Performance Evaluation and Multicenter Consistency Study of Smartphone-based Hipee S2 Point-of-care Testing Urine Dipstick Analyser: Evaluation Study (Preprint)

Abstract

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 POCT devices need to have good analytical and clinical performance, but data are lacking.

The purpose of this study is to evaluate the analytical performance of smartphone-based Hipee S2 POCT urine dipstick analyser.

A total of 1,603 urine samples from three hospitals were collected. Precision, drift, carry-over, interference, and method comparison of Hipee S2 were evaluated.

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, for pondus hydrogenii (pH) was moderate, and for other parameters varied between substantial to excellent, on comparing the results obtained by Hipee S2 with those measured by laboratory reference analysers. The semi-quantitative results of microalbumin and creatinine were highly correlated with the quantitative results.

Hipee S2 POCT urine analyser showed acceptable analytical performance as a semi-quantitative method. It serves as a convenient alternate device for clinicians and individual users for urinalysis and health management.