: 92.9%; 99.8%)
			100% (95% CI: 89.2%; 100%)60.0%
			99.2% (95% CI: 95.2%; 99.9%)
			100% (95% CI: 84.6%; 100%)70.0%
			99.5% (95% CI: 96.8%; 99.9%)
			100% (95% CI: 77.9%; 100%)80.0%
			99.7% (95% CI: 98.1%; 99.9%)
			100% (95% CI: 67.3%; 100%)90.0%
			99.9% (95% CI: 99.2%; 100%)
			100% (95% CI: 47.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataBabson Diagnostics aC19G1

**Developer:** Babson Diagnostics, Inc.**Test:** Babson Diagnostics aC19G1**Technology:** High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (29/29)
			(88.3%; 100%)IgG
			Specificity (NPA)
			100% (100/100)
			(96.3%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 55.7%; 100%)
			100% (95% CI: 99.4%; 100%)10.0%
			100% (95% CI: 72.6%; 100%)
			100% (95% CI: 98.7%; 100%)20.0%
			100% (95% CI: 85.7%; 100%)
			100% (95% CI: 97.1%; 100%)30.0%
			100% (95% CI: 91.1%; 100%)
			100% (95% CI: 95.1%; 100%)40.0%
			100% (95% CI: 94.1%; 100%)
			100% (95% CI: 92.5%; 100%)50.0%
			100% (95% CI: 96.0%; 100%)
			100% (95% CI: 89.2%; 100%)60.0%
			100% (95% CI: 97.3%; 100%)
			100% (95% CI: 84.6%; 100%)70.0%
			100% (95% CI: 98.2%; 100%)
			100% (95% CI: 77.9%; 100%)80.0%
			100% (95% CI: 99.0%; 100%)
			100% (95% CI: 67.3%; 100%)90.0%
			100% (95% CI: 99.5%; 100%)
			100% (95% CI: 47.8%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	EUA SummaryBeckman Coulter Access SARS-CoV-2 IgG

**Developer:** Beckman Coulter, Inc.**Test:** Access SARS-CoV-2 IgG**Technology:** High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			96.8% (92/95)
			(91.1%; 98.9%)IgG
			Specificity (NPA)
			99.6% (1395/1400)
			(99.2%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			93.5% (95% CI: 85.2%; 97.2%)
			99.8% (95% CI: 99.5%; 99.9%)10.0%
			96.8% (95% CI: 92.4%; 98.6%)
			99.6% (95% CI: 99.0%; 99.9%)20.0%
			98.5% (95% CI: 96.5%; 99.4%)
			99.2% (95% CI: 97.8%; 99.7%)30.0%
			99.1% (95% CI: 97.9%; 99.6%)
			98.7% (95% CI: 96.3%; 99.5%)40.0%
			99.4% (95% CI: 98.6%; 99.8%)
			97.9% (95% CI: 94.4%; 99.3%)50.0%
			99.6% (95% CI: 99.1%; 99.8%)
			96.9% (95% CI: 91.8%; 98.9%)60.0%
			99.8% (95% CI: 99.4%; 99.9%)
			95.5% (95% CI: 88.2%; 98.4%)70.0%
			99.8% (95% CI: 99.6%; 99.9%)
			93.1% (95% CI: 82.7%; 97.5%)80.0%
			99.9% (95% CI: 99.8%; 100%)
			88.7% (95% CI: 73.6%; 95.9%)90.0%
			100% (95% CI: 99.9%; 100%)
			77.8% (95% CI: 55.4%; 91.1%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseBeckman Coulter Access SARS-CoV-2 IgM

**Developer:** Beckman Coulter, Inc.**Test:** Access SARS-CoV-2 IgM**Technology:** High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			96.7% (146/151)
			(92.5%; 98.6%)IgM
			Specificity (NPA)
			99.9% (1398/1400)
			(99.5%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			97.3% (95% CI: 90.4%; 99.3%)
			99.8% (95% CI: 99.6%; 99.9%)10.0%
			98.7% (95% CI: 95.2%; 99.6%)
			99.6% (95% CI: 99.2%; 99.8%)20.0%
			99.4% (95% CI: 97.8%; 99.8%)
			99.2% (95% CI: 98.1%; 99.6%)30.0%
			99.7% (95% CI: 98.7%; 99.9%)
			98.6% (95% CI: 96.9%; 99.4%)40.0%
			99.8% (95% CI: 99.2%; 99.9%)
			97.8% (95% CI: 95.2%; 99.1%)50.0%
			99.9% (95% CI: 99.4%; 100%)
			96.8% (95% CI: 93.0%; 98.6%)60.0%
			99.9% (95% CI: 99.6%; 100%)
			95.3% (95% CI: 89.8%; 97.9%)70.0%
			99.9% (95% CI: 99.8%; 100%)
			92.8% (95% CI: 85.0%; 96.8%)80.0%
			100% (95% CI: 99.9%; 100%)
			88.3% (95% CI: 76.8%; 94.6%)90.0%
			100% (95% CI: 99.9%; 100%)
			77.0% (95% CI: 59.5%; 88.6%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseBeckman Coulter, Inc. Access SARS-CoV-2 IgG II

**Developer:** Beckman Coulter, Inc.**Test:** Access SARS-CoV-2 IgG II**Technology:** Semi-quantitative High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			98.9% (90/91)
			(94.0%; 99.8%)IgG
			Specificity (NPA)
			100% (93/93)
			(96.0%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 55.5%; 100%)
			99.9% (95% CI: 99.7%; 100%)10.0%
			100% (95% CI: 72.5%; 100%)
			99.9% (95% CI: 99.3%; 100%)20.0%
			100% (95% CI: 85.6%; 100%)
			99.7% (95% CI: 98.5%; 100%)30.0%
			100% (95% CI: 91.0%; 100%)
			99.5% (95% CI: 97.4%; 99.9%)40.0%
			100% (95% CI: 94.1%; 100%)
			99.3% (95% CI: 96.0%; 99.9%)50.0%
			100% (95% CI: 96.0%; 100%)
			98.9% (95% CI: 94.2%; 99.8%)60.0%
			100% (95% CI: 97.3%; 100%)
			98.4% (95% CI: 91.5%; 99.7%)70.0%
			100% (95% CI: 98.2%; 100%)
			97.5% (95% CI: 87.3%; 99.6%)80.0%
			100% (95% CI: 99.0%; 100%)
			95.8% (95% CI: 80.1%; 99.2%)90.0%
			100% (95% CI: 99.5%; 100%)
			91.0% (95% CI: 64.1%; 98.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseBeijing Wantai Biological Pharmacy Enterprise WANTAI SARS-CoV-2 Ab ELISA

**Developer:** Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.**Test:** WANTAI SARS-CoV-2 Ab ELISA**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)Pan-Ig
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			67.1% (95% CI: 33.6%; 88.4%)
			99.8% (95% CI: 99.0%; 100%)10.0%
			81.1% (95% CI: 51.7%; 94.1%)
			99.6% (95% CI: 98.0%; 99.9%)20.0%
			90.6% (95% CI: 70.6%; 97.3%)
			99.2% (95% CI: 95.6%; 99.9%)30.0%
			94.3% (95% CI: 80.5%; 98.4%)
			98.6% (95% CI: 92.7%; 99.7%)40.0%
			96.3% (95% CI: 86.5%; 99.0%)
			97.8% (95% CI: 89.2%; 99.6%)50.0%
			97.5% (95% CI: 90.6%; 99.3%)
			96.7% (95% CI: 84.6%; 99.4%)60.0%
			98.3% (95% CI: 93.5%; 99.5%)
			95.1% (95% CI: 78.5%; 99.1%)70.0%
			98.9% (95% CI: 95.7%; 99.7%)
			92.6% (95% CI: 70.1%; 98.6%)80.0%
			99.4% (95% CI: 97.5%; 99.8%)
			88.0% (95% CI: 57.8%; 97.7%)90.0%
			99.7% (95% CI: 98.9%; 99.9%)
			76.5% (95% CI: 37.8%; 94.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataBeijing Wantai Biological Pharmacy Enterprise WANTAI SARS-CoV-2 Ab Rapid Test

**Developer:** Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.**Test:** WANTAI SARS-CoV-2 Ab Rapid Test**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Pan-Ig
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			80.8% (95% CI: 40.9%; 96.0%)
			100% (95% CI: 99.4%; 100%)10.0%
			89.9% (95% CI: 59.4%; 98.1%)
			100% (95% CI: 98.7%; 100%)20.0%
			95.2% (95% CI: 76.7%; 99.1%)
			100% (95% CI: 97.0%; 100%)30.0%
			97.2% (95% CI: 84.9%; 99.5%)
			100% (95% CI: 95.0%; 100%)40.0%
			98.2% (95% CI: 89.8%; 99.7%)
			100% (95% CI: 92.5%; 100%)50.0%
			98.8% (95% CI: 92.9%; 99.8%)
			100% (95% CI: 89.2%; 100%)60.0%
			99.2% (95% CI: 95.2%; 99.9%)
			100% (95% CI: 84.6%; 100%)70.0%
			99.5% (95% CI: 96.8%; 99.9%)
			100% (95% CI: 77.9%; 100%)80.0%
			99.7% (95% CI: 98.1%; 99.9%)
			100% (95% CI: 67.3%; 100%)90.0%
			99.9% (95% CI: 99.2%; 100%)
			100% (95% CI: 47.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataBio-Rad Platelia SARS-CoV-2 Total Ab

**Developer:** Bio-Rad Laboratories, Inc**Test:** Platelia SARS-CoV-2 Total Ab**Technology:** ELISA**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			98.0% (49/50)
			(89.5%; 99.6%)Pan-Ig
			Specificity (NPA)
			99.3% (596/600)
			(98.3%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			88.6% (95% CI: 73.5%; 95.3%)
			99.9% (95% CI: 99.4%; 100%)10.0%
			94.2% (95% CI: 85.4%; 97.7%)
			99.8% (95% CI: 98.8%; 100%)20.0%
			97.4% (95% CI: 92.9%; 99.0%)
			99.5% (95% CI: 97.4%; 99.9%)30.0%
			98.4% (95% CI: 95.8%; 99.4%)
			99.1% (95% CI: 95.6%; 99.8%)40.0%
			99.0% (95% CI: 97.2%; 99.6%)
			98.7% (95% CI: 93.4%; 99.8%)50.0%
			99.3% (95% CI: 98.1%; 99.7%)
			98.0% (95% CI: 90.4%; 99.6%)60.0%
			99.5% (95% CI: 98.7%; 99.8%)
			97.1% (95% CI: 86.2%; 99.5%)70.0%
			99.7% (95% CI: 99.2%; 99.9%)
			95.5% (95% CI: 80.1%; 99.2%)80.0%
			99.8% (95% CI: 99.5%; 99.9%)
			92.5% (95% CI: 70.1%; 98.6%)90.0%
			99.9% (95% CI: 99.8%; 100%)
			84.7% (95% CI: 51.0%; 96.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (Combined)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (Combined)Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

**Developer:** Biocan Diagnostics Inc.**Test:** Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			90.0% (27/30)
			(74.4%; 96.5%)IgM
			Specificity
			98.7% (78/79)
			(93.2%; 99.8%)IgG
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)IgG
			Specificity
			96.2% (76/79)
			(89.4%; 98.7%)Combined
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)Combined
			Specificity
			96.2% (76/79)
			(89.4%; 98.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			56.4% (95% CI: 28.1%; 79.9%)
			99.6% (95% CI: 98.8%; 99.9%)10.0%
			73.2% (95% CI: 45.2%; 89.4%)
			99.2% (95% CI: 97.4%; 99.8%)20.0%
			86.0% (95% CI: 65.0%; 95.0%)
			98.3% (95% CI: 94.4%; 99.5%)30.0%
			91.3% (95% CI: 76.1%; 97.0%)
			97.1% (95% CI: 90.7%; 99.2%)40.0%
			94.2% (95% CI: 83.2%; 98.1%)
			95.6% (95% CI: 86.3%; 98.8%)50.0%
			96.1% (95% CI: 88.1%; 98.7%)
			93.5% (95% CI: 80.7%; 98.2%)60.0%
			97.4% (95% CI: 91.8%; 99.1%)
			90.6% (95% CI: 73.7%; 97.3%)70.0%
			98.3% (95% CI: 94.6%; 99.4%)
			86.1% (95% CI: 64.3%; 95.8%)80.0%
			99.0% (95% CI: 96.7%; 99.7%)
			78.3% (95% CI: 51.2%; 93.0%)90.0%
			99.5% (95% CI: 98.5%; 99.9%)
			61.6% (95% CI: 31.8%; 85.6%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataBioCheck SARS-CoV-2 IgG and IgM Combo Test

**Developer:** BioCheck, Inc.**Test:** BioCheck SARS-CoV-2 IgG and IgM Combo Test**Technology:** CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			95.5% (105/110)
			(89.8%; 98.0%)IgM
			Specificity (NPA)
			97.2% (139/143)
			(93.0%; 98.9%)IgG
			Sensitivity (PPA)
			99.1% (109/110)
			(95.0%; 99.8%)IgG
			Specificity (NPA)
			100% (143/143)
			(97.4%; 100%)Combined
			Sensitivity (PPA)
			99.1% (109/110)
			(95.0%; 99.8%)Combined
			Specificity (NPA)
			97.2% (139/143)
			(93.0%; 98.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			65.1% (95% CI: 41.8%; 82.8%)
			100% (95% CI: 99.7%; 100%)10.0%
			79.7% (95% CI: 60.2%; 91.0%)
			99.9% (95% CI: 99.4%; 100%)20.0%
			89.9% (95% CI: 77.3%; 95.8%)
			99.8% (95% CI: 98.7%; 100%)30.0%
			93.8% (95% CI: 85.4%; 97.5%)
			99.6% (95% CI: 97.8%; 99.9%)40.0%
			95.9% (95% CI: 90.1%; 98.4%)
			99.4% (95% CI: 96.6%; 99.9%)50.0%
			97.3% (95% CI: 93.2%; 98.9%)
			99.1% (95% CI: 94.9%; 99.8%)60.0%
			98.2% (95% CI: 95.3%; 99.3%)
			98.6% (95% CI: 92.6%; 99.8%)70.0%
			98.8% (95% CI: 97.0%; 99.5%)
			97.9% (95% CI: 88.9%; 99.6%)80.0%
			99.3% (95% CI: 98.2%; 99.7%)
			96.4% (95% CI: 82.4%; 99.4%)90.0%
			99.7% (95% CI: 99.2%; 99.9%)
			92.2% (95% CI: 67.5%; 98.6%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseBioCheck SARS-CoV-2 IgG Antibody Test Kit

