Evaluation of the Clinitek®, a point-of-care urinalysis system for the measurement of clinically significant urinary metabolites and detection of haematuria in Schistosoma haematobium infected children in southern Côte d'Ivoire

Abstract

Background: Urinary schistosomiasis, caused by Schistosoma haematobium, remains a significant public health problem worldwide, despite years of efforts to control it. Haematuria is one of the notable indirect indicators of S. haematobium infection and is commonly assessed along with other routine screens using a urinary dipstick test. A portable "field friendly" electronic analyser would offer an automated and thus more objective read-out compared to visual-read dipstick methods.

Methods: Within the framework of a Phase 2 praziquantel dose finding study in preschool- and school-aged children infected with S. haematobium, in southern Côte d'Ivoire, we compared a visual-read of the urine dipstick strips (Multistix PRO, Siemens Healthcare Diagnostics) to an automated reader (CLINITEK Status+ analyser™ Siemens Healthcare Diagnostics). Urine samples were collected from 148 pre-school aged and 152 school-aged children for urinalysis. Values were compared using a linear weighted kappa statistic and Bland-Altman analysis.

Results: A very good correlation between the two methods for nitrites and haematuria was observed (κ coefficient of 0.88 and 0.82, respectively), while a good correlation was observed for leukocytes (κ coefficient of 0.63) A moderate to fair correlation was calculated (κ coefficient ≤ 0.6) for all other parameters. When the results were stratified according to infection intensity, the agreements were stronger from the high infection intensity sample measurements, for most of the parameters.

Conclusion: Our results demonstrate the device's utility in detecting haematuria and nitrites but underline the need for further development of this tool in order to improve its performance in the field.

Keywords: Electronic analyser; Haematuria; Schistosoma haematobium; Urinalysis; Urinary dip-stick.

Fig. 1

Difference in measurement between a visual vs a CLINITEK readout for pH and specific gravity. Bland–Altman plots are shown to indicate difference in agreement for a pH for all samples as well as pH stratified by: b light infection intensity and c high infection intensity. The parallel plots are shown for specific gravity (d–f). Dashed black line indicates the mean difference while the grey dotted lines are the upper and lower limits of agreement