Point-of-Care PCR Panel Detects RSV, Influenza, and SARS-CoV-2 in Minutes

Respiratory syncytial virus, influenza, and SARS-CoV-2 remain major respiratory pathogens in ambulatory care. RSV is a particular priority because it can cause significant disease in infants, older adults, and patients with underlying risk factors. In point-of-care settings, rapid detection during the visit can support timely clinical decision-making in urgent care and physician offices. A new system now delivers sample-to-answer reverse transcription polymerase chain reaction results in under 10 minutes at the point of care.

Autonomous Medical Devices Incorporated (AMDI; Santa Ana, CA, USA) has received U.S. Food and Drug Administration 510(k) clearance and CLIA waiver for the AMDI Fast PCR Instrument and AMDI Mini Respiratory Panel. The 4‑plex multiplex reverse transcription polymerase chain reaction (RT-PCR) assay simultaneously detects and differentiates respiratory syncytial virus, influenza A, influenza B, and SARS‑CoV‑2. The test uses anterior nasal swab specimens and is intended to provide lab‑quality molecular results during the office visit.

The Fast PCR System delivers sample‑to‑answer results in under 10 minutes. The platform is built on AMDI’s proprietary HBH technology and an ultrafast PCR consumable architecture with scalability up to 32‑plex to support future menu expansion. Cloud connectivity, enterprise‑wide operational visibility, and broad electronic health record integration are described as enabling deployment across distributed provider networks.

Designed and manufactured in California, the system is intended for decentralized care settings such as urgent care centers, primary care practices, and retail clinics. It combines a streamlined workflow with lab-quality molecular testing performed during the patient visit. In point‑of‑care settings, rapid detection of RSV and other common respiratory pathogens can support more informed decisions during the visit.

“This milestone reflects the coordinated work of teams across AMDI. Pursuing the FDA's dual 510(k) clearance and CLIA waiver pathway was a deliberate strategy to bring this innovation to market with the validation needed for clinical use in the urgent care setting. It shows that Fast PCR combines strong RT-PCR performance with the simplicity needed for confident molecular testing at the point of care,” said Aiying Sun, EVP, Quality, Regulatory and Clinical Affairs at AMDI.

“At the clinical site level, ease of use matters just as much as performance. The AMDI Fast PCR fits naturally into the clinic workflow. Staff can run the test without adding complexity, and getting a molecular result during the visit helps us make decisions while the patient is still in front of us instead of chasing follow-up later,” said Christopher Price, MD, Clinical Investigator at ERA Health Research.

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