Validation of the Seegene RV15 multiplex PCR for the detection of influenza A subtypes and influenza B lineages during national influenza surveillance in hospitalized adults

J Med Microbiol. 2020 Feb;69(2):256-264. doi: 10.1099/jmm.0.001032. Epub 2019 Jun 28.

Abstract

Background. The Serious Outcomes Surveillance Network of the Canadian Immunization Research Network (CIRN SOS) has been performing active influenza surveillance since 2009 (ClinicalTrials.gov identifier: NCT01517191). Influenza A and B viruses are identified and characterized using real-time reverse-transcriptase polymerase chain reaction (RT-PCR), and multiplex testing has been performed on a subset of patients to identify other respiratory virus aetiologies. Since both methods can identify influenza A and B, a direct comparison was performed.Methods. Validated real-time RT-PCRs from the World Health Organization (WHO) to identify influenza A and B viruses, characterize influenza A viruses into the H1N1 or H3N2 subtypes and describe influenza B viruses belonging to the Yamagata or Victoria lineages. In a subset of patients, the Seeplex RV15 One-Step ACE Detection assay (RV15) kit was also used for the detection of other respiratory viruses.Results. In total, 1111 nasopharyngeal swabs were tested by RV15 and real-time RT-PCRs for influenza A and B identification and characterization. For influenza A, RV15 showed 98.0 % sensitivity, 100 % specificity and 99.7 % accuracy. The performance characteristics of RV15 were similar for influenza A subtypes H1N1 and H3N2. For influenza B, RV15 had 99.2 % sensitivity, 100 % specificity and 99.8 % accuracy, with similar assay performance being shown for both the Yamagata and Victoria lineages.Conclusions. Overall, the detection of circulating subtypes of influenza A and lineages of influenza B by RV15 was similar to detection by real-time RT-PCR. Multiplex testing with RV15 allows for a more comprehensive respiratory virus surveillance in hospitalized adults, without significantly compromising the reliability of influenza A or B virus detection.

Keywords: influenza; lineage; multiplex PCR; subtype; validation.

Publication types

  • Validation Study

MeSH terms

  • Adult
  • Canada / epidemiology
  • Female
  • Hospitalization
  • Humans
  • Influenza A virus / classification
  • Influenza A virus / genetics
  • Influenza A virus / isolation & purification*
  • Influenza B virus / classification
  • Influenza B virus / genetics
  • Influenza B virus / isolation & purification*
  • Influenza, Human / diagnosis
  • Influenza, Human / epidemiology
  • Influenza, Human / therapy
  • Influenza, Human / virology*
  • Male
  • Middle Aged
  • Molecular Diagnostic Techniques / methods*
  • Multiplex Polymerase Chain Reaction / methods*
  • Sensitivity and Specificity

Associated data

  • ClinicalTrials.gov/NCT01517191