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| ID | Type | Description | Link |
|---|---|---|---|
| 2005801 | Other Identifier | Sharp HealthCare Institutional Review Board (SHC IRB) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clungene rapid test cassette | Diagnostic Test | Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette. |
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| Measure | Description | Time Frame |
|---|---|---|
| IgG/IgM antibodies | Presence of IgG and/or IgM antibodies | from date of consent to date of test completion, up to 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19 with the standard method of testing.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Miller | Contact | 858-939-7162 | kathryn.miller@sharp.com | |
| Divina Fanning, RN | Contact | (619)823-7347 | divina.fanning@sharp.com |
| Name | Affiliation | Role |
|---|---|---|
| Fadi Haddad, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fadi A. Haddad MD Inc. | Recruiting | La Mesa | California | 91942 | United States |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Sharp Grossmont Hospital | Recruiting | La Mesa | California | 91942 | United States |
|
| Sharp Memorial Hosptial | Recruiting | San Diego | California | 92123 | United States |
|
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |