Influenza A+B Test Kit Performance Study

NCT03895268 | Unknown DMC FDA Device

• 1 other identifier: PEP02-03
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The clinical sensitivity and clinical specificity of the investigational devices

  Establish clinical sensitivity and specificity of investigational devices by comparing with PCR results using fresh and frozen sample

  2 Years

Interventions

ALiA Analyser DEVICE

NPS specimens shall be tested with the investigational device

Influenza A+B Test Kit DEVICE

NPS specimens shall be tested with the investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Influenza A and Influenza B affect all population, any patients of age 18 or above displaying symptoms of respiratory infection will be included as potential participants. There will be no restriction on the ethnicity of patients but the majority of patients to be recruited are expected to be of Asian origin as the clinical trial is based in Hong Kong. However, it has been proved that Influenza strains do not vary / have minimal variation in human of different ethnicity.

You may qualify if:

• Patient is having NPA collected by the hospital as routine testing
• Patient or patient's next of kin/guardian is willing and able to give informed consent for participation in the trial.
• Patients presented with influenza-like illness, i.e. fever and cough, with onset of illness within 7 days of hospital admission
• Male or Female, 18 years of age or above.

You may not qualify if:

• Have had influenza-specific treatment.

Sponsors & Collaborators

• Sanwa BioTech Limited: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study will use nasopharyngeal swab specimens taken from hospitalized subjects displaying influenza-like illness.

Study Officials

• Paul KS Chan, Prof.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Wong, Dr.

CONTACT

+852 2698 7970; veronica@sanwabiotech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: March 29, 2019
• Study Start: October 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

HK (1)