Performance Verification of the LOCMEDT C200 Automatic Biochemistry Analyzer Using Routine Clinical Samples

Abstract

Analytical verification is an essential prerequisite before implementing a new automated biochemistry analyzer in routine clinical laboratories to ensure reliability, accuracy, and compliance with recognized quality standards. This study aimed to verify the analytical performance of the LOCMEDT C200 Automatic Biochemistry Analyzer in accordance with CLSI and ISO 15189 principles by evaluating precision, accuracy (bias), and method comparison against an established routine analyzer using CLIA allowable error limits as performance benchmarks. Precision was assessed using a modified CLSI EP15-A3 approach with two levels of internal quality control materials to determine within-run and between-day coefficients of variation (CV%). Accuracy and method comparison were evaluated according to CLSI EP09-A3 by analyzing 40 patient serum samples in duplicate across clinically relevant concentration ranges. Statistical analyses included correlation assessment, percentage bias, and paired significance testing, with interpretation based on CLIA total allowable error criteria. The LOCMEDT C200 demonstrated acceptable analytical precision for most parameters, with between-day CV values largely within CLIA limits. Method comparison showed very strong correlation between the LOCMEDT C200 and the reference analyzer across all analytes. Most parameters, including glucose (3.58%), urea (4.06%), creatinine (7.07%), triglycerides (7.28%), and HDL (1.85%), showed bias within CLIA allowable limits. However, AST (32.30%) and total cholesterol (22.32%) exceeded CLIA total error thresholds, indicating systematic bias that requires further technical evaluation. Although statistically significant differences were observed for albumin and total protein (p < 0.05), the mean deviations remained within clinically acceptable limits. Overall, the LOCMEDT C200 demonstrated acceptable analytical performance for routine clinical chemistry testing, although targeted calibration assessment is recommended for analytes with elevated bias.