<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN">
<HTML><HEAD>
<META http-equiv=Content-Type content="text/html; charset=iso-8859-1">
<META content="MSHTML 6.00.2900.2802" name=GENERATOR>
<STYLE></STYLE>
</HEAD>
<BODY bgColor=#ffffff>
<DIV><FONT size=4><!--StartFragment --><FONT size=3> </FONT><A
href="http://www.latimes.com/news/local/la-me-hiv20dec20,0,2451144.story?track=tothtml"><FONT
size=3>http://www.latimes.com/news/local/la-me-hiv20dec20,0,2451144.story?track=tothtml</FONT></A><BR>
<H1>More Sites Drop Oral HIV Test</H1>
<H2>A spate of false positives prompts health centers in New York and California
to halt use of the product as federal agencies begin inquiries.</H2>By Rong-Gong
Lin II and Juliet Chung<BR>Times Staff Writers<BR><BR>December 20, 2005<BR><BR>A
recent surge in false positive results produced by a much-heralded oral HIV test
has caused at least six testing sites in Los Angeles, San Francisco and New York
to shelve the test and prompted an inquiry by federal health agencies.<BR><BR>In
the last month, the L.A. Gay & Lesbian Center, San Francisco's largest HIV
testing center, the New York City health department and other facilities have
stopped using the rapid test, which gives results in 20 minutes from a saliva
swab.<BR><BR>The test, OraQuick Advance, has become an important tool at HIV
testing sites in the last year, particularly at clinics and outreach settings
targeting people at high risk for the virus. It is painless and requires no
blood sample, which makes it easier to administer and popular with clients.
<BR><BR>Officials at the U.S. Food and Drug Administration and the national
Centers for Disease Control and Prevention are investigating the complaints. But
they said there is no reason at this point to pull the test off the market. CDC
data collected earlier this year showed that the oral test was 99.8% accurate
for people not infected with the virus.<BR><BR>More recent test results from
some large health clinics have seen rates as low as 99.1%. The difference may be
small, but when testing large groups of people, the number actually affected can
be significant.<BR><BR>For example, New York health officials saw the number of
false positives jump in November to 35 out of 3,754 tests of people not
infected, according to the Centers for Disease Control.<BR><BR>"Some false
positive results are expected with any HIV screening test," said FDA spokeswoman
Kimberly Rawlings. "For this reason, additional testing is always needed to
confirm true positive results."<BR><BR>Rawlings added that the agency would take
"further corrective action, if needed," based on the results of the
inquiry.<BR><BR>The test's manufacturer, OraSure Technologies of Bethlehem, Pa.,
said it is working closely with healthcare and government officials to
investigate the complaints. OraSure officials met with the L.A. Gay &
Lesbian Center and the Los Angeles County health department Monday.
<BR><BR>"We're going to work aggressively … to get to the bottom of this," said
Doug Michels, company president.<BR><BR>The oral test received FDA approval last
year amid great fanfare. It was the first rapid test to use saliva, instead of
blood, to rapidly screen for HIV. Health officials hoped it would make it easier
to get more people tested for HIV and help curtail the spread of the
virus.<BR><BR>The same kit can also utilize a small blood sample, from a pricked
finger, to get an HIV result in 20 minutes. A version of the rapid blood test
has been available since 2002.<BR><BR>Only the saliva test is suspected of
having abnormally high false positives.<BR><BR>"Patients like it," said Dr.
Susan Blank, an assistant health commissioner in New York City. She credited the
saliva test with attracting an estimated 6,000 more people to get tested for the
virus this year. <BR><BR>The Centers for Disease Control spent $2.3 million last
year to purchase kits and distribute them nationwide. The center specifically
mentions OraSure's tests in its outreach effort to promote rapid HIV
testing.<BR><BR>Before rapid tests came on the market, it often took a week to
receive results from an HIV test, and many people never retrieved their results.
<BR><BR>The oral test became so popular at certain HIV testing sites that some
agencies in New York and California used it exclusively for their clients'
preliminary tests.<BR><BR>Testing centers began to notice the increase in false
positive results in the last few months. After New York City health officials
saw their numbers surge last month, they halted use of the oral test Dec. 2.
