Kim Soo-Kyung, Huh Jungwon, Jeong Tae-Dong
Clin Lab. 2019 Oct 1;65(10). doi: 10.7754/Clin.Lab.2019.190341.
Since more sensitive immunoassays have been introduced, false positive Hepatitis B surface antigen (HBsAg) results are increasing. This study was carried out to propose a process to reduce the burden of the laboratory while increasing positive predictive value in HBsAg.
Samples with Elecsys HBsAg II (Roche Diagnostics, Germany) between cutoff index (COI) 0.9 and 10.0 were tested with Elecsys HBsAg Confirmatory Test (Roche Diagnostics). If the COI value after neutralization is less than or equal to 60% of the COI treated with control reagent, the sample was determined as HBsAg positive.
A total of 133 samples were analyzed and 70.7% were confirmed positive. The highest COI of negatively confirmed sample was 5.6. Receiver operating characteristic curve analysis of HBsAg assay showed an area under curve of 0.761. Specificity was 100% at COI 6.0.
Based on this finding, the authors propose that only samples with HBsAg COI less than 6.0 need confirmatory tests.
自从引入更灵敏的免疫测定方法以来，乙肝表面抗原（HBsAg）假阳性结果不断增加。开展本研究旨在提出一个流程，以减轻实验室负担，同时提高HBsAg的阳性预测值。
使用Elecsys HBsAg II（德国罗氏诊断公司）检测临界指数（COI）在0.9至10.0之间的样本，并采用Elecsys HBsAg确证试验（罗氏诊断公司）进行检测。如果中和后的COI值小于或等于用对照试剂处理后的COI值的60%，则该样本被判定为HBsAg阳性。
共分析了133个样本，70.7%被确认为阳性。阴性确证样本的最高COI为5.6。HBsAg检测的受试者工作特征曲线分析显示曲线下面积为0.761。在COI为6.0时，特异性为100%。
基于这一发现，作者建议仅对HBsAg COI小于6.0的样本进行确证试验。
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