乙型肝炎核心相关抗原：乙型肝炎病毒DNA的替代品，以评估

StephenW

Hepatitis B Core-related Antigen: An Alternative to Hepatitis B Virus DNA to Assess Treatment Eligibility in Africa
Yusuke Shimakawa, Gibril Ndow, Ramou Njie, Harr Freeya Njai, Kazuaki Takahashi, Sheikh Mohammad Fazle Akbar, Damien Cohen, Shevanthi Nayagam, Adam Jeng, Amie Ceesay ... Show more
Clinical Infectious Diseases, Volume 70, Issue 7, 1 April 2020, Pages 1442–1452, https://doi.org/10.1093/cid/ciz412
Published:
17 May 2019
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Abstract
Background

To eliminate hepatitis B virus (HBV) infection, it is essential to scale up testing and treatment. However, conventional tools to assess treatment eligibility, particularly nucleic acid testing (NAT) to quantify HBV DNA, are hardly available and affordable in resource-limited countries. We therefore assessed the performance of a novel immunoassay, hepatitis B core-related antigen (HBcrAg), as an inexpensive (US$ <15/assay) alternative to NAT to diagnose clinically important HBV DNA thresholds (≥2000, ≥20 000, and ≥200 000 IU/mL) and to select patients for antiviral therapy in Africa.
Methods

Using a well-characterized cohort of treatment-naive patients with chronic HBV infection in The Gambia, we evaluated the accuracy of serum HBcrAg to diagnose HBV DNA levels and to indicate treatment eligibility determined by the American Association for the Study of Liver Diseases, based on reference tests (HBV DNA, hepatitis B e antigen, alanine aminotransferase, liver histopathology, and/or FibroScan).
Results

A total of 284 treatment-naive patients were included in the analysis. The area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity of serum HBcrAg were 0.88 (95% confidence interval [CI], .82–.93), 83.3%, and 83.9%, respectively, to diagnose HBV DNA ≥2000 IU/mL; and 0.94 (95% CI, .88–.99), 91.4%, and 93.2% for ≥200 000 IU/mL. A simplified treatment algorithm using HBcrAg without HBV DNA showed high AUROC (0.91 [95% CI, .88–.95]) with a sensitivity of 96.6% and specificity of 85.8%.
Conclusions

HBcrAg might be an accurate alternative to HBV DNA quantification as a simple and inexpensive tool to identify HBV-infected patients in need of antiviral therapy in low- and middle-income countries.
hepatitis B core-related antigen, diagnostic test, validation studies, sensitivity and specificity, Africa
Topic:

    hepatitis b africa antigens antiviral agents hepatitis b e antigens hepatitis b surface antigens hepatitis b virus dna immunoassay hepatitis b virus liver area under the roc curve

StephenW

乙型肝炎核心相关抗原：乙型肝炎病毒DNA的替代品，以评估非洲的治疗资格
岛川雄介（Yusuke Shimakawa），吉布里尔·恩多（Gibril Ndow），拉莫·恩杰（Raou Njie），哈里·弗里亚·奈（Harr Freeya Njai），高崎一明（Kazuaki Takahashi），谢赫·穆罕默德·法兹勒·阿克巴尔（Sheikh Mohammad Fazle Akbar），达米恩·科恩（Damien Cohen），谢万提·纳亚甘姆（Shevanthi Nayagam），亚当·简（Adam Jeng），艾米·塞西（Amie Ceesay）...显示更多
《临床传染病》，第70卷，第7期，2020年4月1日，第1442–1452页，https：//doi.org/10.1093/cid/ciz412
发布时间：
2019年5月17日
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抽象
背景

为了消除乙型肝炎病毒（HBV）感染，必须扩大测试和治疗范围。然而，在资源有限的国家，很难获得评估价格和治疗资格的常规工具，尤其是用于量化HBV DNA的核酸测试（NAT）。因此，我们评估了一种新型的免疫测定，乙型肝炎核心相关抗原（HBcrAg）的性能，它是NAT的廉价替代品（<15美元/测定），可用于诊断临床上重要的HBV DNA阈值（≥2000，≥20000和≥200 000 IU / mL），并选择在非洲接受抗病毒治疗的患者。
方法

我们使用冈比亚一个特征明确的未经治疗的慢性HBV感染患者队列，我们​​评估了血清HBcrAg诊断HBV DNA水平的准确性，并指出了由美国肝病研究协会确定的治疗资格，基于参考测试（HBV DNA，乙型肝炎e抗原，丙氨酸氨基转移酶，肝组织病理学和/或FibroScan）。
结果

分析中总共包括284位未接受治疗的患者。接受者工作特征曲线（AUROC）下的面积，血清HBcrAg的敏感性和特异性分别为0.88（95％置信区间[CI] 、. 82–.93），83.3％和83.9％，以诊断HBV DNA ≥2000IU / mL; ≥200000 IU / mL时为0.94（95％CI，.88-.99），91.4％和93.2％。使用不含HBV DNA的HBcrAg的简化治疗算法显示出较高的AUROC（0.91 [95％CI，.88–.95]），敏感性为96.6％，特异性为85.8％。
结论

HBcrAg可能是HBV DNA定量的一种准确替代方法，它是一种简单且便宜的工具，可用于在中低收入国家/地区识别需要抗病毒治疗的HBV感染患者。
乙型肝炎核心相关抗原，诊断测试，验证研究，敏感性和特异性，非洲
话题：

乙型肝炎非洲抗原抗病毒药乙型肝炎e抗原乙型肝炎表面抗原乙型肝炎病毒dna免疫测定法roc曲线下的乙型肝炎病毒肝脏面积

StephenW

https://hal-pasteur.archives-ouv ... crAg_Gambia_CID.pdf