HEM.23453 Heparin Therapeutic Range

HEM.23453 Heparin Therapeutic Range Phase I
There is a record that the aPTT-based heparin therapeutic range is established and
subsequently verified using an appropriate technique.
NOTE: The heparin-responsiveness of aPTT reagents may change from lot to lot and among
different reagents used on different instrument platforms. For this reason, it is necessary to
establish the heparin therapeutic range for the aPTT assay with each change of coagulation
instrument and/or reagent type. The therapeutic range must be verified with each new lot of a
given aPTT reagent.
The aPTT is commonly used to monitor the anticoagulant effects of unfractionated heparin. The
therapeutic range for heparin therapy should be initially validated for new reagents or instruments
by using ex vivo plasma samples anticoagulated with 3.2% sodium citrate obtained from patients
receiving therapeutic doses of unfractionated heparin. This can be accomplished by measuring
the aPTT and heparin activity and then deriving the aPTT therapeutic range by comparison to
heparin activity. For subsequent reagent lot changes, the therapeutic range can be verified by
comparing the aPTT of patient samples using the new and the prior aPTT lots. It is not best
practice to use plasma samples spiked with heparin in vitro to calculate the therapeutic range,
as differences in heparin binding proteins in vitro may lead to overestimation of the therapeutic
range.
Anti-Xa activity is the preferred alternate method to monitor heparin therapy.
Evidence of Compliance:
✓ Written procedure for establishing and verifying the aPTT heparin therapeutic range

結果 (中文) 1:

HEM.23453 Heparin Therapeutic Range Phase IThere is a record that the aPTT-based heparin therapeutic range is established andsubsequently verified using an appropriate technique.NOTE: The heparin-responsiveness of aPTT reagents may change from lot to lot and amongdifferent reagents used on different instrument platforms. For this reason, it is necessary toestablish the heparin therapeutic range for the aPTT assay with each change of coagulationinstrument and/or reagent type. The therapeutic range must be verified with each new lot of agiven aPTT reagent.The aPTT is commonly used to monitor the anticoagulant effects of unfractionated heparin. Thetherapeutic range for heparin therapy should be initially validated for new reagents or instrumentsby using ex vivo plasma samples anticoagulated with 3.2% sodium citrate obtained from patientsreceiving therapeutic doses of unfractionated heparin. This can be accomplished by measuringthe aPTT and heparin activity and then deriving the aPTT therapeutic range by comparison toheparin activity. For subsequent reagent lot changes, the therapeutic range can be verified bycomparing the aPTT of patient samples using the new and the prior aPTT lots. It is not bestpractice to use plasma samples spiked with heparin in vitro to calculate the therapeutic range,as differences in heparin binding proteins in vitro may lead to overestimation of the therapeutic范围。抗 Xa 活性是监测肝素治疗的首选备用方法。法规遵从性的证据:建立和验证的 aPTT 肝素治疗范围 ✓ 书面规程

結果 (中文) 3:

hem.23453肝素治疗范围相我
有记录，基于APTT肝素治疗范围的建立和
并使用适当的技术。
注：APTT试剂肝素反应可能改变很多很多，用不同的试剂在不同仪器平台之间的
。因为这个原因，它是必要的建立肝素治疗范围APTT检测每一次改变凝血
仪器或试剂的类型。治疗范围必须与一个给定的APTT试剂
每一批新的验证。
APTT常用来监测肝素的抗凝作用。治疗范围为肝素治疗应初步验证新试剂或仪器利用体外血浆样品用3.2%枸橼酸钠抗凝的患者
接受普通肝素治疗剂量获得。这可以通过测量
APTT和肝素活性，然后得出APTT治疗范围的
肝素活性的比较完成的。对于随后的试剂很多的变化，治疗范围可以验证比较APTT患者样本使用新的和现有的APTT很多。它不使用最佳实践
血浆样品加肝素体外计算治疗范围，
体外肝素结合蛋白的差异可能导致治疗
范围的高估。
抗Xa因子活性是监测肝素治疗的首选方法。
符合性证据：
✓写程序的建立和验证的APTT肝素治疗范围