Sample-to-Answer, CLIA-Waived PCR System With Visually Read Results for POC

Comparative Flu Detection Analysis With Other FDA-cleared Molecular Assays

Tuesday, August 6, 1 – 1:20 p.m.
Exhibit Hall, Theater 3
Supported by Mesa Biotech


Antiviral drug treatments for influenza are becoming increasingly popular and more widely used. The antivirals work best when taken within 48 hours of symptom onset, therefore highly accurate, near-patient testing is crucial for healthcare professionals to achieve a rapid and accurate confirmation of the infection to enable the best patient care. Molecular point-of-care testing (POCT) platforms render high sensitivity and specificity versus traditional rapid immunoassay tests and are gaining ground as the superior diagnostic technology. Molecular POCT replaces the need to send out tests where long turnaround time diminishes the ability to effectively “test and treat” during a provider visit. This session will provide a technology overview and performance characteristics of a visually interpreted, CLIA-waived polymerase chain reaction platform with the simplicity, convenience, and procedural familiarity of traditional POC rapid immunoassay. In addition, it will provide a performance comparison with other Food and Drug Administration (FDA)-cleared molecular influenza assays.


Attendees will learn to:

  • Understand the technology behind this visually interpreted molecular POCT solution
  • Describe the procedure – Sample to answer
  • Compare and contrast alternative FDA-cleared molecular assays for flu analysis


Stephen Young, PhD, D(ABMM)
Professor Emeritus of Pathology
University of New Mexico
Director of Research and Clinical Trials
TriCore Reference Laboratories
Albuquerque, New Mexico