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This study explores the presence of occult HBV infections in blood donors with not-repeatable ULTRIO assay results, analyzing anti-HBc as a confirmatory marker. Examining HBV DNA screening methods in Poland and the clinical significance of such infections.
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Anti-HBc detection in ULTRIO not-repeatable reactive blood donors Piotr Grabarczyk, Ewa Brojer Institute of Haematology and Transfusion Medicine, Poland
HBV DNA screening in Poland • Obligatory HBVDNA screening in all blood donors since January 2005 • PCR Cobas in pools of 24 donations (since 2007 in pools of 6) • TMA ULTRIO in single donations
ULTRIO TMA not-repeatable reactives • DEFINITION • Triplex (+) • Discrimination HBV (-); HCV (-); HIV(-) • VERIFICATION METHODS • alternative NAT tests (Cobas, Arthus) • HCV RNA(-), HIV RNA(-) and HBV DNA(-) = false positive triplex assay • HBV DNA – positive:testing for anti-HBc to distinguish occult and window period infection
S/co TMA value and anti-HBc detection in samples reactive in ULTRIO assay(2005) 250 191 donations screened 9 positives (triplex+/dHBV+) 129 not-repeatable S/co of ULTRIO>10reactive (0.05%) 12 HBV DNA (+) in PCR (10%) 5/9 (56%) anti HBc positiveS/co of ULTRIO>10 10/12 (83,3%) anti-HBc positive
Analysis of S/Co distribution in samples with not -repeatable results of ULTRIO TMA Assessment of anti-HBc frequency in all samples with not-repeatable results in ULTRIO TMA Aim of the study (2006)
HBV DNA screening yield in 2006 247 263 donations 1positive 366 not-repeatable reactive(0,14%) 3 (0,8%)HBV DNA positive 363 negative in in PCR PCR S/co of TMA>10
S/co of ULTRIO test in 363 HBV DNA negative not-repeatable samples S/co
Anti-HBc frequency in HBV DNA negative samples with not-repeatable results of ULTRIO test – dependence on S/co value Anti-HBc frequency in donors negative in TMA assay: 7% ULTRIO S/co value
Instead of conclusions • Are the anti-HBc positive donors with not-repeatable ULTRIO results infected with occult HBV with virus load below sensitivity of the assay? • What is the clinical significance of such infections? • Can anti-HBc testing be useful in confirmatory procedure?