SARS-CoV-2 IgG and IgM Serologic Assays

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562246
• Other study ID #: 13839
• Status: Completed
• Start date: August 14, 2020
• Est. completion date: February 26, 2024

Study information

• Verified date: February 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: February 26, 2024
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Serologic assays for antibodies to SARS-CoV-2
Beckman Coulter and Roche automated immunoassays

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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