International Survey on NAT testing of Blood Donations 2014

Transcription

1 4. Sitzung der DGTI-Sektion Sicherheit von Blutprodukten International Survey on NAT testing of Blood Donations 2014 On Behalf of the ISBT Working Party - Transfusion Transmitted Infectious Diseases (WP-TTID) T. Veith & W. K. Roth, S. Stramer (chair ISBT WP-TTID subgroup virology), M. Busch (Chair ISBT WP-TTID), R. Y. Dodd

2 International Survey on NAT testing of Blood Donations 2014 Announcement: A New International Survey on NAT Testing of Blood Donations Is Planned for 2014 Organized by WP-TTID of ISBT Discussion, Ideas etc. - Welcome

3 ISBT Working Party Transfusion Transmitted Infectious Diseases The WP-TTID (Working Party - Transfusion Transmitted Infectious Diseases) is the constituent of ISBT (International Society of Blood Transfusion) responsible for evaluation and advocacy of ways to increase blood safety in the world in order to reduce the frequency of TTID. This will be accomplished by: reviewing, gathering and analyzing relevant data developing and coordinating international studies publishing scientific reports proposing guidances, procedures and main technologies in all regions of the world, taking into account different regional epidemiologies

4 Questionnaires on NAT Testing of Blood Donations

5 Questionnaires on NAT Testing of Blood Donations

6 Questionnaires on NAT Testing of Blood Donations Journal Participating countries Parameter (Virus) Vox Sanguinis 82 (2002 ) Vox Sanguinis 88 (2005 ) Vox Sanguinis 102 (2012) HCV HIV HBV (Germany) Mandatory 14 6 / Mandatory

7 2008 Questionnaire - facts Electronic questionnaire sent by To 73 experts from 55 countries 50 experts from 37 countries responded Incomplete data from 7 countries 6 countries only serological data 37 completely filled questionnaires with valid data received from 25 countries Population covered by survey: 1.2 billion Population for which NAT testing data were collected: 1.16 billion

8 Timeline Questionnaire 2008 Years of discussion in the WP-TTID and Subgroup Virology Programming an electronic questionnaire! will be replaced by online questionnaire in 2014 August 2009: distribution of NAT-questionnaire by Sep - Nov 2009: completed files received from most participants. Reminder was sent in Nov 2009 Dec 2009 / Jan 2010: Abstract for ISBT congress in Berlin May 2010: first presentation of preliminary data at IPFA/ PEI meeting in Zagreb Jun 2010: update of analysis for ISBT Berlin poster. Apr 2011: submission of International Forum to Vox Sanguinis and acceptance for publication ~ 2 years

9 Results 2008

10 2008 Questionnaire results Introduction of NAT testing

11 2008 Questionnaire - results NAT Yield Data Since Introduction (total) and in 2008 Virus Testing period Number of donations screened NAT-only positive NAT-only positive / million HIV total 272,520, ,356, HCV total 303,196, ,095, HBV total 114,286, ,887,

12 2008 Questionnaire results NAT-Only Positives Since Introduction of NAT Testing vs. NAT-Only Positives in 2008 Region / country Virus NAT-only positives / million since introduction NAT-only positives / million in 2008 South Africa Asia/Pacific Europe North America total (all countries) HIV HCV HBV HIV HCV HBV HIV HCV HBV HIV HCV HBV HIV HCV HBV

13 estimated/max. estimated 2008 Questionnaire results UNAIDS HIV prevalence 2013 estimates; timeline Estimated adults and children living with HIV 1,00 0,90 0,80 0,70 0,60 0,50 0,40 0,30 0,20 0,10 0,00 average global N. America S. Africa W. & C. Europe year *Data source (03/17/2014):

