Background: We evaluated molecular-based point-of-care influenza detection systems in a laboratory prior to the field evaluations of on-site specimen testing.

Methods: Performance of 1) insulated isothermal PCR on the POCKITTM device and 2) real-time reverse transcription-PCR (rRT-PCR) on a MyGo Mini device were evaluated using human clinical specimens, beta-propiolactone-inactivated influenza viruses, and RNA controls. The rRT-PCR carried out on a CXF-96TM Real-time Detection System was used as a gold standard for comparisons.

Results: Both systems demonstrated 100% sensitivity and specificity and test results were in 100% agreement with the gold standard. POCKITTM only correctly identified influenza A(M gene) in clinical specimens due to the unavailability of typing and subtyping reagents for human influenza viruses, while MyGo Mini had either a one log higher or the same sensitivity in detecting influenza viruses in clinical specimens compared to the gold standard. For inactivated viruses and/or viral RNA, the analytic sensitivity of POCKITTM was shown to be comparable to, or more sensitive, than the gold standard. The analytic sensitivity of MyGo Mini had mixed results depending on the types and subtypes of influenza viruses.

Conclusions: The performance of the two systems in a laboratory is promising and supports further evaluation in field settings.