**Developer:** BioCheck, Inc.**Test:** BioCheck SARS-CoV-2 IgG Antibody Test Kit**Technology:** CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			99.1% (109/110)
			(95.0%; 99.8%)IgG
			Specificity (NPA)
			100% (143/143)
			(97.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 65.7%; 100%)
			100% (95% CI: 99.7%; 100%)10.0%
			100% (95% CI: 80.1%; 100%)
			99.9% (95% CI: 99.4%; 100%)20.0%
			100% (95% CI: 90.1%; 100%)
			99.8% (95% CI: 98.7%; 100%)30.0%
			100% (95% CI: 94.0%; 100%)
			99.6% (95% CI: 97.9%; 99.9%)40.0%
			100% (95% CI: 96.0%; 100%)
			99.4% (95% CI: 96.7%; 99.9%)50.0%
			100% (95% CI: 97.3%; 100%)
			99.1% (95% CI: 95.1%; 99.8%)60.0%
			100% (95% CI: 98.2%; 100%)
			98.7% (95% CI: 92.9%; 99.8%)70.0%
			100% (95% CI: 98.8%; 100%)
			97.9% (95% CI: 89.4%; 99.6%)80.0%
			100% (95% CI: 99.3%; 100%)
			96.5% (95% CI: 83.0%; 99.4%)90.0%
			100% (95% CI: 99.7%; 100%)
			92.4% (95% CI: 68.5%; 98.6%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseBioCheck SARS-CoV-2 IgM Antibody Test Kit

**Developer:** BioCheck, Inc.**Test:** BioCheck SARS-CoV-2 IgM Antibody Test Kit**Technology:** CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			95.5% (105/110)
			(89.8%; 98.0%)IgM
			Specificity (NPA)
			97.2% (139/143)
			(93.0%; 98.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			64.2% (95% CI: 40.4%; 82.5%)
			99.8% (95% CI: 99.4%; 99.9%)10.0%
			79.1% (95% CI: 58.9%; 90.9%)
			99.5% (95% CI: 98.8%; 99.8%)20.0%
			89.5% (95% CI: 76.3%; 95.7%)
			98.8% (95% CI: 97.3%; 99.5%)30.0%
			93.6% (95% CI: 84.7%; 97.5%)
			98.0% (95% CI: 95.5%; 99.2%)40.0%
			95.8% (95% CI: 89.6%; 98.4%)
			97.0% (95% CI: 93.2%; 98.7%)50.0%
			97.2% (95% CI: 92.8%; 98.9%)
			95.5% (95% CI: 90.1%; 98.1%)60.0%
			98.1% (95% CI: 95.1%; 99.3%)
			93.4% (95% CI: 85.9%; 97.1%)70.0%
			98.8% (95% CI: 96.8%; 99.5%)
			90.2% (95% CI: 79.6%; 95.6%)80.0%
			99.3% (95% CI: 98.1%; 99.7%)
			84.2% (95% CI: 69.5%; 92.7%)90.0%
			99.7% (95% CI: 99.1%; 99.9%)
			70.4% (95% CI: 50.3%; 84.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseBiohit Healthcare (Hefei) Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

**Developer:** Biohit Healthcare (Hefei)**Test:** Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit**Technology:** Lateral Flow**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			96.7% (29/30)
			(83.3%; 99.4%)IgM
			Specificity (NPA)
			95.0% (76/80)
			(87.8%; 98.0%)IgG
			Sensitivity (PPA)
			96.7% (29/30)
			(83.3%; 99.4%)IgG
			Specificity (NPA)
			95.0% (76/80)
			(87.8%; 98.0%)Combined
			Sensitivity (PPA)
			96.7% (29/30)
			(83.3%; 99.4%)Combined
			Specificity (NPA)
			95.0% (76/80)
			(87.8%; 98.0%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			50.4% (95% CI: 26.5%; 72.7%)
			99.8% (95% CI: 99.0%; 100%)10.0%
			68.2% (95% CI: 43.2%; 84.9%)
			99.6% (95% CI: 97.9%; 99.9%)20.0%
			82.9% (95% CI: 63.1%; 92.7%)
			99.1% (95% CI: 95.5%; 99.8%)30.0%
			89.2% (95% CI: 74.6%; 95.6%)
			98.5% (95% CI: 92.5%; 99.7%)40.0%
			92.8% (95% CI: 82.0%; 97.1%)
			97.7% (95% CI: 88.8%; 99.6%)50.0%
			95.1% (95% CI: 87.3%; 98.1%)
			96.6% (95% CI: 84.1%; 99.4%)60.0%
			96.7% (95% CI: 91.1%; 98.7%)
			95.0% (95% CI: 77.8%; 99.1%)70.0%
			97.8% (95% CI: 94.1%; 99.2%)
			92.4% (95% CI: 69.3%; 98.6%)80.0%
			98.7% (95% CI: 96.5%; 99.5%)
			87.7% (95% CI: 56.8%; 97.7%)90.0%
			99.4% (95% CI: 98.4%; 99.8%)
			76.0% (95% CI: 36.9%; 94.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DatabioMérieux VIDAS SARS-CoV-2 IgG

**Developer:** bioMérieux SA**Test:** VIDAS SARS-CoV-2 IgG**Technology:** ELFA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (29/29)
			(88.3%; 100%)IgG
			Specificity (NPA)
			99.9% (988/989)
			(99.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			98.1% (95% CI: 89.1%; 99.7%)
			100% (95% CI: 99.4%; 100%)10.0%
			99.1% (95% CI: 94.5%; 99.8%)
			100% (95% CI: 98.7%; 100%)20.0%
			99.6% (95% CI: 97.5%; 99.9%)
			100% (95% CI: 97.1%; 100%)30.0%
			99.8% (95% CI: 98.5%; 100%)
			100% (95% CI: 95.2%; 100%)40.0%
			99.8% (95% CI: 99.0%; 100%)
			100% (95% CI: 92.7%; 100%)50.0%
			99.9% (95% CI: 99.4%; 100%)
			100% (95% CI: 89.5%; 100%)60.0%
			99.9% (95% CI: 99.6%; 100%)
			100% (95% CI: 85.0%; 100%)70.0%
			100% (95% CI: 99.7%; 100%)
			100% (95% CI: 78.5%; 100%)80.0%
			100% (95% CI: 99.8%; 100%)
			100% (95% CI: 68.0%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 48.6%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UsebioMérieux VIDAS SARS-CoV-2 IgM

**Developer:** bioMérieux SA**Test:** VIDAS SARS-CoV-2 IgM**Technology:** ELFA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			100% (23/23)
			(85.7%; 100%)IgM
			Specificity (NPA)
			99.4% (306/308)
			(97.7%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			89.0% (95% CI: 65.9%; 96.7%)
			100% (95% CI: 99.2%; 100%)10.0%
			94.5% (95% CI: 80.3%; 98.4%)
			100% (95% CI: 98.4%; 100%)20.0%
			97.5% (95% CI: 90.2%; 99.3%)
			100% (95% CI: 96.5%; 100%)30.0%
			98.5% (95% CI: 94.0%; 99.6%)
			100% (95% CI: 94.1%; 100%)40.0%
			99.0% (95% CI: 96.1%; 99.7%)
			100% (95% CI: 91.1%; 100%)50.0%
			99.4% (95% CI: 97.3%; 99.8%)
			100% (95% CI: 87.2%; 100%)60.0%
			99.6% (95% CI: 98.2%; 99.9%)
			100% (95% CI: 82.0%; 100%)70.0%
			99.7% (95% CI: 98.8%; 99.9%)
			100% (95% CI: 74.5%; 100%)80.0%
			99.8% (95% CI: 99.3%; 100%)
			100% (95% CI: 63.1%; 100%)90.0%
			99.9% (95% CI: 99.7%; 100%)
			100% (95% CI: 43.1%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseDiabetomics, Inc. CovAb SARS-CoV-2 Ab Test

**Developer:** Diabetomics, Inc.**Test:** CovAb SARS-CoV-2 Ab Test**Technology:** Lateral Flow, Oral Fluid**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			97.1% (67/69)
			(90.0%; 99.2%)Pan-Ig
			Specificity (NPA)
			97.4% (76/78)
			(91.1%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			66.6% (95% CI: 34.8%; 88.1%)
			99.8% (95% CI: 99.4%; 100%)10.0%
			80.8% (95% CI: 53.0%; 94.0%)
			99.7% (95% CI: 98.8%; 99.9%)20.0%
			90.4% (95% CI: 71.7%; 97.2%)
			99.3% (95% CI: 97.3%; 99.8%)30.0%
			94.2% (95% CI: 81.3%; 98.4%)
			98.7% (95% CI: 95.5%; 99.7%)40.0%
			96.2% (95% CI: 87.1%; 98.9%)
			98.1% (95% CI: 93.2%; 99.5%)50.0%
			97.4% (95% CI: 91.0%; 99.3%)
			97.1% (95% CI: 90.1%; 99.2%)60.0%
			98.3% (95% CI: 93.8%; 99.5%)
			95.7% (95% CI: 85.9%; 98.8%)70.0%
			98.9% (95% CI: 95.9%; 99.7%)
			93.5% (95% CI: 79.7%; 98.2%)80.0%
			99.3% (95% CI: 97.6%; 99.8%)
			89.4% (95% CI: 69.6%; 96.9%)90.0%
			99.7% (95% CI: 98.9%; 99.9%)
			78.9% (95% CI: 50.4%; 93.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseDiaSorin LIAISON SARS-CoV-2 S1/S2 IgG

**Developer:** DiaSorin**Test:** LIAISON SARS-CoV-2 S1/S2 IgG**Technology:** High Throughput CMIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			97.6% (40/41)
			(87.4%; 99.6%)IgG
			Specificity (NPA)
			99.3% (1082/1090)
			(98.6%; 99.6%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			87.5% (95% CI: 76.1%; 93.4%)
			99.9% (95% CI: 99.3%; 100%)10.0%
			93.7% (95% CI: 87.1%; 96.7%)
			99.7% (95% CI: 98.6%; 100%)20.0%
			97.1% (95% CI: 93.8%; 98.5%)
			99.4% (95% CI: 96.9%; 99.9%)30.0%
			98.3% (95% CI: 96.3%; 99.1%)
			99.0% (95% CI: 94.8%; 99.8%)40.0%
			98.9% (95% CI: 97.6%; 99.4%)
			98.4% (95% CI: 92.2%; 99.7%)50.0%
			99.3% (95% CI: 98.4%; 99.6%)
			97.6% (95% CI: 88.7%; 99.6%)60.0%
			99.5% (95% CI: 98.9%; 99.8%)
			96.4% (95% CI: 83.9%; 99.4%)70.0%
			99.7% (95% CI: 99.3%; 99.8%)
			94.6% (95% CI: 77.0%; 99.0%)80.0%
			99.8% (95% CI: 99.6%; 99.9%)
			91.1% (95% CI: 66.2%; 98.3%)90.0%
			99.9% (95% CI: 99.8%; 100%)
			81.9% (95% CI: 46.5%; 96.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseDiaSorin, Inc. LIAISON SARS-CoV-2 TrimericS IgG

**Developer:** DiaSorin, Inc.**Test:** LIAISON SARS-CoV-2 TrimericS IgG**Technology:** Semi-quantitative High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			96.9% (31/32)
			(84.3%; 99.4%)IgG
			Specificity (NPA)
			99.5% (1889/1899)
			(99.0%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			90.6% (95% CI: 82.1%; 94.8%)
			99.8% (95% CI: 99.2%; 100%)10.0%
			95.3% (95% CI: 90.6%; 97.5%)
			99.7% (95% CI: 98.3%; 99.9%)20.0%
			97.9% (95% CI: 95.6%; 98.9%)
			99.2% (95% CI: 96.2%; 99.9%)30.0%
			98.7% (95% CI: 97.4%; 99.3%)
			98.7% (95% CI: 93.6%; 99.8%)40.0%
			99.2% (95% CI: 98.3%; 99.6%)
			97.9% (95% CI: 90.4%; 99.6%)50.0%
			99.5% (95% CI: 98.9%; 99.7%)
			97.0% (95% CI: 86.3%; 99.4%)60.0%
			99.6% (95% CI: 99.2%; 99.8%)
			95.5% (95% CI: 80.7%; 99.2%)70.0%
			99.8% (95% CI: 99.5%; 99.9%)
			93.2% (95% CI: 72.9%; 98.7%)80.0%
			99.9% (95% CI: 99.7%; 99.9%)
			88.8% (95% CI: 61.1%; 97.8%)90.0%
			99.9% (95% CI: 99.9%; 100%)
			78.0% (95% CI: 41.1%; 95.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseDiazyme Laboratories Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit

**Developer:** Diazyme Laboratories, Inc.**Test:** Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit**Technology:** High Throughput CLIA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (29/29)
			(88.3%; 100%)IgG
			Specificity (NPA)
			97.4% (830/852)
			(96.1%; 98.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			67.1% (95% CI: 54.5%; 75.5%)
			100% (95% CI: 99.4%; 100%)10.0%
			81.1% (95% CI: 71.7%; 86.7%)
			100% (95% CI: 98.7%; 100%)20.0%
			90.6% (95% CI: 85.1%; 93.6%)
			100% (95% CI: 97.0%; 100%)30.0%
			94.3% (95% CI: 90.7%; 96.2%)
			100% (95% CI: 95.0%; 100%)40.0%
			96.3% (95% CI: 93.8%; 97.5%)
			100% (95% CI: 92.5%; 100%)50.0%
			97.5% (95% CI: 95.8%; 98.3%)
			100% (95% CI: 89.2%; 100%)60.0%
			98.3% (95% CI: 97.2%; 98.9%)
			100% (95% CI: 84.6%; 100%)70.0%
			98.9% (95% CI: 98.2%; 99.3%)
			100% (95% CI: 77.9%; 100%)80.0%
			99.4% (95% CI: 98.9%; 99.6%)
			100% (95% CI: 67.3%; 100%)90.0%
			99.7% (95% CI: 99.5%; 99.8%)
			100% (95% CI: 47.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseDiazyme Laboratories Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit

