Laboratory evaluation of two point-of-care detection systems for early and accurate detection of influenza viruses in the Lao People's Democratic Republic

Int J Infect Dis. 2021 Mar:104:214-221. doi: 10.1016/j.ijid.2020.12.059. Epub 2020 Dec 24.

Abstract

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

Methods: The performance characteristics of 1) insulated isothermal polymerase chain reaction (PCR) on a POCKIT™ 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-96™ real-time detection system was used as a gold standard for comparison.

Results: Both systems demonstrated 100% sensitivity and specificity and test results were in 100% agreement with the gold standard. POCKIT™ 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 POCKIT™ 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.

Keywords: Detection system; Influenza; Laboratory evaluation; Molecular; Point-of-care.

MeSH terms

  • Early Diagnosis
  • Humans
  • Influenza, Human / diagnosis*
  • Laboratories
  • Laos
  • Orthomyxoviridae / isolation & purification*
  • Point-of-Care Systems*
  • RNA, Viral / isolation & purification
  • Real-Time Polymerase Chain Reaction / methods
  • Sensitivity and Specificity

Substances

  • RNA, Viral