中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2015年
34期
2760-2765
,共6页
寿玮龄%陈倩%吴卫%范连凯%谢田%崔巍
壽瑋齡%陳倩%吳衛%範連凱%謝田%崔巍
수위령%진천%오위%범련개%사전%최외
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
狼瘡抗凝物%臨床診斷效能%活化部分凝血活酶時間%改良蝰蛇毒燐脂時間法%硅凝固時間法
랑창항응물%림상진단효능%활화부분응혈활매시간%개량호사독린지시간법%규응고시간법
Lupus anticoagulant%Diagnostic efficiency%Activated partial thromboplastin time%Dilute russell viper venom time%Silica clotting time
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.
目的 研究不同狼瘡抗凝物(LA)試驗的臨床診斷效能,為臨床提供有價值的LA指標.方法 370份檸檬痠鹽抗凝樣本來自2014年9月至2015年3月就診于北京協和醫院的患者或體檢者,分彆通過改良蝰蛇毒燐脂時間法(dRVVT)、硅凝固時間法(SCT)、活化部分凝血活酶時間法APTT-Actin、APTT-Actin FSL和APTT-SS共5種方法及相應的1∶1混閤試驗、確證試驗檢測LA.由此推算每種方法1∶1混閤試驗計算值循環抗凝指數(ICA)、確證試驗計算值糾正百分比(C)和標準化比值(NR)的參攷範圍(RI)/Cut-off值,進而研究每種方法決定的LA的臨床診斷效能.結果 不同試驗方法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法的特異度為91% ~ 100%,SCT法為80.6%~100%,APTT法為85.1% ~98.5%.其中,SCT法確證試驗的特異度均為100%.針對弱暘性LA結果,5種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法的組閤方案檢測的LA與APS血栓形成均具有相關性(OR值:5.562 ~9.240,均P<0.05).結論 實驗室應根據LA具體試驗方法建立RI/Cut-off值.dRVVT法是LA的最佳檢測方法,與指南說明一緻.APTT-SS法優于其他APTT法,dRVVT法及SCT法的組閤方案檢測的LA均與APS血栓形成相關.
목적 연구불동랑창항응물(LA)시험적림상진단효능,위림상제공유개치적LA지표.방법 370빈저몽산염항응양본래자2014년9월지2015년3월취진우북경협화의원적환자혹체검자,분별통과개량호사독린지시간법(dRVVT)、규응고시간법(SCT)、활화부분응혈활매시간법APTT-Actin、APTT-Actin FSL화APTT-SS공5충방법급상응적1∶1혼합시험、학증시험검측LA.유차추산매충방법1∶1혼합시험계산치순배항응지수(ICA)、학증시험계산치규정백분비(C)화표준화비치(NR)적삼고범위(RI)/Cut-off치,진이연구매충방법결정적LA적림상진단효능.결과 불동시험방법LA적RI/Cut-off치불동,dRVVT법적민감도최고(70.3% ~93.1%),APTT법최저(<55.0%).APTT-SS법적민감도(47.5%~53.5%)략고우APTT Actin법(32.7%~39.6%)화APTT-Actin FSL법(29.7% ~36.6%).dRVVT법적특이도위91% ~ 100%,SCT법위80.6%~100%,APTT법위85.1% ~98.5%.기중,SCT법학증시험적특이도균위100%.침대약양성LA결과,5충방법적민감도균하강,단dRVVT법화SCT법적민감도잉>50.0%,APTT-Actin법화APTT-Actin FSL법<16.0%.제APTT-SS법외,dRVVT법급SCT법적조합방안검측적LA여APS혈전형성균구유상관성(OR치:5.562 ~9.240,균P<0.05).결론 실험실응근거LA구체시험방법건립RI/Cut-off치.dRVVT법시LA적최가검측방법,여지남설명일치.APTT-SS법우우기타APTT법,dRVVT법급SCT법적조합방안검측적LA균여APS혈전형성상관.
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.