**Developer:** Diazyme Laboratories, Inc.**Test:** Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit**Technology:** CLIA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			94.4% (102/108)
			(88.4%; 97.4%)IgM
			Specificity (NPA)
			98.3% (297/302)
			(96.2%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			75.0% (95% CI: 54.9%; 87.9%)
			99.7% (95% CI: 99.4%; 99.9%)10.0%
			86.4% (95% CI: 72.0%; 93.9%)
			99.4% (95% CI: 98.7%; 99.7%)20.0%
			93.4% (95% CI: 85.3%; 97.2%)
			98.6% (95% CI: 97.1%; 99.4%)30.0%
			96.1% (95% CI: 90.8%; 98.3%)
			97.6% (95% CI: 95.1%; 98.9%)40.0%
			97.4% (95% CI: 93.9%; 98.9%)
			96.4% (95% CI: 92.6%; 98.3%)50.0%
			98.3% (95% CI: 95.9%; 99.3%)
			94.7% (95% CI: 89.2%; 97.5%)60.0%
			98.8% (95% CI: 97.2%; 99.5%)
			92.2% (95% CI: 84.7%; 96.3%)70.0%
			99.3% (95% CI: 98.2%; 99.7%)
			88.4% (95% CI: 78.0%; 94.3%)80.0%
			99.6% (95% CI: 98.9%; 99.8%)
			81.6% (95% CI: 67.5%; 90.6%)90.0%
			99.8% (95% CI: 99.5%; 99.9%)
			66.3% (95% CI: 48.0%; 81.1%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseEmory Medical Laboratories SARS-CoV-2 RBD IgG test

**Developer:** Emory Medical Laboratories**Test:** SARS-CoV-2 RBD IgG test**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (30/30)
			(88.7%; 100%)IgG
			Specificity (NPA)
			96.4% (615/638)
			(94.6%; 97.6%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			59.3% (95% CI: 46.6%; 68.6%)
			100% (95% CI: 99.4%; 100%)10.0%
			75.5% (95% CI: 64.8%; 82.2%)
			100% (95% CI: 98.7%; 100%)20.0%
			87.4% (95% CI: 80.6%; 91.2%)
			100% (95% CI: 97.1%; 100%)30.0%
			92.2% (95% CI: 87.7%; 94.7%)
			100% (95% CI: 95.1%; 100%)40.0%
			94.9% (95% CI: 91.7%; 96.5%)
			100% (95% CI: 92.6%; 100%)50.0%
			96.5% (95% CI: 94.3%; 97.6%)
			100% (95% CI: 89.3%; 100%)60.0%
			97.7% (95% CI: 96.1%; 98.4%)
			100% (95% CI: 84.8%; 100%)70.0%
			98.5% (95% CI: 97.5%; 99.0%)
			100% (95% CI: 78.1%; 100%)80.0%
			99.1% (95% CI: 98.5%; 99.4%)
			100% (95% CI: 67.6%; 100%)90.0%
			99.6% (95% CI: 99.3%; 99.7%)
			100% (95% CI: 48.1%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	EUA SummaryEUROIMMUN SARS-COV-2 ELISA (IgG)

**Developer:** EUROIMMUN**Test:** SARS-COV-2 ELISA (IgG)**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			90.0% (27/30)
			(74.4%; 96.5%)IgG
			Specificity (NPA)
			100% (80/80)
			(95.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 46.1%; 100%)
			99.5% (95% CI: 98.6%; 99.8%)10.0%
			100% (95% CI: 64.3%; 100%)
			98.9% (95% CI: 97.1%; 99.6%)20.0%
			100% (95% CI: 80.2%; 100%)
			97.6% (95% CI: 93.7%; 99.1%)30.0%
			100% (95% CI: 87.4%; 100%)
			95.9% (95% CI: 89.7%; 98.5%)40.0%
			100% (95% CI: 91.5%; 100%)
			93.8% (95% CI: 84.8%; 97.7%)50.0%
			100% (95% CI: 94.2%; 100%)
			90.9% (95% CI: 78.8%; 96.7%)60.0%
			100% (95% CI: 96.1%; 100%)
			87.0% (95% CI: 71.3%; 95.1%)70.0%
			100% (95% CI: 97.4%; 100%)
			81.1% (95% CI: 61.5%; 92.5%)80.0%
			100% (95% CI: 98.5%; 100%)
			71.4% (95% CI: 48.2%; 87.8%)90.0%
			100% (95% CI: 99.3%; 100%)
			52.6% (95% CI: 29.3%; 76.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataEUROIMMUN US, Inc. EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG)

**Developer:** EUROIMMUN US, Inc.**Test:** EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG)**Technology:** Semi-quantitative ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			91.1% (51/56)
			(80.7%; 96.1%)IgG
			Specificity (NPA)
			100% (107/107)
			(96.5%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 55.1%; 100%)
			99.5% (95% CI: 99.0%; 99.8%)10.0%
			100% (95% CI: 72.1%; 100%)
			99.0% (95% CI: 97.8%; 99.6%)20.0%
			100% (95% CI: 85.4%; 100%)
			97.8% (95% CI: 95.3%; 99.0%)30.0%
			100% (95% CI: 90.9%; 100%)
			96.3% (95% CI: 92.1%; 98.4%)40.0%
			100% (95% CI: 94.0%; 100%)
			94.4% (95% CI: 88.3%; 97.5%)50.0%
			100% (95% CI: 95.9%; 100%)
			91.8% (95% CI: 83.4%; 96.3%)60.0%
			100% (95% CI: 97.2%; 100%)
			88.2% (95% CI: 77.0%; 94.5%)70.0%
			100% (95% CI: 98.2%; 100%)
			82.8% (95% CI: 68.2%; 91.7%)80.0%
			100% (95% CI: 98.9%; 100%)
			73.7% (95% CI: 55.6%; 86.6%)90.0%
			100% (95% CI: 99.5%; 100%)
			55.4% (95% CI: 35.8%; 74.2%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (Combined)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (Combined)Genalyte Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2

**Developer:** Genalyte, Inc.**Test:** Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2**Technology:** Photonic Ring Immunoassay (PRI)**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			96.1% (174/181)
			(92.2%; 98.1%)Pan-Ig
			Specificity (NPA)
			97.7% (842/862)
			(96.4%; 98.5%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			68.6% (95% CI: 57.7%; 77.4%)
			99.8% (95% CI: 99.6%; 99.9%)10.0%
			82.2% (95% CI: 74.2%; 87.9%)
			99.6% (95% CI: 99.1%; 99.8%)20.0%
			91.2% (95% CI: 86.6%; 94.2%)
			99.0% (95% CI: 98.0%; 99.5%)30.0%
			94.7% (95% CI: 91.7%; 96.5%)
			98.3% (95% CI: 96.7%; 99.2%)40.0%
			96.5% (95% CI: 94.5%; 97.7%)
			97.4% (95% CI: 94.9%; 98.7%)50.0%
			97.6% (95% CI: 96.3%; 98.5%)
			96.2% (95% CI: 92.5%; 98.1%)60.0%
			98.4% (95% CI: 97.5%; 99.0%)
			94.4% (95% CI: 89.2%; 97.2%)70.0%
			99.0% (95% CI: 98.4%; 99.3%)
			91.5% (95% CI: 84.2%; 95.7%)80.0%
			99.4% (95% CI: 99.0%; 99.6%)
			86.3% (95% CI: 75.6%; 92.9%)90.0%
			99.7% (95% CI: 99.6%; 99.8%)
			73.7% (95% CI: 58.0%; 85.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseGenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit

**Developer:** GenScript USA Inc.**Test:** cPass SARS-CoV-2 Neutralization Antibody Detection Kit**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig (Neutralizing)
			Sensitivity (PPA)
			100% (26/26)
			(87.1%; 100%)Pan-Ig (Neutralizing)
			Specificity (NPA)
			100% (88/88)
			(95.8%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 52.3%; 100%)
			100% (95% CI: 99.3%; 100%)10.0%
			100% (95% CI: 69.8%; 100%)
			100% (95% CI: 98.5%; 100%)20.0%
			100% (95% CI: 83.9%; 100%)
			100% (95% CI: 96.8%; 100%)30.0%
			100% (95% CI: 89.9%; 100%)
			100% (95% CI: 94.6%; 100%)40.0%
			100% (95% CI: 93.3%; 100%)
			100% (95% CI: 91.8%; 100%)50.0%
			100% (95% CI: 95.4%; 100%)
			100% (95% CI: 88.2%; 100%)60.0%
			100% (95% CI: 96.9%; 100%)
			100% (95% CI: 83.2%; 100%)70.0%
			100% (95% CI: 98.0%; 100%)
			100% (95% CI: 76.1%; 100%)80.0%
			100% (95% CI: 98.8%; 100%)
			100% (95% CI: 65.1%; 100%)90.0%
			100% (95% CI: 99.5%; 100%)
			100% (95% CI: 45.3%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseHangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette

**Developer:** Hangzhou Biotest Biotech**Test:** RightSign COVID-19 IgG/IgM Rapid Test Cassette**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			100% (30/30)
			(88.7%; 100%)IgM
			Specificity (NPA)
			100% (80/80)
			(95.4%; 100%)IgG
			Sensitivity (PPA)
			93.3% (28/30)
			(78.7%; 98.2%)IgG
			Specificity (NPA)
			100% (80/80)
			(95.4%; 100%)Combined
			Sensitivity (PPA)
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity (NPA)
			100% (80/80)
			(95.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 50.5%; 100%)
			100% (95% CI: 99.4%; 100%)10.0%
			100% (95% CI: 68.3%; 100%)
			100% (95% CI: 98.7%; 100%)20.0%
			100% (95% CI: 82.9%; 100%)
			100% (95% CI: 97.1%; 100%)30.0%
			100% (95% CI: 89.2%; 100%)
			100% (95% CI: 95.2%; 100%)40.0%
			100% (95% CI: 92.8%; 100%)
			100% (95% CI: 92.7%; 100%)50.0%
			100% (95% CI: 95.1%; 100%)
			100% (95% CI: 89.4%; 100%)60.0%
			100% (95% CI: 96.7%; 100%)
			100% (95% CI: 84.9%; 100%)70.0%
			100% (95% CI: 97.8%; 100%)
			100% (95% CI: 78.3%; 100%)80.0%
			100% (95% CI: 98.7%; 100%)
			100% (95% CI: 67.8%; 100%)90.0%
			100% (95% CI: 99.4%; 100%)
			100% (95% CI: 48.3%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataHangzhou Laihe Biotech LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

**Developer:** Hangzhou Laihe Biotech**Test:** LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)IgM
			Specificity
			100% (80/80)
			(95.4%; 100%)IgG
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgG
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			80.8% (95% CI: 40.9%; 96.0%)
			100% (95% CI: 99.4%; 100%)10.0%
			89.9% (95% CI: 59.4%; 98.1%)
			100% (95% CI: 98.7%; 100%)20.0%
			95.2% (95% CI: 76.7%; 99.1%)
			100% (95% CI: 97.0%; 100%)30.0%
			97.2% (95% CI: 84.9%; 99.5%)
			100% (95% CI: 95.0%; 100%)40.0%
			98.2% (95% CI: 89.8%; 99.7%)
			100% (95% CI: 92.5%; 100%)50.0%
			98.8% (95% CI: 92.9%; 99.8%)
			100% (95% CI: 89.2%; 100%)60.0%
			99.2% (95% CI: 95.2%; 99.9%)
			100% (95% CI: 84.6%; 100%)70.0%
			99.5% (95% CI: 96.8%; 99.9%)
			100% (95% CI: 77.9%; 100%)80.0%
			99.7% (95% CI: 98.1%; 99.9%)
			100% (95% CI: 67.3%; 100%)90.0%
			99.9% (95% CI: 99.2%; 100%)
			100% (95% CI: 47.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataHealgen COVID-19 IgG/IgM Rapid Test Cassette

**Developer:** Healgen**Test:** COVID-19 IgG/IgM Rapid Test Cassette**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			100% (30/30)
			(88.7%; 100%)IgM
			Specificity (NPA)
			100% (80/80)
			(95.4%; 100%)IgG
			Sensitivity (PPA)
			96.7% (29/30)
			(83.3%; 99.4%)IgG
			Specificity (NPA)
			97.5% (78/80)
			(91.3%; 99.3%)Combined
			Sensitivity (PPA)
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity (NPA)
			97.5% (78/80)
			(91.3%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			67.8% (95% CI: 35.0%; 88.4%)
			100% (95% CI: 99.4%; 100%)10.0%
			81.6% (95% CI: 53.2%; 94.2%)
			100% (95% CI: 98.6%; 100%)20.0%
			90.9% (95% CI: 71.9%; 97.3%)
			100% (95% CI: 97.0%; 100%)30.0%
			94.5% (95% CI: 81.4%; 98.4%)
			100% (95% CI: 94.9%; 100%)40.0%
			96.4% (95% CI: 87.2%; 99.0%)
			100% (95% CI: 92.4%; 100%)50.0%
			97.6% (95% CI: 91.1%; 99.3%)
			100% (95% CI: 88.9%; 100%)60.0%
			98.4% (95% CI: 93.9%; 99.5%)
			100% (95% CI: 84.3%; 100%)70.0%
			98.9% (95% CI: 96.0%; 99.7%)
			100% (95% CI: 77.5%; 100%)80.0%
			99.4% (95% CI: 97.6%; 99.8%)
			100% (95% CI: 66.8%; 100%)90.0%
			99.7% (95% CI: 98.9%; 99.9%)
			100% (95% CI: 47.2%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataImmunodiagnostic Systems IDS SARS-CoV-2 IgG

**Developer:** Immunodiagnostic Systems Ltd.**Test:** IDS SARS-CoV-2 IgG**Technology:** CLIA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			97.6% (41/42)
			(87.7%; 99.6%)IgG
			Specificity (NPA)
			99.6% (552/554)
			(98.7%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			93.4% (95% CI: 77.9%; 98.1%)
			99.9% (95% CI: 99.3%; 100%)10.0%
			96.8% (95% CI: 88.2%; 99.1%)
			99.7% (95% CI: 98.6%; 100%)20.0%
			98.5% (95% CI: 94.4%; 99.6%)
			99.4% (95% CI: 97.0%; 99.9%)30.0%
			99.1% (95% CI: 96.6%; 99.8%)
			99.0% (95% CI: 94.9%; 99.8%)40.0%
			99.4% (95% CI: 97.8%; 99.9%)
			98.4% (95% CI: 92.3%; 99.7%)50.0%
			99.6% (95% CI: 98.5%; 99.9%)
			97.7% (95% CI: 88.9%; 99.6%)60.0%
			99.8% (95% CI: 99.0%; 99.9%)
			96.5% (95% CI: 84.2%; 99.4%)70.0%
			99.8% (95% CI: 99.4%; 100%)
			94.7% (95% CI: 77.4%; 99.0%)80.0%
			99.9% (95% CI: 99.6%; 100%)
			91.3% (95% CI: 66.7%; 98.3%)90.0%
			100% (95% CI: 99.8%; 100%)
			82.3% (95% CI: 47.1%; 96.4%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseInBios International, Inc SCoV-2 Detect IgG Rapid Test

