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Accuracy of Oraquick- Seattle/King County Study
Dear Doctors,
I came across this article (see below) regarding the accuracy of the Oraquick Advance rapid test. I tested negative on the Oraquick Advance HIV 1/2 test (using whole blood) 8 weeks, 3 months, and 4 months post-exposure. Should I be concerned that my results were false negative and seek out additional laboratory-based testing? If I should not be concerned, is there anything you can tell me about this study that could calm my fears? Also, do you know whether the Oraquick false negatives in this study were from oral fluid or fingerstick specimens?
Thank you for your time!
____________________________________
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.....
I came across this article (see below) regarding the accuracy of the Oraquick Advance rapid test. I tested negative on the Oraquick Advance HIV 1/2 test (using whole blood) 8 weeks, 3 months, and 4 months post-exposure. Should I be concerned that my results were false negative and seek out additional laboratory-based testing? If I should not be concerned, is there anything you can tell me about this study that could calm my fears? Also, do you know whether the Oraquick false negatives in this study were from oral fluid or fingerstick specimens?
Thank you for your time!
____________________________________
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.....
MEDICAL PROFESSIONAL
Dr. Hook invited me to comment since the study was done in my clinic. I would point out that it's only one study; it might be onto something, but it conflicts with other published data as well as the manufacturer's study results -- it doesn't necessarily reflect a new truth. (For practical purposes, all such studies require confirmation by additional research before being universally accepted.)
Second, I would reemphasize Dr. Hook's statement that the problem is the test, not differences in ability to detect antibody in one person compared with another. You were tested 3 times at 8 weeks or later, which is long enough to be confident in the results. For you to have HIV, all 3 of those tests would have to have given false results. The odds of that calculate at 0.024 x 0.024 x 0.024 = 0.000014. That's around 1 chance in 70,000. To that figure, you can factor in the odds your partner had HIV and the odds you were infected if s/he was. Assuming those are typical for most exposures described on this forum, the chance you have HIV is zero for all practical purposes.
In other words, even if the new research accurately reflects the true performance of the test, it doesn't change the interpretation of your test results. You can be sure you didn't catch HIV.
HHH, MD
Second, I would reemphasize Dr. Hook's statement that the problem is the test, not differences in ability to detect antibody in one person compared with another. You were tested 3 times at 8 weeks or later, which is long enough to be confident in the results. For you to have HIV, all 3 of those tests would have to have given false results. The odds of that calculate at 0.024 x 0.024 x 0.024 = 0.000014. That's around 1 chance in 70,000. To that figure, you can factor in the odds your partner had HIV and the odds you were infected if s/he was. Assuming those are typical for most exposures described on this forum, the chance you have HIV is zero for all practical purposes.
In other words, even if the new research accurately reflects the true performance of the test, it doesn't change the interpretation of your test results. You can be sure you didn't catch HIV.
HHH, MD
MEDICAL PROFESSIONAL
The last undeleted comment meant what it said. The several comments that followed have no bearing on the advice Dr. Hook and I gave to worriedsick2251. Feel free to continue discussion on the community forum.
MEDICAL PROFESSIONAL
Please take further discussion over to the community forum.
My exposure was real and yes, I absolutely have anxiety about a test's accuracy being questioned. The study says there are true positives that are being missed, and I'm trying to clarify whether they were early infections (within the "window period) or later.
This thread I am sure of was not intended to be posted on for anxiety driven fear
Was the prevalence of false negatives more in people within the 3 or 6 month window period or was that not a factor? I just had a negative OraQuick rapid test using whole blood and my possible exposure was a year ago...this article has frightened me into thinking I'd better go get a standard ELISA.
MEDICAL PROFESSIONAL
I believe the study was on OraQuick's blood test.
this looks like an oral fluid issue, when in doubt, always test with blood.
Thank you very much for your helpful responses!
MEDICAL PROFESSIONAL
I am not familiar with the study quoted here and do not know whether data has been quoted out of context. This report suggests that the sensitivity of the test in this setting was lower than found in other studies. I do note however that in this report, 2.4% of persons tested are said to have been missed by the OraQuick test. When considered among all who were tested this means that 11 of 5460 people or 2 tenths of 1% of those tested had infections missed. Whether there was something peculiar going on here is difficult to say.
The problem mentioned above was most likely with the test performance, not the people who were infected. I suspect repeated testing would have picked up the infections. The probability that an infection would be missed more than once is scant. In your case, you were tested three times. You can be confident of your results and from a medical perspective do not need re-testing. Whether you need re-testing for your own piece of mind however may be another story. Hope this helps. EWH
The problem mentioned above was most likely with the test performance, not the people who were infected. I suspect repeated testing would have picked up the infections. The probability that an infection would be missed more than once is scant. In your case, you were tested three times. You can be confident of your results and from a medical perspective do not need re-testing. Whether you need re-testing for your own piece of mind however may be another story. Hope this helps. EWH
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