Evaluation of SARS-CoV-2 Detection Systems Using Clinical Samples and Standard Material: A Comparative Study

Area of Science:

• Clinical diagnostics
• Molecular biology
• Virology

Background:

• Declining COVID-19 case and testing trends necessitate efficient, high-throughput diagnostic systems.
• Existing laboratory workflows require evaluation of new automated testing platforms for SARS-CoV-2 detection.

Purpose of the Study:

• To compare the analytical and clinical performance of the Aptima SARS-CoV-2 assay against the established Real-Q Direct SARS-CoV-2 detection kit.
• To evaluate the suitability of the Aptima assay for continuous sample loading and efficient processing.

Main Methods:

• Comparative analysis of two SARS-CoV-2 diagnostic assays: Aptima SARS-CoV-2 assay and Real-Q Direct SARS-CoV-2 detection kit.
• Testing of 259 individual and 91 pooled nasopharyngeal specimens collected in January-February 2023.
• Determination of the 95% limit of detection (LoD) using reference materials for both assays.

Main Results:

• The Aptima SARS-CoV-2 assay exhibited a significantly lower limit of detection (17.793 copies/mL) compared to the Real-Q Direct kit (RdRP gene: 131.842 copies/mL; E gene: 241.77 copies/mL).
• Clinical performance evaluation using nasopharyngeal specimens showed near-perfect agreement between the two testing systems.
• Both individual and pooled sample testing demonstrated comparable clinical utility for both assays.

Conclusions:

• The Aptima SARS-CoV-2 assay demonstrates superior sensitivity with a very low limit of detection.
• The Aptima assay and Real-Q Direct kit offer comparable clinical performance, supporting their use in diagnosing SARS-CoV-2 infections.
• The Aptima assay's automated, continuous-loading capability may offer advantages in efficiency for SARS-CoV-2 testing.