Multicenter Clinical Comparison of the 10 Minute AMDI™ Fast PCR Mini Respiratory Panel and the Cepheid Xpert Xpress CoV-2/Flu/RSV plus

RT-PCR is the gold standard to determine the etiology of respiratory viral infections caused by SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus. Multiplex testing panels can test for infections or co-infections with these viruses at the point of care. Treatment using antiviral drugs and/or monoclonal antibodies and public health measures using vaccines and specific infection prevention practices depend upon accurate diagnoses. The AMDI Fast PCR Mini Respiratory Panel is a 10-minute RT-PCR test for use at the point of care to detect these viruses from a single anterior nasal swab. It is run on the Fast PCR Instrument with integrated cloud connectivity for data management. The clinical performance of the Fast PCR Mini Respiratory Panel test was established in a multi-center clinical study of 1906 participants using the Cepheid Xpert Xpress CoV-2/Flu/RSV plus test as the comparator. The study population included 242 Flu A, 77 Flu B, 71 RSV, and 87 SC2 positive samples and had an overall percent agreement of 97.2% (CI 96.4-97.9%), 99.7% (CI 99.4-99.9%), 99.3% (CI 98.8-99.6%) and 99.3% (CI 98.8-99.6%), respectively. Out of the total 85 (4.4%) discrepant results, 61 (72%) were associated with a low viral load. The AMDI Fast PCR Mini Respiratory Panel has excellent clinical performance, providing clinically useful information at the point of care in less than 10 minutes.