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

HKSH Medical Group

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: SARS-CoV-2 antibody immunoassays

Study type: Observational

Funder types: Industry

Identifiers

NCT04496141

RC-2020-12

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

70 participants in 2 patient groups

With COVID-19 infection

Description:

Subjects with a positive SARS-CoV-2 PCR

Treatment:

Diagnostic Test: SARS-CoV-2 antibody immunoassays

Without COVID-19 infection

Description:

Subjects with COVID-19 negative serum

Treatment:

Diagnostic Test: SARS-CoV-2 antibody immunoassays