Data from: A prospective, observational study comparing automated and visual point-of-care urinalysis in general practice

Objective Point-of-care testing (POCT) urinalysis might reduce errors in (subjective) reading, registration and communication of test results, and might also improve diagnostic outcome and optimise patient management. Evidence is lacking. In the present study, we have studied the analytical performance of automated urinalysis and visual urinalysis compared with a reference standard in routine general practice. Setting The study was performed in six general practitioner (GP) group practices in the Netherlands. Automated urinalysis was compared with visual urinalysis in these practices. Reference testing was performed in a primary care laboratory (Saltro, Utrecht, The Netherlands). Primary and secondary outcome measures Analytical performance of automated and visual urinalysis compared with the reference laboratory method was the primary outcome measure, analysed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and Cohen's κ coefficient for agreement. Secondary outcome measure was the user-friendliness of the POCT analyser. Results Automated urinalysis by experienced and routinely trained practice assistants in general practice performs as good as visual urinalysis for nitrite, leucocytes and erythrocytes. Agreement for nitrite is high for automated and visual urinalysis. κ's are 0.824 and 0.803 (ranked as very good and good, respectively). Agreement with the central laboratory reference standard for automated and visual urinalysis for leucocytes is rather poor (0.256 for POCT and 0.197 for visual, respectively, ranked as fair and poor). κ's for erythrocytes are higher: 0.517 (automated) and 0.416 (visual), both ranked as moderate. The Urisys 1100 analyser was easy to use and considered to be not prone to flaws. Conclusions Automated urinalysis performed as good as traditional visual urinalysis on reading of nitrite, leucocytes and erythrocytes in routine general practice. Implementation of automated urinalysis in general practice is justified as automation is expected to reduce human errors in patient identification and transcribing of results.### 研究背景 即时检验（Point-of-care testing, POCT）尿液分析可减少检测结果的主观判读、记录与沟通误差，同时有望改善诊断结局并优化患者管理，但目前相关证据仍较为匮乏。本研究以常规全科诊疗场景为背景，对比自动化尿液分析与手工视觉尿液分析的分析性能，并以参考方法作为金标准。 ### 研究场景 本研究在荷兰的6家全科医师（general practitioner, GP）集团诊所开展，在上述诊所中对比自动化尿液分析与手工视觉尿液分析；参考检测则在荷兰乌得勒支的基层医疗实验室Saltro中完成。 ### 主要与次要结局指标 以参考实验室方法为金标准，对比自动化与手工视觉尿液分析的分析性能，此为主要结局指标，通过计算灵敏度、特异度、阳性预测值（positive predictive value, PPV）、阴性预测值（negative predictive value, NPV）以及一致性检验的科恩κ（Cohen's κ）系数进行分析。次要结局指标为POCT分析仪的用户友好性。 ### 研究结果 在常规全科诊疗场景中，由经验丰富且接受常规培训的诊所助理开展的自动化尿液分析，在亚硝酸盐、白细胞与红细胞的检测性能上与手工视觉尿液分析相当。自动化与手工视觉尿液分析对亚硝酸盐的检测一致性均较高，科恩κ值分别为0.824与0.803，分别被评为"极佳"与"良好"。自动化与手工视觉尿液分析对白细胞的检测与中心实验室参考标准的一致性较差：POCT的κ值为0.256，被评为"尚可"，手工视觉法的κ值为0.197，被评为"较差"。红细胞检测的κ值相对更高：自动化法为0.517，手工视觉法为0.416，二者均被评为"中等"。本次研究使用的Urisys 1100分析仪操作简便，且被认为不易出现操作失误。 ### 研究结论 在常规全科诊疗场景中，自动化尿液分析在亚硝酸盐、白细胞与红细胞的判读性能上与传统手工视觉尿液分析相当。由于自动化技术有望减少患者识别与结果转录过程中的人为误差，因此在全科诊疗中推广自动化尿液分析是合理的。