IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.

Detailed Description
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This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 test.

Official Title
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Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19

Conditions
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SARS-CoV 2

Intervention / Treatment
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* Diagnostic Test: Clungene rapid test cassette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing. Age >/=18 years old. Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail. Able to read/write/speak English or Spanish fluently. Subjects must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information. Hospitalized at the time of consent or recently discharged with leftover blood stored at hospital laboratory Exclusion Criteria: Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A (positive for COVID-19)<br>One or two samples of your blood that were previously collected for routine care will be obtained from the hospital laboratory and will be tested for the antibodies against COVID-19 virus. First blood sample obtained: 7 to 12 days following onset of symptoms; and/or Second blood sample obtained: 12 to 40 days following the onset of symptoms. | Diagnostic Test: Clungene rapid test cassette<br>* Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.<br>|
| Arm B (negative for COVID-19)<br>One sample of blood that was collected for routine care at any point during hospitalization will be obtained from the hospital laboratory and will be tested for the antibodies. | Diagnostic Test: Clungene rapid test cassette<br>* Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG/IgM antibodies | Presence of IgG and/or IgM antibodies | from date of consent to date of test completion, up to 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus, COVID-19, Clungene, IgG/IgM antibodies