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Looking Back: Robbins-Gioia Helps Nation’s Largest Blood Supplier Track Down Hepatitis C
Overview In 1998, the Food and Drug Administration issued regulatory guidance to all blood services organizations directing them to perform a records lookback on donors who have tested positive for hepatitis C since 1990. Although HIV/AIDS remains the most feared blood-borne virus, the hepatitis C virus is actually a bigger killer. This liver disease affects more than 4 million people, is often asymptomatic, and after many years is fatal. For years there was no effective way to test for the virus. In 1990, however, Chiron, a leading biotechnology company, developed the first process capable of screening donated blood for the hepatitis C virus. The test was refined through three iterations before the FDA gave the go-ahead to industry to perform the Hepatitis C Virus (HCV) lookback. The organization had hoped to centrally manage the project with the aid of a national database. Robbins-Gioia, however, immediately decided to set up a back-up manual plan—just in case.
| Publisher | Robbins-Gioia, LLC | File Format | PDF, requires Acrobat Rdr 5 |
|---|---|---|---|
| Date Published | May 2004 | Downloads | 53 |
| Format | Case Studies | ||
| Topics | |||
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