title: A multicenter evaluation of the Biotest legionella urinary antigen EIA.
abstract: OBJECTIVES: To undertake a multicenter study to evaluate the Biotest legionella urinary antigen enzyme immunoassay (EIA) performance against those EIAs already in use in 14 European laboratories. METHODS: Each laboratory examined urine specimens from appropriate patients using both their current assay and the Biotest EIA. Each examined: a standard panel of 12 coded urine samples (distributed by Biotest); a panel of 10 coded urine samples provided as part of a European external quality assurance (EQA) scheme; urine samples from patients with proven legionnaires' disease (LD); urine samples from patients with pneumonia of microbiologically proven cause other than LD; and urine samples submitted for routine examination. Thus, the performance of the Biotest assay (in comparison with current EIAs), its specificity and utility, and the inter-laboratory agreement were assessed. RESULTS: Inter-laboratory agreement was excellent, with all participants obtaining the expected results for 20 of 22 coded urine specimens. Specificity, determined using 123 specimens from patients with infections of known etiology, was 100%. The Biotest EIA gave positive results in 86% of specimens which had been positive in the laboratories' current EIAs, and in 94.6% of those specimens which were positive for Legionella pneumophila serogroup 1. CONCLUSION: The Biotest EIA is simple to use and specific and the results obtained in different laboratories show excellent agreement. The assay compares well existing EIAs, at least for L. pneumophila serogroup 1
authors.affiliation: Respiratory and Systemic Infection Laboratory, Central Public Health Laboratory, London, UK.
authors.forename: Timothy
authors.initials: T
authors.lastname: Harrison
authors.forename: Søren
authors.initials: S
authors.lastname: Uldum
authors.forename: Stella
authors.initials: S
authors.lastname: Alexiou-Daniel
authors.forename: Jette
authors.initials: J
authors.lastname: Bangsborg
authors.forename: Sverker
authors.initials: S
authors.lastname: Bernander
authors.forename: Vladimir
authors.initials: V
authors.lastname: Dra&sbreve;ar
authors.forename: Jerome
authors.initials: J
authors.lastname: Etienne
authors.forename: Jürgen
authors.initials: J
authors.lastname: Helbig
authors.forename: Diane
authors.initials: D
authors.lastname: Lindsay
authors.forename: Ivo
authors.initials: I
authors.lastname: Lochman
authors.forename: Teresa
authors.initials: T
authors.lastname: Marques
authors.forename: Fernando
authors.initials: F
authors.lastname: de Ory
authors.forename: Igor
authors.initials: I
authors.lastname: Tartakovskii
authors.forename: Günther
authors.initials: G
authors.lastname: Wewalka
authors.forename: Franz
authors.initials: F
authors.lastname: Fehrenbach