Tests Screen Organ, Tissue Donations

Nucleic acid tests for screening blood for hepatitis C virus (HCV) and HIV-1 can now also be used to screen organ and tissue donations from cadavers.

The Cobas AmpliScreen HIV-1 and HCV tests have been cleared by the U.S. Food and Drug Administration (FDA) for this expanded use, in addition to testing for whole blood, source plasma, and potential living organ donors. The tests were developed by Roche Diagnostics (Basel, Switzerland).

Tissues from cadaveric sources such as skin, bone, and ligaments are used in about one million medical procedures per year. These tissues can transmit the same viral infections as blood, and the products from a single tissue donation may be transplanted to an average of 50 patients or as many as 100. The Roche tests are designed to detect and thereby prevent transmission of HIV-1 and HCV, making the blood and tissue supply safer sooner. In a recent documented case, a single antibody-negative donor in October 2000 donated 91 tissues and organs. Nucleic acid testing (NAT), as used on Roche's Cobas AmpliScreen HIV-1 and HCV tests, performed after donation and transplantation, found the donor to be HCV-positive. Eight recipients were identified with HCV.

The Roche tests are based on the company's patented and highly sensitive polymerase chain reaction (PCR) technology, which enables detection of genetic material or infectious agents directly as well as earlier in the infection cycle than immunoassays.

"This is a great day for tissue and organ banks worldwide, and a great day for patients awaiting much-needed transplants,” observed Heino von Prondzynski, CEO, Roche Diagnostics and member of the Executive Committee. "The sensitivity and specificity of our tests as both a stand-alone and as used in conjunction with existing screening assays enable tissue banks to further improve the safety of products used in a variety of therapeutic applications.”




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