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.

abstractsObjective 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.