engleski

Validation of a 6-part differential hematology analyser Siemens Advia 2120i

Aim: The aim of this study was to perform the validation of a 6-part differential hematology analyzer Siemens Advia 2120i (Erlangen, Germany), prior to its routine implementation. Materials and methods: Our validation protocol combined the CLSI H26-A2: 2010 and the ICHS 2014 guidelines, and included: precision (within and between run), accuracy (comparison with reference analyzer – 300 samples), linearity, carryover, confirmation of a LoB, determination of a LoD and LoQ. TE% was calculated for all measured parameters. Acceptance criteria were based on: manufacturer technical specifications (Siemens), 2016 state-of-the-art criteria (Vis and Huisman) and biological variation. Analysis was done using MedCalc 16.2.0 statistical software (MedCalc Software bvba, Ostend, Belgium). Results: The lowest within and between run precision CVs were observed for MCV (0.3% and 0.6%, respectively). Bland&Altman plot did not reveal statistically significant bias for any of the measured parameters: WBC (difference (%):-1.0, 95%CI:-10, 2 to 8.1), RBC (difference (%):-1.4, 95%CI:-4.3 to 1.5), Hb (difference (%):-0.2, 95%CI:-2.5 to 2.1) and Plt (difference (%):-6.9, 95%CI:-2.4 to 16.1). Linearity was confirmed for all tested parameters (r>0.99). The carryover estimates ranged from 0.1% for Plt to 0.8% for WBC and were within the manufacturers specifications (≤1%). Manufacturers claims for LoB were confirmed. The estimated LoD and LoQ were 0.05x10*9/L and 0.1x10*9/L for WBC, while for Plt values were 2x10*9/L and 3x10*9/L, respectively. The calculated TE% ranged from 2.35% for Hb to 12.33 for Plt. Conclusion: Hematology analyzer Siemens Advia 2120i is completely in accordance with the predefined quality goals and is suitable for everyday routine practice.

hematology analyzer, validation, quality goals, biological variation

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