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The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.
The design strategy for this study is to validate the detection of COVID-19 antibodies in subjects at HFHS who test positive with RT-PCR for SARS-CoV-2 using fully automated test systems already in the core automated laboratory at HFH. This is a study of the immune response and kidney health of subjects who have recovered from COVID-19 infection.
There are 4 aims:
Aim 1. Assess detection of COVID-19 antibodies in subjects before discharge from HFHS who tested positive with RT-PCR for SARS-CoV-2 using fully automated immunoassays.
Aim 2. Evaluate emergence of immunity over a one-year period in subjects who tested positive with RT-PCR for SARS-CoV-2 using a fully-automated immunoassays.
Aim 3. Monitor renal function and kidney health at 6 and 12- months post diagnosis with COVID-19.
Aim 4. Determine if SAR-COV-2 can be detected in the saliva of patients over a one year period after a positive PCR test.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serologic immunoassays to SARS-CoV-2 antibodies | Diagnostic Test | Detect and characterize antibodies to SARS-CoV-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of antibodies to SARS-CoV-2 in human serum and plasma | The study will assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months. The study will use Beckman Coulter anti-Spike IgG assay and Roche anti-Nucleocapsid assay. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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subjects will be identified from a retrospective data review and a laboratory information system (LIS) SunQuest identification of COVID-19 positive (RT-PCR SARS CoV-2) samples or who are already participating in the TCRC collection protocol. This study will recruit subjects in which a baseline serum sample was already obtained either through standard of care procedures or through voluntary participation in the TCRC biorepository.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |