Improved detection of early acute, late acute, and occult Hepatitis B infections by an increased sensitivity HBsAg assay
Improved detection of early acute, late acute, and occult Hepatitis B infections by an increased sensitivity HBsAg assay
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DOI：
10.1016/j.jcv.2019.08.001
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发表时间：
2019-09-01
影响因子：
8.8
通讯作者：
Cloherty, Gavin A.
中科院分区：
文献类型：
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作者：
Kuhns, Mary C.;Holzmayer, Vera;Cloherty, Gavin A.
背景：B型肝炎表面抗原（HBsAg）是诊断急、慢性B型肝炎的主要标志物。尽管HBsAg检测方法不断改进，但在早期和晚期急性感染和隐匿性B型肝炎感染（OBI）的检测方面仍存在差距。目的：评价在ARCHITECT和Alinity仪器上运行的原型、改进灵敏度的HBsAg检测方法在早期和晚期急性感染和OBI检测方面的性能。研究设计：77份早期急性样本[仅B型肝炎病毒DNA（HBV DNA）阳性]、12份跨越晚期急性感染的血清转换组和101份隐匿性样本（HBsAg阴性，HBV DNA和抗HBc阳性）使用原型检测试剂盒和ARCHITECT HBsAg定性II进行检测。结果：与ARCHITECT HBsAg Qualitative II相比，原型检测试剂盒对NAT产率样本（28/77，36.4%）、晚期急性样本（6/12组HBsAg检测时间延长>= 13天）和OBI样本（11/101，10.9%）的检出率均有所提高。获得了62个样本的HBsAg序列数据。代表的基因型为A1、A2、B2、B4、C1、C2、C5、D3、E和H。在4.8%的NAT产率和38.9%的OBI测序样品中发现HBsAg逃逸突变。原型检测值为188个样本是等效的ARCHITECT和Alinity instruments.Conclusions：新的原型HBsAg检测将是诊断价值，在提供早期急性，晚期急性和隐匿性HBV感染的改善检测。
Background: Hepatitis B surface antigen (HBsAg) is the primary marker for diagnosis of acute and chronic hepatitis B. Although HBsAg assays have undergone continuous improvement, gaps remain in the detection of early and late acute infection and occult hepatitis B infection (OBI).Objectives: The performance of a prototype, improved sensitivity HBsAg assay run on the ARCHITECT and Alinity instruments was evaluated for detection of early and late acute infection and OBI.Study design: Seventy seven early acute samples [positive only for hepatitis B viral DNA (HBV DNA)], twelve seroconversion panels spanning late acute infection, and 101 occult samples (HBsAg negative, positive for HBV DNA and anti-HBc) were tested with the prototype assay and ARCHITECT HBsAg Qualitative II. HBsAg gene sequencing was performed to determine genotype and mutations in the immunodominant region.Results: Compared with ARCHITECT HBsAg Qualitative II, the prototype assay showed increased detection of NAT yield samples (28/77, 36.4%,), late acute samples (>= 13 days longer detection of HBsAg for 6/12 panels), and OBI samples (11/101, 10.9%). HBsAg sequence data were obtained for 62 samples. Genotypes represented were A1, A2, B2, B4, C1, C2, C5, D3, E, and H. HBsAg escape mutations were found in 4.8% of NAT yield and 38.9% of OBI samples sequenced. Prototype assay values for 188 samples were equivalent on the ARCHITECT and Alinity instruments.Conclusions: The new prototype HBsAg assay will be of diagnostic value in providing improved detection of early acute, late acute, and occult HBV infections.