Poller L
Department of Pathological Sciences, University of Manchester, UK.
J Clin Pathol. 1998 May;51(5):356-9. doi: 10.1136/jcp.51.5.356.
To assess the reliability of local international normalised ratios (INR) using a set of three international reference preparation (IRP) certified freeze dried plasmas.
55 centres in the United Kingdom and the Republic of Ireland participated; 36 centres employed coagulometers and 19 a manual prothrombin time technique, all with the same batch of routine commercial thromboplastin. The plasmas had certified INR with the manual technique using a thromboplastin IRP, and results were provided graphically to participants for self assessment. An INR deviation of more than +/- 10% from the certified INR with any of the screening plasmas was regarded as unsatisfactory and clinically significant. Sets of 20 freeze dried plasmas were provided for local ISI calibrations and sets of seven freeze dried normals were provided for supplementary exercises where screening results were unsatisfactory.
15 of 38 coagulometers, but only three of the 19 manual prothrombin time test techniques, gave unsatisfactory results. With 10 of the 15 unsatisfactory coagulometer results the problem was resolved by local ISI calibrations with plasma calibrant sets provided. Unsatisfactory results with manual technique in all four instances were corrected by substitution of the mean result with freeze dried normal plasmas provided.
The freeze dried plasma screening set was useful in detecting incorrect INR in a high proportion of coagulometer users and a smaller number of participants using the manual technique.
使用一组三种经国际认证的冻干血浆评估局部国际标准化比值(INR)的可靠性。
英国和爱尔兰共和国的55个中心参与;36个中心使用凝血仪,19个中心采用手工凝血酶原时间技术,均使用同一批次的常规商用凝血活酶。这些血浆通过使用凝血活酶国际参考制品(IRP)的手工技术获得了认证的INR,并以图形方式向参与者提供结果以供自我评估。与任何一种筛查血浆的认证INR相比,INR偏差超过±10%被视为不满意且具有临床意义。提供20份冻干血浆用于局部国际敏感度指数(ISI)校准,并提供7份冻干正常血浆用于筛查结果不满意时的补充练习。
38台凝血仪中有15台,而19种手工凝血酶原时间检测技术中只有3种给出了不满意的结果。在15个不满意的凝血仪结果中,有10个通过使用提供的血浆校准物进行局部ISI校准解决了问题。在所有4例手工技术不满意的结果中,通过用提供的冻干正常血浆替代平均结果得到了纠正。
冻干血浆筛查套装有助于检测出很大一部分使用凝血仪的用户以及少数使用手工技术的参与者中不正确的INR。