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A Leader in Personal Convenience Diagnostics and
Healthcare Information |
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Advisory Meeting |
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November 3, 2005 |
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OTC Home Use HIV Test Kits |
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Approved July 22, 1996 |
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PMA: BP95002 |
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100% Sensitive, 100% Specific “Greater than 99.9% Accurate” |
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Anonymous “System” Includes: |
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Pre-Test Counseling |
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Repeat Elisa |
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Confirmation Test (IFA) |
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Post-Test Counseling (English, Spanish) |
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Referrals |
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Home Access Views about Misconceptions Driving
Decision to Approve: |
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Rapid HIV Testing = Opens Floodgates to HIV
Infected/Unaware |
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Home Access Views about Misconceptions Driving
Decision to Approve: |
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Rapid HIV Testing = Opens Floodgates to HIV
Infected/Unaware |
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Rapid Pregnancy Testing = Rapid HIV Testing |
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The general population doesn’t understand
HIV/AIDS any better today than 10 years ago |
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Learning that one “may be positive” for HIV is a
personal CATASTROPHE, no different than 10 years ago |
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The moment bad news about HIV status occurs; an
intensive care situation is at hand - “professional” assistance is proven
and needed |
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The living Hell of “I may be positive”
critically requires systematic and timely resolution |
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Should be approved if safety and efficacy are
equal to the existing FDA-approved at-home HIV Testing service |
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System elements “can” and should provide: |
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Educational interaction e.g. window period |
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Confirmation testing |
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Professional “client-centered” counseling &
referrals |
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Notes