Comparison of Results of Biochemistry Analytes by Two Different Commercially Available Reagents on a Conventional Laboratory Analyzer at an Oncology Centre

Consistent and reproducible results from different measurement procedures are a must for diagnosis and appropriate treatment of diseases. The objectives of the study were to compare the results of the biochemistry analytes processed by two different commercially available reagents on a conventional laboratory analyser and to calculate total error for the analytes subjected to comparison. This study was designed for comparing results of three analytes, Creatinine Kinase (CK), CK-MB and Lactate by using reagents from Randox laboratories (India) Pvt Ltd. and from Beckman Coulter India Pvt. Ltd. It also included determination of within-run (N = 20) and between run imprecision (N = 20), inaccuracy (N = 20) and method comparison by both the reagents on Beckman Coulter AU 2700 (N = 40). Total error was calculated for validation of the analytical process. The results indicate that within-run imprecision CVs were all below 5.5% for both the reagents. Between run CVs for all analytes were below 5%. All the analytes have fulfilled requirements for inaccuracy and total error as per the quality specifications. We conclude that t69he reagents from both the manufacturers had low CV values and had satisfactory accuracy and precision and are extremely stable. Method comparison study showed excellent correlation between both the reagents. Hence, the reagents from the two different manufacturer's can be used for routine testing of the respective analytes.