Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19
1 other identifier
observational
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2020
CompletedFirst Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedFebruary 28, 2024
February 1, 2024
1 month
July 30, 2020
February 26, 2024
Conditions
Outcome Measures
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
1 month
Study Arms (2)
With COVID-19 infection
Subjects with a positive SARS-CoV-2 PCR
Without COVID-19 infection
Subjects with COVID-19 negative serum
Interventions
Different commercial SARS-CoV-2 antibody immunoassays
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hong Kong Sanatorium & Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonpaul Sze Tsing Zee, MBChB
Hong Kong Sanatorium & Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in Infectious Disease
Study Record Dates
First Submitted
July 30, 2020
First Posted
August 3, 2020
Study Start
July 27, 2020
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share