使用灵敏度更高的测定法检测隐匿性乙型肝炎患者的乙型肝

StephenW

使用灵敏度更高的测定法检测隐匿性乙型肝炎患者的乙型肝炎表面抗原
Danny Ka-Ho Wong 1 2 , Claire Chen 3 , Lung-Yi Mak 1 2 , James Fung 1 2 , Wai-Kay Seto 1 2 , Man-Fung Yuen 1 2
隶属关系

    PMID：34936478 DOI：10.1128/jcm.02204-21

抽象的

隐匿性乙型肝炎感染 (OBI) 患者的常规检测无法检测到乙型肝炎表面抗原 (HBsAg)，但在血液/肝脏中可检测到乙型肝炎病毒 (HBV) DNA。我们评估了灵敏的 HBsAg 检测（ARCHITECT HBsAg Next Qualitative Assay，简称 NEXT）在 HBsAg 检测方面的关键性能特征。评估了 NEXT 的测定精度、样品残留和血清转化敏感性。 NEXT 检测了 1,138 人的 HBsAg，其中包括在三级医院就诊的 1,038 名患者（200 名 HBV DNA 阳性献血者的 HBsAg 常规检测无法检测到，38 名接受免疫抑制治疗的患者，800 名慢性乙型肝炎患者 HBsAg血清清除）和从社区项目招募的 100 名 HBsAg 阴性受试者。对于阳性样本库，运行内和实验室内的变异系数小于 6%。在测试的 9 个血清转化小组中，NEXT 允许比传统检测更早地检测到 HBsAg。 NEXT 在 10/200 (5%) HBsAg 阴性献血者、1/20 (5%) 和 0/18 名有和没有 HBV 再激活的 HBsAg 阴性患者以及 59/800 (7.3%) 名 HBsAg 患者中检测到 HBsAg血清清除。在 HBsAg 血清学清除后 <3、3-5、>5-8、>8-11 和 >11 年，NEXT 分别可检测到 27.8%、8.2%、6.9%、3.8% 和 1.9% 的样本中的 HBsAg。 NEXT 检测出 100 名 HBsAg 阴性社区受试者中有 7 名呈阳性。与传统的 HBsAg 检测相比，NEXT 显示出更高的灵敏度，并使 OBI 患者的检出率增加 5-7%，从而有助于识别 HBV 携带者并预防 OBI 相关的 HBV 传播和再激活。

StephenW

Detection of the hepatitis B surface antigen in patients with occult hepatitis B using an assay with enhanced sensitivity
Danny Ka-Ho Wong  1   2 , Claire Chen  3 , Lung-Yi Mak  1   2 , James Fung  1   2 , Wai-Kay Seto  1   2 , Man-Fung Yuen  1   2
Affiliations

    PMID: 34936478 DOI: 10.1128/jcm.02204-21

Abstract

Patients with occult hepatitis B infection (OBI) have undetectable hepatitis B surface antigen (HBsAg) by conventional assays but detectable hepatitis B virus (HBV) DNA in blood/liver. We evaluated the key performance characteristics of a sensitive HBsAg assay (ARCHITECT HBsAg Next Qualitative Assay, referred as NEXT) with respect to HBsAg detection. Assay precision, sample carryover and seroconversion sensitivity of NEXT were evaluated. HBsAg was measured by NEXT in 1,138 individuals, including 1,038 patients who attended liver clinics in a tertiary hospital (200 HBV DNA-positive blood donors whose HBsAg was undetectable by conventional assays, and 38 patients receiving immunosuppressive therapy, 800 chronic hepatitis B patients with HBsAg seroclearance) and 100 HBsAg-negative subjects recruited from a community project. The within-run and within-laboratory coefficients of variation were <6% for the positive sample pools. In 9 seroconversion panels tested, NEXT allowed an earlier HBsAg detection than conventional assays. NEXT detected HBsAg in 10/200 (5%) HBsAg-negative blood donors, 1/20 (5%) and 0/18 HBsAg-negative patients with and without HBV reactivation respectively, and 59/800 (7.3%) patients with HBsAg seroclearance. HBsAg was detectable by NEXT in 27.8%, 8.2%, 6.9%, 3.8% and 1.9% samples at <3, 3-5, >5-8, >8-11, and >11 years after HBsAg seroclearance, respectively. Seven out of 100 HBsAg-negative community identified subjects was tested positive by NEXT. Comparing with conventional HBsAg assays, NEXT demonstrated a higher sensitivity and conferred an increment of 5-7% detection rate in patients with OBI, thereby helping in identifying HBV carriers and prevention of OBI-associated HBV transmission and reactivation.