engleski

EVALUATION OF ANALYTICAL PERFORMANCE SPECIFICATIONS OF CLINICAL BIOCHEMISTRY PARAMETERS USINGBIOLOGICAL VARIATION-BASED CRITERI

BACKGROUND-AIM. The aim was to determine if third party control data for coefficient of variation (CV), bias and total allowable error (TEa)of 18 routine clinical chemistry tests collected over a period of 6 months would meet biological variation (BV)-based an alytical performance specifications (APS). METHODS. Test performances were evaluated according to the BV acceptance criteria as updated by the EFLM Biological Variation Database and the 2014 Desirable Biological Variation Database updated and compiled by Ricos and colleagues, for analytes not present in the EFLM Database. The preliminary data was collected over a 6-month period using three Beckman Coulter AU680 analyzers (Beckman Coulter, Brea, USA). Commercial control samples (Bio-Rad Laboratories, Hercules, USA) of two concentration levels were used and the results were evaluated using the Unity Real Time program and the Westgard Advisor software. The data evaluation was conducted by comparison of TEa and total analytic error (TAE) where the acceptance criteria is satisfied if TAE<TEa. RESULTS. For the level 1 control material, 11 tests met the BV optimum (potassium, glucose, urea, creatinine, uric acid, direct andtotal bilirubin, aspartate aminotransferase (AST), amylase (AMY), gamma- glutamyl transferase (GGT), creatine kinase(CK)), 3 tests the BV desirable (alanine aminotransferase (ALT), total proteine, albumin) and 3 tests the BV minimumTEa criteria (chlorid, lactate dehydrogenase (LD), alkaline phosphatase (ALP)). For the level 2 control material, 11 tests met the BV optimum (potassium, glucose, urea, uric acid, direct and total bilirubin, AST, ALT, AMY, GGT, CK), 4 teststhe BV desirable (creatinine, ALP, LD, total proteine) and 2 tests the BV minimum TEa criteria (chlorid, albumin). 1 test did not meet any acceptance criteria in both concentration levels (sodium). CONCLUSIONS. Defining APS based on BV is specific for a particular test and thus can give an objective indicator of the source of anerror, thereby improving the quality and patient safety. Although meeting the APS based on BV is preferable, in some cases, e.g., serum sodium, we need to go down in performance goals hierarchy and use the state-of-the-art approach.

analytical performance criteria ; biological variation-based criteria

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