Verification of a 6-part differential haematology analyser Siemens Advia 2120i.

Abstract

Introduction: The aim of this study was to perform a comprehensive verification of a 6-part differential haematology analyser Siemens Advia 2120i (Erlangen, Germany), prior to its routine implementation.

Materials and methods: Our verification protocol included: precision (within- and between-run), estimated bias (%) as measure of trueness, which was calculated from observed and manufacturers' declared value, analytical measuring interval (AMI), carryover, confirmation of a limit of blank (LoB), determination of a limit of detection (LoD) and limit of quantitation (LoQ). The K₂ ethylenediaminetetraacetic acid (EDTA) patients' leftover samples were used for verification of analyser Advia 2021i. Acceptance criteria were based on manufacturer technical specifications (Siemens), 2016 state-of-the-art criteria (Vis and Huisman), and EFLM Biological Variation Database.

Results: The within- and between-run precision were acceptable for all parameters and the lowest coefficients of variation were observed for mean corpuscular volume (MCV) (0.3% and 0.6%, respectively). Estimated bias was within the acceptance criteria for all parameters except for MCV (the estimated bias was 2.2% (acceptance criteria 2.0%). AMI was confirmed for all tested parameters (r > 0.99). The carryover estimates ranged from 0.1% for platelet count (Plt) to 0.6% for red blood cell count and were within the manufacturers' specifications (≤ 1%). Manufacturers' claims for LoB were confirmed for leukocytes, erythrocytes, haemoglobin, and platelets. The estimated LoD and LoQ were 0.05 x10⁹/L and 0.1 x10⁹/L for white blood cell count, while for Plt values were 2 x10⁹/L and 3 x10⁹/L, respectively.

Conclusions: Analytical performance of the Siemens Advia 2120i meets predefined quality goals and is suitable for routine use in a clinical laboratory.