Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: SARS-CoV-2 antibody immunoassays

• Registration Number: NCT04496141
• Lead Sponsor: Hong Kong Sanatorium & Hospital

Brief Summary

Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the immunoassays is then assessed by comparing the 2 groups of samples.

Detailed Description

Achieved serum samples of the different testing groups are retrieved and tested with the immunoassays according to manufacturer's instruction.

The test results are then compared and analyzed with statistical tests to assess the immunoassays'performance

Study Timeline

• Study Start: 2020-07-27
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-03
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With COVID-19 infection	SARS-CoV-2 antibody immunoassays	Subjects with a positive SARS-CoV-2 PCR
Without COVID-19 infection	SARS-CoV-2 antibody immunoassays	Subjects with COVID-19 negative serum

Primary Outcome Measures

Name	Time	Method
The accuracy of the different commercial SARS-CoV-2 antibody immunoassays	1 month	To investigate the accuracy (including sensitivity, specificity, positive and negative predictive value) of the commercial SARS-CoV-2 antibody immunoassays

Trial Locations

Locations (1)

Hong Kong Sanatorium & Hospital; 🇭🇰 Hong Kong, Hong Kong