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Influenza A+B Test Kit Performance Study

NCT03895268 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2021-09-22

No results posted yet for this study

Summary

Prospective clinical study on the performance of an Influenza A+B rapid test kit. The main goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to a gold standard.

Option of participating in this clinical study will be presented to patients displaying influenza-like illness. Informed consent will be collected from patients or patient's next of kin/guardian before samples (nasopharyngeal swab) are taken from the patient.

Nasopharyngeal swabs are tested using both the investigational test kit and a predicate fluorescence immunoassay test kit. All samples will be tested using a molecular-based PCR test kit as a confirmatory test.

The results will be analysed statistically and the performance of the Influenza A+B test kit can be evaluated.

Conditions

  • Influenza Type A
  • Influenza Type B

Interventions

DEVICE

ALiA Analyser

NPS specimens shall be tested with the investigational device

DEVICE

Influenza A+B Test Kit

NPS specimens shall be tested with the investigational device

Sponsors & Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

    collaborator OTHER

  • Chinese University of Hong Kong

    collaborator OTHER

  • Sanwa BioTech Limited

    lead INDUSTRY

Principal Investigators

  • Paul KS Chan, Prof. · Chinese University of Hong Kong

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-02-28
Completion
2023-02-28
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895268 on ClinicalTrials.gov