Window Period Detection of HBV with the Procleix

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Window Period Detection of HBV with the Procleix
Ultrio Assay

• Blood Products Advisory Committee Meeting
• Gaithersburg, MD
• July 21, 2005
• Larry Mimms, PhD
• Executive Vice President, Research Development
• Gen-Probe Incorporated
• San Diego, CA

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Topics

• Detection of HBV in sero-conversion panels (pools
  of 16, 8, and individual donor testing).
• Comparison of Ultrio Assay results to HBV
  serology (data from Procleix Ultrio US clinical
  trial).
• Summary of ex-US HBV yield cases.

Ultrio Assay and TIGRIS System not approved for
commercial sale in the US
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Procleix Ultrio Assay Compared to theORTHO
HBsAg ELISA System 3Procleix System (eSAS) vs.
Procleix TIGRIS System
Panel ID Days Earlier than HBsAg Detection Days Earlier than HBsAg Detection Days Earlier than HBsAg Detection Days Earlier than HBsAg Detection
Panel ID eSAS eSAS TIGRIS TIGRIS
Panel ID Neat Diluted 116 Neat Diluted 116
62675 19 17 19 12
62825 29 29 29 29
62967 14 5 12 7
63133 11 9 11 9
63568 14 11 14 7
63659 15 0 15 13
63997 21 7 23 7
64006 20 8 20 0
64121 19 0 19 0
64132 23 14 17 8
Mean 18.5 10 17.9 9.2
Median 19 8.5 18 7.5
Range 11-29 0-29 11-29 0-29
ORTHO is a trademark of Johnson Johnson
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Procleix Ultrio Assay Compared to theAbbott
PRISM HBsAg Assay Procleix System (eSAS) vs.
Procleix TIGRIS System
Panel ID Days Earlier than HBsAg Detection Days Earlier than HBsAg Detection Days Earlier than HBsAg Detection Days Earlier than HBsAg Detection
Panel ID eSAS eSAS TIGRIS TIGRIS
Panel ID Neat Diluted 116 Neat Diluted 116
62675 19 17 19 12
62825 29 29 29 29
62967 14 5 12 7
63133 11 9 11 9
63568 10 7 10 3
63659 15 0 15 13
63997 19 5 21 5
64006 20 8 20 0
64121 19 0 19 0
64132 15 6 9 0
Mean 17.1 8.6 16.5 7.8
Median 17 6.5 17 6
Range 10-29 0-29 9-29 0-29
ABBOTT PRISM is a trademark of Abbott Laboratories
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Procleix Ultrio Assay on Procleix System
(eSAS) Compared to Abbott PRISM HBsAg Assay
Neat vs. Diluted 18
Panel ID Days Earlier than HBsAg Detection Days Earlier than HBsAg Detection
Panel ID Neat Diluted 18
BCP 6283 17 3
BCP 6284 11 7
BCP 6285 10 3
BCP 6291 19 19
BCP 6292 23 11
BCP 11006 21 21
BCP 11008 22 12
BCP 11014 18 16
BCP 11015 29 29
BCP 11017 15 6
Mean 18.5 12.7
Median 18.5 11.5
Range 10-29 3-29
ABBOTT PRISM is a trademark of Abbott Laboratories
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Comparison of HBV Serology andProcleix Ultrio
Assay Index Donation Results
Anti-HBc HBsAg DNA N
1 38 0.0181
2 - 7 0.0033
3 - 0 0.000
4 - - 4 0.0019
5 - - 7 0.0033
6 - - - 209,007 99.3993
7 - 1 0.0005
8 - - 1,206 0.5735
Total 210,270
Anti-HBc sero-positive for HBV core antibody,
HBsAg sero-positive for HBV surface antigen,
DNA Procleix Ultrio Assay Reactive (HBV
discriminated)
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Potential NAT Yield SamplesUltrio Assay
reactive, HBV discriminated, and negative for
HBsAg and anti-HBc
Procleix Ultrio Assay (S/CO) Procleix Ultrio Assay (S/CO) Procleix Ultrio Assay (S/CO)
Anti-HBc HBsAg Pool IDS dHBV Alt NAT
1 NR NR N/A 16.81 26.77 Detected
2 NR NR N/A 7.54 23.93 QNS
3 NR NR 15.73 15.89 26.00 Detected
4 NR NR 11.79 15.61 27.07 Detected
5 NR NR 7.66 12.08 25.30 Detected
6 NR NR 8.13 8.29 21.43 Detected
7 NR NR 23.61 1.4 4.52 Not Detected
NR non-reactive, IDS individual donor sample,
S/CO signal to cutoff (gt 1.0 is reactive), N/A
not applicable because tested only as IDS, QNS
quantity not sufficient. No serological
evidence of HBV infection in followup bleeds
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Preliminary Procleix Ultrio Assay Results from
Ex-US Field Testing
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EU and Asia-PacificProcleix Ultrio Assay Yield
HBV NAT only HBV NAT, HBcAb HBV NAT, no addl test
IDT (262K donations) 4 49 11
18 Pools(155K donations) 10
Total (417K donations) 4 59 11
One was HBsAg-/HBcAb not tested on index
sample, but HBsAg-/HBcAb upon follow-up
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Two Madrid Yield Cases

• Case 1 4 days between Index donation DNA
  positivity and HBsAg detection
• Case 2 7 to 32 days between Index donation DNA
  positivity and HBsAg detection

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Conclusions

• From testing seroconversion panels, the Procleix
  Ultrio Assay detected HBV from 0 to 29 days
  earlier than HBsAg Assays depending upon the
  specific donor.
• Seven DNA , HBsAg -, Anti-HBc - donors were
  identified in the Procleix Ultrio Assay clinical
  trial.None were informative concerning window
  period.
• Four NAT yield cases (negative for HBsAg and
  anti-HBc) were identified from outside the US
  (Europe and Asia Pacific)
• Window closure of 4 to 32 days were shown in 2
  cases
• Higher than predicted HBV DNA yield in countries
  not performing anti-HBc testing, with an apparent
  difference between IDT and Pools of 18.