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[ACL TOP自动凝血分析仪(仪器实验室)的评估]

[Evaluation of the automated coagulation analyser ACL TOP (instrumentation laboratory)].

作者信息

Eschwège V, Catillon C, Robert A

机构信息

Service d'immunologie et d'hématologie biologiques, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Paris.

出版信息

Ann Biol Clin (Paris). 2006 May-Jun;64(3):259-64.

Abstract

The ACL TOP is a fully automated random access analyser for coagulometric, chromogenic ou immunologic measurements. The aim of the present study was to evaluate its performances. The tests performed were: prothrombin time (PT), activated partial thromboplastin time (aPTT), prothrombin time derived fibrinogen (FibD), factor VIII (FVIII), antithrombin (AT) and free protein S antigen (PS). The comparison study was performed by analyzing patients samples in duplicate with ACL TOP and the analyser MDA II (BioMérieux) or CA 6000 (Dade-Behring). Imprecision (CV%) was < 4% for routine tests and < 5% for FVIII, AT and PS, except a between-run imprecision < 7,5% for low AT levels. The measured lower limits of linearity for FVIIII, AT and PS were satisfactory. The correlation observed between the ACL TOP and the other analysers was strict for PT and AT and good for TCA and FibD. Triglyceride levels > or = 6 mmol/L interfered with PT and FibD measurements. No sample or reagent carryover was observed in the conditions of the study. Overall, the ACL TO is an analyser with very satisfactory analytical and technical performances and is well suited for routine and specialized coagulation laboratories.

摘要

ACL TOP是一款用于凝血、发色底物或免疫检测的全自动随机存取分析仪。本研究的目的是评估其性能。所进行的检测项目包括:凝血酶原时间(PT)、活化部分凝血活酶时间(aPTT)、凝血酶原时间衍生纤维蛋白原(FibD)、因子VIII(FVIII)、抗凝血酶(AT)和游离蛋白S抗原(PS)。通过使用ACL TOP与MDA II分析仪(生物梅里埃公司)或CA 6000分析仪(达德-拜耳公司)对患者样本进行重复分析来开展对比研究。常规检测的不精密度(CV%)<4%,FVIII、AT和PS的不精密度<5%,但低AT水平时批间不精密度<7.5%。FVIII、AT和PS的线性测量下限令人满意。ACL TOP与其他分析仪之间在PT和AT方面观察到严格的相关性,在TCA和FibD方面相关性良好。甘油三酯水平≥6 mmol/L会干扰PT和FibD的测量。在本研究条件下未观察到样本或试剂残留。总体而言,ACL TOP是一款分析和技术性能非常令人满意的分析仪,非常适合常规和专业凝血实验室使用。

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