Analytical performance of the AMDI™ Fast PCR Mini Respiratory Panel

Influenza A, Influenza B, SARS-CoV-2, Respiratory Syncytial Virus and other respiratory pathogens are an ongoing public health concern. Rapid identification of these viruses early in infection is essential for effective treatment and outbreak control. The AMDI™ Fast PCR Mini Respiratory Panel (MRP) integrates sample preparation and real-time RT-PCR to detect Flu A, Flu B, SARS-CoV-2 and RSV from anterior nasal swab specimens in <10 min at the point of care. We established the analytical performance characteristics of the Fast PCR MRP and determined that the limit of detection (LoD) is 250 copies/mL for Flu A and RSV, and 500 copies/mL for Flu B and SARS-CoV-2. A reproducibility study at 3 clinical sites demonstrated ≥ 98.2% positivity for targets in a weak positive sample, ≥99.6% positivity for targets in a moderate positive sample and ≥99.3% negativity for a negative sample. Fast PCR MRP had 100% analytical reactivity for all strains tested (23 Flu A, 6 Flu B, 8 SARS-CoV-2 and 6 RSV) ≥ 98% predicted in silico inclusivity and no cross-reactivity to 40 microorganisms, nor interference from 15 endogenous and exogenous substances. The Fast PCR MRP delivers excellent analytical performance comparable to high complexity laboratory assays, at the point of care.