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CompletedNCT04496141Updated Feb 28, 2024

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

An observational study in Covid19, sponsored by Hong Kong Sanatorium & Hospital. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Hong Kong Sanatorium & Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Covid19

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 70 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Hong Kong Sanatorium & Hospital is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Eligibility 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:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • With COVID-19 infection

    Subjects with a positive SARS-CoV-2 PCR

    Diagnostic Test: SARS-CoV-2 antibody immunoassays

  • Without COVID-19 infection

    Subjects with COVID-19 negative serum

    Diagnostic Test: SARS-CoV-2 antibody immunoassays

Interventions

  • Diagnostic testSARS-CoV-2 antibody immunoassays

    Different commercial SARS-CoV-2 antibody immunoassays

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Hong Kong Sanatorium & Hospital
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04496141
Lead sponsor
Hong Kong Sanatorium & Hospital
Responsible party
Dr. Jonpaul ST Zee (Specialist in Infectious Disease, Hong Kong Sanatorium & Hospital) — Principal investigator
First posted
Aug 3, 2020
Start date
Jul 27, 2020
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Feb 28, 2024

Study contacts

Jonpaul Sze Tsing Zee, MBChB
principal investigator · Hong Kong Sanatorium & Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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