Aa
False Negatives are real...
Does anyone have any info on this? I just read it on the Doctor's forum:
I myself have had (2) two negative Oral Oraquick tests outside the window period....just when I thought everything was cool....
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=54297
Kaiser Daily HIV/AIDS Report
Science & Medicine | Seattle Department Finds OraSure HIV Test To Be Less Accurate Than Label Claims
[Sep 05, 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 non-rapid 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).
I myself have had (2) two negative Oral Oraquick tests outside the window period....just when I thought everything was cool....
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=54297
Kaiser Daily HIV/AIDS Report
Science & Medicine | Seattle Department Finds OraSure HIV Test To Be Less Accurate Than Label Claims
[Sep 05, 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 non-rapid 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).
believe that everyone's life is important - even one person slipping through is significant. Let's say a couple were to carry out a test and both were tested negative but in reality one was a false negative. The couple goes away feeling re-assured that they are negative and indulge into unprotected sex. That means the one who had a false negative could have infected the real negative one thus destroying another person's life. What would you say to that couple?
Should testing clinics now begin to say make sure you test multiple times at different clinics before becoming re-assured? Many people belive in the tests they are given and do not question. Does it mean it is their fault that the test failed in their case after being told and documented that 3 months or later post exposure gives a definite result?
I read in an article where two guys tested - one came out negative and the other positive. The negative guy few months down the line became very ill and was found to actually have aids and came down with so many OIs. The test used was a mouth swab. The clinic only apologized. In this case, if the other partner had been negative, the other guy could have infected him. There could be many people out there who are in the same boat and found out down the line that they have aids when they had sincerely tested in the past. The dificulty with proofing that you tested outside the window period is that sex is something that is done in private. The clinic could argue that you were not truthful and tested in the window period.
Should testing clinics now begin to say make sure you test multiple times at different clinics before becoming re-assured? Many people belive in the tests they are given and do not question. Does it mean it is their fault that the test failed in their case after being told and documented that 3 months or later post exposure gives a definite result?
I read in an article where two guys tested - one came out negative and the other positive. The negative guy few months down the line became very ill and was found to actually have aids and came down with so many OIs. The test used was a mouth swab. The clinic only apologized. In this case, if the other partner had been negative, the other guy could have infected him. There could be many people out there who are in the same boat and found out down the line that they have aids when they had sincerely tested in the past. The dificulty with proofing that you tested outside the window period is that sex is something that is done in private. The clinic could argue that you were not truthful and tested in the window period.
You mean did not stop blood rapid, correct? Blood ***** rapids are still valid at 12 weeks
No not at all. They've only stopped using the oral portion of the test until further investigation is done. They did stop the use of blood and plasma use of the OraQuick Advance test.
Whoa, wait. Do you know for a fact that these people tested too early? I'm just curious because that would make total sense. Maybe I should pay $15 to ask Dr.HHH too since it was conducted in his clinic.
http://www.medhelp.org/posts/show/621245
http://www.medhelp.org/posts/show/621245
If you had read the leiture that comes with the tests it says anyone that receives a negative result earlier than 3 months should be retested at 3 months post exposure. That article does not say that out of the false negatives were from people that tested to early.
Can you elaborate a little on your comment Teak? I'm not too sure I understand how being outside the window period is going to improve the tests accuracy. I've been trying to research on how (if) testing outside the window period (say 1 year +) will actually improve test accuracy. Thanks!
Rick
Rick
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