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

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    Fadi Haddad, M.D.
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Updated on 19 February 2024
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SARS
acute respiratory syndrome (sars)

Summary

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.

Details
Condition SARS-CoV 2
Age 18-100 years
Treatment Clungene rapid test cassette
Clinical Study IdentifierNCT04402814
SponsorFadi Haddad, M.D.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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)
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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