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Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection

NCT06175611 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-01-11

No results posted yet for this study

Summary

The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of:

1. ClariLight Influenza A/B \& SARS-CoV-2 test kits and
2. ClariLight Influenza A/B \& RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care.

Conditions

  • SARS-CoV2 Infection
  • Influenza A
  • Influenza B
  • Respiratory Syncytial Virus (RSV)

Interventions

DEVICE

COVID-19/Flu A/Flu B/RSV Test Kit

The performance characteristics of EDAN's Test Kit will be evaluated in a prospective, non-randomized, observational, post-market, multicenter, comparison clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection. Samples will be obtained fresh, collected prospectively and will be tested with the study device COVID- 19/Flu A/Flu B/RSV Test Kit. The results will be compared against a reference, CE marked, in-vitro diagnostic device, used in the standard of care. This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants.

Sponsors & Collaborators

  • EDAN Instruments Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-10
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT06175611 on ClinicalTrials.gov