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Viral Safety of Blood Products in Taiwan

Viral Safety of Blood Products in Taiwan. Dr. Hwei-Fang Cheng National Laboratories of Foods and Drugs ( Bureau of Food and Drug Analysis ) Department of Health, Taiwan, R.O.C. Prevalence of HBV 、 HCV and HIV reactive donations in Taiwan.

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Viral Safety of Blood Products in Taiwan

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  1. Viral Safety of Blood Products in Taiwan Dr. Hwei-Fang Cheng National Laboratories of Foods and Drugs ( Bureau of Food and Drug Analysis ) Department of Health, Taiwan, R.O.C.

  2. Prevalence of HBV、HCV and HIV reactive donations in Taiwan • Based on the donations in Chinese Blood Service Foundation ( CBSF ), Taiwan, R.O.C. in the year of 2001. • All donors are voluntary non-remunerated. • 3. PH: plasmapheresis or plateletpheresis

  3. Sensitivity of NAT for Taiwanese mini-plasma pool* * 480 donation units / pool ** 2/4 of mini-pools was tested

  4. Frequency of detection of HBV、HCV and B19 in blood products manufactured from Taiwanese plasma by NAT tests • 17 lots of IVIG and 7 lots of Factor VIII were manufactured from 22,000 liters of plasma. • Detection limits for HBV、HCV and B19 were 12.5 IU/ml、6.25 IU/ml and 25 IU/ml, respectively. • 3. *The lot was no B19 NAT conducted on plasma pool.

  5. Detection of B19 DNA in Factor VIII Blood products marketed in Taiwan by NAT tests

  6. New Guidance to Improve the Safety of Blood Productsby Department of Health, Taiwan on Dec. 19, 2002effective date: March 31, 2003 1. NAT tests on plasma pool are required: negative for HIV, HBV, HCV 2. Virus inactivation/removal steps for enveloped and non-enveloped viruses: two steps or one step ( shown to be reliably effective ) 3. For S/D treated blood products, One additional step should be performed e.g. monoclonal purification or nanofiltration ( at least 4 log reduction of HAV ) or The plasma pool should be HAV NAT(-) before the manufacturing process. 4. NAT test for Parvovirus B19 is suggested on plasma pool or mini-pool The plasma pool for manufacture should be < 105 IU/ml

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