The Food and Drug
Administration's Blood Products Advisory Committee,
considering a request by OraSure Technologies to market its
rapid HIV antibody test to consumers for at-home use,
has ruled that the company must launch a clinical
trial to gauge its safety and accuracy when used in
nonclinical settings. The test should determine whether
people could perform the test correctly at home and
what the psychological risks would be for those who
received a positive result, the panel said.
OraSure officials
say the test is easy to use; an oral swab is rubbed on
the gums and then placed in a holder. After 20 minutes, one
line appears on the test strip if the results are
negative; two lines appear if the test is positive.
Because of its ease of use, the OraQuick rapid HIV test
already has been approved for use by nonmedical personnel,
including outreach workers conducting street-level HIV
testing programs.
OraSure CEO
Douglas Michels says the company will have clinical trial
plans in place by the end of the month and hopes to launch
the study by this summer. (The Advocate)
