- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034978
Novel SARS-CoV-2 Point-of-care Testing
Point-of-care Testing for Improving the Detection of SARS-CoV-2 Infection in Healthcare Setting
Study Overview
Detailed Description
A CRISPR-based lateral flow assay (LFA) detection kit would be designed and developed for testing for the presence of SARS-CoV-2. The aim of the project is to study the feasibility of implementing the novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection in health service setting, with the following objectives: (b) Evaluation of the performance of novel POCT in comparison with conventional quantitative PCR in diagnosis SARS-CoV-2 infection and (c) Assessment of the practicability of LFA-CRISPR-based tests in the operating environments in healthcare settings.
Patients who are admitted to the isolation wards of Prince of Wales Hospital, Hong Kong would be invited to join the study. A total of 600 persons with suspected SARS-CoV-2 infection presenting with different symptomatology and epidemiological history will be recruited. Nasal, deep saliva and/or mouth gargle samples will be collected from all recruited subjects in accordance with standard clinical protocol. The samples would be tested for SARS-CoV-2 by the new Point-of-care test, in parallel with standard diagnostic testing of the hospital.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong, 0000
- Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients admitted to isolation wards of the hospital who are
- of age of 18 or above;
- presentation with symptoms of COVID-19 and/or
- demonstration of exposure risk to SARS-CoV-2 infection.
Exclusion Criteria:
- inability to communicate in English or Chinese;
- known history of mental illness;
- prisoners.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test performance
Time Frame: 1 year
|
agreement of point-of-care test result and conventional test
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol HK POCT study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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