A performance evaluation of sthemO 301 coagulation analyzer and associated reagents

Author:

Pontis Adeline12ORCID,Delanoe Mélanie1,Schilliger Nathalie1,Carlo Audrey3ORCID,Guéret Pierre1,Nédélec‐Gac Fabienne1,Gouin‐Thibault Isabelle12

Affiliation:

1. Laboratoire d'Hématologie‐Hémostase Centre Hospitalo‐Universitaire de Rennes Pontchaillou Rennes France

2. INSERM, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail), UMR_S 1085 Université de Rennes Rennes France

3. Diagnostica Stago Asnières‐sur‐Seine France

Abstract

AbstractAimThe study objective was to evaluate the performance of sthemO 301 system and to compare it with the analyzer used in our university hospital laboratory (STA R Max® 2), for a selection of hemostasis parameters.MethodsMethod comparison (according to CLSI EP09‐A3), carryover (according to CLSI H57‐A), APTT sensitivity to heparin (according to CLSI H47‐A2), HIL level assessment, and productivity were performed using leftover samples from our laboratory (n > 1000). Commercial quality control materials were used to evaluate precision (according to CLSI EP15‐A3) and accuracy. The assays tested on sthemO 301 were: PT, APTT (silica and kaolin activators), fibrinogen (Fib), thrombin time (TT), chromogenic and clotting protein C (PC) activity, and von Willebrand factor antigen (VWF:Ag) levels.ResultsAll intra‐assay and inter‐assay precision CVs were below the maximal precision limit proposed by the French Group for Hemostasis and Thrombosis (GFHT). Accuracy was verified with bias below GFHT criteria and most Z‐scores were between −2 and +2. No clinically relevant carryover was detected. Silica APTT reagent sensitivity to unfractionated heparin was moderate, as expected. Productivity results were consistent over the 10 repeats performed. The overall agreement between the two systems was excellent for all assays, with Spearman rank correlation coefficient all above 0.9 and slopes of Passing–Bablok correlation near 1 and intercepts close to 0.ConclusionFor the methods tested, sthemO 301 system met all the criteria to implement a novel coagulation analyzer in the laboratory and result comparability with STA R Max® 2 was good.

Publisher

Wiley

Subject

Microbiology (medical),Biochemistry (medical),Medical Laboratory Technology,Clinical Biochemistry,Public Health, Environmental and Occupational Health,Hematology,Immunology and Allergy

Reference11 articles.

1. Normes d'acceptabilité en hémostase.Groupe français d'études sur l'hémostase et la thrombose. [En ligne] 08 2014. [Citation: 10 03 2022.]https://site.geht.org/app/uploads/2016/12/Normes_acceptables_hemostase_GEHT2014.pdf

2. Illuminating Z‐score in external quality assessment for medical laboratory;Sareen R;Health Care Current Review,2018

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