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

February 26, 2024 updated by: Dr. Jonpaul ST Zee, Hong Kong Sanatorium & Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Hong Kong Sanatorium & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who attended clinic and had a positive SARS-CoV-2 PCR and subjects who had COVID-19 negative serum during the epidemic in Hong Kong.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
With COVID-19 infection
Subjects with a positive SARS-CoV-2 PCR
Diagnostic test: SARS-CoV-2 antibody immunoassays
Different commercial SARS-CoV-2 antibody immunoassays
Without COVID-19 infection
Subjects with COVID-19 negative serum
Diagnostic test: SARS-CoV-2 antibody immunoassays
Different commercial SARS-CoV-2 antibody immunoassays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Sanatorium & Hospital

Investigators

  • Principal Investigator: Jonpaul Sze Tsing Zee, MBChB, Hong Kong Sanatorium & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2020

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-2020-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on SARS-CoV-2 antibody immunoassays

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe