July 6, 1999

Dear :

The U.S. Food and Drug Administration (FDA) is writing to alert you about an unapproved HIV rapid Home-Use test kit from Cyberlinx Marketing, Inc., Las Vegas, Nevada that is being sold through the Internet. The website address was "www.ezmedtest.com/hiv.html". This kit contains materials for in-home testing of a person's blood for Human Immunodeficiency Virus (HIV), the virus that causes AIDS. This test kit uses a simple finger prick process for blood collection at home. The blood sample is then added to a plastic testing device that provides a negative or positive result in 15 minutes or less in your home.

This test kit was advertised on the Internet as the "EZ MedTest" and was labeled, "HIV 1/2 STAT-PAK Ultra Fast manufactured for Sovo Tec Diagnostics, Inc.".

FDA has not approved this test kit. The test kit was tested by the FDA on behalf of the Federal Trade Commission and, in some cases, gave a negative result when tested with a sample known to be HIV positive. Therefore, it is important that you know that results given by this test kit may be wrong!

If you purchased the "EZ MedTest" over the Internet, what should you do?

• If you purchased a test kit from Cyberlinx Marketing, Nevada, do not use it. If you have questions, call the FDA at 1-800-835-4709. Your call will be confidential. We ask that you send any used or unused test kits to the FDA (call FDA at 1-800-835-4709 for the address).

• If you used a test kit from Cyberlinx Marketing, Nevada, go to a health center that tests for HIV, see a doctor to get another test, or you may buy an FDA approved kit. There is only one HIV test kit approved by the FDA for home collection. The approved test system is "Home Access HIV-1 Test System," made by Home Access Health Corporation, Hoffman Estates, Illinois (1-800-HIV-TEST).

• If you bought a test kit from Cyberlinx Marketing, Nevada, and gave or sold it to someone else, tell that person not to use it. If the person used the test kit, tell him or her to get another HIV test.

If you purchased the "EZ MedTest" kit for business purposes (to sell to others or to set up a distributorship) and further distributed the kit(s), what should you do?

• notify the purchaser and request that they either
  
  1. return the kit(s) to you so you may notify the FDA at 1-800-835-4709 and send any unused kit(s) to the FDA, or
  2. quarantine the kit(s) and notify the FDA. These test kits need to be removed from the market and should not be distributed to any person or business for the purpose of testing for HIV.

If you have any questions or concerns, please call the FDA at 1-800-835-4709.

Sincerely yours,

Daniel L. Michels
Director, Office of Enforcement
United States Food and Drug Administration

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