凝血酶原时间衍生法与冯·克劳斯法测定纤维蛋白原结果的一致性及临床应用  

Consistency of fibrinogen determination by prothrombin time-derived method and von Clauss method and its application

作　　者：张艳 杨怡 金心 ZHANG Yan;YANG Yi;JIN Xin(Department of Clinical Laboratory,The Third Clinical Medical College of the Three Gorges University,Gezhouba Central Hospital of Sinopharm,Yichang 443002,Hubei,China)

机构地区：[1]国药葛洲坝中心医院&三峡大学第三临床医学院检验科,湖北宜昌443002

出　　处：《临床检验杂志》2021年第7期485-488,494,共5页Chinese Journal of Clinical Laboratory Science

基　　金：三峡大学科学基金青年科学基金(KJ2019A004)。

摘　　要：目的建立沃芬TOP系列仪器纤维蛋白原(Fib)凝血酶原时间衍生法(PT-der法)与冯·克劳斯法(Von Clauss法)测定结果的一致性区间和PT-der法的适用范围,提升PT-der法的临床应用价值。方法将30份低、正常和高Fib浓度的新鲜血浆按比例制备混合血浆,用Von Clauss法对其Fib浓度进行赋值,再用此血浆校准PT-der法。参考美国临床和实验室标准协会(CLSI)EP15-A和EP6-A文件,评价精密度、线性范围,使用WS/T 402—2012推荐方法重新制定其参考区间;分别使用上述2种方法检测5142例标本Fib,建立PT-der法与Von Clauss法99%的检测结果符合WS/T 406—2012中Fib准确度要求范围内的数值区间和适用范围。结果重新校准后PT-der法精密度和线性范围经验证符合说明书要求,测定Fib浓度在1.51~7.00 g/L时与Von Clauss法的准确度符合率为99.72%,其适用范围不包括:使用大剂量抗凝药物后;肝硬化失代偿期;纤维蛋白降解产物(FDP)≥30 mg/L;凝血酶时间(TT)≥20 s,活化部分凝血活酶时间(APTT)≥80 s。结论通过量值传递的方式校准PT-der法后,建立了PT-der法和Von Clauss法检测Fib结果的一致性区间,并确定PT-der法适用范围和参考区间。在保证PT-der法检测结果准确性的同时提升了其临床应用价值。Objective To establish the consistent interval of the results of the fibrinogen(Fib)determined by Prothrombin Time-de-rived(PT-der)method and Von Claus method of Wolfen TOP series instruments,and the applicable scope of PT-der method,and im-prove the clinical application value of PT-der method.Methods Mixed plasmas were prepared by proportioning 30 fresh plasmas with low,normal and high Fib concentrations.Von Clauss method was used to assign Fib concentration in the plasma samples,and then the results were calibrated by PT-der method.Refering to EP15-A and EP6-A documents of Clinical and Laboratory Standards Institute(CLSI),precision,linear range(range consistent results)were evaluated.WS/T 402—2012 recommended method was used to re-es-tablish the reference interval.The Fib level in 5142 samples were detected using the two methods.The numerical range and applicable range for 99%of the results detected by the two methods were established,in which Fib accuracy met with the requirements of WS/T 406—2012.Results The precision and linearity of PT-der method after recalibration were certified to comply with the specification.The determinable concentrations of Fib were 1.51 to 7.00 g/L when the coincidence rate of accuracy of Von Clauss method was 99.72%.The scope of application should not include the following cases:after the use of high-dose anticoagulant drugs,decompensated cirrho-sis,fibrinogen degradation products(FDP)≥30 mg/L,thrombin time(TT)≥20 s,activated partial thromboplastin time(APTT)≥80 s.Conclusion After calibrating of PT-Der method by the means of quantity value transfer,the consistent interval of PT-der method and Von Clauss method for Fib detection was established.The applicable scope and reference interval of PT-der method were deter-mined.The accuracy of PT-der method may be guaranteed and improved for its clinical application.

关 键 词：纤维蛋白原 凝血酶原衍生法 冯·克劳斯法 量值传递 一致性 适用范围 

分 类 号：R446[医药卫生—诊断学]