Evaluation of the Sysmex UC-1000 test strip reader: fit for purpose in a point-of-care setting?

OBJECTIVES: Urinalysis is essential for detecting kidney disease, urinary tract infections, and diabetes mellitus. Point-of-care testing enables rapid screening in decentralized settings and supports low-throughput laboratories. This study evaluated the Sysmex UC-1000 according to the 2023 EFLM urinalysis guidelines in a real-life clinical point-of-care setting. METHODS: In total, 331 urine samples were analyzed on the UC-1000 using MEDITAPE™ UC-12S strips, of which 129 were processed by medical laboratory technologists (MLTs) and 202 by nurses at Ghent University Hospital, Belgium. All samples were reanalyzed within stability limits using reference methods (UC-3500, Cobas pro/c503, or Architect c16000). RESULTS: Imprecision based on reflectance data ranged from 0.3 % to 7.1 %, depending on the parameter and concentration level. Minimum ordinal scale agreement met EFLM criteria for all parameters in both groups, except urobilinogen and creatinine in nurses. Trueness analysis demonstrated optimal (<10 %) false-positive rates (FPR) at the limit of detection for all parameters except leukocyte esterase (MLTs and nurses) and protein-to-creatinine ratio, which met the desirable criteria (<20 %). Albumin and albumin-to-creatinine ratio exceeded desirable criteria, with FPR of 22.5-47.3 % in both groups. EFLM criteria for false-negative rates within the grey zone and above the limit of confirmation were met for all parameters. Diagnostic sensitivity and specificity ranged from 95.0 to 100 % and 52.7 to 100 %, respectively, with no significant differences between MLTs and nurses except for higher albumin specificity in nurses. CONCLUSIONS: The UC-1000 shows strong concordance with the UC-3500, meets EFLM performance specifications, and reliably detects clinically significant albuminuria and proteinuria, supporting its use in point-of-care settings.