Comparative Performance of a New SARS-CoV-2 Rapid Detection System

Area of Science:

• Clinical diagnostics
• Molecular biology
• Virology

Background:

• Global demand for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) diagnostic tools has outstripped availability.
• Existing molecular diagnostic methods, while effective, require specialized equipment and trained personnel.
• Development of rapid, accessible diagnostic alternatives is crucial for timely infection detection.

Purpose of the Study:

• To evaluate the accuracy, sensitivity, and specificity of the Hyris bKIT Virus Finder COVID-19 rapid molecular test.
• To assess the impact of different swab storage media on test performance.
• To determine the suitability of the Hyris system for rapid SARS-CoV-2 diagnosis in diverse settings.

Main Methods:

• Evaluation of the Hyris bKIT Virus Finder COVID-19 assay using 74 retrospective positive nasopharyngeal swabs.
• Comparison of results with a standard comparator assay.
• Assessment of cross-reactivity with common respiratory microorganisms and interference from respiratory drugs.

Main Results:

• The Hyris assay demonstrated 100% overall agreement with the comparator assay.
• No false-positive results were observed in negative samples or due to cross-reactivity.
• The assay showed reliable analytical performance unaffected by common respiratory medications.

Conclusions:

• The Hyris bKIT Virus Finder COVID-19 is a reliable and accurate assay for the rapid qualitative detection of SARS-CoV-2.
• The system offers unambiguous results interpretation, not requiring skilled technicians.
• The Hyris system is a valuable tool for accessible and efficient SARS-CoV-2 diagnosis.