Orasure test information
Sep 10, 2008
If I've tested negative from an Orasure oral HIV 1/2 up to a year (3/4/6/9/12 months), can I trust my test results with this new info about Seattle stating that the test are as accurate as the manufacture claims? Should I go and take a blood based ELISA test?
Thanks in advance from all of us worry warts out here...
Response from Dr. Frascino
1. Can you trust your five negative OraSure oral fluid tests out to a year? Yes, absofrickinlutely! The chance of five false-negative test results is essentially nonexistent. (See below for the latest information about OraSure.)
2. Should you take a blood-based ELISA? Nope! It's not warranted or necessary.
Ding Dong Injury- Can people trust the rapid hiv tests? (Seattle Department Finds OraSure HIV Test to Be Less Accurate Than Label Claims) Sep 10, 2008
Greetings and well wishes!! I hope your having a fabulous evening!! First let me tell you that you give hope to the hopeless. Thats power!! Here is my story. I tested negative at 96 days with the finger prick test. I then went back and tested negative with the oral test at 100 days & 115 days past exposure. Can I woohoo?? My risk was a bruised penis (black and blue)from a rough bj. I ask this because of the article from the seattle dept of heath which says rapid test arent accurate. Please give your thoughts? My Dr said I didnt even need testing but I have OCD?
Response from Dr. Frascino
Actually, it was indeed a fabulous evening! I spent it having dinner with two of my favorite people: Broadway legend Stephen Sondheim and New York Times op-ed columnist Frank Rich!
Regarding your ding-dong problem, the blowjob actually bruised Mr. Happy? Yikes! That's some powerful sucking action. However, please note, despite the unsightliness of a black-and-blue tallywhacker, bruises do not affect the integrity of the skin. In essence, your skin, although bruised, remained intact. Therefore, if the blowjob was latex protected, there would be essentially no HIV risk. If it were unprotected, the risk remains the same as a less forceful unprotected oral sexperience, i.e. very low. Your negative finger-prick rapid test at 96 days plus your two negative "oral tests" at 100 and 115 days are definitive and conclusive. You are Dr. Bob-certified WOO-HOOable!
We are monitoring the OraQuick story closely. The CDC has not altered its recommendations of the test. I'll reprint below some information from the archives that addresses this issue. However, please note the chance that your three tests were all false-negatives is essentially nonexistent. Stop worrying and start WOO-HOOing! OK?
Seattle Department Finds OraSure HIV Test to Be Less Accurate Than Label Claims
September 5, 2008
A report by Public Health -- Seattle and King County in Washington state has found that testing with OraSure Technologies' OraQuick test provides less accurate results than the label claims, Bloomberg reports. The OraQuick test is the only rapid test licensed to screen both oral fluids and blood for HIV, according to Bloomberg. Bob Wood, director of the HIV/AIDS control program at the Seattle-based department, said that in 5,460 tests, OraQuick failed to detect at least 8% of 133 people found to be HIV-positive with a comparable diagnostic. This compared with the 0.7% rate given on the test's label.
Elliot Cowan, chief of FDA's Center for Biologics Evaluation and Research Office of Blood Research and Review, said the agency has asked OraSure to investigate the issue. "We're keeping an ear to the phone and making sure they're doing what they're supposed to do," Cowan said, adding, "The ultimate goal is that the package insert appropriately represents the performance of the test." According to Bloomberg, CDC, which recommends testing with blood over oral fluids, also has contacted Seattle officials. Nonetheless, the agency sent a letter to physicians on Aug. 20, voicing support for oral fluid HIV testing and stating that the test has performed well "overall" and is important for increasing the number of people tested for HIV. Richard Wolitski, acting director of CDC's Division of HIV/AIDS Prevention, said, "At this time, based on all the available data, we're not changing our recommendations regarding oral fluid rapid testing."
OraSure Chief Science Officer Stephen Lee said the company tracks the performance of its test and routinely investigates complaints. Lee also said OraSure keeps FDA informed of all the product information it gathers. "All the data that we've accumulated indicates the product continues to perform according to its FDA-approved claims," Lee said.
Wood said that the department has sent its data to physicians and clinics in the area along with a recommendation to test blood rather than oral fluids when possible. "Our recommendation is that people shouldn't use rapid oral tests if they can avoid it, but there are some situations where it can't be avoided and it's better than nothing," Wood said.
According to Wood, Seattle in 2003 began back-up testing of samples screened with OraQuick. A laboratory test, called EIA, showed that OraQuick missed 10 out of 133 patients with HIV antibodies in their blood. Lee said that studies have shown rapid tests to be less sensitive than lab antibody tests, adding that other rapid tests have produced similar results. Seattle officials also tested the samples with a more accurate test that looks for HIV's genetic material. The test can detect more HIV cases because the virus appears in blood before antibodies, according to Bloomberg. When compared with the RNA test, OraQuick missed 17% of cases, according to Wood, who added that the results might be published in a journal in the future (Lauerman, Bloomberg, 9/3).
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