Analytical Performance of the AMDI Fast PCR Mini Respiratory Panel

Abstract

Influenza A, Influenza B, SARS-CoV-2, Respiratory Syncytial Virus and other respiratory pathogens are an ongoing public health concern. The ability to rapidly identify these viruses early in infection is essential for effective treatment and outbreak control. The AMDI Fast PCR Mini Respiratory Panel (MRP) incorporates sample preparation and real-time RT-PCR for detection of Flu A, Flu B, SARS-CoV-2 and RSV from anterior nasal swab (ANS) specimens in less than 10 minutes 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. In a reproducibility study at 3 clinical sites, there was at least 98.2% positivity for each target for a weak positive (2x LoD) sample, at least 99.6% positivity for a moderate positive (5x LoD) sample and the negative sample returned a negative result for at least 99.3% of the tests. Fast PCR MRP had 100% analytical reactivity to all strains tested (23 Flu A, 6 Flu B, 8 SARS-CoV-2 and 6 RSV) and at least 98% predicted inclusivity from in silico analysis. There was no cross-reactivity to 40 viruses, bacteria and fungi, nor interference for 15 endogenous and exogenous substances in ANS matrix. The Fast PCR MRP delivers excellent analytical performance comparable to high complexity laboratory assays, at the point of care.

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