Novel SARS-CoV-2 Point-of-care Testing

Terminated

• Conditions: SARS-CoV2 Infection

• Registration Number: NCT05034978
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The aim of the project is to study the feasibility of implementing a novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection. A CRISPR-based detection kit would be piloted for testing of suspected SARS-CoV-2 infection in healthcare setting, with the objectives of evaluating the performance of the new test in the detection of SARS-CoV-2, and assessing the practicability of the new test for diagnosing SARS-CoV-2 infection in healthcare settings.

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 Timeline

• Study Start: 2021-03-16
• Study First Submitted: 2021-08-29
• Study First Submitted QC: 2021-08-29
• Study First Posted: 2021-09-05
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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.

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Exclusion Criteria

• inability to communicate in English or Chinese;
• known history of mental illness;
• prisoners.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test performance	1 year	agreement of point-of-care test result and conventional test

Trial Locations

Locations (1)

Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong