Performance Evaluation of Four Commercial Point-of-Care Testing Urine Analyzers for Diagnosing Urinary Tract Infection

Background: Urinalysis is used as a screening tool in case of a clinical suspicion of urinary tract infection (UTI). The purpose of this study is to evaluate the analytical performance, agreement, and screening value of four commercial point-of-care testing (POCT) urine analyzers for UTI. Methods: The following four POCT analyzers were evaluated: Clinitek Status+, BW-200, Hipee S2, and URS-14K. The agreement of the four analyzers with the laboratory standard was assessed. The diagnostic indicators of the screening tests performed using POCT analyzers for UTI were calculated against the bacterial culture as the gold standard. Results: Overall agreement of the four analyzers was good. For nitrite and leukocytes, all the analyzers showed substantial or excellent agreement with the laboratory reference standard, whereas agreement for erythrocytes varied from moderate to excellent. With each POCT analyzer, combined detection of nitrite, leukocytes, and erythrocytes provided better diagnostic performance than individual detection. Combined detection had higher sensitivity and negative predictive value, while the specificity and positive predictive value were higher for single detection of nitrite. Conclusions: Present findings demonstrate that the overall performance of the four POCT urine analyzers was sufficient for routine use for screening UTI. A result positive for nitrite is helpful for early diagnosis of UTI, and a result negative for the combination of nitrite, leukocytes, and erythrocytes is helpful for early elimination of UTI. (Clin. Lab. 2021;67:2331-2338. DOI: 10.7754/Clin.Lab.2021.210214)