FDA Approved Home Access Express® HIV-1 Test and Home Access® Standard HIV-1 Test

Home Access HIV-1 Test Systems

• Anonymous test system that combines a test kit, education, lab processing, counseling and lab results.
• Two versions

1. HIV Express Test – provides results next business day. Customers return fingerstick blood samples to the Home Access CLIA regulated and CAP certified laboratory using a prepaid Fedex mailer included in the test kit.
2. HIV Standard Test – provides results within 7 days. Customers return fingerstick blood samples using prepaid US mailer included in test kit.

How is it regulated?

• FDA approved since 1996 under PMA guidance, the strictest level of approval available from the FDA

How do the tests work?

• Test kits include everything necessary for the successful collection, packaging and mailing of a small fingerstick blood sample to a certified laboratory.
• Anonymous pre and post-test counseling using the 1-800 number supplied in the kit combined with the unique personal identification number (PIN) assigned to the blood collection card
• Anonymous results using 1-800 number supplied in the kit combined with the user PIN
• Centers for Disease Control client-centered counseling, education and referral capabilities through call center staffed with highly trained, experienced counselors.

What is the science of the tests?

• Dried blood samples received in the HAHC laboratory are first subjected to an initial screen using ELISA reagents, the same chemicals used when testing is done on a venous sample
• If the sample is “reactive” it is then subjected to a duplicate ELISA screen
• Still reactive? Samples will be subjected to confirmation testing using IFA technology. We do not use Western Blot as our experience shows the IFA technology to be more robust.
• Results are then integrated with our call center. Each counselor can communicate with each user of the test on an individualized basis, anonymously, using the unique PIN assigned to that customer.

How accurate is the Home Access HIV-1 Test System?

• Very accurate. Our claims structure with the FDA includes an accuracy claim of 99.9%.
• Specificity in actual clinical trials – 100%
• Sensitivity in actual clinical trials – 100%
• We can support this level of accuracy, because, unlike rapid tests used in clinical and public health environments, our process takes reactive blood samples through to confirmation testing.
• Our accuracy is the same as is provided by Doctors and Hospitals

What do the results mean?

• We generally provide four types of results
  • Negative – Our test system did not identify antibodies to the HIV –1 virus in the blood sample provided
  • Indeterminate – Our test system could not confirm the presence of the HIV-1 antibodies in the sample (in this instance, we recommend that the customer test again)
  • Positive – Our test system identified antibodies to the HIV-1 virus in the blood sample provided
  • Not Tested – Our laboratory could not test the blood sample provided, either because it was soiled/contaminated, too small/clotted/not shipped in the enclosed foil pouch, etc., generally what we describe as “user error”.

What information is included in the pre and post-test counseling?

• Background information on HIV and AIDS
  • The difference between HIV and AIDS
  • How to prevent the spread of HIV or reduce the risk of transmission
  • Description of HIV Antibodies
• Information on the Home Access HIV-1 Test System
  • Test Accuracy
  • Test Methods, including reference to ELISA screen and IFA confirmation testing
  • Seroconversion or “window” period
  • Interpretation of results
• Who has access to results?
  • Only the user of the unique PIN
  • Home Access has no responsibility for Partner notification or notification to various Public Health entities
  • “Hard Copy” results are available upon client request
    • Request must be in writing
    • Client must provide a self-addressed stamped envelope to Home Access to maintain anonymity
    • Hard Copy results reference the PIN number and the test methodology (ELISA, IFA, and Seroconversion period)

Are there any limitations on Geographic Distribution?

• Kits are designed to be sold and used within the 50 United States and Puerto Rico
• For distribution and use outside of the 48 contiguous states, only the Standard configuration of the HIV-1 test is available.
• For distribution and use within the 48 contiguous states, both the Standard and Express versions of the HIV-1 test kit are available.