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OpenTrials
Completed

NCT Number: NCT04496141

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hong Kong Sanatorium & Hospital

Hong Kong

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

SARS-CoV-2 antibody immunoassays

Diagnostic Test

Different commercial SARS-CoV-2 antibody immunoassays

Primary outcomes

  1. The accuracy of the different commercial SARS-CoV-2 antibody immunoassays

    Time frame: 1 month

    To investigate the accuracy (including sensitivity, specificity, positive and negative predictive value) of the commercial SARS-CoV-2 antibody immunoassays

Sponsors and collaborators

Lead sponsor

Hong Kong Sanatorium & Hospital

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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