Analytical Performance of the RIDASCREEN® Hantavirus Puumala IgG/IgM ELISA Assay

Viruses. 2020 Feb 18;12(2):226. doi: 10.3390/v12020226.

Abstract

The National Reference Center for Hantavirus in Belgium is currently using the Hantavirus IgM/IgG ELISA Progen kit (Heidelberg, Germany) for the detection of the most prevalent Hantavirus in Western Europe, Puumala virus (PUUV). Two commercially available PUUV kits were compared: Progen and RIDASCREEN® Hantavirus Puumala IgM/IgG ELISA assay (Darmstadt, Germany).

Methods: The sensitivity was evaluated with a panel of 68 samples from patients with an acute infection (n = 44) or a past infection (n = 24). Specificity was evaluated with a panel of 62 samples from patients with potentially false borderline results (n = 7) (no seroconversion), seronegative samples (n = 25) and potentially cross reacting samples (n = 30). Discordances were resolved by immunoblot. Substantial agreement was calculated using Cohen kappa coefficient.

Results: The RIDASCREEN® kit showed a higher specificity (IgM: 94.3%; IgG: 94.4%) than the Progen kit (IgM: 77.0% IgG: 93.0%). The sensitivity for IgM ELISA was 100% for both assays. IgG sensitivity was, respectively, 98.3% and 100% for Progen and RIDASCREEN®. A Cohen kappa coefficient of 0.76 and 0.90 was found between Puumala IgM and IgG, respectively.

Conclusions: This study showed a higher specificity for the RIDASCREEN® kit than the Progen kit, while the sensitivity was as good as for the Progen kit.

Keywords: Hantavirus; Orthohantavirus; Puumalavirus; Ridascreen.

Publication types

  • Comparative Study

MeSH terms

  • Antibodies, Viral / blood*
  • Cross Reactions
  • Enzyme-Linked Immunosorbent Assay / methods
  • Hantavirus Infections / diagnosis
  • Hantavirus Infections / immunology
  • Humans
  • Immunoglobulin G / blood*
  • Immunoglobulin M / blood*
  • Puumala virus / immunology*
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Immunoglobulin M
  • Reagent Kits, Diagnostic