Performance Evaluation of Automated Urit 5160 Haematology Analyser at the Bamenda Regional Hospital, Cameroon

Abstract

BACKGROUND: The Urit 5160 is a five-part leucocyte automated haematology analyser routinely used to improve workflow, patient management, and research. It is essential to confirm the instrument's performance by examining objective evidence that the laboratory can achieve the manufacturer-provided performance characteristics. Surprisingly, some analysers are used without evaluation. Our objectives were to evaluate the performance characteristics of Urit 5160 using blank count, precision, carryover, linearity, and method-comparison experiments to improve workflow, patient management, and research. MATERIAL AND METHODS: This was a cross-sectional prospective study conducted between October 2024 and March 2026 at the Bamenda Regional Hospital Laboratory, Cameroon. The parameters examined included: White Blood Cell Count, Haemoglobin, Red Blood Cell Count, Haematocrit, and Platelet Count. Excellent agreement was considered if the results from various experiments matched the manufacturer-provided specifications. Method comparison was performed by analysing 100 specimens in parallel on Urit 5160 and 3000 plus (reference instrument). Bland-Altman plots and Passing-Bablok regression analysis were used to evaluate the slopes, intercepts, and bias relative to the total allowable error (TEa) limits. RESULTS: Our results demonstrated acceptable blank count (0.0%), imprecision (%CV ≤ 3.9), carry-over (≤ 0.6%), and linearity (r ≥ 0.999) and the comparison study across all parameters. Bland-Altman analysis and Passing-Bablok regression showed acceptable correlation and minimal bias. CONCLUSION: The instrument demonstrated acceptable blank count, imprecision, carry-over, linearity, and method comparison within the constraints of the comparator instrument-Urit 3000 plus across all parameters. Thus, laboratories should ensure that manufacturer-provided characteristics are verified before instruments are routinely used.