Don't buy unapproved home test kits, FDA warns

FDA Consumer, Jan-Feb, 1998

Two home-use kits distributed by

Lei-Home Access Care of Sunnyvale,

Calif.--one intended to test for the

AIDS virus and the other for the hepatitis

A virus--are unapproved, unreliable,

and should not be used, FDA warns.

The agency asked pharmacies last

September to remove these two kits

from their shelves: the "Lei-Home

Access HIV Test," advertised on the

Internet as the "Personal HIV Test Kit,"

and the "In-home Hepatitis A Test Kit."

The only HIV home test approved by

FDA is the Home Access HIV-1 Test

System, made by Home Access Health

Corp., Hoffman Estates, Ill. Users send

a blood sample obtained from a finger

prick to a laboratory for testing.

Confidential results are given over the phone,

with a trained counselor available.

FDA has not approved a hepatitis A

test kit for use in the home. Hepatitis A,

usually transmitted by food, causes a

mild, rarely serious, liver disease.

Consumers who used either of the

unapproved kits should consult their

doctors for retesting.