[Performance Utility of High Sensitivity Quantitative Assay for HBs Antigen].

Itsuko Sato, Kenichi Uto, Noriko Fukuzumi, Shoko Kitaaki, Yuki Watanabe, Kosuke Sakurai, Nami Ishida, Chinami Oyabu, Yuji Nakamachi, Nobuhide Hayashi, Jun Saegusa
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Abstract

A high sensitivity quantitative assay for hepatitis B virus (HBV) surface antigen (HBsAg-HQ assay) was recently developed and is useful for earlier detection of HBV reactivation. We created HBsAg-HQ assay operational proce- dures by the sample transport system and laboratory information system. In this study, we evaluated the perfor- mance and utility of the HBsAg-HQ assay based on our operational procedures using internal quality control (IQC) data and 13,762 samples routinely measured for 8 months. The IQC data of the HBsAg-HQ assay demonstrated good accuracy (CV: 1.6-2.7%). The difference in IQC data between two of the same analyzers or several reagent lots had no clinical significance. Of 13,762 samples, HBsAg titer was negative in 12,592(91.5%) and positive in 1,169(8.5%), and HBsAg negative samples were remarkably lower(<0.001 IU/mL) than the cut-off value(0.005 IU/mL). Among 114 HBsAg weakly positive samples ranging from 0.005 to 1.000 IU/mL, false positive results occurred in 12 samples, which were converted into negative results after re-measurement. We could effectively perform carry-over prevention and dilution of high titer samples using our operational procedures. Furthermore, we performed inhibition test in 52 HBsAg weakly positive samples, and 20 samples, most of which were taken from patients with connective tissue disease or malignancy, were judged as non-specific reactivity. Taken together, our operational HBsAg-HQ assay procedures may contribute to efficient workflow for routine testing. Moreover, the HBsAg-HQ assay may be clinically useful for not only highly sensitive assays, but also for reducing false positives.

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HBs抗原高灵敏度定量检测的性能与应用
乙型肝炎病毒(HBV)表面抗原的高灵敏度定量测定(HBsAg-HQ测定)最近被开发出来,可用于早期检测HBV再激活。通过样品运输系统和实验室信息系统建立了HBsAg-HQ检测操作规程。在这项研究中,我们根据我们的操作程序,使用内部质量控制(IQC)数据和8个月常规测量的13762个样本,评估了HBsAg-HQ检测的性能和效用。HBsAg-HQ法的IQC数据具有良好的准确性(CV: 1.6-2.7%)。两个相同分析仪或几个试剂批次间IQC数据的差异无临床意义。在13762份样本中,HBsAg滴度阴性12592份(91.5%),阳性1169份(8.5%),HBsAg阴性样本明显低于(
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