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Home Access Health Corporation

Home Access Health Corporation. A Leader in Personal Convenience Diagnostics and Healthcare Information Advisory Meeting November 3, 2005 OTC Home Use HIV Test Kits. OTC Home Use HIV Test. Approved July 22, 1996 PMA: BP95002 100% Sensitive, 100% Specific “Greater than 99.9% Accurate”

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Home Access Health Corporation

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  1. Home Access Health Corporation A Leader in Personal Convenience Diagnostics and Healthcare Information Advisory Meeting November 3, 2005 OTC Home Use HIV Test Kits

  2. OTC Home Use HIV Test • Approved July 22, 1996 PMA: BP95002 • 100% Sensitive, 100% Specific “Greater than 99.9% Accurate” • Anonymous “System” Includes: • Pre-Test Counseling • Repeat Elisa • Confirmation Test (IFA) • Post-Test Counseling (English, Spanish) • Referrals

  3. OTC HIV Rapid Test Home Access Views about Misconceptions Driving Decision to Approve: • Rapid HIV Testing = Opens Floodgates to HIV Infected/Unaware

  4. OTC HIV Rapid Test Home Access Views about Misconceptions Driving Decision to Approve: • Rapid HIV Testing = Opens Floodgates to HIV Infected/Unaware • Rapid Pregnancy Testing = Rapid HIV Testing

  5. OTC HIV Testing Efficacy • The general population doesn’t understand HIV/AIDS any better today than 10 years ago • Learning that one “may be positive” for HIV is a personal CATASTROPHE, no different than 10 years ago • The moment bad news about HIV status occurs; an intensive care situation is at hand - “professional” assistance is proven and needed • The living Hell of “I may be positive” critically requires systematic and timely resolution

  6. OTC HIV Rapid Testing • Should be approved if safety and efficacy are equal to the existing FDA-approved at-home HIV Testing service • System elements “can” and should provide: • Educational interaction e.g. window period • Confirmation testing • Professional “client-centered” counseling & referrals

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