The AMDI Fast PCR System is a point-of-care molecular testing platform designed to deliver RT-PCR results in under 10 minutes, supporting clinical decision-making while the patient is still present. The AMDI Fast PCR Instrument and Mini Respiratory Panel are FDA 510(k) cleared and CLIA waived for use in point-of-care settings.
The Mini Respiratory Panel detects and differentiates RSV, Influenza A, Influenza B, and SARS-CoV-2 from anterior nasal swab specimens. These respiratory pathogens can present with overlapping symptoms, making timely and accurate test results important for diagnosis, treatment decisions, patient counseling, and follow-up planning.
Fast PCR is designed to bring molecular testing closer to the clinical encounter without requiring send-out testing or delayed result review. In physician offices, urgent care centers, and other CLIA waived settings, this can help reduce callbacks, support same-visit decision-making, and limit workflow disruptions caused by waiting for external laboratory results.
The system is intended to fit into existing point-of-care workflows, with a compact instrument and a simplified testing process for use by untrained operators in CLIA waived environments. By combining RT-PCR technology with rapid turnaround time, the AMDI Fast PCR System supports a practical approach to molecular testing at the Time of Care™.
AMDI is also developing additional assays, including Strep A and sexually transmitted infection panels, to expand the platform’s potential use across other high-volume clinical testing needs.