**Developer:** InBios International, Inc**Test:** SCoV-2 Detect IgG Rapid Test**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgG
			Specificity
			100% (80/80)
			(95.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 50.5%; 100%)
			100% (95% CI: 99.4%; 100%)10.0%
			100% (95% CI: 68.3%; 100%)
			100% (95% CI: 98.7%; 100%)20.0%
			100% (95% CI: 82.9%; 100%)
			100% (95% CI: 97.1%; 100%)30.0%
			100% (95% CI: 89.2%; 100%)
			100% (95% CI: 95.2%; 100%)40.0%
			100% (95% CI: 92.8%; 100%)
			100% (95% CI: 92.7%; 100%)50.0%
			100% (95% CI: 95.1%; 100%)
			100% (95% CI: 89.4%; 100%)60.0%
			100% (95% CI: 96.7%; 100%)
			100% (95% CI: 84.9%; 100%)70.0%
			100% (95% CI: 97.8%; 100%)
			100% (95% CI: 78.3%; 100%)80.0%
			100% (95% CI: 98.7%; 100%)
			100% (95% CI: 67.8%; 100%)90.0%
			100% (95% CI: 99.4%; 100%)
			100% (95% CI: 48.3%; 100%)**Test Facts:**

Information for Healthcare Providers
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	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataInBios International, Inc. SCoV-2 Detect Neutralizing Ab ELISA

**Developer:** InBios International, Inc.**Test:** SCoV-2 Detect Neutralizing Ab ELISA**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig (Neutralizing)
			Sensitivity (PPA)
			96.2% (51/53)
			(87.2%; 99.0%)Pan-Ig (Neutralizing)
			Specificity (NPA)
			96.3% (79/82)
			(89.8%; 98.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			58.1% (95% CI: 31.0%; 80.6%)
			99.8% (95% CI: 99.3%; 99.9%)10.0%
			74.5% (95% CI: 48.7%; 89.8%)
			99.6% (95% CI: 98.4%; 99.9%)20.0%
			86.8% (95% CI: 68.1%; 95.2%)
			99.0% (95% CI: 96.6%; 99.7%)30.0%
			91.9% (95% CI: 78.5%; 97.1%)
			98.3% (95% CI: 94.3%; 99.6%)40.0%
			94.6% (95% CI: 85.1%; 98.1%)
			97.5% (95% CI: 91.4%; 99.3%)50.0%
			96.3% (95% CI: 89.5%; 98.8%)
			96.2% (95% CI: 87.6%; 99.0%)60.0%
			97.5% (95% CI: 92.8%; 99.2%)
			94.5% (95% CI: 82.4%; 98.4%)70.0%
			98.4% (95% CI: 95.2%; 99.5%)
			91.6% (95% CI: 75.1%; 97.6%)80.0%
			99.1% (95% CI: 97.2%; 99.7%)
			86.5% (95% CI: 63.8%; 96.0%)90.0%
			99.6% (95% CI: 98.7%; 99.9%)
			73.9% (95% CI: 43.9%; 91.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseInBios SCoV-2 Detect IgG ELISA

**Developer:** InBios**Test:** SCoV-2 Detect IgG ELISA**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgG
			Specificity
			100% (80/80)
			(95.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 50.5%; 100%)
			100% (95% CI: 99.4%; 100%)10.0%
			100% (95% CI: 68.3%; 100%)
			100% (95% CI: 98.7%; 100%)20.0%
			100% (95% CI: 82.9%; 100%)
			100% (95% CI: 97.1%; 100%)30.0%
			100% (95% CI: 89.2%; 100%)
			100% (95% CI: 95.2%; 100%)40.0%
			100% (95% CI: 92.8%; 100%)
			100% (95% CI: 92.7%; 100%)50.0%
			100% (95% CI: 95.1%; 100%)
			100% (95% CI: 89.4%; 100%)60.0%
			100% (95% CI: 96.7%; 100%)
			100% (95% CI: 84.9%; 100%)70.0%
			100% (95% CI: 97.8%; 100%)
			100% (95% CI: 78.3%; 100%)80.0%
			100% (95% CI: 98.7%; 100%)
			100% (95% CI: 67.8%; 100%)90.0%
			100% (95% CI: 99.4%; 100%)
			100% (95% CI: 48.3%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataInBios SCoV-2 Detect IgM ELISA

**Developer:** InBios International, Inc.**Test:** SCoV-2 Detect IgM ELISA**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)IgM
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			80.3% (95% CI: 39.4%; 96.0%)
			99.8% (95% CI: 99.1%; 100%)10.0%
			89.6% (95% CI: 57.9%; 98.0%)
			99.6% (95% CI: 98.1%; 99.9%)20.0%
			95.1% (95% CI: 75.5%; 99.1%)
			99.2% (95% CI: 95.7%; 99.9%)30.0%
			97.1% (95% CI: 84.1%; 99.5%)
			98.6% (95% CI: 92.9%; 99.7%)40.0%
			98.1% (95% CI: 89.2%; 99.7%)
			97.8% (95% CI: 89.4%; 99.6%)50.0%
			98.7% (95% CI: 92.5%; 99.8%)
			96.7% (95% CI: 84.8%; 99.4%)60.0%
			99.1% (95% CI: 94.9%; 99.9%)
			95.2% (95% CI: 78.9%; 99.1%)70.0%
			99.4% (95% CI: 96.6%; 99.9%)
			92.7% (95% CI: 70.6%; 98.6%)80.0%
			99.7% (95% CI: 98.0%; 99.9%)
			88.1% (95% CI: 58.3%; 97.7%)90.0%
			99.9% (95% CI: 99.1%; 100%)
			76.7% (95% CI: 38.3%; 95.0%)**Test Facts:**

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	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataInnovita (Tangshan) Biological Technology Innovita 2019-nCoV Ab Test (Colloidal Gold)

**Developer:** Innovita (Tangshan) Biological Technology Co., Ltd.**Test:** Innovita 2019-nCoV Ab Test (Colloidal Gold)**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)IgM
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)IgG
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)IgG
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			67.8% (95% CI: 35.0%; 88.4%)
			100% (95% CI: 99.4%; 100%)10.0%
			81.6% (95% CI: 53.2%; 94.2%)
			100% (95% CI: 98.6%; 100%)20.0%
			90.9% (95% CI: 71.9%; 97.3%)
			100% (95% CI: 97.0%; 100%)30.0%
			94.5% (95% CI: 81.4%; 98.4%)
			100% (95% CI: 94.9%; 100%)40.0%
			96.4% (95% CI: 87.2%; 99.0%)
			100% (95% CI: 92.4%; 100%)50.0%
			97.6% (95% CI: 91.1%; 99.3%)
			100% (95% CI: 88.9%; 100%)60.0%
			98.4% (95% CI: 93.9%; 99.5%)
			100% (95% CI: 84.3%; 100%)70.0%
			98.9% (95% CI: 96.0%; 99.7%)
			100% (95% CI: 77.5%; 100%)80.0%
			99.4% (95% CI: 97.6%; 99.8%)
			100% (95% CI: 66.8%; 100%)90.0%
			99.7% (95% CI: 98.9%; 99.9%)
			100% (95% CI: 47.2%; 100%)**Test Facts:**

Information for Healthcare Providers
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	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataInova Diagnostics, Inc. QUANTA Flash SARS-CoV-2 IgG

**Developer:** Inova Diagnostics, Inc.**Test:** QUANTA Flash SARS-CoV-2 IgG**Technology:** Semi-quantitative High Throughput CLIA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (29/29)
			(88.3%; 100%)IgG
			Specificity (NPA)
			99.9% (1027/1028)
			(99.5%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			98.2% (95% CI: 89.4%; 99.7%)
			100% (95% CI: 99.4%; 100%)10.0%
			99.1% (95% CI: 94.7%; 99.8%)
			100% (95% CI: 98.7%; 100%)20.0%
			99.6% (95% CI: 97.6%; 99.9%)
			100% (95% CI: 97.1%; 100%)30.0%
			99.8% (95% CI: 98.6%; 100%)
			100% (95% CI: 95.2%; 100%)40.0%
			99.9% (95% CI: 99.1%; 100%)
			100% (95% CI: 92.7%; 100%)50.0%
			99.9% (95% CI: 99.4%; 100%)
			100% (95% CI: 89.5%; 100%)60.0%
			99.9% (95% CI: 99.6%; 100%)
			100% (95% CI: 85.0%; 100%)70.0%
			100% (95% CI: 99.7%; 100%)
			100% (95% CI: 78.5%; 100%)80.0%
			100% (95% CI: 99.8%; 100%)
			100% (95% CI: 68.0%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 48.6%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseJiangsu Well Biotech Orawell IgM/IgG Rapid Test

**Developer:** Jiangsu Well Biotech**Test:** Orawell IgM/IgG Rapid Test**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			93.1% (54/58)
			(83.6%; 97.3%)IgM
			Specificity
			95.9% (93/97)
			(89.9%; 98.4%)IgG
			Sensitivity
			100% (58/58)
			(93.8%; 100%)IgG
			Specificity
			99.0% (96/97)
			(94.4%; 99.8%)Combined
			Sensitivity
			100% (58/58)
			(93.8%; 100%)Combined
			Specificity
			94.8% (92/97)
			(88.5%; 97.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			50.5% (95% CI: 30.0%; 70.3%)
			100% (95% CI: 99.6%; 100%)10.0%
			68.3% (95% CI: 47.5%; 83.3%)
			100% (95% CI: 99.2%; 100%)20.0%
			82.9% (95% CI: 67.1%; 91.8%)
			100% (95% CI: 98.3%; 100%)30.0%
			89.3% (95% CI: 77.7%; 95.1%)
			100% (95% CI: 97.1%; 100%)40.0%
			92.8% (95% CI: 84.5%; 96.8%)
			100% (95% CI: 95.5%; 100%)50.0%
			95.1% (95% CI: 89.1%; 97.8%)
			100% (95% CI: 93.4%; 100%)60.0%
			96.7% (95% CI: 92.4%; 98.5%)
			100% (95% CI: 90.5%; 100%)70.0%
			97.8% (95% CI: 95.0%; 99.1%)
			100% (95% CI: 85.9%; 100%)80.0%
			98.7% (95% CI: 97.0%; 99.4%)
			100% (95% CI: 78.1%; 100%)90.0%
			99.4% (95% CI: 98.7%; 99.8%)
			100% (95% CI: 61.3%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (Combined)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (Combined)Kantaro Biosciences COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit

**Developer:** Kantaro Biosciences, LLC**Test:** COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit**Technology:** Semi-quantitative 2-Step ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			99.1% (233/235)
			(97.0%; 99.8%)IgG
			Specificity (NPA)
			99.6% (283/284)
			(98.0%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			93.7% (95% CI: 72.2%; 98.8%)
			100% (95% CI: 99.8%; 100%)10.0%
			96.9% (95% CI: 84.6%; 99.4%)
			99.9% (95% CI: 99.7%; 100%)20.0%
			98.6% (95% CI: 92.5%; 99.8%)
			99.8% (95% CI: 99.2%; 99.9%)30.0%
			99.2% (95% CI: 95.5%; 99.9%)
			99.6% (95% CI: 98.7%; 99.9%)40.0%
			99.5% (95% CI: 97.0%; 99.9%)
			99.4% (95% CI: 98.0%; 99.8%)50.0%
			99.6% (95% CI: 98.0%; 99.9%)
			99.2% (95% CI: 97.0%; 99.8%)60.0%
			99.8% (95% CI: 98.7%; 100%)
			98.7% (95% CI: 95.5%; 99.7%)70.0%
			99.8% (95% CI: 99.1%; 100%)
			98.0% (95% CI: 93.2%; 99.5%)80.0%
			99.9% (95% CI: 99.5%; 100%)
			96.7% (95% CI: 88.9%; 99.1%)90.0%
			100% (95% CI: 99.8%; 100%)
			92.9% (95% CI: 78.1%; 97.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseLuminex xMAP SARS-CoV-2 Multi-Antigen IgG Assay

**Developer:** Luminex Corporation**Test:** xMAP SARS-CoV-2 Multi-Antigen IgG Assay**Technology:** High Throughput FMIA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			96.3% (79/82)
			(89.8%; 98.7%)IgG
			Specificity (NPA)
			99.3% (599/603)
			(98.3%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			88.4% (95% CI: 73.6%; 95.3%)
			99.8% (95% CI: 99.5%; 99.9%)10.0%
			94.2% (95% CI: 85.5%; 97.7%)
			99.6% (95% CI: 98.9%; 99.9%)20.0%
			97.3% (95% CI: 93.0%; 99.0%)
			99.1% (95% CI: 97.5%; 99.7%)30.0%
			98.4% (95% CI: 95.8%; 99.4%)
			98.4% (95% CI: 95.7%; 99.5%)40.0%
			99.0% (95% CI: 97.2%; 99.6%)
			97.6% (95% CI: 93.5%; 99.2%)50.0%
			99.3% (95% CI: 98.1%; 99.7%)
			96.4% (95% CI: 90.6%; 98.8%)60.0%
			99.5% (95% CI: 98.8%; 99.8%)
			94.8% (95% CI: 86.5%; 98.2%)70.0%
			99.7% (95% CI: 99.2%; 99.9%)
			92.1% (95% CI: 80.5%; 97.2%)80.0%
			99.8% (95% CI: 99.5%; 99.9%)
			87.2% (95% CI: 70.6%; 95.2%)90.0%
			99.9% (95% CI: 99.8%; 100%)
			75.1% (95% CI: 51.7%; 89.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseLumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ab Test

