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.
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.
Diagnostic Test: Clungene rapid test cassette
Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
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)
Fadi A. Haddad MD Inc.
La Mesa, California, United States
Sharp Grossmont Hospital
La Mesa, California, United States
Sharp Memorial Hosptial
San Diego, California, United States
Kathryn Miller
858-939-7162
kathryn.miller@sharp.com
Divina Fanning, RN
(619)823-7347
divina.fanning@sharp.com
Fadi Haddad, MD, Principal Investigator
Sharp HealthCare