Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium®

Abstract

ABSTRACT Introduction: The harmonization of equipment is recommended in clinical laboratory practice aiming for the homogeneity of results when similar or equivalent analyzers are used to perform routine testing. Objectives: To conduct a study of equivalence between the biochemical analyzers Labmax 240® (E1) and Labmax 240 Premium® (E2) through the matching results and the statistical value analysis of dosages. Materials and methods: We evaluated tests with glucose, total cholesterol, triglycerides, uric acid, aspartate transaminase (AST), alanine transaminase (ALT) and lactate dehydrogenase (LDH), all with 40 repeated measurements, performed in both equipments. The Clinical and Laboratory Standards Institute (CLSI) EP09-3A protocol was used to conduct the comparison test between E1 and E2 equipment, with subsequent evaluation of the results for statistical analysis determining the Pearson correlation coefficient (r) and indexes comparison error with EP Evaluator® software. Results: Regarding the values of the Pearson correlation coefficient, all tests showed a strong correlation between equipment with r > 0.989, except for the dosage of LDH (r = 0.982). This dosage failed not because the value of r, but due to the values obtained in the error index being larger than the total errors index allowed. Discussion: Compared to clinical criteria, the results of the analyzers are approximately equal, but this control process must be done continuously in order to prevent and track random errors within the laboratory routine. Conclusion: The process of harmonization of multiple devices that perform the same laboratory parameters is essential for ensuring quality and reliability of laboratory results and should be standardized and included in routine clinical analysis laboratories.

Keywords

• quality control
• quality assurance health care
• laboratory equipment
• automation laboratory