Evaluation of clinical specimens for influenza A virus positivity using various diagnostic methods

Acta Virol. 2006;50(3):181-6.

Abstract

The diagnostic method for Influenza A virus, utilizing the SERION ELISA Antigen kit (SERION EIA), if results were evaluated according to the manufacturer's instructions, has repeatedly failed to detect a great number of clinical samples positive by virus isolation and RT-PCR. Therefore we compared the SERION EIA with the one-step 44/107L-Px immunocapture enzyme immunoassay (44/107L-Px EIA), developed in our laboratory (Tkácová and Varecková, J. Virol. Methods 60, 65-71, 1996). Seventy-three clinical specimens, of which 65 were positive by virus isolation (used as reference method), were tested by both EIAs. By the SERION EIA, out of the 65 reference-positive samples only 8 (12%) were positive, 5 (8%) were ambiguous, and 52 (80%) were negative, which corresponded to the sensitivity of 12%. On the contrary, the sensitivity of the 44/107L-Px EIA was 74%. However, the calculation of cut-off values for the evaluation of positivity of clinical specimens in these two assays were not the same. If the evaluation procedure used for the 44/107L-Px EIA was applied to the SERION EIA, the sensitivity and the specificity of both EIAs became comparable, namely 71% and 100% for the SERION EIA and 74% and 100% for the 44/107L-Px EIA, respectively. From these results it follows that not the detection ability of the SERION EIA, but the evaluation procedure recommended by its manufacturer led to a loss of large number of positive specimens.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral / analysis
  • Antigens, Viral / immunology
  • Humans
  • Immunoenzyme Techniques / methods
  • Influenza A virus* / genetics
  • Influenza A virus* / immunology
  • Influenza A virus* / isolation & purification
  • Influenza, Human / diagnosis*
  • Influenza, Human / virology
  • Nasopharynx / virology
  • Reverse Transcriptase Polymerase Chain Reaction
  • Sensitivity and Specificity
  • Specimen Handling / methods

Substances

  • Antibodies, Viral
  • Antigens, Viral