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oraquick advance oral mucosal transudate
Jul 29, 2012

dear doctor.i would like to know if the 2011-2012 oraquick advance kit is more accurate of

the 2005 oraquick test kit that uses the oral mucosal transudate in the mouth.i say this

because i have read a journal article of the 21 december 2005 (firmed by: natasha t.

metzler,a journalist),about the possibility of some false positive.in this article talks of

an unexplained rise in the false positive results rate.an higher than expected rates of

false positives.13 per 600 tests instead of the range of 4 per a thousand test.and so,for

this reason it says that in the 2005 the los angeles gay and lesbian center,and several

major clinics of this town,(los angeles),stopped using this test.but i hope that now,in the

2011-2012,these los angeles clinics have resumed the use of the oraquick advance to test

people for the hiv 1 and hiv 2 because now they fully trust in this kind of test produced by

the orasure.do you know if these los angeles hospital and clinics have resumed the use of

the oraquick advance?or if the great,the major part of the los angeles hospital and clinics

normally uses the oraquick advance?i hope so.because i am going to an hospital,in los

angeles,to do this test,the oraquick advance that uses the oral mucosal transudate in the

mouth and i trust in this test.thank you. god bless you. seanconneryp@libero.it this is the article of the year 2005: An unexplained rise in the false-positive rate of OraSure Technologies' breakthrough rapid

oral test for HIV has led several major clinics to discontinue using the test. Most

recently, the LA Gay and Lesbian Center stopped using the OraQuick Advance oral test Dec.

16, after an unusual number of people received inaccurate results.

According to center spokesman Jim Key, the organization has noted 13 false positive

tests since they began tracking these occurrences in November. They don't know exactly how

many oral tests they administered during this period, but Key estimated around 600.

Clinics that provide HIV testing typically expect false positives in the range of four

per thousand tests administered. All patients with a positive oral test are given follow-up

blood tests. This fall, however, clinics in New York, San Francisco and Los Angeles have

noted higher-than-expected rates of false positives.

Between September and November, the San Francisco County Health Department recorded six

to eight false positives out of every 1000 tests.

The LA Gay and Lesbian Center has not changed the way it administers the OraQuick tests,

Key said. It began using the oral rapid test before its June 2004 FDA approval, during the

product's clinical trials. Prior to this fall, they have always been confident in the

OraQuick Advance oral test. The center continues to use the OraQuick fingerstick test, which

uses blood rather than oral fluid, Key noted.

OraSure Technologies met with the Gay and Lesbian Center earlier this week and with San

Francisco County in October. Dowling said the company provided her department with cameras

to take pictures of problematic test results. OraSure is also contacting other customers to

address questions or problems with the product, according to spokeswoman Jennifer Moritz.

"The company is moving forward in a scientific and systematic manner, in collaboration

with affected customers, healthcare officials, and government agencies, in order to

determine the reasons for these unexpected results as rapidly as possible," she said via e-

mail.

Similar to a pregnancy test, the OraQuick Advance test shows one line if the individual

is negative and two lines if he is positive. The problematic test results tend to show one

strong line and a second, very faint, line, Dowling said. Since there is more than one line,

it is counted as positive but results for tests with this faint second line are often

reversed in the follow-up stage, she added.

Dowling speculated that the faint line could show up when someone is seroconverting, an

early stage of infection when HIV antibodies are first present. The oral test is more

sensitive to HIV antibodies than the blood test, so the antibodies might not be detected in

the follow-up. As a result, a second blood test should be administered two weeks after

getting results from the first one, she said.

But no one is certain about the cause of this recent increase in false positives.

Neither the Gay and Lesbian Center nor OraSure are speculating publicly about what may cause

this increase in false positive test results.

"The jury is still out," Dowling said. "We still have to figure it out."

The county is working with state officials on a protocol for tests with a faint second

line. This would involve following up with the OraQuick fingerstick test. A blood test would

still be required even if the second test was negative, but it could help offer people with

these types of confusing results peace of mind while they wait two weeks for the results of

the blood test.

Both Key and Dowling emphasized the importance of reliable results that people can get

right away. Rapid results have increased the number of people getting tested, according to

Key, and he is very concerned that if they are perceived as unreliablethe testing rates

might decrease.

"We want to make it as easy as possible for people to get an HIV test," Dowling said.

Dowling noted that San Francisco County has not seem a decrease in the number of people

being tested since the increase in false positives was made public, but these reports have

not been out for very long. Key added that his organization wants to make it clear that they

still have confidence in the OraSure fingerstick test and that rapid testing is still

available at the clinic. seanconneryp@libero.it qp

Response from Dr. McGowan

Dear Sean,

All screening tests have some risk of producing a "false positive" result. That means that the tests comes out positive (indicating that infection may be present) but the person really has no infection. The reason for this is that with a "screening" test, we really want to find all the people with the infection, and when we spread this wide net, we are willing to also pick up a few uninfected people. But we do not stop the testing there. In order to be sure that the people who test positive are truly infected we do an additional test called the Western Blot on all people who test positive on the oraquick (or any antibody screening test). BOTH tests must be positive to diagnose HIV infection. The Western Blot is not likely to produce a "false positive" result. To keep things in context, the oraquick is 99.8% accurate. so false positive results are very rare.

Best, Joe



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