我们是否需要“内部”中和测定来确证乙型肝炎表面抗原？来自印度一家三级保健医院的答案。

Do we need an 'in-house' neutralization assay for confirmation of hepatitis B surface antigen? Answers from a tertiary care hospital in India.

机构信息

Department of Clinical Virology, Christian Medical College, Vellore, India.

出版信息

J Gastroenterol Hepatol. 2010 May;25(5):942-5. doi: 10.1111/j.1440-1746.2009.06088.x. Epub 2009 Nov 19.

DOI:10.1111/j.1440-1746.2009.06088.x

PMID:19929924

Abstract

BACKGROUND AND AIMS

Hepatitis B surface antigen (HBsAg) is an important serological marker for diagnosis of hepatitis B virus (HBV) infection. Commercial kits for detection of HBsAg emphasize confirmation by neutralization assays. In this study, we have standardized an 'in-house' neutralization test for HBsAg confirmation.

METHODS

Among 6684 HBsAg-positive samples, 615 were subjected to an 'in-house' HBsAg neutralization test (NT). Of these, 91 (100%) high-reactive samples (optical density [OD] 1.000-3.000) and 286 (93%) of 289 low-reactive samples (OD < 1.000) were neutralized, and 235 (100%) grey-zone reactive samples were 'in-house' NT negative. Eighty-four samples of varying reactivities that were tested by the 'in-house' NT were compared with a commercial NT (AxSYM, Abbott).

RESULTS

The 'in-house' NT showed an excellent agreement (kappa = 0.83, P < 0.001) with the commercial confirmatory assay. The sensitivity, specificity, positive and negative predictive values were 90%, 94%, 96% and 87%, respectively.

CONCLUSION

The enzyme immunoassay-based 'in-house' HBsAg neutralization assay is a feasible alternative to the commercial HBsAg confirmatory assay. This technique is easily adaptable, cost-effective and reliable for the confirmation of HBsAg in a low resource setting, enhancing the overall quality of HBsAg screening.

摘要

背景与目的

乙型肝炎表面抗原（HBsAg）是乙型肝炎病毒（HBV）感染诊断的重要血清学标志物。用于检测 HBsAg 的商业试剂盒强调中和测定的确认。在本研究中，我们已经标准化了一种用于 HBsAg 确认的“内部”中和试验。

方法

在 6684 例 HBsAg 阳性样本中，有 615 例进行了“内部”HBsAg 中和试验（NT）。其中，91 例（100%）高反应性样本（吸光度[OD] 1.000-3.000）和 286 例（93%）低反应性样本（OD < 1.000）被中和，235 例（100%）灰色区域反应性样本“内部”NT 阴性。用“内部”NT 测试的 84 例不同反应性的样本与商业 NT（AxSYM，雅培）进行了比较。