Defining a metrologically traceable and sustainable calibration hierarchy of international normalized ratio for monitoring of vitamin K antagonist treatment in accordance with International Organization for Standardization (ISO) 17511:2020 standard: communication from the International Federation of Clinical Chemistry and Laboratory Medicine–SSC/ISTH working group on prothrombin time/international normalized ratio standardization

标准化 校准 计算机科学 数学 统计 操作系统
作者
A M H P van den Besselaar,Anne Stavelin,Steve Kitchen,Michelle Bryant,Armando Tripodi,Erica Scalambrino,Marigrazia Clerici,Petra Herbel,Anja Jünschke,Sascha Meyer dos Santos,Piet Meijer,René W.L.M. Niessen,Joost C.M. Meijers,Craig Thelwell,Adam Cuker,C. C. Kung,Zhenghua Cao,Norbert Zander,Yosuke Iwasaki,François Depasse,C. van Rijn,Shanti Baktawar,Charmane F. Abdoel,Christa M. Cobbaert
出处
期刊:Journal of Thrombosis and Haemostasis [Elsevier BV]
卷期号:22 (4): 1236-1248 被引量:4
标识
DOI:10.1016/j.jtha.2023.12.013
摘要

Calibration of Prothrombin Time (PT) in terms of the International Normalized Ratio (INR) has been outlined in 'Guidelines for thromboplastins and plasmas used to control oral anticoagulant therapy' (World Health Organization, 2013). International Standard ISO 17511:2020 presents requirements for manufacturers of In-vitro Diagnostic Medical Devices (IVD MD) in documenting the calibration hierarchy for a measured quantity in human samples using a specified IVD MD. The objective of this article is to define an unequivocal, metrologically traceable calibration hierarchy for the INR measured in plasma as well as in whole blood samples. Calibration of PT and INR for IVD MD according to WHO Guidelines is similar to cases where there is a reference measurement procedure that defines the measurand for value assignment as described in ISO 17511:2020. We conclude that for PT/INR standardization the optimal calibration hierarchy includes a primary process to prepare an international reference reagent and measurement procedure that defines the measurand by a value assignment protocol conforming to clause 5.3 in ISO 17511:2020. A panel of freshly prepared human plasma samples from healthy adult individuals and patients on vitamin K antagonists is used as a commutable secondary calibrator as described in ISO 17511:2020. A sustainable metrologically traceable calibration hierarchy for INR should be based on an international protocol for value assignment with a single primary reference thromboplastin and the harmonized manual tilt tube technique for clotting time determination. The primary international reference thromboplastin reagent should be used only for calibration of successive batches of secondary reference thromboplastin reagent.

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
水晶茶杯发布了新的文献求助10
1秒前
欢欢完成签到,获得积分10
2秒前
茯苓完成签到 ,获得积分10
4秒前
小鱼发布了新的文献求助10
5秒前
香香丿完成签到 ,获得积分10
5秒前
6秒前
万能图书馆应助zz123采纳,获得10
6秒前
杜康完成签到,获得积分10
6秒前
Cheung2121发布了新的文献求助10
6秒前
医学小王完成签到 ,获得积分10
7秒前
9秒前
刘涵完成签到 ,获得积分10
10秒前
帅气的沧海完成签到 ,获得积分10
11秒前
辣辣辣辣辣辣完成签到 ,获得积分10
14秒前
15秒前
18秒前
乐观半兰完成签到,获得积分10
20秒前
20秒前
小丸子和zz完成签到 ,获得积分10
21秒前
量子星尘发布了新的文献求助10
22秒前
江雁完成签到,获得积分10
22秒前
坚定芯完成签到,获得积分10
22秒前
叶子兮完成签到,获得积分10
24秒前
幽默的妍完成签到 ,获得积分10
24秒前
Snow完成签到 ,获得积分10
24秒前
24秒前
liuyuh完成签到,获得积分10
25秒前
悠明夜月完成签到 ,获得积分10
26秒前
乌云乌云快走开完成签到,获得积分10
26秒前
你是我的唯一完成签到 ,获得积分10
26秒前
洁白的故人完成签到 ,获得积分10
28秒前
乐观半兰发布了新的文献求助10
28秒前
water应助科研通管家采纳,获得10
29秒前
zhang完成签到 ,获得积分10
29秒前
water应助科研通管家采纳,获得10
29秒前
Jasper应助科研通管家采纳,获得10
29秒前
科研通AI2S应助科研通管家采纳,获得10
29秒前
orixero应助科研通管家采纳,获得10
29秒前
CodeCraft应助科研通管家采纳,获得10
29秒前
大模型应助科研通管家采纳,获得10
29秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038112
求助须知:如何正确求助?哪些是违规求助? 3575788
关于积分的说明 11373801
捐赠科研通 3305604
什么是DOI,文献DOI怎么找? 1819255
邀请新用户注册赠送积分活动 892655
科研通“疑难数据库(出版商)”最低求助积分说明 815022