Clinical Laboratory, Branch of Tianjin Third Central Hospital, Tianjin, China
Clinical Laboratory, Tianjin Stomatological Hospital, Tianjin, China.
BMJ Open. 2022 Oct 27;12(10):e063781. doi: 10.1136/bmjopen-2022-063781.
With advances in mobile technology, smartphone-based point-of-care testing (POCT) urinalysis hold great potential for disease screening and health management for clinicians and individual users. The purpose of this study is to evaluate the analytical performance of Hipee S2 POCT urine dipstick analyser.
A multicentre, hospital-based, cross-sectional study.
Analytical performance of the POCT analyser was conducted at a clinical laboratory, and method comparison was performed at three clinical laboratories in China.
Urine samples were collected from 1603 outpatients and inpatients at three hospitals, and 5 health check-up population at one of the hospitals.
All tests were performed by clinical laboratory technicians. Precision, drift, carry-over, interference and method comparison of Hipee S2 were evaluated. Diagnostic accuracy of semiquantitative albumin-to-creatinine ratio (ACR) for albuminuria was carried out using quantitative ACR as the standard.
The precision for each parameter, assessed by control materials, was acceptable. No sample carry-over or drift was observed. Ascorbate solution with 1 g/L had an inhibitory effect for the haemoglobin test. Agreement for specific gravity (SG) varied between moderate to substantial (κ values 0.496-0.687), for pH was moderate (κ values 0.423-0.569) and for other parameters varied between substantial to excellent (κ values 0.669-0.991), on comparing the Hipee S2 with laboratory analysers. The semiquantitative microalbumin and creatinine were highly correlated with the quantitative results. The sensitivity of semiquantitative ACR to detect albuminuria was 87.2%-90.7%, specificity was 70.7%-78.4%, negative predictive value was 85.3%-87.9% and positive predictive value was 73.9%-83%.
Hipee S2 POCT urine analyser showed acceptable analytical performance as a semiquantitative method. It serves as a convenient alternate device for clinicians and individual users for urinalysis and health management. In addition, the POCT semiquantitative ACR would be useful in screening for albuminuria.
随着移动技术的进步，基于智能手机的即时检测（POCT）尿液分析在临床医生和个体用户的疾病筛查和健康管理方面具有巨大潜力。本研究旨在评估 Hipee S2 POCT 尿液试纸条分析仪的分析性能。
多中心、基于医院的横断面研究。
在临床实验室进行 POCT 分析仪的分析性能评估，在中国的三个临床实验室进行方法比较。
从三家医院的 1603 名门诊和住院患者以及其中一家医院的 5 名健康检查人群中采集尿液样本。
所有测试均由临床实验室技术人员进行。评估了 Hipee S2 的精密度、漂移、携带污染、干扰和方法比较。使用定量 ACR 作为标准，对白蛋白/肌酐比值（ACR）半定量检测白蛋白尿的诊断准确性进行了评估。
使用质控品评估每个参数的精密度均在可接受范围内。未观察到样本携带污染或漂移。1g/L 的抗坏血酸溶液对血红蛋白检测有抑制作用。Hipee S2 与实验室分析仪比较，比重（SG）的一致性为中度至高度（κ 值 0.496-0.687），pH 值为中度（κ 值 0.423-0.569），其他参数的一致性为高度至极好（κ 值 0.669-0.991）。微量白蛋白和肌酐的半定量结果与定量结果高度相关。半定量 ACR 检测白蛋白尿的灵敏度为 87.2%-90.7%，特异性为 70.7%-78.4%，阴性预测值为 85.3%-87.9%，阳性预测值为 73.9%-83%。
Hipee S2 POCT 尿液分析仪作为半定量方法，具有可接受的分析性能。它是临床医生和个体用户进行尿液分析和健康管理的便捷替代设备。此外，POCT 半定量 ACR 可用于筛查白蛋白尿。
