Overview of the testing strategy stages that the Japanese Red Cross has gone through (HBV, HIV)

Transcription

1 2014/LSIF/PD/006 Overview of the Testing Strategy Stages That the Japanese Red Cross (JRC) Has Gone Through (HBV, HIV) - The JRC Approach to Donor Recruitment in the Era of Aging Population Submitted by: Japanese Red Cross (JRC) Policy Dialogue and Workshop on Attaining a Safe and Sustainable Blood Supply Chain Manila, Philippines 30 September 1 October 2014

2 Overview of the testing strategy stages that the Japanese Red Cross has gone through (HBV, HIV) The JRC approach to donor recruitment in the era of aging population Masahiro Satake Japanese Red Cross Headquarters Central Blood Institute

3 Transfusion-transmitted HBV infection Risk-harboring population Donors in Window Period Sensitive NAT Donors with occult HBV infection (OBI) (HBsAg-negative but HBV DNA-positive, usually anti- HBc-positive) Highly sensitive NAT Rejection of anti-hbc-positive donors

4 Development of screening strategies for HBV Serology 1972 HBsAg (agglutination method) 1989 Anti-HBc/anti-HBs Anti-HBc cutoff.. x years sample storage NAT 1997 Anti-HBc cutoff.. x p-NAT (HBV, HCV, HIV) p-NAT p-NAT 2008 ŐŐůƵƟŶĂƟŽŶї >/ p-NAT (sample vol. x3) 2012 Entire anti-hbc-positives rejected 2014 ID-NAT

5 Anti-HBc/anti-HBs combination assay for HBsAg-negative blood Anti-HBc 12.9 % among first time donors in 1980s Anti-HBc titer Low < 2 6 (2 5 ) or 1.0 S/CO < 12.0 High 2 6 (2 5 ) or S/CO 12.0 Anti-HBs 200 IU/L Accepted Accepted Anti-HBs < 200 IU/L Accepted Rejected

6 Development of screening strategies for HBV Serology 1972 HBsAg (agglutination method) 1989 Anti-HBc/anti-HBs Anti-HBc cutoff.. x years sample storage NAT 1997 Anti-HBc cutoff.. x p-NAT (HBV, HCV, HIV) p-NAT p-NAT 2008 ŐŐůƵƟŶĂƟŽŶї >/ p-NAT (sample vol. x3) 2012 Entire anti-hbc-positives rejected 2014 ID-NAT

7 Recent incidence of TT-HBV after introduction of entire exclusion of anti-hbc-positives 8 Cases/y WP-related OBI-related p-NAT 20p-NAT new Improved 20p 20p-NAT HBcAb Aug 2012 Total exclusion of anti-hbc-positives

8 HIV-1-positive blood donations in Japan Seronegative but NAT-positives ; 1.9 / y

9 May p-NAT-negative Source plasma Nov 2003 HIV-Ab-positive RBC FFP Repository sample Discarded Ab-positive, HIV-RNA-positive ID-NAT-positive Feb p-NAT-negative Nov 2013 HIV-Ab-positive RBC FFP Ab-negative, HIV-RNA-negative Ab-positive, HIV-RNA-positive Repository sample ID-NAT-positive (1 of 3 NAT system)

10 Blood needs of the aging population and JRC approach to donor recruitment

11 Composition of Japanese population y 15 million 100 y 29.5 million M F M F M F 27 million 20 million

12 Future prospect of blood donors in Japan Population eligible for blood donation million % decrease No. of donors needed Predicted no. of donors

13 For Securing a Stable Blood Supply 1. To promote the appropriate use of blood products (Law on Securing a Stable Supply of Safe Blood Products, 2003) It is obligatory for physicians to use blood appropriately 2. Incorporation of blood donation into the guideline of study in high school (2009) Insertion of the pictures of blood mobile and blood donation room in the textbook of health and physical education (2013) 3. To increase educational session on blood science, blood transfusion and blood donation at schools

14 No. of school visits and lessons Elementary school Jr. high school High school Technical school University Others No. of participants Elementary school Jr.high school High school University Technical school Others

15 Class of Blood, health and blood donation at elementary school Youth Seminar Blood Donation at university

16 For Securing a Stable Blood Supply 4. To increase the number of young donors Donors in teens ( % in 2020) Donors in twenties ( % in 2020) 5. To increase companies cooperating on blood donation (50,712 companies and organizations registered in 2013) Symbol mark given companies joining group blood donation

17 For Securing a Stable Blood Supply 6. To increase repeat donors up to 1,200,000 (996,684 at present) Establishment of Multiple blood donation club Registration of address through mobiles/ PCs Offering information and sending request for donation by e- mail 7. Blood donation promoting campaigns Give Blood at Twenty : January~ February Supporting each other with love : July Christmas Blood Donation Nationwide Students Campaign : December 300 volunteer organizations consisting of 5,000 students LOVE in Action PROJECT since 2012 targeting 10s and 20s

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19 Incidence of post-transfusion hepatitis in Japan (%) % paid donors 31.1% paid & voluntary donors % voluntary donors 14.3 % HBs Ag testing 8.7 % 400mL collection 2.1 % HBcAb & HCV Ab 0.48 % HCV Ab 2 nd gen

20 Established TT-HBV cases in Japan 16 Cases pool NAT 20-pool NAT Improved 20-pool NAT

21 輸血による HCV 感染 献血者採血日検査結果 44 歳女性 2004/04/07 スクリーニンク 検査 (-) 保管検体個別 NAT copies/ml (1b) 21 歳女性 2003/11/07 スクリーニンク 検査 (-) 保管検体個別 NAT copies/ml (2a) 22 歳男性 2007/08/-- スクリーニンク 検査 (-) 保管検体個別 NAT copies/ml (2a) 30 歳代女性 2006/11/-- スクリーニンク 検査 (-) 保管検体個別 NAT 増幅不可 (2a) 2 例に感染 50 歳代女性 2009/06/-- スクリーニンク 検査 (-) 2013 年抗体陽転化にて遡及保管検体個別 NAT 陽性 (1b)

22 Bacterial infection caused by transfusion (SHOT in UK) Data in before cultural screening Components Bacteria Storage (Days) Patient outcome AP-PC AP-PC Klebsiella pneumoniae Group G Streptococcus 3 Fatal 4 Fatal 4 Serious, Recovered 5 Serious, Recovered Pooled PC Group G Streptococcus 4 Serious, Recovered AP-PC S. pneumoniae 5 Serious, Recovered 3 Serious, Recovered Pooled PC S. epidermidis 6 Serious, Recovered RBC Pseudomonas koreensis 19 Fatal

23 Suspected and established TT-sepsis RBC RBC PC PC PC Red ; established cases PC PC PC PC PC RBC PC JRC will keep PC shelf life short (3.5 days) Culture negative etc

24 Age distribution of blood donors and blood recipients (2012) % recipients donors Age

25 Number of blood donors by age group 250 X s 40s s '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13

26 LOVE in Action PROJECT since 2012 targeting 10s and 20s Musicians Students Volunteers Football Player Radio Program

27 Final Event - LOVE in Action Meeting(LIVE) Numbers of Love in Action were conducted from July 2012 to June 2013, and as a final event a live-music concert was held with great success.

28 For Securing a Stable Blood Supply 6. To increase repeat donors up to 1,200,000 (now 996,684) Establishment of Multiple blood donation club Registration of address through mobiles/ PCs Offering information and sending request for donation by 7. Blood donation promoting campaigns Give Blood at Twenty : January February Supporting each other with love : July Christmas Blood Donation Nationwide Students Campaign : December 300 volunteer organizations consisting of 5,000 students