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

NCT ID: NCT04496141

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-27

Study Completion Date

2020-08-31

Brief Summary

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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

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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

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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With COVID-19 infection

Subjects with a positive SARS-CoV-2 PCR

SARS-CoV-2 antibody immunoassays

Intervention Type DIAGNOSTIC_TEST

Different commercial SARS-CoV-2 antibody immunoassays

Without COVID-19 infection

Subjects with COVID-19 negative serum

SARS-CoV-2 antibody immunoassays

Intervention Type DIAGNOSTIC_TEST

Different commercial SARS-CoV-2 antibody immunoassays

Interventions

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SARS-CoV-2 antibody immunoassays

Different commercial SARS-CoV-2 antibody immunoassays

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hong Kong Sanatorium & Hospital

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Jonpaul ST Zee

Specialist in Infectious Disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonpaul Sze Tsing Zee, MBChB

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Sanatorium & Hospital

Locations

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Hong Kong Sanatorium & Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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RC-2020-12

Identifier Type: -

Identifier Source: org_study_id

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