Clinical performance study of SARS-CoV-2 & influenza A/B antigen test

This study evaluated the clinical performance of the SARS-CoV-2 & Influenza A/B Antigen Test under conditions of use of the device by a non-professional user. The study focused on the sensitivity and specificity of the test and the usability of the instructions for self-testing and interpretation of results by non-professionals.

From the coordinator

In this study, the key focus was on ensuring that lay users could easily understand and follow the instructions for test use, while maintaining diagnostic accuracy comparable to professional standards.

PROJECT COORDINATOR Małgorzata
Pawlikowska Head of Clinical Study Department

Challenges

Ensuring accurate sample collection and result interpretation by lay users.

Verifying the sensitivity and specificity of the test when used by non-professionals, as compared to the standard RT-PCR method performed by healthcare professionals.

Evaluating the clarity and usability of the instructions provided with the test for lay

Description of the study

The purpose of this clinical performance study was to assess the usability and diagnostic accuracy of a self-test designed for lay users. The test allows for the detection of antigens from SARS-CoV-2 and Influenza A and B viruses using a nasal swab. This lay user study was conducted in compliance with European Regulation 2017/746 (IVDR) and the requirements of common specifications for Class D in vitro diagnostic devices.

The evaluation covered two key areas: first, the diagnostic accuracy of the test when used by non-professionals, and second, the comprehensibility of the instructions and the ability of lay users to properly collect a sample and interpret the test results. The results showed that lay users could correctly perform the nasal swab collection and accurately read the test outcomes. The sensitivity and specificity of the test were comparable to the method used as a reference.

Results

The study confirmed that the SARS-CoV-2 & Influenza A/B Antigen Test showed acceptable sensitivity and specificity when used by lay users.

Most participants were able to follow the instructions for use and correctly interpret the test results. The overall performance met the standards outlined in European regulations for in vitro diagnostic devices.

Key findings

The study demonstrated that the SARS-CoV-2 & Influenza A/B Antigen Test can be effectively used by lay users, meeting IVDR requirements for sensitivity, specificity, and instruction usability.

Małgorzata Pawlikowska

Project Manager

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