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Blood Borne Virus Unit Virus Reference Department Centre for Infections HPA Colindale

Role for HCV antigen detection: a new generation of assays. Blood Borne Virus Unit Virus Reference Department Centre for Infections HPA Colindale. Samples used for the study. Part 1: 94 acute phase seronegative plasma donors, 51 of which contained detectable RNA

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Blood Borne Virus Unit Virus Reference Department Centre for Infections HPA Colindale

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  1. Role for HCV antigen detection: a new generation of assays Blood Borne Virus Unit Virus Reference Department Centre for Infections HPA Colindale

  2. Samples used for the study Part 1: 94 acute phase seronegative plasma donors, 51 of which contained detectable RNA genotyped, titrated as appropriate Part 2: Plasma samples from 65 individuals in a randomised clinical trial of Ribavarin/IFN samples from first 14 days of treatment to assess early dynamics

  3. Part 1 inferences to be drawn:- • Proficient across limited selection of genotypes 1-3 available • Linearity also maintained over 3 log10 • Interpolated LOD in range 2-3 log10

  4. Part 2: 300 samples from 65 patients HCV Ag log10 f/mole HCV RNA Viral load log10 iu/ml

  5. Part 2: Pre- or D3 samples from 59 patients

  6. 4.00 7.00 3.50 6.00 3.00 5.00 2.50 4.00 2.00 log HCV RNA log HCV Ag 3.00 1.50 2.00 1.00 1.00 0.50 0.00 0.00 Base D3 D7 D10 D14 W12 Time 3.00 6.00 2.50 5.00 2.00 4.00 1.50 3.00 log HCV RNA log HCV Ag 1.00 2.00 0.50 1.00 0.00 0.00 BASE D7 D14 W12 Time 49 RA 4.00 7.00 3.50 6.00 3.00 5.00 2.50 4.00 log HCV RNA 2.00 log HCV Ag 3.00 1.50 2.00 1.00 1.00 0.50 0.00 0.00 Base D3 D7 D10 D14 W12 Time 64

  7. 4 7 3.5 6 3 5 2.5 4 2 log HCV RNA log HCV Ag 3 1.5 2 1 1 0.5 0 0 Base D3 D7 D10 D14 W12 Time 257 292 4 6 3.5 5 3 4 2.5 log HCV Ag 2 3 log HCV RNA 1.5 2 1 1 0.5 0 0 Base D3 D7 D14 W12 Time 268 4.5 8 4 7 3.5 6 3 5 2.5 4 log HCV RNA log HCV Ag 2 3 1.5 2 1 1 0.5 0 0 Base D3 D7 D14 W12 Time

  8. Part 2 inferences to be drawn:- • Good correlation between HCV Ag quantitification and HCV RNA BUT NOT absolute, what is nature of the relationship? • Response to R/IFN paralleled by both markers • Idiosyncrasies rare but significant, reason? • Qualitative therapy prediction possible early • Need to pin antigenaemia against HCV RNA for each patient • Positioning- adjunct or alternative? • High risk population or resource-limited sites?

  9. Thanks to: • Prof Howard Thomas and colleagues for permission to use the “Mild Trial” samples • Paul Grant, UCL for HCV RNA data • Nigel Wallis, Phil Tuke, Siew Lin Ngui and colleagues in BBVU, VRD • Abbott Diagnostics for Architect reagents and support

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