engleski

Verification of body fluid mode on hematology analyzer Siemens Advia 2120i

Introduction: Body fluid mode on Siemens Advia 2120i (Erlangen, Germany) is intended for counting total nucleated cells (TNC) and red blood cells (RBC) in pleural and peritoneal fluids. Our aim was to verify performance of body fluid (BF) mode on Siemens Advia 2120i analyzer for pleural and peritoneal fluid samples. Materials and methods: According to CLSI H56 (2006) and ICSH 2014 guidelines, we performed verification of precision (within-run and day-to-day), accuracy (comparison with the routine reference analyzer, i.e. second Advia 2120i), linearity, limit of quantification (LOQ) and carryover using inpatient samples (pleural and peritoneal body fluids) and commercial complete blood count mode (CBC) control materials. Acceptance criteria were based on Siemens specifications (precision for TNC ≤15% and RBC ≤10% ; carryover <0.4%), biological variation (precision for white blood cells (WBC) 5.73%, RBC 1.6% ; bias for WBC 6.1% and RBC 1.7%) and state-of-the-art (bias for WBC 4.4% and RBC 3.2% ; proposed by Vis and Huisman, 2016). Data were analyzed using MedCalc Statistical Software version 12.5.0.0 (MedCalc Software bvba, Ostend, Belgium). Results: Within-run and day-to-day precision were 16.7% and 15.6% for TNC and 0.7% and 1.1% for RBC, respectively. Although assay principle for cell counting in BF and CBC mode on Advia 2120i is the same, declared target values for WBC count in control materials were not adequate for TNC count, since this control material is not suitable for BF mode. Passing Bablok showed perfect agreement between two analyzers for TNC in peritoneal (N=31 ; intercept -0.83 (-10.33-10.74) ; slope 1.01 (0.98-1.04)) and in pleural fluid (N=43 ; intercept -0.15 (-5.31-10.42) ; slope 1.00 (0.97-1.02)). Linearity was acceptable for both TNC and RBC (r>0.99). LOQ was 79.6x106/L for TNC and 11.1x109/L for RBC. Both LOQ were higher than declared by the manufacturer (27x106/L and 4.94x109/L, respectively). Carryover for TNC and RBC was within declared limits. Conclusion: Performance of BF mode on automated Advia 2120i analyzer meets manufacturer and state-of-the-art criteria for all tested parameters, except for precision estimated on CBC control samples. Commercial controls for CBC mode are not suitable material for BF mode application.

verification ; body fluid ; hematology

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