摘要
目的验证并优化活化部分凝血活酶时间(APTT)延长混合试验结果判断方法及临界值,提升其在单纯因子缺乏、狼疮抗凝物阳性、FⅧ抑制物阳性不同病因鉴别中的临床应用价值。方法回顾性横断面研究收集2022年1月1日至2023年12月31日在吉林大学第一医院检验科检出的不明原因APTT单独延长进行混合纠正试验的患者130例,其中男性84例,女性46例。分别采用罗斯纳指数(RI)法、百分比纠正(“Chang”)法、正常参考区间(NRI)法、差值法、孵育后延长时间及百分比法进行结果计算(包括混合即刻和混合孵育2 h)。按照临床诊断分为单纯因子缺乏组(51例)、狼疮抗凝物阳性(LA)组(56例)、FⅧ抑制物阳性组(23例)。采用受试者工作特征(ROC)曲线分析APTT延长混合纠正试验的不同判断方法在不同病因者的临界值,通过曲线下面积(AUC)、敏感度、特异度等指标对临界值加以优化,并与实验室现有判读方式比较。结果对于单纯因子缺乏,即刻RI指数<7.5%、孵育RI指数<13.9%时的AUC分别为0.87、0.90,敏感度分别为87.8%、83.8%,特异度分别为72.0%、80.0%,二者联合诊断的敏感度、特异度分别为87.3%、94.0%,判定准确度从现有规则的84.6%(110/130)提升至93.1%(121/130);对于LA阳性者,即刻RI指数>10.3%联合孵育后延长时间百分比<9.1%的敏感度、特异度分别为88.5%、99.8%,判定准确度从现有规则的80.0%(104/130)提升至86.2%(112/130);对FⅧ抑制物阳性者,孵育RI指数>17.0%联合孵育后延长时间百分比>9.1%的敏感度、特异度分别为99.8%、100.0%。判定准确度从现有规则的89.2%(116/130)上升至94.6%(123/130)。结论验证并优化了APTT延长混合纠正试验鉴别单纯因子缺乏、FⅧ抑制物及LA阳性的判断方法及临界值,能够有效提高判定敏感度和特异度。
ObjectiveTo validate and optimize the interpretation methods and cut-off values of prolonged activated partial thromboplastin time(APTT)mixing test,in order to elevate the clinical applicational value in differentiating single factor deficiency,positive lupus anticoagulant(LA)and FⅧinhibitors.MethodsThis cross-sectional retrospective study involved 130 cases with single APTT prolongation for unknown reasons who underwent mixing tests in the First Hospital of Jilin University from January 1st,2022 to December 31st,2023,including 84 males and 46 females.Rosner index(RI),Percentage correction("Chang")method,Normal reference interval(NRI)method,differential analysis,post-incubation prolongation time and percentage(including mixed immediately and)were respectively calculated and analyzed for both immediate mixing and 2-hour post-mixing incubation.According to clinical diagnosis,patients were divided into single factor deficiency(51 cases),positive lupus anticoagulant(LA)(56 cases),and positive factorⅧ(FⅧ)inhibitor(23 cases).Receiver operation characteristic(ROC)curve analysis was used to determine the cut-off values for APTT mixing test methods in patients with different reasons for prolonged APTT,which were evaluted and adjusted by AUC,sensitivity,and specificity,and compared with the methods currently used for interpretations.ResultsFor the single factor deficiency cases,the AUCs of immediate RI index<7.5%and incubated RI index<13.9%were 0.87 and 0.90,respectively,with sensitivities at 87.8%and 83.8%,and specificities at 72.0%and 80.0%,whose combination had sensitivity and specificity at 87.3%,and 94.0%,respectively;the judging accuracy increased from 84.6%(110/130)in currently used rule to 93.1%(121/130).For the positive lupus anticoagulant(LA)cases,the combination of immediate RI index>10.3%and prolonged post-incubation clotting time percentage<9.1%showed 88.5%sensitivity and 99.8%specificity;the judging accuracy improved from 80.0%(104/130)in currently used rule to 86.2%(112/130).For positive FⅧinhibitor cases,the combination of incubated RI index>17.0%and prolonged post-incubation clotting time percentage>9.1%had 99.8%sensitivity and 100.0%specificity;the judging accuracy increased from 89.2%(116/130)in currently used rule to 94.6%(123/130).ConclusionThis study validated and optimized the interpretation methods and cut-off values for the prolonged APTT mixing test in differentiating single factor deficiencies,prositive FⅧinhibitors and LA positive cases,significantly improving the judging sensitivity and specificity.
作者
翟宏
续薇
李昱瑛
孙京男
安倍莹
曲林琳
Zhai Hong;Xu Wei;Li Yuying;Sun Jingnan;An Beiying;Qu Linlin(Department of Laboratory Medicine,First Hospital of Jilin University,Changchun 130021,China;Department of Hematology,First Hospital of Jilin University,Changchun 130021,China)
出处
《中华检验医学杂志》
北大核心
2025年第8期1022-1027,共6页
Chinese Journal of Laboratory Medicine
