IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Arm A (positive for COVID-19) 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
Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
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Arm B (negative for COVID-19) 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
Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
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Outcome Measures
Primary Outcome Measures
- IgG/IgM antibodies [from date of consent to date of test completion, up to 40 days]
Presence of IgG and/or IgM antibodies
Eligibility Criteria
Criteria
Inclusion Criteria:
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Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing.
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Age >/=18 years old.
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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.
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Able to read/write/speak English or Spanish fluently.
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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.
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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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Fadi A. Haddad MD Inc. | La Mesa | California | United States | 91942 |
2 | Sharp Grossmont Hospital | La Mesa | California | United States | 91942 |
3 | Sharp Memorial Hosptial | San Diego | California | United States | 92123 |
Sponsors and Collaborators
- Fadi Haddad, M.D.
Investigators
- Principal Investigator: Fadi Haddad, MD, Sharp HealthCare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IgG/IgM COVID19
- 2005801