engleski

Comparison of within-laboratory precision, trueness and a total error of measurement procedures for CMIA and ECLIA methods in cyclosporine measurement

Introduction: In the laboratory, verification of measurement procedures opens the possibility to compare different methods. The aim of this study was to compare within-laboratory precision (CVSl), trueness (BIAS) and total error (TE) for CMIA (Chemiluminescent microparticle immunoassay) and ECLIA (Electrochemiluminescence immunoassay) method used for cyclosporine measurement. Materials and Methods: According to CLSI guideline protocol EP15-A2, verification of measurement procedures for cyclosporine measurement was conducted for CMIA method on Architect i2000SR (Abbott Laboratories, Illinois, USA) and for ECLIA method on Elecsys 2010 (Roche Diagnostics GmbH, Mannheim, Germany). For both measurement procedures calibration was performed on the first day. Cyclosporine concentration was measured in quality control materials in two concentration levels (L1 and L3) in triplicate for 5 days. Used control material for CMIA- Abbott method was MultiChem WBT (Technopath, Ireland) target values 92.3 ng/mL and 905 ng/mL and for ECLIA-Roche method PreciControl ISD (Roche Diagnostics GmbH, Germany) target values 91.5 ng/mL and 1170 ng/mL. Pretreatment of all used samples was performed using the same automatic pipette. Resulting values for precision were compared against the manufacturer’s criteria. Results: Precision of measurement procedures CMIA-Abbott and ECLIA- Roche method meet manufacturer’s set criteria. Obtained values for CMIA-Abbott vs. ECLIA-Roche method for within-laboratory precision (CVSl), trueness (BIAS) and total error (TE) were as following: CVSl (L1) 13.87% vs. 2.91% and CVSl (L3) 9.49% vs. 2.23%, BIAS (L1) -8.86% vs. 1.57% and BIAS (L3) -14.91% vs 1.37%, TE (L1) 36.04% vs. 7.27% and TE (L3) 33.51% vs. 5.74%. Conclusion: With the advantage of easier and faster sample pretreatment, measurement procedure for ECLIA- Roche method showed better accuracy, better trueness according to target values assigned to control materials and lower total error.

immunoassay ; quality control ; cyclosporine

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