**Developer:** LumiraDx UK Ltd.**Test:** LumiraDx SARS-CoV-2 Ab Test**Technology:** Fluorescence Immunoassay**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Pan-Ig
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			80.8% (95% CI: 40.9%; 96.0%)
			100% (95% CI: 99.4%; 100%)10.0%
			89.9% (95% CI: 59.4%; 98.1%)
			100% (95% CI: 98.7%; 100%)20.0%
			95.2% (95% CI: 76.7%; 99.1%)
			100% (95% CI: 97.0%; 100%)30.0%
			97.2% (95% CI: 84.9%; 99.5%)
			100% (95% CI: 95.0%; 100%)40.0%
			98.2% (95% CI: 89.8%; 99.7%)
			100% (95% CI: 92.5%; 100%)50.0%
			98.8% (95% CI: 92.9%; 99.8%)
			100% (95% CI: 89.2%; 100%)60.0%
			99.2% (95% CI: 95.2%; 99.9%)
			100% (95% CI: 84.6%; 100%)70.0%
			99.5% (95% CI: 96.8%; 99.9%)
			100% (95% CI: 77.9%; 100%)80.0%
			99.7% (95% CI: 98.1%; 99.9%)
			100% (95% CI: 67.3%; 100%)90.0%
			99.9% (95% CI: 99.2%; 100%)
			100% (95% CI: 47.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataMegna Health Rapid COVID-19 IgM/IgG Combo Test Kit

**Developer:** Megna Health, Inc.**Test:** Rapid COVID-19 IgM/IgG Combo Test Kit**Technology:** Lateral Flow**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			83.3% (25/30)
			(66.4%; 92.7%)IgM
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)IgG
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgG
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			95.0% (76/80)
			(87.8%; 98.0%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			51.3% (95% CI: 27.7%; 72.9%)
			100% (95% CI: 99.3%; 100%)10.0%
			69.0% (95% CI: 44.7%; 85.0%)
			100% (95% CI: 98.6%; 100%)20.0%
			83.3% (95% CI: 64.6%; 92.7%)
			100% (95% CI: 96.9%; 100%)30.0%
			89.6% (95% CI: 75.8%; 95.6%)
			100% (95% CI: 94.8%; 100%)40.0%
			93.0% (95% CI: 82.9%; 97.1%)
			100% (95% CI: 92.1%; 100%)50.0%
			95.2% (95% CI: 87.9%; 98.1%)
			100% (95% CI: 88.6%; 100%)60.0%
			96.8% (95% CI: 91.6%; 98.7%)
			100% (95% CI: 83.8%; 100%)70.0%
			97.9% (95% CI: 94.4%; 99.2%)
			100% (95% CI: 76.8%; 100%)80.0%
			98.8% (95% CI: 96.7%; 99.5%)
			100% (95% CI: 65.9%; 100%)90.0%
			99.4% (95% CI: 98.5%; 99.8%)
			100% (95% CI: 46.2%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataMount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody Test

**Developer:** Mount Sinai Hospital Clinical Laboratory**Test:** Mt. Sinai Laboratory COVID-19 ELISA Antibody Test**Technology:** 2-Step ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalCombined
			Sensitivity (PPA)
			92.5% (37/40)
			(80.1%; 97.4%)Combined
			Specificity (NPA)
			100% (74/74)
			(95.1%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 46.1%; 100%)
			99.6% (95% CI: 98.9%; 99.9%)10.0%
			100% (95% CI: 64.3%; 100%)
			99.2% (95% CI: 97.7%; 99.7%)20.0%
			100% (95% CI: 80.2%; 100%)
			98.2% (95% CI: 95.0%; 99.4%)30.0%
			100% (95% CI: 87.4%; 100%)
			96.9% (95% CI: 91.8%; 98.9%)40.0%
			100% (95% CI: 91.5%; 100%)
			95.2% (95% CI: 87.8%; 98.3%)50.0%
			100% (95% CI: 94.2%; 100%)
			93.0% (95% CI: 82.7%; 97.5%)60.0%
			100% (95% CI: 96.1%; 100%)
			89.9% (95% CI: 76.1%; 96.3%)70.0%
			100% (95% CI: 97.4%; 100%)
			85.1% (95% CI: 67.2%; 94.3%)80.0%
			100% (95% CI: 98.5%; 100%)
			76.9% (95% CI: 54.5%; 90.6%)90.0%
			100% (95% CI: 99.3%; 100%)
			59.7% (95% CI: 34.7%; 81.1%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	EUA SummaryNanoEntek America FREND COVID-19 total Ab

**Developer:** NanoEntek America, Inc.**Test:** FREND COVID-19 total Ab**Technology:** FIA**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence Interval(IgM / IgG)
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)(IgM / IgG)
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			80.3% (95% CI: 39.4%; 96.0%)
			99.8% (95% CI: 99.1%; 100%)10.0%
			89.6% (95% CI: 57.9%; 98.0%)
			99.6% (95% CI: 98.1%; 99.9%)20.0%
			95.1% (95% CI: 75.5%; 99.1%)
			99.2% (95% CI: 95.7%; 99.9%)30.0%
			97.1% (95% CI: 84.1%; 99.5%)
			98.6% (95% CI: 92.9%; 99.7%)40.0%
			98.1% (95% CI: 89.2%; 99.7%)
			97.8% (95% CI: 89.4%; 99.6%)50.0%
			98.7% (95% CI: 92.5%; 99.8%)
			96.7% (95% CI: 84.8%; 99.4%)60.0%
			99.1% (95% CI: 94.9%; 99.9%)
			95.2% (95% CI: 78.9%; 99.1%)70.0%
			99.4% (95% CI: 96.6%; 99.9%)
			92.7% (95% CI: 70.6%; 98.6%)80.0%
			99.7% (95% CI: 98.0%; 99.9%)
			88.1% (95% CI: 58.3%; 97.7%)90.0%
			99.9% (95% CI: 99.1%; 100%)
			76.7% (95% CI: 38.3%; 95.0%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataNirmidas Biotech MidaSpot COVID-19 Antibody Combo Detection Kit

**Developer:** Nirmidas Biotech, Inc.**Test:** MidaSpot COVID-19 Antibody Combo Detection Kit**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgM
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)IgG
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)IgG
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			96.2% (77/80)
			(89.5%; 98.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			58.4% (95% CI: 30.9%; 80.4%)
			100% (95% CI: 99.3%; 100%)10.0%
			74.8% (95% CI: 48.5%; 89.7%)
			100% (95% CI: 98.6%; 100%)20.0%
			87.0% (95% CI: 67.9%; 95.1%)
			100% (95% CI: 96.9%; 100%)30.0%
			92.0% (95% CI: 78.4%; 97.1%)
			100% (95% CI: 94.8%; 100%)40.0%
			94.7% (95% CI: 85.0%; 98.1%)
			100% (95% CI: 92.2%; 100%)50.0%
			96.4% (95% CI: 89.5%; 98.7%)
			100% (95% CI: 88.8%; 100%)60.0%
			97.6% (95% CI: 92.7%; 99.2%)
			100% (95% CI: 84.0%; 100%)70.0%
			98.4% (95% CI: 95.2%; 99.5%)
			100% (95% CI: 77.2%; 100%)80.0%
			99.1% (95% CI: 97.1%; 99.7%)
			100% (95% CI: 66.4%; 100%)90.0%
			99.6% (95% CI: 98.7%; 99.9%)
			100% (95% CI: 46.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataNirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit

**Developer:** Nirmidas Biotech, Inc.**Test:** Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			93.1% (54/58)
			(83.6%; 97.3%)IgM
			Specificity
			97.9% (95/97)
			(92.8%; 99.4%)IgG
			Sensitivity
			87.9% (51/58)
			(77.1%; 94.0%)IgG
			Specificity
			100% (97/97)
			(96.2%; 100%)Combined
			Sensitivity
			96.6% (56/58)
			(88.3%; 99.1%)Combined
			Specificity
			97.9% (95/97)
			(92.8%; 99.4%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			71.1% (95% CI: 39.2%; 90.2%)
			99.8% (95% CI: 99.3%; 99.9%)10.0%
			83.9% (95% CI: 57.6%; 95.1%)
			99.6% (95% CI: 98.6%; 99.9%)20.0%
			92.1% (95% CI: 75.4%; 97.8%)
			99.1% (95% CI: 96.9%; 99.8%)30.0%
			95.3% (95% CI: 84.0%; 98.7%)
			98.5% (95% CI: 94.9%; 99.6%)40.0%
			96.9% (95% CI: 89.1%; 99.1%)
			97.7% (95% CI: 92.2%; 99.4%)50.0%
			97.9% (95% CI: 92.5%; 99.4%)
			96.6% (95% CI: 88.8%; 99.1%)60.0%
			98.6% (95% CI: 94.8%; 99.6%)
			95.0% (95% CI: 84.1%; 98.6%)70.0%
			99.1% (95% CI: 96.6%; 99.8%)
			92.4% (95% CI: 77.2%; 97.8%)80.0%
			99.5% (95% CI: 98.0%; 99.9%)
			87.7% (95% CI: 66.4%; 96.3%)90.0%
			99.8% (95% CI: 99.1%; 99.9%)
			75.9% (95% CI: 46.8%; 92.1%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (Combined)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (Combined)NOWDiagnostics, Inc. ADEXUSDx COVID-19 Test

**Developer:** NOWDiagnostics, Inc.**Test:** ADEXUSDx COVID-19 Test**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)Pan-Ig
			Specificity
			100% (80/80)
			(95.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 47.5%; 100%)
			99.7% (95% CI: 98.8%; 99.9%)10.0%
			100% (95% CI: 65.6%; 100%)
			99.3% (95% CI: 97.6%; 99.8%)20.0%
			100% (95% CI: 81.1%; 100%)
			98.4% (95% CI: 94.7%; 99.5%)30.0%
			100% (95% CI: 88.0%; 100%)
			97.2% (95% CI: 91.3%; 99.2%)40.0%
			100% (95% CI: 92.0%; 100%)
			95.7% (95% CI: 87.0%; 98.8%)50.0%
			100% (95% CI: 94.5%; 100%)
			93.8% (95% CI: 81.7%; 98.2%)60.0%
			100% (95% CI: 96.3%; 100%)
			90.9% (95% CI: 74.9%; 97.3%)70.0%
			100% (95% CI: 97.6%; 100%)
			86.5% (95% CI: 65.7%; 95.9%)80.0%
			100% (95% CI: 98.6%; 100%)
			78.9% (95% CI: 52.8%; 93.1%)90.0%
			100% (95% CI: 99.4%; 100%)
			62.5% (95% CI: 33.2%; 85.8%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataOrtho-Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG test

**Developer:** Ortho-Clinical Diagnostics, Inc.**Test:** VITROS Anti-SARS-CoV-2 IgG test**Technology:** High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			90.0% (36/40)
			(76.9%; 96.0%)IgG
			Specificity (NPA)
			100% (407/407)
			(99.1%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 81.2%; 100%)
			99.5% (95% CI: 98.8%; 99.8%)10.0%
			100% (95% CI: 90.1%; 100%)
			98.9% (95% CI: 97.5%; 99.6%)20.0%
			100% (95% CI: 95.4%; 100%)
			97.6% (95% CI: 94.5%; 99.0%)30.0%
			100% (95% CI: 97.2%; 100%)
			95.9% (95% CI: 90.9%; 98.3%)40.0%
			100% (95% CI: 98.2%; 100%)
			93.8% (95% CI: 86.6%; 97.4%)50.0%
			100% (95% CI: 98.8%; 100%)
			90.9% (95% CI: 81.1%; 96.2%)60.0%
			100% (95% CI: 99.2%; 100%)
			87.0% (95% CI: 74.1%; 94.4%)70.0%
			100% (95% CI: 99.5%; 100%)
			81.1% (95% CI: 64.8%; 91.5%)80.0%
			100% (95% CI: 99.7%; 100%)
			71.4% (95% CI: 51.8%; 86.3%)90.0%
			100% (95% CI: 99.9%; 100%)
			52.6% (95% CI: 32.3%; 73.7%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	CDC's Evaluation Report
	CDC's Evaluation DataOrtho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator

**Developer:** Ortho-Clinical Diagnostics, Inc.**Test:** VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator**Technology:** High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			100% (49/49)
			(92.7%; 100%)Pan-Ig
			Specificity (NPA)
			100% (400/400)
			(99.0%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 83.7%; 100%)
			100% (95% CI: 99.6%; 100%)10.0%
			100% (95% CI: 91.6%; 100%)
			100% (95% CI: 99.2%; 100%)20.0%
			100% (95% CI: 96.1%; 100%)
			100% (95% CI: 98.2%; 100%)30.0%
			100% (95% CI: 97.7%; 100%)
			100% (95% CI: 97.0%; 100%)40.0%
			100% (95% CI: 98.5%; 100%)
			100% (95% CI: 95.3%; 100%)50.0%
			100% (95% CI: 99.0%; 100%)
			100% (95% CI: 93.2%; 100%)60.0%
			100% (95% CI: 99.3%; 100%)
			100% (95% CI: 90.1%; 100%)70.0%
			100% (95% CI: 99.6%; 100%)
			100% (95% CI: 85.4%; 100%)80.0%
			100% (95% CI: 99.7%; 100%)
			100% (95% CI: 77.3%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 60.2%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseOrtho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator

**Developer:** Ortho-Clinical Diagnostics, Inc.**Test:** VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator**Technology:** Quantitative High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			91.9% (217/236)
			(87.8%; 94.8%)IgG
			Specificity (NPA)
			100% (533/533)
			(99.3%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 86.6%; 100%)
			99.6% (95% CI: 99.4%; 99.7%)10.0%
			100% (95% CI: 93.2%; 100%)
			99.1% (95% CI: 98.6%; 99.4%)20.0%
			100% (95% CI: 96.8%; 100%)
			98.0% (95% CI: 97.0%; 98.7%)30.0%
			100% (95% CI: 98.1%; 100%)
			96.7% (95% CI: 95.0%; 97.8%)40.0%
			100% (95% CI: 98.8%; 100%)
			94.9% (95% CI: 92.4%; 96.6%)50.0%
			100% (95% CI: 99.2%; 100%)
			92.5% (95% CI: 89.0%; 95.0%)60.0%
			100% (95% CI: 99.5%; 100%)
			89.2% (95% CI: 84.4%; 92.7%)70.0%
			100% (95% CI: 99.7%; 100%)
			84.2% (95% CI: 77.7%; 89.2%)80.0%
			100% (95% CI: 99.8%; 100%)
			75.6% (95% CI: 67.0%; 82.7%)90.0%
			100% (95% CI: 99.9%; 100%)
			58.0% (95% CI: 47.4%; 68.1%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseOrtho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators

