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Impact of Testing Strategies to Reduce Transmission Risk for HBV Ravi Reddy, M Vermeulen South African National Blood Service (SANBS) 29 July 2013

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Overview of SANBS SANBS is a private not for profit company operating on a fee for service basis Provides a vein to vein blood transfusion service in 8 of the 9 provinces in SA. WPBTS in Western Cape 807,000 units of blood collected annually (100% voluntary) 2 800 units bled daily 2 testing centres - Johannesburg and Durban Also test for Namibia BTS (ID-NAT as well) 7 blood processing centres 82 blood banks serving > 600 hospitals and clinics. SANBS is accredited with the South African National Accreditation System (SANAS) Specific laboratories are ISO 17025 accredited HQ in Johannesburg

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Donation Testing Strategy Quality assured testing of each donation EQAS and internal QC systems in place Serology is mandatory Anti-HIV-1,2, anti-HCV, HBsAg Quality assured testing with sensitive serology assays leads to detection of most of the viral positive donations cost effectively Individual Donation Nucleic Acid Testing (ID-NAT) Implemented in October 2005 Primarily to reduce risk of HIV window period transmission but also HBV transmission as well

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Rationale for ID-NAT in South Africa HIV prevalence in blood donors 0.21% HBV prevalence in Blood Donors is 0.1% Implemented ID-NAT testing in October 2005 ULTRIO assay on the TIGRIS platform for: HIV-1 RNA HCV RNA HBV DNA Serology testing for anti-HIV, anti-HCV and HBsAg done concurrently Evaluated and implemented Ultrio Plus assay in May 2011 because of increased sensitivity for HBV detection in window period

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Geographic Distribution of Chronic HBV Infection HBsAg Prevalence 8% - High 2-7% - Intermediate