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

Hong Kong Sanatorium & Hospital70 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Covid19

Interventions

SARS-CoV-2 antibody immunoassaysDIAGNOSTIC_TEST

Different commercial SARS-CoV-2 antibody immunoassays

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (1)

Hong Kong Sanatorium & Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

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

Time frame: 1 month

Data from ClinicalTrials.gov

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