CLSI H47-A3-2023 单阶段凝血酶原时间 (PT) 检测和活化部分凝血酶原时间 (APTT) 检测

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H47

One-Stage Prothrombin Time (PT) Test and

Activated Partial Thromboplastin Time (APTT)

Test

This document provides guidelines for performing the PT and

APTT tests in the clinical laboratory, for reporting results, and for

identifying sources of error.

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

3rd Edition

Clinical and Laboratory Standards Institute

Setting the standard for quality in medical laboratory testing around the world.

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together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a

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H47-Ed3

March 2023

Replaces H47-A2

One-Stage Prothrombin Time (PT) Test and Activated Partial

Thromboplastin Time (APTT) Test

Donna D. Castellone, MS, MASCP, MT(ASCP)SH

Karen A. Moser, MD

Elizabeth M. Van Cott, MD

Richard A. Marlar, PhD

Janet Cook, MT(ASCP)

Marilyn Johnston, ART

Stephen Kitchen, FIBMS, PhD

Samuel J. Machin, MB, ChB, FRCPath

Diane Shafer, MT(ASCP)

Laura Worfolk, PhD

Abstract

Clinical and Laboratory Standards Institute document H47—One-Stage Prothrombin Time (PT) Test and Activated Partial

Thromboplastin Time (APTT) Test describes the principles and procedures necessary for the routine performance of the

PT and APTT by conventional techniques using citrated plasma. Each of the two tests measures the time for a brin clot

to develop in test plasma after activation. The chemical reactions are complex and, characteristically, results are aﬀected

by preexamination (preanalytical) and examination (analytical) variables. The PT and APTT are important screening tests

used in laboratory evaluation of patients suspected to have disorders of blood coagulation, including the presence of

circulating coagulation inhibitors. The PT measures the extrinsic or tissue factor pathway of the coagulation system and

is used to monitor vitamin K antagonist therapy. The APTT measures the intrinsic coagulation pathway and is used in

monitoring heparin therapy, as well as parenteral direct thrombin inhibitor anticoagulant therapy such as argatroban

and lepirudin. The objective of this guideline is to improve test reproducibility through standardization of technique and

ensure clinical relevance by setting test performance goals. The document also highlights the international eﬀort for

standardization of the PT through the use of the international normalized ratio.

Clinical and Laboratory Standards Institute (CLSI). One-Stage Prothrombin Time (PT) Test and Activated Partial

Thromboplastin Time (APTT) Test. 3rd ed. CLSI guideline H47 (ISBN 978-1-68440-172-7 [Print]; ISBN 978-1-68440-173-4

[Electronic]). Clinical and Laboratory Standards Institute, USA, 2023.

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标签： #CLSI #检测

摘要：

该文档为 CLSI H47-A3-2023 标准规范，主要涵盖单阶段凝血酶原时间 (PT) 和活化部分凝血酶原时间 (APTT) 检测的标准化流程与最新技术要求。作为临床实验室凝血功能检测的核心参考文件，该标准详细规定了样本采集、试剂选择、仪器校准、质控措施及结果解读的规范化操作，旨在提升凝血检测的准确性与一致性。适用于血液学实验室、临床检验科及体外诊断行业从业者，帮助优化凝血功能评估流程，降低检测变异，确保患者诊疗安全。通过学习该标准，实验室可更好地满足国际质量管理要求，实现 PT 与 APT

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CLSI H47-A3-2023 单阶段凝血酶原时间 (PT) 检测和活化部分凝血酶原时间 (APTT) 检测

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