Home Access Health Corporation - PowerPoint PPT Presentation

1 / 6
About This Presentation
Title:

Home Access Health Corporation

Description:

Home Access Health Corporation – PowerPoint PPT presentation

Number of Views:30
Avg rating:3.0/5.0
Slides: 7
Provided by: barbg9
Learn more at: http://www.fda.gov
Category:

less

Transcript and Presenter's Notes

Title: Home Access Health Corporation


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 doesnt 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
Write a Comment
User Comments (0)
About PowerShow.com