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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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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
- 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 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.
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BPAC Meeting 7/21/05 COBAS® AmpliScreen
Seroconversion Panel TestsPanel #24 Detailed Test Results
BPAC Meeting 7/21/05 COBAS® AmpliScreen
Seroconversion Panel TestsPanel #40 Detailed Test Results
BPAC Meeting 7/21/05 COBAS® AmpliScreen
Seroconversion Panel TestsPanel #39 Detailed Test Results
BPAC Meeting 7/21/05 COBAS® AmpliScreen
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
BPAC Meeting 7/21/05 COBAS® AmpliScreen
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
- 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
26 year old male repeat donor with no know risk factors
BPAC Meeting 7/21/05 COBAS® AmpliScreen
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
- 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
27 year old male repeat donor, multiple high-risk male sexual partners
BPAC Meeting 7/21/05 COBAS® AmpliScreen
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
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
