Evaluation of analytical performance and clinical applicability of the UriSed Mini, a semi-automated urine analyzer for cell counting in cerebrospinal fluid.

Abstract

Introduction: Cerebrospinal fluid (CSF) analysis is essential in diagnosing central nervous system pathologies. While manual cell counting by optical microscopy is the gold standard, it is labor-intensive and time-consuming, posing challenges particularly in urgent cases, automated hematology analyzers offer alternatives but come with limitations. The aim of the study was to evaluate the performance of the UriSed Mini instrument for CSF in accordance with ICSH guidelines.

Materials and methods: A total of 77 CSF patient samples were analyzed by both methods from September 2023 to September 2024. Following the International Council for Standardization in Hematology guidelines, the UriSed Mini was evaluated for short- and long-term imprecision, limit of blank, limit of detection and analytical measurement range. Quantitative comparison between the two methods was conducted using Bland-Altman and Passing-Bablok analyses. Qualitative agreement was assessed through inter-rater agreement testing.

Results: The UriSed Mini successfully met all performance criteria, both in comparison to the manufacturer's claims and in the context of practical clinical requirements. While statistically significant differences were observed in the quantitative comparison (0.6 cells/µL), these discrepancies are unlikely to have clinical significance at the medical decision-making level. The qualitative comparison demonstrated excellent agreement, with a weighted kappa coefficient of 0.96 (95% confidence interval: 0.89-1.00).

Conclusions: This study demonstrates that the UriSed Mini meets analytical standards for CSF cell counting and aligns closely with optical microscopy at clinically relevant thresholds.