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

NCT05034978 | Terminated

• 1 other identifier: Protocol HK POCT study
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection

Keywords

SARS-CoV-2; point-of-care testing; rapid diagnostics; Hong Kong

Outcome Measures

Primary Outcomes (1)

• Test performance

  agreement of point-of-care test result and conventional test

  1 year

Interventions

no intervention OTHER

evaluating the performance of a novel point-of-care test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

persons with exposure risk to SARS-CoV-2 infection who subsequently test positive or negative to conventional PCR-based testing for the diagnosis of the infection.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 5, 2021
• Study Start: March 16, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)