Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

In 1978, and following efforts over several years, FDA finalized regulations to help lessen the likelihood of hepatitis contamination of blood through labeling. Research suggested a significant difference in likelihood of such contamination from paid blood donors rather than volunteers. Henceforth, blood intended for transfusion had to be labeled as either paid or volunteer sourced.

Attention to nonNon-A, non-B Hepatitis Antigen attracted more research attention of Bureau scientists in 1978. This antibody system was detected using the older counter-electrophoresis test. It was found in s of 7 experimental animals infected by another animal infected with the same antibody system. Also, the same antigen was collected over 5-6 years from a patient suffering chronic hepatitis. That patient transmitted the same antigen to a nurse who experienced an accidental needle stick, and the patient’s antigen also was transmitted to an animal model. By mid-1984 90 percent of post-transfusion cases of hepatitis and up to 40 percent of community acquired cases in the U. S. were non-A, non-B. Though the agent had not yet been identified, research shed more light on its characteristics. It appeared to be a retrovirus or retrovirus-like entity, and additional observations of the agent in a half-dozen samples of serum- or plasma-based products brought the Office of Biologics Research and Review (OBRR), what biologics regulation at FDA was called in the early 1980s, closer to develop screening tests for non-A, non-B.

...