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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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.

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.

Eligibility

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)

Study details
    SARS-CoV 2

NCT04402814

Fadi Haddad, M.D.

1 February 2023

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