Evaluation of two commercially available immunoassays for the detection ofhantavirus antibodies in serum samples

Background: hantaviruses are members of the family Bunyaviridae and the spe ctrum of clinical symptoms in humans may vary from sub-clinical to severe h aemorrhagic fever with renal syndrome (HFRS) or pulmonary syndrome (HPS). S everal serotypes have been described from which at least five are pathogeni c to humans. Each serotype has a different animal reservoir and geographica l distribution. In the acute phase of the disease the clinical diagnosis ma y be confirmed by serology or by polymerase-chain reaction (PCR). Objective : to evaluate two commercially available immunoassays using sera from hanta virus suspected and non-hantavirus patients: an enzyme immunoassay (EIA) de veloped by MRL Diagnostics, for the detection of immunoglobulins M (IgM) an d G (Igc) against several hantavirus serotypes and an indirect immunofluore scence assay (IFA) from Progen, based on slides coated with Hantaan virus ( HNTV) and Puumala virus (PUUV), infected cells. Study design: a total of 14 5 serum samples were used for this study. The serum panel included serum sa mples from patients suspected of mild (n = 91), severe (n = 10) HFRS and pa tients with other viral infections (n = 44). Results: the agreement between the MRL EIA and the Progen IFA for the detection of IgM and Ige serum anti bodies ranged from 87 to 91%, respectively. In the non-hantavirus group one out of 44 samples was positive by the Progen HNTV IgM IFA, none in the:Pro gen PUUV IFA and two samples in the MRL IgM EIA, resulting in specificities of 98, 100 and 95%, respectively. The sensitivities and specificities of t he MRL EIAs compared to the Progen overall PUUV and HNTV IFAs were 90 and 9 1% for IgM, respectively, and 96% for IgG in both immunoassays. Conclusions . the MRL EIA proved to be relatively sensitive and specific assay for the serological diagnosis of mild and severe HFRS. (C) 2000 Published by Elsevi er Science B.V.