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.
Diagnostic Test: Serologic immunoassays to SARS-CoV-2 antibodies
Detect and characterize antibodies to SARS-CoV-2
Inclusion Criteria:
- Patients ≥18 years of age
- Positive COVID-19 by RT-PCR SARS-CoV-2 assay
- Patients must have a serum sample stored by pathology or within the TCRC biorepository
around the date of their COVID-19 RT-PCR positive test
Exclusion Criteria:
- < 18 years of age
- negative for RT-PCR
- no serum sample
Henry Ford Health System
Detroit, Michigan, United States
Investigator: Bernard C Cook
Contact: 313-916-0134
bcook10@hfhs.org
Bernard C Cook, PhD
3139160134
bcook10@hfhs.org
John Zajechowski, BS
313-916-9114
JZAJECH1@hfhs.org