SARS-CoV-2 IgG and IgM Serologic Assays

NCT ID: NCT04562246

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 214 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2024-02-26

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PCR positive subjects

Patients who receive positive test result from RT-PCR for SARS-CoV-2.

Serologic assays for antibodies to SARS-CoV-2

Intervention Type: DIAGNOSTIC_TEST

Beckman Coulter and Roche automated immunoassays

Interventions

Serologic assays for antibodies to SARS-CoV-2

Beckman Coulter and Roche automated immunoassays

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Bernard Cook

Division Head, Chemistry-Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

Other Identifiers

13839

Identifier Type: -

Identifier Source: org_study_id