Prior
to
last
year,
about
one-third
of
publicly
funded
HIV
tests
in
the
U.S.
were
a
waste
of
time
and
money.
“Of
the
people
who
tested,
about
32
percent
never
came
back
to
get
their
test
results,
so
the
effectiveness
of
testing
at
public
health
sites
was
impaired,”
said
Bernard
Branson,
associate
director
for
laboratory
diagnostics
at
the
Centers
for
Disease
Control
&
Prevention.
That’s
because
using
the
conventional
blood
test
for
HIV
—
known
as
enzyme
immunoassay,
or
EIA,
tests
—
required
clinics
to
draw
blood
from
a
patient’s
vein,
send
the
sample
to
a
laboratory
to
detect
antibodies
to
HIV
and
wait
from
a
few
days
to
two
weeks
for
the
results
to
return.
But
in
November
2002,
the
U.S.
Food
&
Drug
Administration
approved
OraQuick
—
a
rapid
test
that
HIV
activists
and
health
researchers
hope
will
help
revolutionize
when
and
how
people
are
tested
for
the
disease
that
causes
AIDS.
Manufactured
by
OraSure
Technologies,
OraQuick
requires
a
drop
of
blood
from
a
patient’s
finger
to
be
mixed
with
a
developing
solution,
and
test
results
are
usually
available
within
20
minutes.
“The
rapid
test
is
wonderful
because
you’re
able
to
give
a
person
their
results
and
counseling
essentially
immediately
after
you’ve
given
them
the
test,”
said
Stephen
Kagan,
a
doctor
at
AbsoluteCare,
an
HIV
clinic
in
Atlanta.
“It
also
enables
you
to
screen
a
lot
of
people
at
the
same
time.
“As
a
community
service,
we’re
able
to
do
a
very
large
screening
and
give
them
all
results
and
counseling
on
the
same
day,”
Kagan
said.
About
95
percent
of
the
clients
who
get
tested
at
the
Gay
Men’s
Health
Crisis
in
New
York
choose
the
OraQuick
test,
said
Drew
De
Los
Reyes,
associate
director
of
the
David
Geffen
Center
at
GMHC.
“For
many
people,
the
wait
alone
was
enough
of
a
barrier
to
keep
them
from
going
in
and
getting
tested,”
De
Los
Reyes
said.
“[Now]
they
all
say
what
a
relief
it
is
for
them
not
to
have
to
wait.”
Tests
that
deliver
results
more
quickly
than
traditional
blood
tests
may
help
to
trim
the
estimated
180,000
to
280,000
Americans
who
are
unaware
they
are
HIV
positive,
according
to
the
CDC.
On
the
eve
of
World
AIDS
Day
on
Dec.
1,
HIV
activists
say
it’s
critical
that
people
know
as
early
as
possible
if
they
are
infected
with
the
disease.
“It’s
important
because
the
sooner
a
person
knows
their
HIV
status,
the
more
effectively
we
can
treat
them,”
said
Greg
Smith,
director
of
prevention
services
at
AIDS
Survival
Project
in
Atlanta.
“We
can
get
them
into
direct
medical
care
so
they
will
know
over
the
long-term
what
they
need
to
do
to
stay
healthy.”
Health
experts
and
patients
alike
are
hopeful
that
OraQuick’s
rapid
return
rate
doesn’t
appear
to
compromise
the
accuracy
of
the
test
results.
In
clinical
trials
conducted
by
OraSure,
OraQuick
identified
99.6
of
the
people
who
were
infected
with
HIV,
while
correctly
clearing
100
percent
of
the
people
who
were
not
infected.
CDC
evaluations
of
the
test
since
it
appeared
on
the
domestic
market
continue
to
reveal
that
OraQuick
is
“extremely
accurate,”
Branson
said.
But
as
popular
as
OraQuick
is
among
community-based
organizations
and
re-searchers,
its
entry
into
clinics
across
the
country
was
controversial,
Branson
said.
The
FDA
is
responsible
for
categorizing
all
laboratory
tests
into
one
of
three
categories
depending
on
the
degree
of
difficulty
implementing
the
test
—
high,
moderate
and
waived
—
according
to
the
Clinical
Laboratory
Improvement
Amendments
of
1998,
or
CLIA.
While
high
and
moderate
tests
must
be
conducted
by
doctors
or
other
licensed
lab
technicians
and
are
subject
to
regular
inspections,
“tests
waived
from
the
requirements
of
CLIA
are
tests
that
the
FDA
finds
so
simple
and
accurate
that
there
is
little
risk
of
an
incorrect
testing
result,”
according
to
the
FDA
Web
site.
In
January
2003,
the
FDA
granted
OraQuick
a
CLIA
waiver,
opening
the
door
for
HIV
tests
to
be
administered
by
clinical
workers
who
complete
a
training
program.
Many
in
the
clinical
laboratory
industry
objected
to
the
FDA
decision
to
grant
a
waiver,
“fear[ing]
the
agency’s
move
signaled
a
crack
in
the
regulatory
dam”
that
would
make
it
easier
for
other
vital
tests
to
receive
a
CLIA
waiver,
according
to
an
April
2004
report
in
the
College
of
American
Pathologists.
“There
was
a
...
