CDC Urges the FDA to Expedite Approval of Rapid
HIV Tests [AIDS Reference Guide, News Notes, July 2000, pg
1]: This is a brief news update regarding the rapid test for detection
of HIV. The CDC interest is based on reports showing that about ¼ of patients
who are tested for HIV fail to return for test results, and the estimate
that as many as 700,000 in the U.S. have HIV infection and don't know
it. The new tests are easier to use and cost only about $2.
Comment: There has been frequent reference to these new tests in
"What's News." There are at least four different suppliers. Most use blood,
but there is one product (Ora Sure) that uses saliva. Accuracy in terms
of sensitivity and specificity is quite similar to that achieved with
standard serologic tests, and the results are available in 10 minutes.
The currently available FDA-approved test that will achieve rapid results
is SUDS, but a major difference with the newer tests is that they are
provider read, which means that they do not need to be submitted to the
laboratory, and they will probably be much less expensive. Many authorities
feel that these new tests, which can be easily performed in emergency
rooms, STD clinics, needle-exchange vans, street corners and the like,
may revolutionize HIV testing. posted 8/3/2000