**Developer:** Ortho-Clinical Diagnostics, Inc.**Test:** VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators**Technology:** High Throughput CLIA**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			90.0% (63/70)
			(80.8%; 95.1%)Pan-Ig
			Specificity (NPA)
			99.1% (1039/1048)
			(98.4%; 99.5%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			84.7% (95% CI: 72.4%; 91.7%)
			99.5% (95% CI: 99.0%; 99.7%)10.0%
			92.1% (95% CI: 84.7%; 95.9%)
			98.9% (95% CI: 97.9%; 99.5%)20.0%
			96.3% (95% CI: 92.6%; 98.1%)
			97.5% (95% CI: 95.3%; 98.8%)30.0%
			97.8% (95% CI: 95.5%; 98.9%)
			95.9% (95% CI: 92.3%; 97.9%)40.0%
			98.6% (95% CI: 97.1%; 99.3%)
			93.7% (95% CI: 88.5%; 96.8%)50.0%
			99.1% (95% CI: 98.0%; 99.5%)
			90.8% (95% CI: 83.6%; 95.3%)60.0%
			99.4% (95% CI: 98.7%; 99.7%)
			86.9% (95% CI: 77.3%; 93.1%)70.0%
			99.6% (95% CI: 99.1%; 99.8%)
			80.9% (95% CI: 68.7%; 89.6%)80.0%
			99.8% (95% CI: 99.5%; 99.9%)
			71.3% (95% CI: 56.1%; 83.5%)90.0%
			99.9% (95% CI: 99.8%; 99.9%)
			52.4% (95% CI: 36.2%; 69.2%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UsePhadia AB EliA SARS-CoV-2-Sp1 IgG Test

**Developer:** Phadia AB**Test:** EliA SARS-CoV-2-Sp1 IgG Test**Technology:** Semi-quantitative Fluoroenzyme Immunoassay**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			97.6% (80/82)
			(91.5%; 99.3%)IgG
			Specificity (NPA)
			99.4% (338/340)
			(97.9%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			89.7% (95% CI: 69.5%; 97.0%)
			99.9% (95% CI: 99.5%; 100%)10.0%
			94.9% (95% CI: 82.8%; 98.6%)
			99.7% (95% CI: 99.0%; 99.9%)20.0%
			97.6% (95% CI: 91.5%; 99.4%)
			99.4% (95% CI: 97.9%; 99.8%)30.0%
			98.6% (95% CI: 94.9%; 99.6%)
			99.0% (95% CI: 96.4%; 99.7%)40.0%
			99.1% (95% CI: 96.6%; 99.8%)
			98.4% (95% CI: 94.6%; 99.6%)50.0%
			99.4% (95% CI: 97.7%; 99.8%)
			97.6% (95% CI: 92.0%; 99.3%)60.0%
			99.6% (95% CI: 98.5%; 99.9%)
			96.5% (95% CI: 88.5%; 99.0%)70.0%
			99.7% (95% CI: 99.0%; 99.9%)
			94.6% (95% CI: 83.2%; 98.5%)80.0%
			99.8% (95% CI: 99.4%; 100%)
			91.1% (95% CI: 74.3%; 97.4%)90.0%
			99.9% (95% CI: 99.7%; 100%)
			81.9% (95% CI: 56.2%; 94.3%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseQIAGEN, GmbH QIAreach Anti-SARS-CoV-2 Total Test

**Developer:** QIAGEN, GmbH**Test:** QIAreach Anti-SARS-CoV-2 Total Test**Technology:** Lateral Flow, Digital**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Pan-Ig
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			67.8% (95% CI: 35.0%; 88.4%)
			100% (95% CI: 99.4%; 100%)10.0%
			81.6% (95% CI: 53.2%; 94.2%)
			100% (95% CI: 98.6%; 100%)20.0%
			90.9% (95% CI: 71.9%; 97.3%)
			100% (95% CI: 97.0%; 100%)30.0%
			94.5% (95% CI: 81.4%; 98.4%)
			100% (95% CI: 94.9%; 100%)40.0%
			96.4% (95% CI: 87.2%; 99.0%)
			100% (95% CI: 92.4%; 100%)50.0%
			97.6% (95% CI: 91.1%; 99.3%)
			100% (95% CI: 88.9%; 100%)60.0%
			98.4% (95% CI: 93.9%; 99.5%)
			100% (95% CI: 84.3%; 100%)70.0%
			98.9% (95% CI: 96.0%; 99.7%)
			100% (95% CI: 77.5%; 100%)80.0%
			99.4% (95% CI: 97.6%; 99.8%)
			100% (95% CI: 66.8%; 100%)90.0%
			99.7% (95% CI: 98.9%; 99.9%)
			100% (95% CI: 47.2%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataQuansys Biosciences Q-Plex SARS-CoV-2 Human IgG (4 Plex)

**Developer:** Quansys Biosciences, Inc.**Test:** Q-Plex SARS-CoV-2 Human IgG (4 Plex)**Technology:** CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			95.5% (21/22)
			(78.2%; 99.2%)IgG
			Specificity (NPA)
			99.7% (583/585)
			(98.8%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			93.6% (95% CI: 76.9%; 98.2%)
			99.8% (95% CI: 98.9%; 100%)10.0%
			96.9% (95% CI: 87.5%; 99.2%)
			99.5% (95% CI: 97.6%; 99.9%)20.0%
			98.6% (95% CI: 94.0%; 99.6%)
			98.9% (95% CI: 94.8%; 99.8%)30.0%
			99.2% (95% CI: 96.4%; 99.8%)
			98.1% (95% CI: 91.4%; 99.7%)40.0%
			99.5% (95% CI: 97.7%; 99.9%)
			97.0% (95% CI: 87.2%; 99.5%)50.0%
			99.6% (95% CI: 98.4%; 99.9%)
			95.6% (95% CI: 81.9%; 99.2%)60.0%
			99.8% (95% CI: 99.0%; 99.9%)
			93.6% (95% CI: 75.1%; 98.8%)70.0%
			99.8% (95% CI: 99.3%; 100%)
			90.4% (95% CI: 66.0%; 98.2%)80.0%
			99.9% (95% CI: 99.6%; 100%)
			84.6% (95% CI: 53.1%; 96.9%)90.0%
			100% (95% CI: 99.8%; 100%)
			70.9% (95% CI: 33.5%; 93.2%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseQuanterix Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

**Developer:** Quanterix Corporation**Test:** Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test**Technology:** Semi-quantitative Paramagnetic Microbead-based Sandwich ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (28/28)
			(87.9%; 100%)IgG
			Specificity (NPA)
			99.2% (492/496)
			(97.9%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			86.7% (95% CI: 69.3%; 94.4%)
			100% (95% CI: 99.4%; 100%)10.0%
			93.2% (95% CI: 82.6%; 97.3%)
			100% (95% CI: 98.7%; 100%)20.0%
			96.9% (95% CI: 91.5%; 98.8%)
			100% (95% CI: 97.0%; 100%)30.0%
			98.2% (95% CI: 94.8%; 99.3%)
			100% (95% CI: 95.0%; 100%)40.0%
			98.8% (95% CI: 96.6%; 99.5%)
			100% (95% CI: 92.4%; 100%)50.0%
			99.2% (95% CI: 97.7%; 99.7%)
			100% (95% CI: 89.0%; 100%)60.0%
			99.5% (95% CI: 98.5%; 99.8%)
			100% (95% CI: 84.4%; 100%)70.0%
			99.7% (95% CI: 99.0%; 99.9%)
			100% (95% CI: 77.7%; 100%)80.0%
			99.8% (95% CI: 99.4%; 99.9%)
			100% (95% CI: 67.0%; 100%)90.0%
			99.9% (95% CI: 99.7%; 100%)
			100% (95% CI: 47.4%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseRoche Elecsys Anti-SARS-CoV-2

**Developer:** Roche**Test:** Elecsys Anti-SARS-CoV-2**Technology:** High Throughput ECLIA**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			100% (29/29)
			(88.3%; 100%)Pan-Ig
			Specificity (NPA)
			99.8% (5262/5272)
			(99.7%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			96.5% (95% CI: 93.0%; 98.1%)
			100% (95% CI: 99.4%; 100%)10.0%
			98.3% (95% CI: 96.6%; 99.1%)
			100% (95% CI: 98.7%; 100%)20.0%
			99.2% (95% CI: 98.4%; 99.6%)
			100% (95% CI: 97.1%; 100%)30.0%
			99.6% (95% CI: 99.1%; 99.8%)
			100% (95% CI: 95.2%; 100%)40.0%
			99.7% (95% CI: 99.4%; 99.8%)
			100% (95% CI: 92.7%; 100%)50.0%
			99.8% (95% CI: 99.6%; 99.9%)
			100% (95% CI: 89.5%; 100%)60.0%
			99.9% (95% CI: 99.7%; 99.9%)
			100% (95% CI: 85.0%; 100%)70.0%
			99.9% (95% CI: 99.8%; 100%)
			100% (95% CI: 78.5%; 100%)80.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 68.1%; 100%)90.0%
			100% (95% CI: 100%; 100%)
			100% (95% CI: 48.6%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NIH Clinical Center's Evaluation Report
	NIH Clinical Center's DataRoche Elecsys Anti-SARS-CoV-2 S

**Developer:** Roche Diagnostics, Inc.**Test:** Elecsys Anti-SARS-CoV-2 S**Technology:** Semi-quantitative High Throughput ECLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			96.6% (225/233)
			(93.4%; 98.3%)Pan-Ig
			Specificity (NPA)
			100% (5990/5991)
			(99.9%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			99.7% (95% CI: 98.1%; 99.9%)
			99.8% (95% CI: 99.7%; 99.9%)10.0%
			99.8% (95% CI: 99.1%; 100%)
			99.6% (95% CI: 99.3%; 99.8%)20.0%
			99.9% (95% CI: 99.6%; 100%)
			99.1% (95% CI: 98.4%; 99.6%)30.0%
			100% (95% CI: 99.8%; 100%)
			98.5% (95% CI: 97.2%; 99.3%)40.0%
			100% (95% CI: 99.8%; 100%)
			97.8% (95% CI: 95.8%; 98.8%)50.0%
			100% (95% CI: 99.9%; 100%)
			96.7% (95% CI: 93.8%; 98.3%)60.0%
			100% (95% CI: 99.9%; 100%)
			95.1% (95% CI: 91.0%; 97.4%)70.0%
			100% (95% CI: 100%; 100%)
			92.6% (95% CI: 86.6%; 96.1%)80.0%
			100% (95% CI: 100%; 100%)
			87.9% (95% CI: 79.0%; 93.5%)90.0%
			100% (95% CI: 100%; 100%)
			76.4% (95% CI: 62.6%; 86.4%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSalofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette

**Developer:** Salofa Oy**Test:** Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			90.0% (27/30)
			(74.4%; 96.5%)IgM
			Specificity
			100% (80/80)
			(95.4%; 100%)IgG
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)IgG
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)Combined
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)Combined
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			79.7% (95% CI: 38.0%; 95.9%)
			99.6% (95% CI: 98.8%; 99.9%)10.0%
			89.2% (95% CI: 56.4%; 98.0%)
			99.3% (95% CI: 97.5%; 99.8%)20.0%
			94.9% (95% CI: 74.5%; 99.1%)
			98.3% (95% CI: 94.6%; 99.5%)30.0%
			97.0% (95% CI: 83.3%; 99.5%)
			97.2% (95% CI: 91.1%; 99.2%)40.0%
			98.0% (95% CI: 88.6%; 99.7%)
			95.7% (95% CI: 86.8%; 98.8%)50.0%
			98.7% (95% CI: 92.1%; 99.8%)
			93.7% (95% CI: 81.4%; 98.2%)60.0%
			99.1% (95% CI: 94.6%; 99.9%)
			90.8% (95% CI: 74.5%; 97.3%)70.0%
			99.4% (95% CI: 96.5%; 99.9%)
			86.4% (95% CI: 65.2%; 95.9%)80.0%
			99.7% (95% CI: 97.9%; 99.9%)
			78.7% (95% CI: 52.2%; 93.1%)90.0%
			99.9% (95% CI: 99.1%; 100%)
			62.2% (95% CI: 32.7%; 85.7%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataShenzhen New Industries Biomedical Engineering MAGLUMI 2019-nCoV IgM/IgG

**Developer:** Shenzhen New Industries Biomedical Engineering Co., Ltd.**Test:** MAGLUMI 2019-nCoV IgM/IgG**Technology:** CLIA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity (PPA)
			77.5% (110/142)
			(69.9%; 83.6%)IgM
			Specificity (NPA)
			99.6% (225/226)
			(97.5%; 99.9%)IgG
			Sensitivity (PPA)
			100% (142/142)
			(97.4%; 100%)IgG
			Specificity (NPA)
			99.1% (224/226)
			(96.8%; 99.8%)Combined
			Sensitivity (PPA)
			100% (142/142)
			(97.4%; 100%)Combined
			Specificity (NPA)
			98.7% (223/226)
			(96.2%; 99.5%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			79.9% (95% CI: 57.2%; 92.1%)
			100% (95% CI: 99.9%; 100%)10.0%
			89.3% (95% CI: 73.9%; 96.1%)
			100% (95% CI: 99.7%; 100%)20.0%
			95.0% (95% CI: 86.4%; 98.2%)
			100% (95% CI: 99.3%; 100%)30.0%
			97.0% (95% CI: 91.6%; 99.0%)
			100% (95% CI: 98.8%; 100%)40.0%
			98.0% (95% CI: 94.4%; 99.3%)
			100% (95% CI: 98.2%; 100%)50.0%
			98.7% (95% CI: 96.2%; 99.5%)
			100% (95% CI: 97.3%; 100%)60.0%
			99.1% (95% CI: 97.4%; 99.7%)
			100% (95% CI: 96.1%; 100%)70.0%
			99.4% (95% CI: 98.3%; 99.8%)
			100% (95% CI: 94.0%; 100%)80.0%
			99.7% (95% CI: 99.0%; 99.9%)
			100% (95% CI: 90.1%; 100%)90.0%
			99.9% (95% CI: 99.6%; 99.9%)
			100% (95% CI: 80.2%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T)

