Roche推出一種乙肝檢測方法叫做Cobas AmpliScreen，現在可以用于篩查捐獻的尸體器官與組織。這項檢測方法已經獲得了美國食品藥品管理局的許可。

擴大的應用范圍包括已經獲得批準的檢測活體捐獻者的全血、血液成份、血漿。尸體組織包括皮膚、骨骼和韌帶。來自一個捐獻者的產品可能會被移植到100多位患者體內。這些組織能夠象血液一樣傳染相同的病毒。

這種Cobas AmpliScreen是由瑞士Roche診斷學公司(Basel, Switzerland)研制成功的。該公司的血液和組織篩查檢測方法是根據獲得的高度敏感的聚合酶鏈反應(PCR)而研制開發的，該方法已經成為全球標準的快速可靠的檢測微量基因物質方法。大多數組織供體接受免疫檢測，該方法檢測感染晚期的目標病毒抗體。核酸檢測，例如Cobas AmpliScreen，能夠在早期檢測乙肝病毒脫氧核酸（HBV DNA），減少檢測的“窗口期”，即感染與首次檢測到抗原或者抗體之間的時間。這種檢測窗口期的縮短使得實驗室能夠進一步確定組織的安全性。

Roche分子診斷學主任Heiner Dreismann指出：“這對等待移植的患者以及全球的組織與器官庫都是一個好消息，我們十分自豪，因為我們是唯一同時獲得FDA批準和CE標志認證的公司，可以在尸體中進行人體免疫缺陷病毒（HIV-1）、丙型肝炎病毒(HCV)、乙型肝炎病毒(HBV)核酸檢測方法。”

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.”