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Establishment of National Quality Control Reference Panels and Requirements for Hepatitis B diagnosis reagents in

S Wu1, T Su, J Lin

  • 1National Institute for the Control of Pharmaceutical and Biological Products, Beijing, People's Republic of China.

A National Quality Control Reference Panel for Hepatitis B Diagnostic Kits has been established. Markers for these standards which were prepared include National Standards for HBsAg and anti-HBs calibrated against WHO International Standards. In addition, Reference Panels for HBeAg, anti-HBe, anti-HBc, anti-HBc IgM and HBV were established and National Requirements set. These panels have been used for the nationwide evaluation of HB kits and for licensing purposes.

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