HBV感染早期和晚期HBV核酸检测呈阳性[已修正]的献血者：窗口期及HBV DNA动力学分析

HBV NAT positive [corrected] blood donors in the early and late stages of HBV infection: analyses of the window period and kinetics of HBV DNA.

作者信息

Yoshikawa Akira, Gotanda Yuhko, Itabashi Masako, Minegishi Kiyoshi, Kanemitsu Kimihiro, Nishioka Kusuya

机构信息

Japanese Red Cross Saitama Blood Center, Hidaka, Saitama, Japan.

出版信息

Vox Sang. 2005 Feb;88(2):77-86. doi: 10.1111/j.1423-0410.2005.00602.x.

DOI:10.1111/j.1423-0410.2005.00602.x

PMID:15720604

Abstract

BACKGROUND AND OBJECTIVES

The Japanese Red Cross (JRC) carries out nucleic acid amplification testing (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus-1 (HIV-1) by using a multiplex (MPX) reagent. Screening is undertaken on serologically negative units. In this study we characterized HBV NAT-positive donations individually and analysed the window period and kinetics of HBV DNA, during acute infection, in follow-up studies.

MATERIALS AND METHODS

Two hundred and seventy-seven HBV DNA-positive donations have been identified in Japan since the introduction of NAT screening of 50-donation minipools. The viral loads and genotypes of these HBV DNA-positive donations were characterized. The doubling time and half-life of HBV was estimated from the data of 123 follow-up donors. The sensitivity of the NAT system (based on 50-donation minipools) was compared with the sensitivities of the enzyme immunoassay (EIA) and the chemiluminescence immunoassay (CLIA). Samples that were CLIA negative, but with > 10(4) copies/ml of HBV DNA, were analysed by sequencing the hepatitis B surface antigen (HBsAg) region.

RESULTS

Out of 277 HBV NAT-positive samples, 125 (45%) were found to have an increasing viral load and 45 (16%) a decreasing viral load. Forty per cent of HBV NAT-positive samples with an increasing viral load, and 33% of those with a decreasing viral load, were negative when tested by using the CLIA. No mutations related to escape mutants were found in the samples that were CLIA negative but with HBV DNA loads of > 10(4) copies/ml. The median HBV doubling time was 2.6 days (n = 93, 1.3-15.2 days) and the half-life was 1.6 days (n = 55, 0.9-6.3 days). Some kinetic difference was observed between genotypes A and B.

CONCLUSIONS

HBV NAT screening detected HBV DNA in both early (the so-called serological window period) and late stages of acute HBV infection.

摘要

背景与目的

日本红十字会（JRC）使用多重（MPX）试剂对乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和人类免疫缺陷病毒1型（HIV-1）进行核酸扩增检测（NAT）。对血清学阴性单位进行筛查。在本研究中，我们对HBV NAT阳性献血进行了个体特征分析，并在后续研究中分析了急性感染期间HBV DNA的窗口期和动力学。

材料与方法

自采用50份献血混合样本进行NAT筛查以来，日本已鉴定出277份HBV DNA阳性献血。对这些HBV DNA阳性献血的病毒载量和基因型进行了特征分析。根据123名随访献血者的数据估算HBV的倍增时间和半衰期。将NAT系统（基于50份献血混合样本）的灵敏度与酶免疫测定（EIA）和化学发光免疫测定（CLIA）的灵敏度进行比较。对CLIA阴性但HBV DNA>10⁴拷贝/ml的样本进行乙型肝炎表面抗原（HBsAg）区域测序分析。

结果

在277份HBV NAT阳性样本中，125份（45%）病毒载量增加，45份（16%）病毒载量降低。病毒载量增加的HBV NAT阳性样本中，40%在CLIA检测时为阴性；病毒载量降低的样本中，33%在CLIA检测时为阴性。CLIA阴性但HBV DNA载量>10⁴拷贝/ml的样本中未发现与逃逸突变体相关的突变。HBV的中位倍增时间为2.6天（n = 93，1.3 - 15.2天），半衰期为1.6天（n = 55，0.9 - 6.3天）。在A基因型和B基因型之间观察到一些动力学差异。