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

Fadi Haddad, M.D.

Status: Unknown

Conditions: SARS-CoV 2

Treatments: Diagnostic Test: Clungene rapid test cassette

Study type: Observational

Funder types: Other

Identifiers

NCT04402814

2005801 (Other Identifier)

IgG/IgM COVID19

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

90 participants in 2 patient groups

Arm A (positive for COVID-19)

Description:

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.

Treatment:

Diagnostic Test: Clungene rapid test cassette

Arm B (negative for COVID-19)

Description:

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.

Treatment:

Diagnostic Test: Clungene rapid test cassette