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Congress May Strip $12 Million Funding for Oral HIV Test
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--Rapid oral HIV results questioned
--East, West Coast groups stop using OraQuick after rash of false positives
By Tammye Nash
Dec 23, 2005
Dallas Voice Staff Writer
Congress has stripped a provision from a Health and Human Services funding bill that would have allotted $12 million to purchase OraQuick Advance Rapid HIV 1/2 Antibody Tests following reports of a large number of false positive results from San Francisco, Los Angeles and New York.
Groups in those cities, including the San Francisco health department's City Clinic and the Los Angeles Gay and Lesbian Center, said late last week they would no longer use OraQuick tests.
Dr. Chris Wilkie, manager of community health programs for the AIDS Resource Center in Dallas, said the center has never used the OraQuick tests.
A spokeswoman for Parkland Memorial Hospital said the HIV clinic there does not use any kind of oral rapid response HIV test.
Jacquelyne Bell, public information officer for Dallas County Health and Human Services, said Wednesday the county HIV clinics do use the OraQuick test but have had no false positive results. In light of recent reports, however, Bell said county officials are carefully watching the investigation and will take precautions to avoid questionable results.
The funds cut by Congress would have provided about one-fifth of test maker OraSure Technologies' annual revenue.
Despite the false positive results, some health care officials say the test is reliable.
Jeffrey Klausner, the director of prevention efforts for sexually transmitted diseases for the San Francisco Health Department, said he no longer uses the OraQuick test at the City Clinic.
But Klausner said he believes the tests hold promise as a prevention tool and that he is "not ready to discard" them citywide, according to the San Francisco Chronicle.
Peter Kerndt, director of Los Angeles County's sexually transmitted disease program, told the Los Angeles Times the county has not found an abnormal rate of false positive results. "I think the wrong thing to do here is to stop using the test," he said.
But Quentin O'Brien, director of health and mental health services for the Los Angeles Gay and Lesbian Center, told the Los Angeles Times that if the public loses confidence in the HIV testing results, they would stop getting tested and "we can't allow that to happen."
OraSure Technologies, Inc. released a statement Dec. 9 announcing several steps the company is taking to "ensure that customers receive the highest quality results and that interested parties receive timely and accurate information."
Douglas Michaels, CEO of OraSure, said that from Jan. 1 to Nov. 1 of this year, doctors and clinics reported 107 confirmed false positive results from OraQuick, out of 28,436 tests conducted, for a specificity of 99.6 percent.
"That is within the FDA's range [of acceptability]. No product or test is 100 percent sensitive or specific," Michaels said, according to the Washington Times.
The statement said OraSure initiated scientific and systematic evaluation of each situation involving a false positive, and is working with health care officials and government agencies including the Centers for Disease Control and Prevention and the Federal Drug Administration to determine the cause or causes.
The company has already met with each of the agencies recording false positives and is working to resolve the issues, the statement said.
OraSure is also contacting customers throughout the country to find out if other testing locations are getting false positives, the statement said.
Findings to date, according to the company, indicate that the majority of agencies using the OraQuick test have reported low rates of false positive results that are within the products label claims.
The information will help OraSure Technologies determine what if any site-specific factors may be contributing to the rash of false positive results.
The Centers for Disease Control and Prevention this week issued a public health advisory recommending that all HIV-positive results from the OraQuick test be followed up with OraSure's rapid "finger stick" test, a method which has not had similar problems with false positive results.
Bernard Branson, associate director of laboratory diagnostics with the Centers for Disease Control, told the San Francisco Examiner that the OraQuick test has been proven safe, effective and easy to use.
It is currently sold only to doctors and clinics.
To use the OraSure test, a person's gums are swabbed, and the swab is placed in a holder. After 20 minutes, one line will appear on the strip to indicate an HIV-negative result, or two lines appear to indicate an HIV-positive report, according to a report in the Kaiser Daily HIV/AIDS Report from November.
The same test can be used to test for HIV antibodies using blood from a finger stick.
According to the San Francisco Department of Public Health, of the 9,400 tests conducted at 14 public health clinics in the city in 2005, 49 results were later determined to be false positives.
Susan Blank, assistant health commissioner for New York City, told the New York Times the city has recorded an average of about five false positive results out of every 3,600 to 3,700 tests conducted each month.
Blank said that most of the tests were conducted with the OraQuick test and that the false positive rate was within the accuracy rate predicted by OraSure Technologies.
But, Blank said, the city recorded 30 false positive results in November.
The Los Angeles Gay and Lesbian Center decided to stop using the OraQuick test last week after recording 13 false positive results in November, according to a report in the Los Angeles Times.
Center officials said that before November, false positive results had been rare.
Deanne Sykes, a research scientist with the California Department of Health, told the Los Angeles Times there have also been reports of false positive reports in Ohio.
News of the questionable results caused sock in OraSure Technologies to plummet. On Dec. 9 alone the stock fell 26 percent and it has lost 39 percent of its total value since, according to a report on Advocate.com.
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