Performance evaluation of Hipee S2 point-of-care testing urine dipstick analyser: a cross-sectional study

OBJECTIVE: 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. DESIGN: A multicentre, hospital-based, cross-sectional study. SETTING: Analytical performance of the POCT analyser was conducted at a clinical laboratory, and method comparison was performed at three clinical laboratories in China. PARTICIPANTS: Urine samples were collected from 1603 outpatients and inpatients at three hospitals, and 5 health check-up population at one of the hospitals. OUTCOME MEASURES: 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. RESULTS: 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%. CONCLUSIONS: 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.