Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

Abstract

ObjectiveVarious point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice.SettingAll testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices.Primary and secondary outcome measuresAnalytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers.ResultsThe following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice.ConclusionsThe overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine use in suspected urinary tract infections in general practice.

Prospective, observational study comparing automated and visual point-of-care urinalysis in general practice

“…In a previous study, we compared the analytical performance of six commercially available POCT urine analysers with the laboratory standard for the diagnosis of UTI. 6 The overall performance of these urine analysers for nitrite, leucocytes and erythrocytes compared with the two reference methods in the laboratory was adequate and justifies the routine use of POCT urine analysers in primary care. The procedure of automatic reading through POCT is less susceptible to erroneous labelling and registration of test results in the medical record of the patient compared with manual handling and could therefore enhance patient safety.…”

“…The Urisys 1100 uses reflectance photometry to semiquantitatively measure specific gravity, pH, leucocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and erythrocytes. This analyser was tested previously, 6 together with five other devices, and found suitable for use in general practice. Its quality and user-friendliness was judged sufficiently for use in general practice; GP practice assistants and midwives reported the analysers as easy to use, while their susceptibility to flaws was considered low.…”

“…Its quality and user-friendliness was judged sufficiently for use in general practice; GP practice assistants and midwives reported the analysers as easy to use, while their susceptibility to flaws was considered low. 6 For this study, the Combur 10-test strips (Roche) were used. Although these strips contain a total of 10 tests, we have focused this study on nitrite, leucocyte and erythrocyte tests.…”

“…We have previously evaluated and validated the POCT analyser, which showed that it could be used in daily practice. 6 No formal power analysis was performed. Our prerequisite was that automated urine POCT could be implemented in general practice if the results show that automated urine POCT performs at least similarly to manual urine POCT.…”

Performance of urinalysis tests and their ability in predicting results of urine cultures: a comparison between automated test strip analyser and flow cytometry in various subpopulations and types of samples

“…The high specificity of nitrite test and high sensitivity of bacteria count can help in deciding whether the treatment should be initiated at initial encounter since the results of these tests are available earlier than urine culture 24. Positive nitrite test result confirms UTI and one can initiate the treatment, and negative bacteria count excludes the possibility of UTI and treatment can be avoided.…”