engleski

Evaluation and validation of the Cobas 6000 analyzer series modules c501: the urine analytes

Background: The aim of study was to assess the analytical performance of the Cobas 6000 analyzer series modules c501 (Roche iagnostics) and to validate it in our routine set of urine analytes. Materials and methods: We investigated 12 routine urine analytes tests (amylase, glucose, urea, creatinine, urate, total proteins, sodium, potassium, chloride, calcium, phosphate, magnesium) on two modules c501 (R1+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 (Liquicheck, Biorad ; Precinorm PUC/Precipath PUC, Roche), inaccuracy (N = 20), and method comparison (routine urine samples, N = 30) vs. Beckman Coulter AU640. Results: All analytes on both modules have within-run imprecision < 3%, except phosphate and magnesium (R2). For all analytes between-run imprecision was < 5%. All analytes fulfilled quality requirements for imprecision and for total error. A quality requirement for inaccuracy was met by all analytes on both modules with exception of urate on R1 and amylase on R1+R2. The correlation with comparison method showed no difference between methods for glucose, amylase, urea, sodium, phosphate, magnesium on R2 and for potassium, amylase, urea on R1. Constant difference was observed for five analytes on R1, and three on R2. Proportional difference was found for five analytes on R1, and two on R2. Two tests need further investigation, chloride on R1, and creatinine on both modules, due to significant deviation from linearity. Conclusions: Cobas 6000 analyzer showed optimal analytical performance with mostly fulfilled quality control requirements and acceptable method comparisons for urine analytes.

Validation; urine analytes

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