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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04496141

Enrollment

Registered

2020-08-03

Start date

2020-07-27

Completion date

2020-08-31

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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

Interventions

DIAGNOSTIC_TESTSARS-CoV-2 antibody immunoassays

Different commercial SARS-CoV-2 antibody immunoassays

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026