Multicenter evaluation of a simple and sensitive nucleic acid self-testing for SARS-CoV-2

Area of Science:

• Biotechnology
• Medical Diagnostics
• Infectious Disease Research

Background:

• Rapid and accurate COVID-19 diagnosis is crucial for controlling infection spread and initiating timely medical interventions.
• Current diagnostic methods face challenges in accessibility and speed for widespread application.

Purpose of the Study:

• To develop and evaluate GeneClick, a novel device for self-administered nucleic acid testing of SARS-CoV-2.
• To assess the clinical performance of GeneClick compared to established RT-qPCR and antigen testing methods.

Main Methods:

• GeneClick, comprising a sampling kit, microfluidic chip, and amplification reader, was developed for SARS-CoV-2 nucleic acid self-testing.
• Clinical validation involved 2162 nasal swabs tested against commercial RT-qPCR kits and an antigen self-test.

Main Results:

• GeneClick demonstrated high clinical performance with 97.93% sensitivity and 99.72% specificity compared to RT-qPCR (kappa=0.979).
• The nucleic acid self-test identified 63 positive cases missed by antigen tests among 314 positive samples.
• GeneClick showed superior accuracy to antigen-based detection.

Conclusions:

• GeneClick provides a reliable, accurate, and user-friendly nucleic acid self-test for SARS-CoV-2.
• Its portability, affordability, and smartphone integration make it suitable for field-based detection in primary care and at-home settings.