engleski

Evaluation and validation of the Cobas 6000 analyzer modules c501: the routine serum analytes

Background The aim of the study was to assess the analytical performance of the Cobas 6000 analyzer series modules c501 (Roche Diagnostics) and to validate it in routine set of serum analytes. Materials and methods We investigated complete routine serum tests for 36 analytes and preliminary present the results for cholesterol, HDL, LDL, triglycerides, uric acid, iron, and UIBC on two modules c501 (R1+R2) plus ACE (R1), and cooper (R2). The evaluation protocol consisted of imprecision: within-run (10 sequential runs) and between-run (10 consecutive working days, 2 sequential runs) with commercial controls (PreciControl ClinChem Multi 1/2, Roche ; HumAsy Control 2/3, Randox ; ACE controls N/H, Bühlmann), inaccuracy (N=20), and method comparison (routine serum samples, N=30) vs. Beckman Coulter AU640. Results The majority of analytes on the assigned modules have a within-run imprecision <2%. For all analytes, except cooper and UIBC, the between-run imprecision was <3%. Quality requirements for imprecision and total error were met by all analytes on the assigned modules, excluding cooper. Quality requirement for inaccuracy were fulfilled by all analytes with the exception of HDL (R2). The correlation with comparison method showed no difference between methods for cholesterol, LDL, cooper, uric acid, and ACE on the assigned modules. Triglycerides and HDL showed some difference on both modules. UIBC and triglycerides on R1, due to significant deviation from linearity need further investigation. Conclusions These preliminary results showed that Cobas 6000 analyzer has optimal analytical performance with mostly fulfilled quality control requirements and acceptable method comparisons for our routine serum analytes.

Validation; serum analytes

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