Viral Safety of Blood Products in Taiwan

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Presentation transcript:

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 Virus test Total donations （1,601,577 units） PH donations （63,610 units） HBV HBsAg (+) 24,962 1.56 % 31 0.05% HCV Anti-HCV (+) 5,895 0.37% 12 0.02% HIV Anti-HIV & WB（+） 61 0.0039% 0% 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

Sensitivity of NAT for Taiwanese mini-plasma pool* Virus Detection Limit HIV 7.25 IU/mL HCV HBV 56.25 geq/mL HAV 7.1 geq/mL B19** 2,500 copies/mL * 480 donation units / pool ** 2/4 of mini-pools was tested

Frequency of detection of HBV、HCV and B19 in blood products manufactured from Taiwanese plasma by NAT tests Blood Product HBV ( + ) / Total HCV B19 IVIG 0/17 Factor VIII 0/7 1*/7 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.

Detection of B19 DNA in Factor VIII Blood products marketed in Taiwan by NAT tests Virus inactivation/removal method B19( + ) / total A S/D, Dry heat 72hr. 1/1 B 6/11 C S/D, mAb chromatography 9/14 D S/D, Dry heat 30min. 7/7 E Chromatography, Pasteurization 2/2 F Pasteurization 4/8 G S/D, Chromatography 1/7

New Guidance to Improve the Safety of Blood Products by Department of Health, Taiwan on Dec. 19, 2002 effective 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