Multicenter evaluation of the novel enzyme immunoassay based on P1-enriched protein for the detection of Mycoplasma pneumoniae infection

The aim of the study was to evaluate new Mycoplasma pneumoniae IgG, IgA and IgM EIA methods based on the enrichment of Pl-protein (ThermoLabsystems, H elsinki, Finland) (L) for the detection of acute infection. This evaluation was performed in two independent routine clinical microbiology laboratorie s. The first laboratory used samples preselected by IgG and IgM Platelia (R ) enzyme immunoassay (P) and the second used samples preseleced by Serion E LISA Classic M. pneumoniae IgG, IgM (V). The L method was also compared to the FDA approved method of ImmunoWell (R) K pneumoniae IgG and I-M (G). Whe n the agreement of two methods was applied as a serologic criteria for an a cute infection, the following ratios of acute to nonacute infection were ca lculated 32/86 (totally 118) in the first and 20/72 (totally 92) in the sec ond laboratory. In the first laboratory, the corresponding ratios by method s were 35/83 (sensitivity 100%, specificity 96.5%), 31/87 (sensitivity 97%, specificity 100%), and 55/63 (sensitivity 100%, specificity 79%) for the L , P and G methods, respectively. In the second laboratory, the ratios were 21/71 (sensitivity 100%, specificity 99%), 16/76 (sensitivity 83%, specific ity 100%), and 53/39 (sensitivity 100, specificity 69%) for the L, V and G methods, respectively. taking into account that the tested sample material was preselected by the P and V methods, which may have introduced some bias in their favor, the newly developed L method utilizing PI-enriched protein was found reliable for serodiagnosis of acute M. pneumoniae infection. The method G was the least specific in detection of acute infection. (C) 2001 Elsevier Science B.V. All rights reserved.