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

Objective: Various 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. Setting: All 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 measures: Analytical 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. Results: The 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. Conclusions: The 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.

研究背景与目的：目前市售多款即时检验（point-of-care testing, POCT）尿液分析仪可用于全科医疗中的常规尿液分析。本研究旨在对比6款不同POCT尿液分析仪用于全科医疗中诊断尿路感染时的分析性能、检测一致性与用户友好性。
研究场景：所有检测流程均在荷兰一家基层医疗诊断中心完成，尿液样本采集自4家全科诊所。
主要与次要结局指标：以实验室参考标准为参照，评估POCT尿液分析仪对亚硝酸盐、白细胞与红细胞的分析性能及检测一致性，此为本研究的主要结局指标；分析方法包括计算灵敏度、特异度、阳性预测值与阴性预测值，以及用于评估一致性的科恩κ系数（Cohen's κ coefficient）。次要结局指标则涵盖POCT尿液分析仪的用户友好性，以及该类分析仪的其他特性。
研究结果：本次评估的6款POCT尿液分析仪分别为：Uryxxon Relax（Macherey Nagel）、Urisys 1100（Roche）、Clinitek Status（Siemens）、Aution 11（Menarini）、Aution Micro（Menarini）与Urilyzer（Analyticon）。所有分析仪均表现出良好的分析性能。与实验室参考标准相比，整体检测一致性良好，但因检测参数与分析仪型号不同而存在差异。就临床实践中最重要的亚硝酸盐检测而言，除1款分析仪外，其余均与实验室标准表现出极佳的一致性。针对白细胞与红细胞检测，分析仪的特异度较高，但灵敏度显著偏低。白细胞检测的一致性介于良好至极佳之间，红细胞检测的一致性则处于一般至良好水平。首次使用的用户反馈，该类分析仪操作简便；他们预期在日常临床工作中使用此类仪器可提升工作效率与检测准确性。
研究结论：本次评估的6款市售POCT尿液分析仪，其整体性能与用户友好性均满足要求，可用于全科医疗中疑似尿路感染患者的常规检测。