Comparison of Diagnostic Performance of Five Molecular Assays for Detection of SARS-CoV-2

Kanwar, Neena; Banerjee, Dithi; Sasidharan, Anjana; Abdulhamid, Ayah; Larson, Marissa; Lee, Brian; Selvarangan, Rangaraj; Liesman, Rachael M

BACKGROUND: We compared the performance of the Abbott RealTime SARS-CoV-2 assay (Abbott assay), Aptima™ SARS-CoV-2 assay (Aptima assay), BGI Real-Time SARS-CoV-2 assay (BGI assay), Lyra® SARS-CoV-2 assay (Lyra assay), and DiaSorin Simplexa™ COVID assay for SARS-CoV-2 detection. METHODS: Residual nasopharyngeal samples (n=201) submitted for routine SARS-CoV-2 testing by Simplexa assay during June-July 2020 and January 2021 were salvaged. Aliquots were tested on other assays and compared against the CDC 2019-nCoV Real-Time RT-PCR assay. Viral load in positive samples was determined by droplet digital PCR. RESULTS: Among 201 samples, 99 were positive and 102 were negative by the CDC assay. The Aptima and Abbott assays exhibited the highest positive percent agreement (PPA) at 98.9% while the BGI assay demonstrated the lowest PPA of 89.9% with 10 missed detections. Negative percent agreement for all 5 platforms were comparable, ranging from 96.1% to 100%. CONCLUSIONS: The performance of all five assays were comparable.