Nationwide nucleic acid amplification testing of hepatitis B virus, hepatitis C virus and human immunodeficiency virus type 1 for blood transfusion and follow-up study of nucleic acid amplification positive donors.
Nationwide nucleic acid amplification testing of hepatitis B virus, hepatitis C virus and human immunodeficiency virus type 1 for blood transfusion and follow-up study of nucleic acid amplification positive donors.
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全国范围内输血乙型肝炎病毒、丙型肝炎病毒和人类免疫缺陷病毒1型核酸扩增检测及核酸扩增阳性献血者随访研究。
DOI：
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发表时间：
2000
期刊：
影响因子：
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通讯作者：
M. Alexa
中科院分区：
文献类型：
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作者：
Kristian Hildebrand;M. Alexa
本研究描述了一个采用混合系统的多重试剂对乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和1型人类免疫缺陷病毒（HIV - 1）进行全国性核酸扩增检测（NAT）筛查的方案及其结果。在常规血清学筛查之后进行此项检测，是为了能及时用于输血。日本红十字会目前在日本各地提供用于输血的捐献血液。截至2000年1月，以500份为一个混合池对2140207份血液样本（5093个混合池）进行了检测，发现19例HBV DNA阳性病例和8例HCV RNA阳性病例。自2000年2月起，混合池规模改为50份，在420770份血液样本（8564个混合池）中，发现7例HBV DNA阳性病例和1例HCV RNA阳性病例。在所有检测的混合池中均未检测到HIV RNA。在26例HBV DNA阳性病例中，22例为野生型；其中6例（23%）的乙型肝炎表面抗原（HBsAg）通过过夜酶免疫测定（EIA）无法检测到。除1例因共存抗体抑制免疫反应外，后续追踪的17例均出现血清学转换。在其中10例中，HBV DNA降至检测水平以下，且在观察期间出现了IgM抗 - HBc和抗 - HBc抗体的血清学转换。其余4例为前C区突变型，且通过EIA检测HBsAg均为不可测水平。3例未出现IgM抗 - HBc血清学转换，而这在HBV感染早期应该是可以观察到的。对于HCV RNA，确定了以下基因型：2例为基因型II（1b），3例为基因型III（2a），4例为基因型IV（2b）。在后续追踪的4例中有2例观察到弱抗 - HCV阳性反应，1例出现强血清学转换。尽管不是100%，但NAT缩短了早期感染的窗口期，从而使输血用血的血清学筛查试验中漏检的病毒载量呈指数级减少。就HBV而言，NAT筛查可在HBV抗原和抗体水平极低的持续感染个体中检测到HBV DNA，这在HBV突变体的情况下经常出现。
This study described a program for and the results of a nationwide nucleic acid amplification testing (NAT) screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type 1 (HIV-1) by multiplex reagent with a pooled system. After routine serological screening, this test was used in order to be in time for blood transfusions. The Japanese Red Cross currently supplies donated blood all over Japan for blood transfusion. As of January 2000, 2,140,207 units (5,093 pools) were tested by a pool size of 500 and 19 HBV DNA-positive cases and 8 HCV RNA-positive cases were found. Since February 2000, the pool size was switched to 50 and among 420,770 units (8,564 pools), 7 HBV DNA-positive cases and 1 HCV RNA-positive case were found. HIV RNA was not detected in any of the tested pools. Among the 26 HBV DNA positives, 22 were wild type; of these, 6 (23%) had hepatitis B surface antigen (HBsAg) that was undetectable by overnight enzyme immunoassay (EIA). Except for one case, in which coexisting antibody inhibited the immune reaction, all 17 cases that were followed later showed seroconversion. In 10 of these cases, HBV DNA disappeared below the level of detection and seroconversion of IgM anti-HBc and anti-HBc antibody occurred during the observation period. The remaining 4 cases were precore mutants and all had an undetectable level of HBsAg by EIA. Three cases did not show IgM anti-HBc seroconversion, which should be observed during the early stage of HBV infection. As for the HCV RNA, the following types were identified: 2 genotype II (1b), 3 genotype III (2a), and 4 genotype IV (2b). A weak anti-HCV positive reaction was observed in two cases and strong seroconversion in one case among 4 of the cases that were followed. Although it is not 100%, NAT narrows the window period in early-stage infection, resulting in an exponential reduction of the virus load that escapes serological screening tests for blood destined for blood transfusions. In the case of HBV, NAT screening detects HBV DNA in persistently infected individuals with extremely low levels of HBV antigen and antibody often observed in the case of HBV mutants.