Covid19NCT04496141
Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19
An observational study of Covid19, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- SARS-CoV-2 antibody immunoassays
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Jul 2020to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Covid19
- Being tested
- SARS-CoV-2 antibody immunoassays
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 antibody immunoassaysDiagnostic test
Different commercial SARS-CoV-2 antibody immunoassays
| Study group | Role | What they receive |
|---|---|---|
| With COVID-19 infection | Subjects with a positive SARS-CoV-2 PCR Receives: Diagnostic Test: SARS-CoV-2 antibody immunoassays | |
| Without COVID-19 infection | Subjects with COVID-19 negative serum Receives: Diagnostic Test: SARS-CoV-2 antibody immunoassays |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start27 Jul 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Sanatorium & Hospital
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Jonpaul ST Zee, Hong Kong Sanatorium & Hospital
- Investigators
- Jonpaul Sze Tsing Zee, MBChB, Principal investigator, Hong Kong Sanatorium & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496141
- Sponsor's protocol ID
- RC-2020-12
- Status last verified
- Feb 2024
- First submitted
- 30 Jul 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19
- ClinicalTrials.gov ID
- NCT04496141
- Acronym / sponsor ID
- RC-2020-12
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hong Kong Sanatorium & HospitalIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With COVID-19 infection | – | Diagnostic Test: SARS-CoV-2 antibody immunoassaysSubjects with a positive SARS-CoV-2 PCR |
| Without COVID-19 infection | – | Diagnostic Test: SARS-CoV-2 antibody immunoassaysSubjects with COVID-19 negative serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 antibody immunoassaysDifferent commercial SARS-CoV-2 antibody immunoassays | Diagnostic test | With COVID-19 infection, Without COVID-19 infection |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonpaul Sze Tsing Zee, MBChB principal investigator
Hong Kong Sanatorium & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the different commercial SARS-CoV-2 antibody immunoassays (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.