<BR><BR>The city of San Francisco saw an uptick in false positives since
February, reporting 47 out of about 7,800 oral tests. During that period, 175
tests were confirmed positive. <BR><BR>The false positives were detected during
standard follow-up laboratory tests, whose results come in about a week after
the preliminary rapid oral test. Both the New York City health department and
the UCSF AIDS Health Project, which also dropped the test, looked carefully at
how it was administered by employees and found no problems. <BR><BR>"It was so
excruciating for our clients and for our staff to be getting these results," not
knowing whether they were accurate, said Barbara Adler, an HIV testing program
manager at the health project, San Francisco's largest testing center.
<BR><BR>The center had used the oral rapid tests between April and mid-November,
recording 31 false positives and 40 confirmed positives. The center tests about
300 people a month. <BR><BR>Since the center shifted to the rapid blood test
made by OraSure, no false positives have occurred, Adler said. <BR><BR>Three
other smaller HIV testing sites in San Francisco have also switched to the rapid
blood test, said Shelley Facente, who coordinates HIV rapid testing for the
public health department. <BR><BR>Last week the L.A. Gay & Lesbian Center
announced it had seen a sudden jump in suspected false positives — 13 in
November — and abandoned the test. The center had been using the rapid oral test
on about 600 people a month. <BR><BR>A Los Angeles County public health official
has questioned how the center has evaluated the false positives.<BR><BR>Dr.
Bernard Branson, associate director of laboratory diagnostics at the CDC
Division of HIV/AIDS Prevention, said he could offer no explanation for the rise
in false positives in recent months. But he said he had confidence in the test.
<BR><BR>The oral test passed a Centers for Disease Control survey this year of
more than 17,000 results, which found that it was 99.8% accurate for people not
infected with HIV, Branson said. The survey was conducted between January and
June. <BR><BR>"The sky is not falling," he said. "The problem is, I think,
people are expecting perfection."<BR><BR>Other major testing sites have not
reported problems with the test. AIDS Healthcare Foundation in Los Angeles, the
Whitman-Walker Clinic in Washington, D.C., and the Gay Men's Health Crisis
center in New York have not seen any unusual increase in false
positives.<BR><BR>Still, many people remain concerned about the reliability of
the test.<BR><BR>Chris Horan, 38, a nursing student at Santa Monica College who
had received a false positive from a different oral test administered at the
L.A. Gay & Lesbian Center in 2002, said he was glad the agency was dropping
the test. <BR><BR>"It's too emotional information to give people unless you're
100% sure," he said. <BR><BR>Horan said he had taken the oral test to offer
support to a nervous friend who was getting tested for the first time. Because
he had not engaged in any risky behavior since a prior test, Horan said he was
devastated by the results. <BR><BR>Even though he knew the oral test was
preliminary, he said he was convinced he had HIV. He informed his closest
friends and his partner at the time and even attended an HIV support group.
<BR><BR>"I still get emotional thinking about it," he said, referring to the
seven days he waited until follow-up tests showed he was not infected. "I had
this week of my life where I really, truly believed I was HIV-positive. It was
the worst week of my life."<BR><BR>But not everyone is quick to write off the
test.<BR><BR>Clark Kelly, 45, a West Hollywood resident, said he would continue
to use the oral test if it remained an option.<BR><BR>"It's easy, it's painless
and it's fast," said Kelly, who said he gets tested every six months.
<BR><BR>"I'd just keep in mind that it might not be correct," he said. "Then I'd
go and take the next test."<BR><BR>OraSure's stock has tumbled more than 40%
since Dec. 8, a day before news about the false positive results was first
reported. The stock fell 53 cents Monday to close at $7.93.<BR><BR>This is not
the first time questions have arisen about the oral test's false positive
rate.<BR><BR>OraSure delayed the release of its oral rapid test for several
months in 2004 after a higher than expected number of false positives was
reported in Minnesota. The company and the CDC concluded that it was an isolated
event but could not explain why it happened. <BR><BR>The false positives could
also delay consideration of making an oral rapid test kit available for home
use, which OraSure had asked an FDA panel to consider last month.
</FONT></DIV></BODY></HTML>