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
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

3. 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
* 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
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.

5. 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

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