不同狼疮抗凝物检测试验的临床诊断效能研究  

Research of the efficiency of different lupus anticoagulant assays

作　　者：寿玮龄[1] 陈倩[1] 吴卫[1] 范连凯[1] 谢田[1] 崔巍[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院检验科,100730

出　　处：《中华医学杂志》2015年第34期2760-2765,共6页National Medical Journal of China

摘　　要：目的 研究不同狼疮抗凝物（LA）试验的临床诊断效能,为临床提供有价值的LA指标.方法 370份柠檬酸盐抗凝样本来自2014年9月至2015年3月就诊于北京协和医院的患者或体检者,分别通过改良蝰蛇毒磷脂时间法（dRVVT）、硅凝固时间法（SCT）、活化部分凝血活酶时间法APTT-Actin、APTT-Actin FSL和APTT-SS共5种方法及相应的1∶1混合试验、确证试验检测LA.由此推算每种方法1∶1混合试验计算值循环抗凝指数（ICA）、确证试验计算值纠正百分比（C）和标准化比值（NR）的参考范围（RI）/Cut-off值,进而研究每种方法决定的LA的临床诊断效能.结果 不同试验方法LA的RI/Cut-off值不同,dRVVT法的敏感度最高（70.3％ ～93.1％）,APTT法最低（＜55.0％）.APTT-SS法的敏感度（47.5％～53.5％）略高于APTT Actin法（32.7％～39.6％）和APTT-Actin FSL法（29.7％ ～36.6％）.dRVVT法的特异度为91％ ～ 100％,SCT法为80.6％～100％,APTT法为85.1％ ～98.5％.其中,SCT法确证试验的特异度均为100％.针对弱阳性LA结果,5种方法的敏感度均下降,但dRVVT法和SCT法的敏感度仍＞50.0％,APTT-Actin法和APTT-Actin FSL法＜16.0％.除APTT-SS法外,dRVVT法及SCT法的组合方案检测的LA与APS血栓形成均具有相关性（OR值：5.562 ～9.240,均P＜0.05）.结论 实验室应根据LA具体试验方法建立RI/Cut-off值.dRVVT法是LA的最佳检测方法,与指南说明一致.APTT-SS法优于其他APTT法,dRVVT法及SCT法的组合方案检测的LA均与APS血栓形成相关。Objective To provide valuable test by evaluating the efficiency of lupus anticoagulant assays based on different principles.Methods 370 citrated samples were recruited,LA were tested by dRVVT,SCT,APTT-Actin,APTT-Actin FSL and APTT-SS respectively,and 1∶1 mixing tests before incubation were studied in all the recruited subjects.For LA testing,the results of 1 ∶ 1 mixing test were expressed as index of circulating anticoagulant （ICA）,and the confirm test results were expressed as percent of correction （C） and normalized ratio （NR）.The reference interval （RI）/Cut-off values of all the assays were established,and the efficiency of all the assays were further studied.Results The RI/Cut-off values of all assays were different.The sensitivity of dRVVT were the highest among all the assays （70.3%-93.1%）,and the sensitivity of APTT （〈55.0%） were the lowest.The sensitivity of APTT-SS （47.5%-53.5%） were higher than APTT-Actin （32.7%-39.6%） and APTT-Actin FSL （29.7%-36.6%）.The specificity of dRVVT,SCT and three APTT were 91%-100%,80.6%-100%,and 85.1%-98.5%,respectively.The specificity of SCT confirm test were 100%.Sensitivity of all the five methods were decreased in the weak positive LA.The sensitivity of dRVVT and SCT were more than 50.0%,however,the sensitivity of APTT-Actin and APTT-Acitn FSL were less than 16.0%.The sensitivity of APTT-SS were 23.7%-30.5%.Except the APTT-SS,dRVVT and SCT were correlated with thrombotic risk in APS patients （OR：5.562-9.240,P 〈 0.05）.Conclusions Every Laboratory should establish local LA RI/Cut-off values.dRVVT is the best assay for LA test,and APTT-SS method is superior to the other APTT method.The different test combinations of dRVVT and SCT are correlated with thrombotic risk in APS patients.

关 键 词：狼疮抗凝物 临床诊断效能 活化部分凝血活酶时间 改良蝰蛇毒磷脂时间法 硅凝固时间法 

分 类 号：R446.1[医药卫生—诊断学]