SARS-CoV-2 IgG and IgM Serologic Assays

Overview: The design validation strategy for this study is to validate the detection of
COVID-19 antibodies in subjects at Henry Ford Health System (HFHS) who test negative or
positive with RT-PCR for SARS-CoV-2 using a fully automated system. This is a study of the
immune response of subjects who have recovered from COVID-19 infection.

Methods: There are now commercial testing products from major invitro diagnostic diagnostics
companies that appear to have been developed with significantly greater test performance in
mind. HFHS (HFHS) intends to make this testing available in the near future after a rigorous
verification of analytical performance. This verification will be done in collaboration a
with select and proven IVD partner.

All HFHS patients > 18 years of age who were evaluated and who have COVID-19 PCR test results
will have their medical records studies and a left-over specimen tested for validation
purposes. This validation study will begin May 15, 2020 through November 15, 2020.

Impact: IVD manufacturers must rely on test specimens from suppliers (typically hospitals and
reference laboratories) and attempt to replicate the test performance that will be achieved
in the actual medical testing environment. In fact, samples collected and provided to vendors
are usually at the convenience of the supplying institution. Data on the real-world
performance of COVID-19 antibody tests derived from this study will have significant
implications for patients and health systems, including patient disposition, risk prediction,
return to work decisions, health system operations and more. Furthermore, assessment of
immunity in patients with minimal or symptom free infections will provide rich knowledge to
assess if certain patients need further risk mitigations (masks, distancing) and which may be
safely return to more normal activities.