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

SARS-CoV2 Infection Clinical Trial

Official title:

Point-of-care Testing for Improving the Detection of SARS-CoV-2 Infection in Healthcare Setting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05034978
• Other study ID #: Protocol HK POCT study
• Status: Terminated
• Start date: March 16, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV2 Infection

Intervention

Other:
• no intervention
evaluating the performance of a novel point-of-care test

Locations

Country	Name	City	State
Hong Kong	Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test performance	agreement of point-of-care test result and conventional test	1 year