Comparison of Legionella K-set(R) and BinaxNOW(R) Legionella for diagnosing Legionnaires' disease on concentrated urine samples.

Detection of Legionella pneumophila serogroup 1 urinary antigens is the most widely used technique for the diagnosis of Legionnaires' disease (LD). The aim of this study was to evaluate the performance of the Legionella K-set(R) immunochromatographic test, in comparison with the BinaxNOW(R) Legionella urinary antigen card (UAC) on concentrated urine samples (US). A total of 250 concentrated US including 200 prospective US sent to the laboratory for urinary antigens' testing and 50 frozen US from patients with confirmed LD were tested. Positive US were retested after boiling (5 min, 100 degrees C). Each US leading to discordant results between the two tests was further tested using Binax Legionella EIA. Then, 10 additional positive non-concentrated US were tested using both tests. On concentrated US, Legionella K-set(R) test showed concordant results with that of BinaxNOW(R) Legionella. All negative US with BinaxNOW(R) were negative with Legionella K-set(R) test. For the 50 frozen US, all were positive with BinaxNOW(R) and 49 were positive with Legionella K-set(R), all confirmed after boiling except 3 US which led to uninterpretable results with Legionella K-set(R), due to a migration defect. Three of the 10 additional positive non-concentrated US were found negative with Legionella K-set(R) and only 1 US remained negative after concentration. All these positive non-concentrated US were positive with BinaxNOW(R) Legionella. The performance of the Legionella K-set(R) test is comparable to that of BinaxNOW(R) Legionella UAC, if performed on concentrated US.