摘要： 目的 探讨3种狼疮抗凝物（LA）检测方法的临床应用价值。方法 回顾分析2019年2月至2020年1月于我院检测LA的血液样本1 240例，检测方法包括二氧化硅凝固时间（SCT）法、改良的稀释蝰蛇毒时间（DRVVT）法及活化部分凝血活酶时间（APTT）即刻纠正试验法（APTT法）。筛选出SCT法和DRVVT法检测LA阳性332例（A组），应用SCT法、DRVVT法及APTT法同时检测LA135例（B组），应用3种方法同时检测且LA持续阳性87例（C组），将各组再分为相应亚组。采用非参数检验、Spearman秩相关和受试者工作特征（ROC）曲线，分析组间差异、相关程度，评估3种检测方法的诊断价值。结果 A组中，SCT法阳性率（74.4%）与DRVVT法阳性率（78.3%）无统计学差异；当SCT法或DRVVT法的标准化比值（NR）分别≥1.2、1.5、2.0时，两者的阳性符合率（52.7%、48.3%、45.9%）无统计学差异。B组中，SCT阳性/DRVVT阳性组APTT即刻纠正试验罗斯纳指数（RI）高于仅SCT阳性组、仅DRVVT阳性组、LA阴性组，差异有统计学意义，后3个亚组间则无统计学差异；当NR分别≥1.2、1.5、2.0时，RI诊断LA阳性的ROC曲线下面积（AUC）分别为0.792、0.851、0.891，临界值分别为22.2、23.9、26.5，敏感度分别为57.4%、71.0%、89.2%，特异度分别为89.1%、88.9%、81.4%。C组中，38例诊断为抗磷脂综合征（APS），其他49例诊断为非APS，SCT NR、DRVVT NR及RI诊断APS的ROC-AUC分别为0.683、0.653、0.664，临界值分别为2.26、1.66、28.2，敏感度分别为57.9%、63.2%、71.1%，特异度分别为78.6%、73.2%、67.9%。结论 SCT法和DRVVT法联合检测可提高筛查LA的阳性率。APTT即刻纠正试验对判断LA及其阳性程度有重要价值。在LA持续阳性患者中，可用SCT NR、DRVVT NR和RI适当的临界值对APS和非APS患者进行初步实验室指标的鉴别诊断。

3种狼疮抗凝物检测方法的临床应用价值评价

张家红, 夏楠, 王金行, 宋鉴清

中国医科大学附属第一医院检验科, 沈阳 110001

收稿日期:2020-07-03出版日期:2021-02-28发布日期:2021-01-21
通讯作者:宋鉴清E-mail:songlisw@yeah.net
作者简介:张家红(1969-),女,主管技师,本科.
基金资助:国家自然科学基金青年基金（81902958）


关键词: 狼疮抗凝物, 二氧化硅凝固时间, 改良的稀释蝰蛇毒时间, 活化部分凝血活酶时间, 罗斯纳指数
Abstract: Objective To evaluate the clinical application value of three types of lupus anticoagulant (LA) detection methods. Methods Data obtained from 1 240 samples regarding the detection of LA using the silica coagulation time (SCT) method,the dilute Russell viper venom time (DRVVT) method,and the activated partial thromboplastin time (APTT) immediate correction method (APTT method) from February 2019 to January 2020 were collected from our hospital for retrospective analysis. LA-positive cases were screened and divided into three groups:group A,332 LA cases involving the use of the SCT and DRVVT methods;group B,135 LA cases involving the use of the SCT,DRVVT,and APTT methods;and group C,87 LA cases involving the use of the three detection methods which were further divided into corresponding subgroups. Nonparametric tests,Spearman rank correlation,and receiver operating characteristic (ROC) curves were used to analyze the differences between groups,degree of correlation,and diagnostic values of the three detection methods. Results In group A,there was no significant difference in positivity rates between the SCT (74.4%) and DRVVT (78.3%) methods. The normalized ratios (NR) of the SCT and DRVVT methods were ≥ 1.2,1.5,and 2.0,respectively. There was no significant difference in the positive coincidence rate (52.7%,48.3%,45.9%) of the two. In group B,the SCT-positive/DRVVT-positive group,the Rosner index (RI) was higher in the APTT immediate correction group than in the only SCT-positive group,only DRVVT-positive group,and LA-negative group. The difference was statistically significant. However,there was no significant difference among the last three subgroups. With NRs of ≥ 1.2,1.5,and 2.0,the areas under the ROC curve (AUC) for RI for the diagnosis of LA positivity were 0.792,0.851,and 0.891,respectively. The corresponding cut-off values were 22.2,23.9,and 26.5,respectively. The corresponding sensitivities were 57.4%,71.0%,and 89.2%,respectively. The corresponding specificities were 89.1%,88.9%,and 81.4%,respectively. In group C,38 patients were diagnosed with antiphospholipid syndrome (APS),and the other 49 patients were diagnosed with non-APS. The AUC values of the SCT NR,DRVVT NR,and RI for APS diagnosis were 0.683,0.653,and 0.664,respectively. The corresponding cut-off values were 2.26,1.66,and 28.2,respectively. The corresponding sensitivities were 57.9%,63.2%,and 71.1%,respectively,and the corresponding specificities were 78.6%,73.2%,and 67.9%,respectively. Conclusion Combined detection of the SCT and DRVVT methods can improve the positivity rate for LA screening. The APTT immediate correction method provides important data for assessing the presence of LA and the degree of LA positivity. In patients with persistently positive LA,appropriate cut-off values of SCT NR,DRVVT NR,and RI can be used as preliminary laboratory indicators for the differential diagnosis of patients with APS and non-APS.
Key words: lupus anticoagulant, silica coagulation time, diluted Russell viper venom time, activated partial thromboplastin time, Rosner index
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