PIVKA-Ⅱ与AFP对原发性肝癌诊断性能的验证及荟萃分析
Labeled Immunoassays and Clinical Medicine（2020）
Abstract
目的 比较异常凝血酶原(prothrombin induced by vitamin K absence or antagonist-Ⅱ,PIVKA-Ⅱ)化学发光法和酶联免疫法检测结果的一致性,并验证PIVKA-Ⅱ和AFP化学发光检测法对原发性肝癌的诊断性能.方法 采用Spearman相关系数分析、偏差分析和阴阳性的符合率来评估化学发光法和酶联免疫法检测结果的一致性;观察健康人、肝炎和肝硬变以及肝癌组PIVKA-Ⅱ和AFP的水平,采用界值移动法评价PIVKA-Ⅱ和AFP诊断肝癌的特异性和灵敏度,并与荟萃分析得到的诊断性能比较.结果 两种方法检测的血清PIVKA-Ⅱ水平具有良好的相关性(R2=0.925);以40 mAU/mL为诊断界值,两种方法检测PIVKA-Ⅱ阴阳性的符合率为100％.当PIVKA-Ⅱ<200 mAU/mL时,两种方法检测肝癌患者血清PIVKA-Ⅱ的绝对偏差小于10 Mau/Ml,相对偏差大部分在20％以内.PIVKA-Ⅱ和AFP无相关性.当PIVKA-Ⅱ和AFP临界值分别为26.5 Mau/Ml和15.5 ng/Ml时,两者诊断肝癌的灵敏度分别为79.7％、56.3％,特异性分别为80.6％、78.3％.联合检查两项指标的阳性率可达86％,本结果与荟萃分析的诊断性能相似.结论 酶联免疫法与电化学发光法检测PIVKA-Ⅱ水平具有良好的可比性,但仍有一定差异;AFP联合PIVKA-Ⅱ检测可提高原发性肝癌的诊断效率.
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