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.

中文翻译：

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通过提高灵敏度的HBsAg检测，可以改善对早期急性，晚期急性和隐匿性乙型肝炎感染的检测。

背景

乙型肝炎表面抗原（HBsAg）是诊断急性和慢性乙型肝炎的主要标志物。尽管HBsAg的检测方法不断改进，但在早期和晚期急性感染和隐匿性乙型肝炎感染（OBI）的检测中仍存在差距。

目标

评估了在ARCHITECT和Alinity仪器上运行的原型，提高灵敏度的HBsAg测定的性能，以检测早期和晚期急性感染和OBI。

学习规划

使用原型测定法测试了77例早期急性样品[仅对乙型肝炎病毒DNA（HBV DNA）呈阳性]，十二个跨越晚期急性感染的血清转换面板和101例隐匿样品（HBsAg阴性，HBV DNA阳性和抗HBc）和ARCHITECT HBsAg定性II。进行HBsAg基因测序以确定免疫优势区域的基因型和突变。

结果

与ARCHITECT HBsAg Qualitative II相比，原型分析显示增加了NAT产量样品的检出率（28/77，36.4％），晚期急性样品（6/12组的HBsAg检测时间延长了13天以上）和OBI样品（11 /101，10.9%）。获得了62个样品的HBsAg序列数据。代表的基因型是A1，A2，B2，B4，C1，C2，C5，D3，E和H。在4.8％的NAT产量和38.9％的OBI样品测序中发现HBsAg逃逸突变。在ARCHITECT和Alinity仪器上，188个样品的原型测定值相等。

结论

新的原型HBsAg检测将具有诊断价值，可提高对早期急性，晚期急性和隐匿性HBV感染的检测能力。