Performance of a commercial assay for the diagnosis of influenza A (H1N1) infection in comparison to the Centers for Disease Control and Prevention protocol of real time RT-PCR

Rev Argent Microbiol. 2012 Jan-Mar;44(1):26-9. doi: 10.1590/S0325-75412012000100006.

Abstract

At the time of influenza A (H1N1) emergency, the WHO responded with remarkable speed by releasing guidelines and a protocol for a real-time RT-PCR assay (rRT-PCR). The aim of the present study was to evalúate the performance of the "Real Time Ready Influenza A/H1N1 Detection Set" (June 2009)-Roche kit in comparison to the CDC reference rRT-PCR protocol. The overall sensitivity of the Roche assay for detection of the Inf A gene in the presence or absence of the H1 gene was 74.5 %. The sensitivity for detecting samples that were only positive for the Inf A gene (absence of the H1 gene) was 53.3 % whereas the sensitivity for H1N1-positive samples (presence of the Inf A gene and any other swine gene) was 76.4 %. The specificity of the assay was 97.1 %. A new version of the kit (November 2009) is now available, and a recent evaluation of its performance showed good sensitivity to detect pandemic H1N1 compared to other molecular assays.

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

  • Argentina / epidemiology
  • Centers for Disease Control and Prevention, U.S.
  • Disease Outbreaks
  • Hemagglutinin Glycoproteins, Influenza Virus / genetics
  • Humans
  • Influenza A Virus, H1N1 Subtype* / genetics
  • Influenza A Virus, H1N1 Subtype* / isolation & purification
  • Influenza, Human / diagnosis*
  • Influenza, Human / epidemiology
  • Influenza, Human / virology
  • Nasal Cavity / virology
  • Nucleocapsid Proteins
  • Pharynx / virology
  • RNA, Viral / genetics
  • RNA-Binding Proteins / genetics
  • Reagent Kits, Diagnostic*
  • Real-Time Polymerase Chain Reaction / methods
  • Reproducibility of Results
  • Sensitivity and Specificity
  • United States
  • Viral Core Proteins / genetics

Substances

  • H1N1 virus hemagglutinin
  • Hemagglutinin Glycoproteins, Influenza Virus
  • NP protein, Influenza A virus
  • Nucleocapsid Proteins
  • RNA, Viral
  • RNA-Binding Proteins
  • Reagent Kits, Diagnostic
  • Viral Core Proteins