HIV Testing Healthcare Info

Background - Patient Info - Health Provider Info

HIV Testing

Health Care Professional Information:

What is the specific information we can provide?

Counsel or warn consumers that there is a number of different HIV home test systems and kits that are being marketed on the Internet, magazines, or newspaper promotions. These advertisements claim to detect HIV antibodies in blood or saliva samples and results would be available in the home in 15 minutes or less. The FDA has NOT APPROVED these rapid HIV-1 home test kits. Some of the HIV home test kits falsely claim to be approved by the FDA or manufactured in a FDA approved/registered/licensed facility. The only products currently approved by the FDA are The Home AccessÒ HIV-1 Test System and The Home AccessÒ Express HIV-1 Test System.

Are there any drugs or medical conditions that could influence the results?

The test is not recommended for hemophiliacs or individuals on anticoagulant therapy.

Is there an age limit on the person purchasing or using the test?

Persons under the age of 18 of using the HIV-1 test system have not been investigated.

What is the laboratory test methods Home Access Health Corporation use to find out the results?

Once the lab receives the blood spot samples the first thing they do is to evaluate for adequacy (quantity and quality) of the specimen. Then the samples are punched out of its card, removed by a solvent, and tested according to Organon Teknika Corporation Vironostika HIV-1 enzyme immunoassay (EIA) licensed protocol, or the Genetic Systems LAV EIA HIV-1 EIA, at the direction of Home Access Health Corporation. The Waldheim Pharmazeutika Fluorognost Immunofluorescent HIV-1 Antibody (IFA) test is performed on all repeatedly EIA reactive blood spot samples. Results are retrieved from the laboratory’s computer system twice a day and imported into the CLIENTtrakÔ database. Once the results are in the computer system, it is readily available for the consumers to find out.

Understanding the Result Interpretations:

There are four possible outcomes for the Home Access HIV-1 Test:

Results	Interpretations
Negative	HIV antibodies were not found (uninfected)
Positive	HIV antibodies were found (infected)**
Indeterminate	HIV antibodies could not be confirmed Should be re-tested in 1-3 months & abstain from unsafe sex
Not Tested	Blood sample could not be tested because the sample card was either soiled, wet, or did not contain enough blood to test from.

**Patient is infected with HIV & is capable of passing the disease on to others. Patient should seek a medical physician immediately for appropriate drug treatment.

NOTE: The results of the Home Access HIV-1 test should be discussed with a health care professional, such as a pharmacist or a physician in interpreting the results and managing the symptoms. Contraception should not be discontinued unless directed otherwise by the physician.

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NOTE: California Residents - Business and Professions Code 1246.5 Requires That Any Test that has not been approved by the Federal Food and Drug Administration for sale to the public without a prescription as an Over-The-Counter Test kit must be ordered by a Licensed physician acting on a patient's behalf. All orders for test kits within the state of California

NOTE: New York State Residents New York State health law prohibits the testing of certain specimens collected in or mailed from New York, and prohibits the transmission of data from our laboratory to NY physicians or residents. Therefore, direct receipt of lab results for NY residents is not possible.

International Residents & Orders: Extra shipping charges may be added for international orders. Patients will be contacted by e-mail or telephone to approve charges.