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NCT04496141 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04496141
Other study ID # RC-2020-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 27, 2020
Est. completion date August 31, 2020

Study information
Verified date February 2024
Source Hong Kong Sanatorium & Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria for COVID-19 infected sera: any patient with PCR confirmed COVID-19 infection Inclusion criteria for COVID-19 negative sera: sera collected after a negative SARS-CoV-2 PCR Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• SARS-CoV-2 antibody immunoassays
Different commercial SARS-CoV-2 antibody immunoassays

Locations
Country Name City State
Hong Kong Hong Kong Sanatorium & Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Hong Kong Sanatorium & Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary The accuracy of the different commercial SARS-CoV-2 antibody immunoassays To investigate the accuracy (including sensitivity, specificity, positive and negative predictive value) of the commercial SARS-CoV-2 antibody immunoassays 1 month
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