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COBAS AmpliScreen HBV Test HBV Seroconversion Panel Results and HBV NAT Positive / Serology Negative Donors Larry Pietrelli Director, Clinical Affairs Roche Molecular Diagnostics. Data Summary. Today’s focus:

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slide1

COBAS AmpliScreen HBV Test HBV Seroconversion Panel Results and HBV NAT Positive / Serology Negative Donors Larry PietrelliDirector, Clinical AffairsRoche Molecular Diagnostics

BPAC Meeting 7/21/05 COBAS® AmpliScreen

data summary
Data Summary
  • Today’s focus:
    • Overview of the COBAS AmpliScreen HBV Test Performance on 40 HBV Seroconversion Panels Compared to HBsAg Tests
    • Clinical Study Summary of Donors Found HBV DNA Positive / HBsAg & anti-HBc Negative & Enrolled in Follow-up Studies

BPAC Meeting 7/21/05 COBAS® AmpliScreen

seroconversion panel tests detection of hbv dna prior to ortho hbsag test system 3
Seroconversion Panel TestsDetection of HBV DNA Prior to Ortho HBsAg Test System 3

On average, the COBAS AmpliScreen HBV Test detected HBV 15 days with Mini-pool Test and 20 days with Single Unit Test earlier than the Ortho HBsAg Test System 3. There was no case in which serological tests detected HBV prior to NAT.

.

BPAC Meeting 7/21/05 COBAS® AmpliScreen

seroconversion panel tests panel 24 detailed test results
Seroconversion Panel TestsPanel #24 Detailed Test Results

BPAC Meeting 7/21/05 COBAS® AmpliScreen

seroconversion panel tests panel 40 detailed test results
Seroconversion Panel TestsPanel #40 Detailed Test Results

BPAC Meeting 7/21/05 COBAS® AmpliScreen

seroconversion panel tests panel 39 detailed test results
Seroconversion Panel TestsPanel #39 Detailed Test Results

BPAC Meeting 7/21/05 COBAS® AmpliScreen

slide7
Summary of COBAS AmpliScreen HBV Test vs. Ortho HBsAg ELISA Test System 3 with 39 HBV Seroconversion Panels
  • * One seroconversion panel was not included in the calculations which was detected by the COBAS AmpliScreen HBV Test 108+ days prior to the Ortho HBsAg ELISA Test System 3.

BPAC Meeting 7/21/05 COBAS® AmpliScreen

clinical trial summary
Clinical Trial Summary

BPAC Meeting 7/21/05 COBAS® AmpliScreen

follow up study
Follow-up Study
  • Donor enrolled in the follow-up study were to return weekly for the first month and then monthly for 5 months for a total of 6 months
  • Testing was to include the following:
    • IgM anti-HBc
    • anti-HBc (total)
    • anti-HBs
    • HBsAg
    • HBV DNA

BPAC Meeting 7/21/05 COBAS® AmpliScreen

potential window cases
Potential Window Cases
  • 23 Donors were HBV DNA + / HBsAg - / Anti-HBc –

- 14 were enrolled into the follow-up study

- 2 confirmed Window Period cases

  • 12 presumed false positive due to persistently negative Anti-HBc, HBsAg and HBV DNA
    • 9 subject declined follow-up (calculated as false positive for sensitivity/specificity determination)

BPAC Meeting 7/21/05 COBAS® AmpliScreen

follow up subject aa110001
Follow-up Subject AA110001

26 year old male repeat donor with no know risk factors

BPAC Meeting 7/21/05 COBAS® AmpliScreen

follow up subject da120001
Follow-up Subject DA120001

49 year old female, repeat donor, health care worker, previously vaccinated

BPAC Meeting 7/21/05 COBAS® AmpliScreen

additional window cases detected post clinical study
Additional Window Cases Detected Post Clinical Study
  • Three of the five sites continued screening for HBV under the IND after conclusion of the Clinical Study
  • Three additional window period cases identified

BPAC Meeting 7/21/05 COBAS® AmpliScreen

follow up subject la150001
Follow-up Subject LA150001

27 year old male repeat donor, multiple high-risk male sexual partners

BPAC Meeting 7/21/05 COBAS® AmpliScreen

follow up subject la150002
Follow-up Subject LA150002

29 year old male repeat donor, only possible risk factor was acupuncture once a week for 8 weeks prior to donation

BPAC Meeting 7/21/05 COBAS® AmpliScreen

follow up subject la151303
Follow-up Subject LA151303

50 year old male repeat donor

BPAC Meeting 7/21/05 COBAS® AmpliScreen

conclusions from the window period cases identified
Conclusions from the Window Period Cases Identified
  • Four of the five window period cases seroconverted to HBsAg positivity. Time from first minipool NAT positivity to HBsAg Positivity Ranged from 7 to 17 with a median of 11 days.
  • One donor who was previously vaccinated against HBV failed to seroconvert.
  • 12 donors were negative for all markers at the end of the 6 month follow-up period and were classified as false positive

BPAC Meeting 7/21/05 COBAS® AmpliScreen

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