OraQuick Results Are Less Accurate than Label Suggests
According to a new study, Orasure Technologies Inc.’s OraQuick HIV rapid test is 10 times less accurate than the product’s label describes, Bloomberg reports.
OraQuick—the only rapid test licensed to scan both oral floods and blood for HIV—failed to detect at least 8 percent of 133 people who tested positive with a comparable diagnostic. OraQuick’s label says the test’s rate of failure is only 0.7 percent.
This report is the third since June 16 that affirms that OraQuick’s results are less accurate than the label claims. The U.S. Food and Drug Administration has asked the manufacturer to investigate the test’s false results.
“We’re keeping an ear to the phone and making sure they’re doing what they’re supposed to do,” Elliott Cowan, chief of FDA’s product review branch in the Center for Biologics Evaluation and Research Office of Blood Research and Review, told Bloomberg. “The ultimate goal is that the package insert appropriately represents the performance of the test.”
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comments 1 - 2 (of 2 total)
poz4life, , 2008-09-06 12:18:25
I tested neg on the Oraquick and had been poz for 5 years. I don't recommend this as a sure test.
Laaw, New York / Bangkok, 2008-09-05 22:36:47
I have been positive for nearly a year and have tested 5 times with OraQuick. All have shown a Negative, nonreactive result as recent as just 5 weeks ago.
Beth Benne, RN, is HIV negative, but
the virus has impacted her life. She currently supervises a biannual HIV/AIDS awareness week as
the director of the student health center at Pierce College, a
community commuter school in Woodland Hills, California.
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Overheard in the Women's Forum
"I recently met a guy who is negative. I did tell him about my status and he decided to kiss me anyway (we didn't go further than that). But a day later, he called and said that he actually had a mouth ulcer that time when we kissed and he was very worried. Asked if he can get the virus from me that way. For that moment, I felt so insulted and yet I felt so bad. It was my first time having a contact with a "negative" guy."