14 2008 Questionnaire results NAT-Only Positives vs. UNAIDS (WHO) epidemiology 2013* - HIV Country NAT-only positives/ million since intro. NAT-only positives/ million in 2008 Prevalence (average per year) [million] Prevalence in 2008 [million] South Africa Europe % 0.64** ** % North Europe America ** total (all 0.64** % 31.03*** *** % countries) North America % % total (all countries) Good accordance for S. Africa 0.9 All countries (with NAT) vs. global values (`99 - `07)!Careful incidence vs. prevalence! *** 31.03*** % % ** Centr. & West E.! *** Global estimates! *Data source (03/17/2014):

15 2009 Questionnaire results Proportion of NAT Positives Among Serologically Confirmed Positives Region Virus Total (first time and repeat donations) Number of tested donations NAT positives among serologically positives South Africa HIV /1304 = 99.39% HCV /79 = 62.03% HBV /732 = 96.99% Europe, total HIV /348 = 98.28% HCV ,648/2,169 = 75.05% HBV ,304/1,818 = 71.73% N. America HIV /265 = 89.43% HCV ,480/3,658 = 67.80% HBV /293 = 54.95% Total (all countries) HIV ,130/2,174 = 97.98% HCV ,723/6,706 = 70.43% HBV ,943/3,737 = 78.75% HIV-1: 99% HCV: 62% HBV: 97% ID NAT HIV-1: 98% HCV: 75% HBV: 72% Pool / ID NAT HIV-1: 92% HCV: 62% HBV: 83% Germany 96-pools HIV-1: 89% HCV: 67% HBV: 55% Pool / ID NAT

16 comparison

17 Questionnaire 2008 vs Data were requested for whole blood and apheresis donations only Number of inhabitants and donor population per country Number of first-time and repeat donations Serological and NAT tests employed for screening (HIV, HBV, HCV) Confirmation testing strategies Viruses tested for by NAT Number of donations screened in 2008 and over the entire period since the introduction of NAT testing Yes Just inhabitants (donors?) Depending on Virus + pre-donation Drop-down menues for suppliers + text field for alternatives (e.g. in-house) depends on suppliers and parameter (see above) Yes (extended) cross sectional 2014, to be discussed: since 2008 or since the introduction of NAT testing

18 Questionnaire 2008 vs Whether NAT is mandated or not Number of NAT-only positives and yield rate in 2008 and since introduction The current NAT technology employed including pool size Sensitivity and specificity Viral subtype distribution per country Sufficiency of controls HBV vaccination programmes Yes to be discussed: since 2008 or since the introduction of NAT testing Drop-down menues for suppliers + text field for alternatives (in-house) depends on suppliers (see above) No! No! Yes +Increased serology part (to be discussed)

19 Questionnaire 2008 vs Answer No leads to next page

20 Summary questionnaire 2008 and outlook 2008 Electronic surveys are feasible and efficient Years of discussion/ preparation Commitment of participants is a key prerequisite WP-TTID provides relevant structures: dedicated members and an international network Comprehensive survey/ huge data set (Highly relevant NAT data + serology) Excellent cross sectional data (2008) STATUS QUO Excel-based questionnaire, partially cumbersome; programmer assistance needed!

21 Questionnaire 2014 Changes: Convenience for the user: - web-based survey tool: - Weblink/ , embeded into homepage (no programmer needed) - By using page/question logics: Answer only questions which fit your profile, e.g. if you do not use NAT you are directed to questions regarding serology - Creation of drop down menus for e.g. NAT suppliers Modifications: - Use a modified set-up but in accordance to the 2008 version - Statistical analysis of data, trends via text analysis, Excel/pdf export etc. & SPSS integration more countries using NAT development of NAT only pos. in relation to the questionnaire 2008

22 Questionnaire 2014 Challenges: - Reach more participants in more countries - Trustworthy & reasonable statistical analysis - Comparison to Comparison to other national and international statistics - Comparison to serology

23 4. Sitzung der DGTI-Sektion Sicherheit von Blutprodukten Thanks for Your Attention - time for discussion