Minegishi K, Yoshikawa A, Kishimoto S, Yugi H, Yokoya N, Sakurada M, Kiyokawa H, Nishioka K
Japanese Red Cross Headquarter, Blood Services Department, Tokyo, Japan.
Vox Sang. 2003 May;84(4):287-91. doi: 10.1046/j.1423-0410.2003.00289.x.
The Japanese Red Cross (JRC) have developed a fully automated multiplex (MPX) nucleic acid amplification technology (NAT) system for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus 1 (HIV-1). This is used to test serologically negative blood units from volunteer, non-remunerated donors. The system utilizes a 50-sample pool for NAT screening with an input volume of each pool. This results in a significantly higher sensitivity for hepatitis B than that seen with highly sensitive hepatitis B surface antigen (HBsAg) testing.
From 1 February 2000 to 15 October 2001, over 11 million donations, which were serologically negative, were tested using the MPX NAT system. Donations found to be HBV DNA positive were further tested by using the chemiluminescence immunoassay (CLIA).
Out of 181 HBV DNA-positive donations, 96 (53%) and 76 (42%) were negative by individual enzyme immunoassay (EIA) and CLIA testing, respectively.
The sensitivity of the 50-sample pool MPX NAT system was higher than that of individual HBsAg screening by CLIA. By adopting this NAT-screening system, the JRC has improved the safety of the blood supply and maintained supply across Japan.
日本红十字会（JRC）开发了一种用于检测乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和人类免疫缺陷病毒1型（HIV-1）的全自动多重（MPX）核酸扩增技术（NAT）系统。该系统用于检测来自志愿无偿献血者的血清学阴性血液样本。该系统采用50份样本混合进行NAT筛查，每份混合样本有一个输入体积。这使得乙型肝炎检测的灵敏度显著高于高灵敏度乙型肝炎表面抗原（HBsAg）检测。
从2000年2月1日至2001年10月15日，使用MPX NAT系统对超过1100万份血清学阴性的献血样本进行了检测。对检测出HBV DNA阳性的献血样本进一步采用化学发光免疫分析法（CLIA）进行检测。
在181份HBV DNA阳性的献血样本中，分别有96份（53%）和76份（42%）通过个体酶免疫分析法（EIA）和CLIA检测呈阴性。
50份样本混合的MPX NAT系统的灵敏度高于CLIA单独进行HBsAg筛查的灵敏度。通过采用这种NAT筛查系统，日本红十字会提高了血液供应的安全性，并维持了全日本的血液供应。
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