**Developer:** Siemens Healthcare Diagnostics**Test:** ADVIA Centaur SARS-CoV-2 Total (COV2T)**Technology:** High Throughput CMIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			100% (47/47)
			(92.4%; 100%)Pan-Ig
			Specificity (NPA)
			99.8% (1586/1589)
			(99.4%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			96.5% (95% CI: 89.8%; 98.8%)
			100% (95% CI: 99.6%; 100%)10.0%
			98.3% (95% CI: 94.9%; 99.4%)
			100% (95% CI: 99.2%; 100%)20.0%
			99.3% (95% CI: 97.7%; 99.7%)
			100% (95% CI: 98.1%; 100%)30.0%
			99.6% (95% CI: 98.6%; 99.9%)
			100% (95% CI: 96.8%; 100%)40.0%
			99.7% (95% CI: 99.1%; 99.9%)
			100% (95% CI: 95.2%; 100%)50.0%
			99.8% (95% CI: 99.4%; 99.9%)
			100% (95% CI: 92.9%; 100%)60.0%
			99.9% (95% CI: 99.6%; 100%)
			100% (95% CI: 89.8%; 100%)70.0%
			99.9% (95% CI: 99.7%; 100%)
			100% (95% CI: 84.9%; 100%)80.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 76.7%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 59.4%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T)

**Developer:** Siemens Healthcare Diagnostics**Test:** Atellica IM SARS-CoV-2 Total (COV2T)**Technology:** High Throughput CMIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			100% (42/42)
			(91.6%; 100%)Pan-Ig
			Specificity (NPA)
			99.8% (1089/1091)
			(99.3%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			96.6% (95% CI: 87.9%; 99.1%)
			100% (95% CI: 99.6%; 100%)10.0%
			98.4% (95% CI: 93.9%; 99.5%)
			100% (95% CI: 99.1%; 100%)20.0%
			99.3% (95% CI: 97.2%; 99.8%)
			100% (95% CI: 97.9%; 100%)30.0%
			99.6% (95% CI: 98.3%; 99.9%)
			100% (95% CI: 96.5%; 100%)40.0%
			99.7% (95% CI: 98.9%; 99.9%)
			100% (95% CI: 94.7%; 100%)50.0%
			99.8% (95% CI: 99.3%; 99.9%)
			100% (95% CI: 92.2%; 100%)60.0%
			99.9% (95% CI: 99.5%; 100%)
			100% (95% CI: 88.8%; 100%)70.0%
			99.9% (95% CI: 99.7%; 100%)
			100% (95% CI: 83.6%; 100%)80.0%
			100% (95% CI: 99.8%; 100%)
			100% (95% CI: 74.8%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 56.8%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 IgG (CV2G)

**Developer:** Siemens Healthcare Diagnostics**Test:** Dimension EXL SARS-CoV-2 IgG (CV2G)**Technology:** Semi-quantitative High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (90/90)
			(95.9%; 100%)IgG
			Specificity (NPA)
			100% (1509/1509)
			(99.7%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 95.2%; 100%)
			100% (95% CI: 99.8%; 100%)10.0%
			100% (95% CI: 97.7%; 100%)
			100% (95% CI: 99.5%; 100%)20.0%
			100% (95% CI: 99.0%; 100%)
			100% (95% CI: 99.0%; 100%)30.0%
			100% (95% CI: 99.4%; 100%)
			100% (95% CI: 98.3%; 100%)40.0%
			100% (95% CI: 99.6%; 100%)
			100% (95% CI: 97.3%; 100%)50.0%
			100% (95% CI: 99.7%; 100%)
			100% (95% CI: 96.1%; 100%)60.0%
			100% (95% CI: 99.8%; 100%)
			100% (95% CI: 94.2%; 100%)70.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 91.3%; 100%)80.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 85.9%; 100%)90.0%
			100% (95% CI: 100%; 100%)
			100% (95% CI: 73.0%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)

**Developer:** Siemens Healthcare Diagnostics**Test:** Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)**Technology:** High Throughput ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			100% (79/79)
			(95.4%; 100%)Pan-Ig
			Specificity (NPA)
			99.9% (1527/1529)
			(99.5%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			97.6% (95% CI: 91.3%; 99.3%)
			100% (95% CI: 99.8%; 100%)10.0%
			98.8% (95% CI: 95.7%; 99.7%)
			100% (95% CI: 99.5%; 100%)20.0%
			99.5% (95% CI: 98.0%; 99.9%)
			100% (95% CI: 98.8%; 100%)30.0%
			99.7% (95% CI: 98.8%; 99.9%)
			100% (95% CI: 98.0%; 100%)40.0%
			99.8% (95% CI: 99.3%; 99.9%)
			100% (95% CI: 97.0%; 100%)50.0%
			99.9% (95% CI: 99.5%; 100%)
			100% (95% CI: 95.5%; 100%)60.0%
			99.9% (95% CI: 99.7%; 100%)
			100% (95% CI: 93.5%; 100%)70.0%
			99.9% (95% CI: 99.8%; 100%)
			100% (95% CI: 90.2%; 100%)80.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 84.3%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 70.5%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 IgG (COV2G)

**Developer:** Siemens Healthcare Diagnostics**Test:** Dimension Vista SARS-CoV-2 IgG (COV2G)**Technology:** Semi-quantitative High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (90/90)
			(95.9%; 100%)IgG
			Specificity (NPA)
			100% (1509/1509)
			(99.7%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 95.2%; 100%)
			100% (95% CI: 99.8%; 100%)10.0%
			100% (95% CI: 97.7%; 100%)
			100% (95% CI: 99.5%; 100%)20.0%
			100% (95% CI: 99.0%; 100%)
			100% (95% CI: 99.0%; 100%)30.0%
			100% (95% CI: 99.4%; 100%)
			100% (95% CI: 98.3%; 100%)40.0%
			100% (95% CI: 99.6%; 100%)
			100% (95% CI: 97.3%; 100%)50.0%
			100% (95% CI: 99.7%; 100%)
			100% (95% CI: 96.1%; 100%)60.0%
			100% (95% CI: 99.8%; 100%)
			100% (95% CI: 94.2%; 100%)70.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 91.3%; 100%)80.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 85.9%; 100%)90.0%
			100% (95% CI: 100%; 100%)
			100% (95% CI: 73.0%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)

**Developer:** Siemens Healthcare Diagnostics**Test:** Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)**Technology:** High Throughput ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			100% (79/79)
			(95.4%; 100%)Pan-Ig
			Specificity (NPA)
			99.8% (1526/1529)
			(99.4%; 99.9%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			96.4% (95% CI: 89.7%; 98.7%)
			100% (95% CI: 99.8%; 100%)10.0%
			98.3% (95% CI: 94.9%; 99.4%)
			100% (95% CI: 99.5%; 100%)20.0%
			99.2% (95% CI: 97.6%; 99.7%)
			100% (95% CI: 98.8%; 100%)30.0%
			99.5% (95% CI: 98.6%; 99.8%)
			100% (95% CI: 98.0%; 100%)40.0%
			99.7% (95% CI: 99.1%; 99.9%)
			100% (95% CI: 97.0%; 100%)50.0%
			99.8% (95% CI: 99.4%; 99.9%)
			100% (95% CI: 95.5%; 100%)60.0%
			99.9% (95% CI: 99.6%; 100%)
			100% (95% CI: 93.5%; 100%)70.0%
			99.9% (95% CI: 99.7%; 100%)
			100% (95% CI: 90.2%; 100%)80.0%
			100% (95% CI: 99.8%; 100%)
			100% (95% CI: 84.3%; 100%)90.0%
			100% (95% CI: 99.9%; 100%)
			100% (95% CI: 70.4%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 IgG (sCOVG)

**Developer:** Siemens Healthcare Diagnostics Inc.**Test:** ADVIA Centaur SARS-CoV-2 IgG (sCOVG)**Technology:** Semi-quantitative High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			95.6% (238/249)
			(92.3%; 97.5%)IgG
			Specificity (NPA)
			99.9% (1993/1995)
			(99.6%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			98.0% (95% CI: 93.0%; 99.5%)
			99.8% (95% CI: 99.6%; 99.9%)10.0%
			99.1% (95% CI: 96.6%; 99.7%)
			99.5% (95% CI: 99.1%; 99.7%)20.0%
			99.6% (95% CI: 98.4%; 99.9%)
			98.9% (95% CI: 98.1%; 99.4%)30.0%
			99.8% (95% CI: 99.1%; 99.9%)
			98.1% (95% CI: 96.8%; 98.9%)40.0%
			99.8% (95% CI: 99.4%; 100%)
			97.1% (95% CI: 95.1%; 98.4%)50.0%
			99.9% (95% CI: 99.6%; 100%)
			95.8% (95% CI: 92.8%; 97.6%)60.0%
			99.9% (95% CI: 99.7%; 100%)
			93.8% (95% CI: 89.6%; 96.4%)70.0%
			100% (95% CI: 99.8%; 100%)
			90.6% (95% CI: 84.7%; 94.5%)80.0%
			100% (95% CI: 99.9%; 100%)
			85.0% (95% CI: 76.3%; 91.0%)90.0%
			100% (95% CI: 100%; 100%)
			71.5% (95% CI: 58.9%; 81.7%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSiemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 IgG (sCOVG)

**Developer:** Siemens Healthcare Diagnostics Inc.**Test:** Atellica IM SARS-CoV-2 IgG (sCOVG)**Technology:** Semi-quantitative High Throughput CLIA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			95.6% (238/249)
			(92.3%; 97.5%)IgG
			Specificity (NPA)
			99.9% (1993/1995)
			(99.6%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			98.0% (95% CI: 93.0%; 99.5%)
			99.8% (95% CI: 99.6%; 99.9%)10.0%
			99.1% (95% CI: 96.6%; 99.7%)
			99.5% (95% CI: 99.1%; 99.7%)20.0%
			99.6% (95% CI: 98.4%; 99.9%)
			98.9% (95% CI: 98.1%; 99.4%)30.0%
			99.8% (95% CI: 99.1%; 99.9%)
			98.1% (95% CI: 96.8%; 98.9%)40.0%
			99.8% (95% CI: 99.4%; 100%)
			97.1% (95% CI: 95.1%; 98.4%)50.0%
			99.9% (95% CI: 99.6%; 100%)
			95.8% (95% CI: 92.8%; 97.6%)60.0%
			99.9% (95% CI: 99.7%; 100%)
			93.8% (95% CI: 89.6%; 96.4%)70.0%
			100% (95% CI: 99.8%; 100%)
			90.6% (95% CI: 84.7%; 94.5%)80.0%
			100% (95% CI: 99.9%; 100%)
			85.0% (95% CI: 76.3%; 91.0%)90.0%
			100% (95% CI: 100%; 100%)
			71.5% (95% CI: 58.9%; 81.7%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for UseSugentech SGTi-flex COVID-19 IgG

**Developer:** Sugentech, Inc.**Test:** SGTi-flex COVID-19 IgG**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)IgG
			Specificity
			100% (80/80)
			(95.4%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 48.9%; 100%)
			99.8% (95% CI: 99.1%; 100%)10.0%
			100% (95% CI: 66.9%; 100%)
			99.6% (95% CI: 98.1%; 99.9%)20.0%
			100% (95% CI: 82.0%; 100%)
			99.2% (95% CI: 95.8%; 99.9%)30.0%
			100% (95% CI: 88.6%; 100%)
			98.6% (95% CI: 93.0%; 99.7%)40.0%
			100% (95% CI: 92.4%; 100%)
			97.8% (95% CI: 89.6%; 99.6%)50.0%
			100% (95% CI: 94.8%; 100%)
			96.8% (95% CI: 85.1%; 99.4%)60.0%
			100% (95% CI: 96.5%; 100%)
			95.2% (95% CI: 79.2%; 99.1%)70.0%
			100% (95% CI: 97.7%; 100%)
			92.8% (95% CI: 71.0%; 98.6%)80.0%
			100% (95% CI: 98.6%; 100%)
			88.2% (95% CI: 58.9%; 97.7%)90.0%
			100% (95% CI: 99.4%; 100%)
			76.9% (95% CI: 38.9%; 95.0%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataSymbiotica, Inc. COVID-19 Self-Collected Antibody Test System

**Developer:** Symbiotica, Inc.**Test:** COVID-19 Self-Collected Antibody Test System**Technology:** ELISA (with home collection)**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity (PPA)
			100% (28/28)
			(87.9%; 100%)IgG
			Specificity (NPA)
			98.0% (50/51)
			(89.7%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			72.9% (95% CI: 31.0%; 93.8%)
			100% (95% CI: 99.3%; 100%)10.0%
			85.0% (95% CI: 48.7%; 97.0%)
			100% (95% CI: 98.5%; 100%)20.0%
			92.7% (95% CI: 68.1%; 98.6%)
			100% (95% CI: 96.7%; 100%)30.0%
			95.6% (95% CI: 78.5%; 99.2%)
			100% (95% CI: 94.6%; 100%)40.0%
			97.1% (95% CI: 85.1%; 99.5%)
			100% (95% CI: 91.8%; 100%)50.0%
			98.1% (95% CI: 89.5%; 99.7%)
			100% (95% CI: 88.1%; 100%)60.0%
			98.7% (95% CI: 92.8%; 99.8%)
			100% (95% CI: 83.2%; 100%)70.0%
			99.2% (95% CI: 95.2%; 99.9%)
			100% (95% CI: 76.1%; 100%)80.0%
			99.5% (95% CI: 97.2%; 99.9%)
			100% (95% CI: 65.0%; 100%)90.0%
			99.8% (95% CI: 98.7%; 100%)
			100% (95% CI: 45.2%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	EUA SummaryTBG Biotechnology TBG SARS-CoV-2 IgG / IgM Rapid Test Kit

**Developer:** TBG Biotechnology Corp.**Test:** TBG SARS-CoV-2 IgG / IgM Rapid Test Kit**Technology:** Lateral Flow**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)IgM
			Specificity
			95.0% (76/80)
			(87.8%; 98.0%)IgG
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)IgG
			Specificity
			96.2% (77/80)
			(89.5%; 98.7%)Combined
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)Combined
			Specificity
			95.0% (76/80)
			(87.8%; 98.0%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			49.6% (95% CI: 25.4%; 72.5%)
			99.6% (95% CI: 98.7%; 99.9%)10.0%
			67.5% (95% CI: 41.8%; 84.8%)
			99.2% (95% CI: 97.4%; 99.8%)20.0%
			82.4% (95% CI: 61.8%; 92.6%)
			98.3% (95% CI: 94.3%; 99.5%)30.0%
			88.9% (95% CI: 73.5%; 95.5%)
			97.1% (95% CI: 90.6%; 99.2%)40.0%
			92.6% (95% CI: 81.2%; 97.1%)
			95.5% (95% CI: 86.1%; 98.8%)50.0%
			94.9% (95% CI: 86.6%; 98.0%)
			93.4% (95% CI: 80.5%; 98.2%)60.0%
			96.6% (95% CI: 90.7%; 98.7%)
			90.5% (95% CI: 73.3%; 97.3%)70.0%
			97.8% (95% CI: 93.8%; 99.2%)
			85.9% (95% CI: 63.8%; 95.8%)80.0%
			98.7% (95% CI: 96.3%; 99.5%)
			78.1% (95% CI: 50.7%; 93.0%)90.0%
			99.4% (95% CI: 98.3%; 99.8%)
			61.3% (95% CI: 31.4%; 85.5%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataThermo Fisher Scientific OmniPATH COVID-19 Total Antibody ELISA Test

