Clinical trial NCT04562246: SARS-CoV-2 IgG and IgM Serologic Assays
Official title: Laboratory Validation of SARS-CoV-2 IgG and IgM Serologic Assays on an Automated Immunoassay System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 500, but up to 1000 subjects will be enrolled from a retrospective data review and a laboratory information system (LIS) SunQuest identification of COVID-19 (RT-PCR SARS CoV-2) samples.

Brief summary: The primary objective is to assess and validate the ability of the Beckman Coulter Access COVID-19 IgG and IgM assays to detect immunity in COVID-19 patients in the Henry Ford Hospital Health System.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age; COVID-19 by RT-PCR SARS-CoV-2 assay. (Phase I)

Exclusion Criteria:

* Subjects who tested for COVID-19, but have no available serum specimen.

Primary outcomes:
measure: Prevalence of antibodies to SARS-CoV-2
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References: