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Analytical Performance of the RIDASCREEN® Hantavirus Puumala IgG/IgM ELISA Assay
Melissa Depypere1, Katrien Lagrou1, Marjan Van Esbroeck2
1National Reference Center for Hantavirus, Department of Laboratory Medicine, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.
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.
