SARS-CoV-2 IgG and IgM Serologic Assays

Laboratory Validation of SARS-CoV-2 IgG and IgM Serologic Assays on an Automated Immunoassay System

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Serologic assays for antibodies to SARS-CoV-2

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.

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCR positive subjects; Patients who receive positive test result from RT-PCR for SARS-CoV-2.	Diagnostic test: Serologic assays for antibodies to SARS-CoV-2; Beckman Coulter and Roche automated immunoassays

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of antibodies to SARS-CoV-2	Assessment of prevalence of antibodies to SARS-CoV-2 in subjects tested positive by RT-PCR	12 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 13839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No