Comparison of a new immunochromatographic rapid test with a commercial EIA for the detection of Puumala virus specific IgM antibodies.
BACKGROUND
Hantaviruses are associated with two human diseases: haemorrhagic fever with renal syndrome (HFRS) and Hantavirus pulmonary syndrome (HPS). Puumala virus (PUUV), which is one of the Hantaviruses, is a causative agent of nephropathia epidemica (NE), a mild form of HFRS.


OBJECTIVE
a new 5 min rapid test, POC PUUMALA (Erilab Ltd, Finland), for detecting IgM antibodies to PUUV was evaluated and compared with the commercially available Hantavirus (Puumala) IgM ELISA test (Progen, Germany). Discrepant test results between the two tests were confirmed by a mu-capture reference EIA.


METHODS
Two hundred and thirty five serum samples, which had earlier been analyzed with the Progen IgM ELISA, were assayed with the POC PUUMALA rapid test. Five persons, without knowing the Progen IgM ELISA test results, interpreted independently the rapid test results. In addition, a panel of 48 serum samples was analyzed in parallel with the rapid test and the Progen IgM ELISA by one technician in daily routine diagnostics in a clinical microbiology laboratory.


RESULTS
the agreement between the results of the five interpreters was 95%, and the congruence of the results between individual readers and commercial ELISA test varied from 93 to 96%. Diagnostic efficacy of the rapid test varied between 98 and 99% compared with 96% of the Progen IgM ELISA. The POC PUUMALA rapid test showed higher or similar sensitivity compared with the Progen IgM ELISA, whereas both the tests had similar levels of specificity.


CONCLUSIONS
the analytical performance of the POC PUUMALA rapid test was found to be as good or even slightly better than the analytical performance of the Progen IgM ELISA. In addition, the rapid and straightforward procedure makes the POC PUUMALA a feasible tool for the diagnosis of the acute PUUV infection.
Hujakka
H
H
Department of Chemistry, University of Kuopio, PO Box 1627, FIN-70211 Kuopio, Finland. helena.hujakka@uku.fi
Koistinen
V
V
Eerikäinen
P
P
Kuronen
I
I
Laatikainen
A
A
Kauppinen
J
J
Vaheri
A
A
Vapalahti
O
O
Närvänen
A
A
D000914:Antibodies, Viral / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay; D006480:Hemorrhagic Fever with Renal Syndrome / Q000097:blood / Q000821:virology*; D006801:Humans; D007124:Immunoenzyme Techniques; D007075:Immunoglobulin M / Q000097:blood*; D029262:Puumala virus / Q000276:immunology / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D012698:Serologic Tests
D000914:Antibodies, Viral; D007075:Immunoglobulin M