IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.
Purpose
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
- SARS-CoV 2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
| 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. |
|
Recruiting Locations
Fadi A. Haddad MD Inc.
La Mesa, California 91942
La Mesa, California 91942
Sharp Grossmont Hospital
La Mesa, California 91942
La Mesa, California 91942
Sharp Memorial Hosptial
San Diego, California 92123
San Diego, California 92123
More Details
- NCT ID
- NCT04402814
- Status
- Unknown status
- Sponsor
- Fadi Haddad, M.D.
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.