Question: Does a lab need a certificate to be able to test for Covid 19?

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
My facility would like to begin SARS-CoV-2 testing. Do we need a Clinical Laboratory Improvement Amendments (CLIA) certificate? Can my facility be granted a waiver from the CLIA certification requirements so that I can begin testing immediately?
section_content: Before conducting SARS-CoV-2 viral testing, a laboratory must be CLIA-
certified and meet applicable regulatory requirements. The Centers for
Medicare and Medicaid Services (CMS) does not have the authority to grant
waivers of exceptions that are not established in a statute or regulation. For
additional information, please refer to the FAQs on the CMS website: CMS
Coronavirus Informationexternal icon.

Reviewer feedback on this answer:
The answer directly states what certification a lab has to have in order to do testing.
This answer is excellent because it directly answers the question by stating that yes, a lab must be certified in order to conduct COVID testing.

Reviewer ratings:
Excellent
Excellent

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
Under what circumstances should laboratories use either a SARS-CoV-2 viral or serology (antibody) test that has received EUA from FDA?
section_content: FDA has authorized EUAs for both viral and antibody tests for COVID-19. Viral
(nucleic acid and antigen) tests are used to diagnose the presence of SARS-
CoV-2 infections. In contrast, antibody tests can detect IgG, IgA, and IgM
antibodies from an immune response to SARS-CoV-2.
Whenever possible, laboratories should rely on viral tests to diagnose the
presence of SARS-CoV-2 infections. However, a negative result from viral
testing does not rule out COVID-19.
Most of the PCR-based tests that use two or more targets are likely to have
high specificity (few false positives). However, there is some variation in
the stated sensitivity of the different assays, and sensitivity is highly
dependent on the stage of the disease. For this reason, negative results
should always be interpreted in the context of the exposure history and
symptoms of the patient.
Results from antibody testing should not be used to diagnose or exclude SARS-
CoV-2 infections or to inform infection status. Negative results from antibody
testing do not rule out SARS-CoV-2 infections, particularly for those
individuals who have been exposed to the virus and are still within the
estimated incubation period. Until the performance characteristics of antibody
tests have been evaluated, it is possible that positive results from such
testing may be due to past or present infections with a coronavirus other than
SARS-CoV-2.
If a laboratory initially uses antibody testing for diagnostic purposes,
follow-up testing using a viral test should be performed.
Read: Important Information on the Use of Serological (Antibody) Tests for
COVID-19: FDA Letter to Healthcare Providersexternal
icon
More: FDA EUA Authorized Serology Test Performanceexternal
icon

Reviewer feedback on this answer:
The passage offers a lot of information about testing, but there is no information about whether or not a lab has to have a certification in order to run testing.
This answer is acceptable because it gives information about labs and who can conduct COVID tests. It is not excellent because it contains too much extra information that does not relate to the question.

Reviewer ratings:
Could be Improved
Acceptable

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
How do I apply for a CLIA certificate so that my testing facility can perform SARS-CoV-2 testing?
section_content: The federal CLIA program contracts with states to carry out certain oversight
and recording functions of the CLIA program. The state in which the laboratory
is located processes applications for CLIA certificates. After the laboratory
has identified a qualified and certified laboratory directorexternal
icon and has
provided all required information on the CMS-116 application, a CLIA number
will be assigned and the laboratory can begin testing if applicable CLIA
requirements have been met. For additional information, please refer to the
FAQs on the CMS website: CMS Coronavirus Informationexternal
icon.

Reviewer feedback on this answer:
The answer states exactly what type of certificate a lab has to have to be able to test.
This answer is acceptable because it does answer the question, but not explicitly. It takes an assumption to link the answer to the question.

Reviewer ratings:
Excellent
Acceptable