Roche推出捐赠器官组织乙型肝炎病毒检测方法

Roche推出一种乙肝检测方法叫做Cobas AmpliScreen，现在可以用于筛查捐献的尸体器官与组织。这项检测方法已经获得了美国食品药品管理局的许可。

扩大的应用范围包括已经获得批准的检测活体捐献者的全血、血液成份、血浆。尸体组织包括皮肤、骨骼和韧带。来自一个捐献者的产品可能会被移植到100多位患者体内。这些组织能够象血液一样传染相同的病毒。

这种Cobas AmpliScreen是由瑞士Roche诊断学公司(Basel, Switzerland)研制成功的。该公司的血液和组织筛查检测方法是根据获得的高度敏感的聚合酶链反应(PCR)而研制开发的，该方法已经成为全球标准的快速可靠的检测微量基因物质方法。大多数组织供体接受免疫检测，该方法检测感染晚期的目标病毒抗体。核酸检测，例如Cobas AmpliScreen，能够在早期检测乙肝病毒脱氧核酸（HBV DNA），减少检测的“窗口期”，即感染与首次检测到抗原或者抗体之间的时间。这种检测窗口期的缩短使得实验室能够进一步确定组织的安全性。

Roche分子诊断学主任Heiner Dreismann指出：“这对等待移植的患者以及全球的组织与器官库都是一个好消息，我们十分自豪，因为我们是唯一同时获得FDA批准和CE标志认证的公司，可以在尸体中进行人体免疫缺陷病毒（HIV-1）、丙型肝炎病毒(HCV)、乙型肝炎病毒(HBV)核酸检测方法。”

HBV Test for Cadaver Organs, Tissue
 
A hepatitis B test called Cobas AmpliScreen can now be used for screening cadaver organ and tissue donations. This application has been cleared by the U.S. Food and Drug Administration (FDA).

The expanded claims add to existing approvals for testing whole blood, blood components, and source plasma from living donors. Tissues from cadavers include skin, bone, and ligaments. Products from a single donation may be transplanted in as many as 100 patients. These tissues can transmit the same viral infection as blood.

The Cobas AmpliScreen was developed by Roche Diagnostics (Basel, Switzerland). The company’s blood and tissue screening tests are based on a patented and highly sensitive polymerase chain reaction (PCR), which has become the global standard for fast and reliable replication of minute amounts of genetic material at detectable levels. Most tissue donors are tested by immunoassays, which detect antibodies to the target virus late in the infection cycle. Nucleic acid tests (NATs), such as the Cobas AmpliScreen, can detect HBV DNA much earlier and can reduce the “window period” of detection, which is the time between infection and the first detection of antigen or antibody. This shortening enables labs to further ensure the safety of tissues.

“This is very good news for patients awaiting much-needed transplants, as well as for tissue and organ banks worldwide,” noted Heiner Dreismann, head of Roche Molecular Diagnostics. “We are proud to be the only company that has both FDA approval and CE Mark certification for cadaveric claims for human immunodeficiency virus (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) nucleic acid tests.”