Brulé Justine, Sinegre Thomas, Pereira Bruno, Berger Marc G, Serre-Sapin Anne-Françoise, Lebreton Aurélien
Service d'hématologie biologique, CHU de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France.
Unité de biostatistiques, Direction de la recherche clinique et de l'innovation, CHU Gabriel-Montpied, Clermont-Ferrand, France.
Ann Biol Clin (Paris). 2018 Apr 1;76(2):143-149. doi: 10.1684/abc.2018.1333.
The STA R Max is a fully automated multiparameter coagulometer using clotting (viscosity-based detection system), chromogenic and immunologic assays. STA R Max is equipped with an innovative software (STA Coag Expert) designed to assist laboratory in accreditation. The aim of this study was to evaluate its performances for the certification according to ISO 15189 quality standard in the haemostasis unit of our university hospital. The following tests were evaluated: prothrombin time (PT), activated partial thromboplastin time (aPTT), kaolin cephalin clotting time (KCCT), fibrinogen, anti-Xa assay and D-dimers. In normal and pathological range, the intra-assay coefficients of variation (CV) for PT, aPTT, KCCT and fibrinogen were below 4.0%. Intra-assay CV was of 4.0% for the anti-Xa assay and intra-assay CV was of 7.9% for D-dimers. Inter-assay CV were below 5.0% for PT, aPPT, KCCT and fibrinogen, 14.9% for anti-Xa assay and 8.6% for D-dimers. The interlaboratory comparisons were below 8.7% for PT, aPPT and KCCT, 5.0% for fibrinogen and 15.5% for anti-Xa assay. All results were acceptable according to suitable CV established by GFHT and the provider. The concordance between all coagulometers was excellent, with correlation coefficient close to 1 (0.99 for all parameters except for aPPT which was 0.98) calculated thanks to an intra-class correlation study. In conclusion, the STA R Max analyser is suitable for haemostasis laboratories and facilitates certification of a laboratory.
STA R Max是一款全自动多参数凝血分析仪，采用凝固法（基于粘度的检测系统）、发色底物法和免疫分析法。STA R Max配备了一款创新软件（STA Coag Expert），旨在协助实验室进行认证。本研究的目的是根据我校医院止血科室的ISO 15189质量标准评估其认证性能。评估了以下检测项目：凝血酶原时间（PT）、活化部分凝血活酶时间（aPTT）、高岭土部分凝血活酶时间（KCCT）、纤维蛋白原、抗Xa测定和D-二聚体。在正常和病理范围内，PT、aPTT、KCCT和纤维蛋白原的批内变异系数（CV）低于4.0%。抗Xa测定的批内CV为4.0%，D-二聚体的批内CV为7.9%。PT、aPPT、KCCT和纤维蛋白原的批间CV低于5.0%，抗Xa测定的批间CV为14.9%，D-二聚体的批间CV为8.6%。PT、aPPT和KCCT的实验室间比对低于8.7%，纤维蛋白原的实验室间比对为5.0%，抗Xa测定的实验室间比对为15.5%。根据GFHT和供应商确定的合适CV，所有结果均可接受。所有凝血分析仪之间的一致性极佳，通过组内相关研究计算得出的相关系数接近1（除aPPT为0.98外，所有参数均为0.99）。总之，STA R Max分析仪适用于止血实验室，并有助于实验室认证。
