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大型实验室网络中活化部分凝血活酶时间(APTT)检测对凝血因子缺乏症的敏感性分析。

An Analysis of the Sensitivity of the Activated Partial Thromboplastin Time (APTT) Assay, as Used in a Large Laboratory Network, to Coagulation Factor Deficiencies.

机构信息

Institute of Clinical Pathology and Medical Research (ICPMR) & Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, Australia.

Diagnostic Haemostasis Laboratory, Westmead, Australia.

出版信息

Am J Clin Pathol. 2022 Jul 1;158(1):132-141. doi: 10.1093/ajcp/aqac013.

Abstract

OBJECTIVES

To advance knowledge in using the ex vivo method to identify factor sensitivity of the activated partial thromboplastin time (APTT), using data from a hemophilia and reference hemostasis laboratory; to evaluate application of inclusion and exclusion criteria to eliminate data outliers; and to discuss outcomes with reference to comparable studies.

METHODS

An ex vivo, retrospective analysis was performed on patient samples with conjointly ordered APTT and intrinsic pathway factors (VIII, IX, XI, XII) for application to a large network of laboratories. The relationship between factor levels and APTT, before and after application of exclusion criteria, is demonstrated.

RESULTS

Curvilinear relationships were found between all factor levels and APTTs, which demonstrated both similarities and differences with available studies. Factor sensitivity data are presented. Study strengths include large sample size and use of real-world data. Limitations include inability to exclude all residual outliers and paucity of patient samples singularly deficient in factors other than FVIII.

CONCLUSIONS

This ex vivo, retrospective analysis of the sensitivity of the APTT assay to intrinsic pathway factor deficiencies using real-world data from a hemophilia and reference hemostasis laboratory contains the largest sample size using this approach to date. The outcomes assist in informing practice in this area and can be used as a reference for further studies.

摘要

目的

利用血友病和参考止血实验室的数据,通过体外方法来确定激活部分凝血活酶时间(APTT)的因子敏感性,从而提高相关知识水平;评估纳入和排除标准的应用,以消除数据异常值;并结合可比研究讨论结果。

方法

对联合检测 APTT 和内源性途径因子(VIII、IX、XI、XII)的患者样本进行体外回顾性分析,适用于大型实验室网络。展示了在应用排除标准前后,因子水平与 APTT 之间的关系。

结果

发现所有因子水平与 APTT 之间均存在曲线关系,这些关系与现有研究既有相似之处,也有不同之处。呈现了因子敏感性数据。研究的优势包括样本量大和使用真实数据。局限性包括无法排除所有残留异常值,以及除 FVIII 以外的其他因子单独缺乏的患者样本较少。

结论

这项利用血友病和参考止血实验室的真实数据,对 APTT 检测对内源性途径因子缺乏的敏感性进行的体外回顾性分析,是迄今为止使用该方法获得的最大样本量。结果有助于为该领域的实践提供信息,并可作为进一步研究的参考。

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