**Developer:** Thermo Fisher Scientific**Test:** OmniPATH COVID-19 Total Antibody ELISA Test**Technology:** ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)Pan-Ig
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			67.1% (95% CI: 33.6%; 88.4%)
			99.8% (95% CI: 99.0%; 100%)10.0%
			81.1% (95% CI: 51.7%; 94.1%)
			99.6% (95% CI: 98.0%; 99.9%)20.0%
			90.6% (95% CI: 70.6%; 97.3%)
			99.2% (95% CI: 95.6%; 99.9%)30.0%
			94.3% (95% CI: 80.5%; 98.4%)
			98.6% (95% CI: 92.7%; 99.7%)40.0%
			96.3% (95% CI: 86.5%; 99.0%)
			97.8% (95% CI: 89.2%; 99.6%)50.0%
			97.5% (95% CI: 90.6%; 99.3%)
			96.7% (95% CI: 84.6%; 99.4%)60.0%
			98.3% (95% CI: 93.5%; 99.5%)
			95.1% (95% CI: 78.5%; 99.1%)70.0%
			98.9% (95% CI: 95.7%; 99.7%)
			92.6% (95% CI: 70.1%; 98.6%)80.0%
			99.4% (95% CI: 97.5%; 99.8%)
			88.0% (95% CI: 57.8%; 97.7%)90.0%
			99.7% (95% CI: 98.9%; 99.9%)
			76.5% (95% CI: 37.8%; 94.9%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataUnited Biomedical UBI SARS-CoV-2 ELISA

**Developer:** United Biomedical, Inc.**Test:** UBI SARS-CoV-2 ELISA**Technology:** ELISA**Target:** Spike, Nucleocapsid, and Membrane

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity
			89.7% (52/58)
			(79.2%; 95.2%)IgG
			Specificity
			100% (97/97)
			(96.2%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 52.3%; 100%)
			99.5% (95% CI: 98.9%; 99.7%)10.0%
			100% (95% CI: 69.8%; 100%)
			98.9% (95% CI: 97.7%; 99.5%)20.0%
			100% (95% CI: 83.9%; 100%)
			97.5% (95% CI: 94.9%; 98.8%)30.0%
			100% (95% CI: 89.9%; 100%)
			95.8% (95% CI: 91.5%; 98.0%)40.0%
			100% (95% CI: 93.3%; 100%)
			93.5% (95% CI: 87.4%; 96.9%)50.0%
			100% (95% CI: 95.4%; 100%)
			90.6% (95% CI: 82.2%; 95.4%)60.0%
			100% (95% CI: 96.9%; 100%)
			86.6% (95% CI: 75.5%; 93.2%)70.0%
			100% (95% CI: 98.0%; 100%)
			80.6% (95% CI: 66.5%; 89.9%)80.0%
			100% (95% CI: 98.8%; 100%)
			70.7% (95% CI: 53.6%; 83.8%)90.0%
			100% (95% CI: 99.5%; 100%)
			51.8% (95% CI: 34.0%; 69.7%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (1)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (2)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report (Combined)
	NCI's Frederick National Laboratory for Cancer Research Evaluation Data (Combined)University of Arizona COVID-19 ELISA pan-Ig Antibody Test

**Developer:** University of Arizona Genetics Core for Clinical Services**Test:** COVID-19 ELISA pan-Ig Antibody Test**Technology:** 2-Step ELISA**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			97.5% (39/40)
			(87.1%; 99.6%)Pan-Ig
			Specificity (NPA)
			99.1% (317/320)
			(97.3%; 99.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			84.6% (95% CI: 62.8%; 94.3%)
			99.9% (95% CI: 99.3%; 100%)10.0%
			92.0% (95% CI: 78.1%; 97.2%)
			99.7% (95% CI: 98.6%; 100%)20.0%
			96.3% (95% CI: 88.9%; 98.7%)
			99.4% (95% CI: 96.8%; 99.9%)30.0%
			97.8% (95% CI: 93.2%; 99.3%)
			98.9% (95% CI: 94.6%; 99.8%)40.0%
			98.6% (95% CI: 95.5%; 99.5%)
			98.3% (95% CI: 91.9%; 99.7%)50.0%
			99.0% (95% CI: 97.0%; 99.7%)
			97.5% (95% CI: 88.3%; 99.6%)60.0%
			99.4% (95% CI: 98.0%; 99.8%)
			96.4% (95% CI: 83.4%; 99.3%)70.0%
			99.6% (95% CI: 98.7%; 99.9%)
			94.4% (95% CI: 76.4%; 99.0%)80.0%
			99.8% (95% CI: 99.2%; 99.9%)
			90.8% (95% CI: 65.4%; 98.3%)90.0%
			99.9% (95% CI: 99.7%; 100%)
			81.5% (95% CI: 45.6%; 96.2%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	EUA SummaryVibrant America Clinical Labs Vibrant COVID-19 Ab Assay

**Developer:** Vibrant America Clinical Labs**Test:** Vibrant COVID-19 Ab Assay**Technology:** High Throughput CLIA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalCombined
			Sensitivity (PPA)
			98.1% (52/53)
			(90.1%; 99.7%)Combined
			Specificity (NPA)
			98.6% (494/501)
			(97.1%; 99.3%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			78.7% (95% CI: 62.4%; 88.6%)
			99.9% (95% CI: 99.5%; 100%)10.0%
			88.6% (95% CI: 77.8%; 94.2%)
			99.8% (95% CI: 98.9%; 100%)20.0%
			94.6% (95% CI: 88.7%; 97.3%)
			99.5% (95% CI: 97.5%; 99.9%)30.0%
			96.8% (95% CI: 93.1%; 98.4%)
			99.2% (95% CI: 95.8%; 99.9%)40.0%
			97.9% (95% CI: 95.5%; 99.0%)
			98.7% (95% CI: 93.6%; 99.8%)50.0%
			98.6% (95% CI: 96.9%; 99.3%)
			98.1% (95% CI: 90.7%; 99.7%)60.0%
			99.1% (95% CI: 97.9%; 99.5%)
			97.2% (95% CI: 86.7%; 99.5%)70.0%
			99.4% (95% CI: 98.7%; 99.7%)
			95.7% (95% CI: 80.7%; 99.2%)80.0%
			99.6% (95% CI: 99.2%; 99.8%)
			92.9% (95% CI: 71.0%; 98.7%)90.0%
			99.8% (95% CI: 99.6%; 99.9%)
			85.3% (95% CI: 52.1%; 97.1%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	EUA SummaryWadsworth New York SARS-CoV Microsphere Immunoassay for Antibody Detection

**Developer:** Wadsworth Center, New York State Department of Health**Test:** New York SARS-CoV Microsphere Immunoassay for Antibody Detection**Technology:** MIA**Target:** Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity (PPA)
			88.0% (95/108)
			(80.5%; 92.8%)Pan-Ig
			Specificity (NPA)
			98.8% (428/433)
			(97.3%; 99.5%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			80.0% (95% CI: 61.3%; 90.8%)
			99.4% (95% CI: 99.0%; 99.6%)10.0%
			89.4% (95% CI: 77.0%; 95.4%)
			98.7% (95% CI: 97.8%; 99.2%)20.0%
			95.0% (95% CI: 88.3%; 97.9%)
			97.0% (95% CI: 95.2%; 98.2%)30.0%
			97.0% (95% CI: 92.8%; 98.8%)
			95.0% (95% CI: 92.1%; 97.0%)40.0%
			98.1% (95% CI: 95.3%; 99.2%)
			92.5% (95% CI: 88.2%; 95.4%)50.0%
			98.7% (95% CI: 96.8%; 99.5%)
			89.1% (95% CI: 83.3%; 93.3%)60.0%
			99.1% (95% CI: 97.8%; 99.6%)
			84.6% (95% CI: 76.9%; 90.2%)70.0%
			99.4% (95% CI: 98.6%; 99.8%)
			77.9% (95% CI: 68.1%; 85.6%)80.0%
			99.7% (95% CI: 99.2%; 99.9%)
			67.2% (95% CI: 55.5%; 77.6%)90.0%
			99.9% (95% CI: 99.6%; 99.9%)
			47.7% (95% CI: 35.7%; 60.7%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	EUA SummaryXiamen Biotime Biotechnology BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test

**Developer:** Xiamen Biotime Biotechnology Co., Ltd.**Test:** BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test**Technology:** Lateral Flow**Target:** Spike

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgM
			Sensitivity
			100% (30/30)
			(88.7%; 100%)IgM
			Specificity
			98.8% (79/80)
			(93.3%; 99.8%)IgG
			Sensitivity
			96.7% (29/30)
			(83.3%; 99.4%)IgG
			Specificity
			97.5% (78/80)
			(91.3%; 99.3%)Combined
			Sensitivity
			100% (30/30)
			(88.7%; 100%)Combined
			Specificity
			96.2% (77/80)
			(89.5%; 98.7%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			58.4% (95% CI: 30.9%; 80.4%)
			100% (95% CI: 99.3%; 100%)10.0%
			74.8% (95% CI: 48.5%; 89.7%)
			100% (95% CI: 98.6%; 100%)20.0%
			87.0% (95% CI: 67.9%; 95.1%)
			100% (95% CI: 96.9%; 100%)30.0%
			92.0% (95% CI: 78.4%; 97.1%)
			100% (95% CI: 94.8%; 100%)40.0%
			94.7% (95% CI: 85.0%; 98.1%)
			100% (95% CI: 92.2%; 100%)50.0%
			96.4% (95% CI: 89.5%; 98.7%)
			100% (95% CI: 88.8%; 100%)60.0%
			97.6% (95% CI: 92.7%; 99.2%)
			100% (95% CI: 84.0%; 100%)70.0%
			98.4% (95% CI: 95.2%; 99.5%)
			100% (95% CI: 77.2%; 100%)80.0%
			99.1% (95% CI: 97.1%; 99.7%)
			100% (95% CI: 66.4%; 100%)90.0%
			99.6% (95% CI: 98.7%; 99.9%)
			100% (95% CI: 46.7%; 100%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataZEUS Scientific ZEUS ELISA SARS-CoV-2 IgG Test System

**Developer:** ZEUS Scientific, Inc.**Test:** ZEUS ELISA SARS-CoV-2 IgG Test System**Technology:** ELISA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalIgG
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)IgG
			Specificity
			100% (70/70)
			(94.8%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 44.3%; 100%)
			99.7% (95% CI: 98.8%; 99.9%)10.0%
			100% (95% CI: 62.7%; 100%)
			99.3% (95% CI: 97.6%; 99.8%)20.0%
			100% (95% CI: 79.1%; 100%)
			98.4% (95% CI: 94.7%; 99.5%)30.0%
			100% (95% CI: 86.6%; 100%)
			97.2% (95% CI: 91.2%; 99.2%)40.0%
			100% (95% CI: 91.0%; 100%)
			95.7% (95% CI: 87.0%; 98.8%)50.0%
			100% (95% CI: 93.8%; 100%)
			93.8% (95% CI: 81.6%; 98.2%)60.0%
			100% (95% CI: 95.8%; 100%)
			90.9% (95% CI: 74.8%; 97.3%)70.0%
			100% (95% CI: 97.2%; 100%)
			86.5% (95% CI: 65.6%; 95.9%)80.0%
			100% (95% CI: 98.4%; 100%)
			78.9% (95% CI: 52.6%; 93.1%)90.0%
			100% (95% CI: 99.3%; 100%)
			62.5% (95% CI: 33.1%; 85.8%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 Total Antibody Test System

**Developer:** ZEUS Scientific, Inc.**Test:** ZEUS ELISA SARS-CoV-2 Total Antibody Test System**Technology:** ELISA**Target:** Spike and Nucleocapsid

Antibody
			Performance Measure
			Estimate of Performance
			95% Confidence IntervalPan-Ig
			Sensitivity
			93.3% (28/30)
			(78.7%; 98.2%)Pan-Ig
			Specificity
			100% (70/70)
			(94.8%; 100%)

Prevalence Assumption
			Estimate of PPV
			Estimate of NPV5.0%
			100% (95% CI: 44.3%; 100%)
			99.7% (95% CI: 98.8%; 99.9%)10.0%
			100% (95% CI: 62.7%; 100%)
			99.3% (95% CI: 97.6%; 99.8%)20.0%
			100% (95% CI: 79.1%; 100%)
			98.4% (95% CI: 94.7%; 99.5%)30.0%
			100% (95% CI: 86.6%; 100%)
			97.2% (95% CI: 91.2%; 99.2%)40.0%
			100% (95% CI: 91.0%; 100%)
			95.7% (95% CI: 87.0%; 98.8%)50.0%
			100% (95% CI: 93.8%; 100%)
			93.8% (95% CI: 81.6%; 98.2%)60.0%
			100% (95% CI: 95.8%; 100%)
			90.9% (95% CI: 74.8%; 97.3%)70.0%
			100% (95% CI: 97.2%; 100%)
			86.5% (95% CI: 65.6%; 95.9%)80.0%
			100% (95% CI: 98.4%; 100%)
			78.9% (95% CI: 52.6%; 93.1%)90.0%
			100% (95% CI: 99.3%; 100%)
			62.5% (95% CI: 33.1%; 85.8%)**Test Facts:**

Information for Healthcare Providers
	Information for Recipients
	Instructions for Use
	NCI's Frederick National Laboratory for Cancer Research Evaluation Report
	NCI's Frederick National Laboratory for Cancer Research Evaluation DataA note about the performance measures calculated:

In some cases, there may be minor differences between the numbers on this page and those in the instructions for use. Confidence intervals for sensitivity and specificity that appear on this page were calculated per a score method described in CLSI EP12-A2 (2008). See Recognized Consensus Standards. Confidence intervals for PPV and NPV were calculated using the values from the 95% confidence intervals for sensitivity and specificity.

                                                                                  Content current as of:
      08/22/2022
              
              
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