engleski

Assuring internal analytical quality of blood cells examination with the different automated hematology analyzers according to the EN ISO 15189:2003

Background: One of the most important responsibilities of laboratory professionals in clinical hematology laboratories is to ensure the quality of test results performed using principal different automated hematology analyzers. The aim of present study is to investigate according to the EN ISO 15189:2003.: the differences between CBC results performed on analysers already validated in our Division (Beckman Coulter HmXBCHmX, CellDyn3200-CD3200 and CellDyn- CDSapphire), limits of acceptably differences and frequency most appropriate for this internal quality control, and procedures of verification. Methods: We determinate CBC on BCHmx, CD3200 and CDSapphire. Analysis has been done in two blood samples, K1 (normal sample) at 6 a.m. after internal control with commercial control, and K2 (abnormal sample) during morning. We calculated differences of the results of RBC, HGB, MCV, WBC and PLT between BCHmX– as referent analyzer and two others analysers. We decided that limits of comparability should be the same as limits of external control of Croatian Society of Medical Biochemists (RBC, HGB, MCV<5%, WBC, PLT<15%) and created automatic calculator for calculation of the difference in results. Results: The following results were obtained during the time of three months (July 1 until September 30, 2008, N=2769 data) and statistical analysis was performed by MedCalc using Bland&Altman method. Mean differences between BCHmX and CD3200 were: RBC=-1.6% ; HGB=-0.8% ; MCV=2.6% ; PLT=-0.1% ; WBC=1.9% and for CDSapphire: RBC=-1.7% ; HGB=-3.1% ; MCV=0.7% ; PLT=-4.8% ; WBC=-3.4%. Conclusions: The inter-comparability results of three different hematolgy analyzers two times a day of our verified procedures are completely acceptable according the EN ISO 15189:2003.

EN ISO 15189; blood cells; hematology analyzer

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