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Oraquick Advance Test Confusion (RELIABILITY OF ORAQUICK TESTS, 2009)
Sep 27, 2009

Dr Bob

I tested negative using the Oraquick Advance HIV 1/2 rapid test. I started reading some things on line that stated the accuracy of the rapid test was not as good as the standard ELISA test and had a higher rate of false negative test. This of course has me concerned. I could not tell if the study done in Seattle and other places was just on the oral fluid or if it was both oral and fingerstick. I had the fingerstick test. Can you please give me a little piece of mind on this?

Thanks for all you do on here!

Response from Dr. Frascino

Hi,

Sure thing. I've addressed these types of concerns many times in the past. Below I'll repost some information from the archives that pertains to your question.

The problem with OraQuick testing when it was first released was a relatively short shelf life. The FDA has since approved an enhanced version of OraQuick with a longer shelf life plus some improvements in the manufacturing process of the test. This seems to have resolved the problem. The OraQuick tests (with confirmatory Western Blot if positive) are now as accurate and reliable as other HIV-screening tests. The bottom line is that your OraQuick finger stick test is very reliable and accurate.

Be well.

Dr. Bob

My college health class has a question for you!!!! Apr 21, 2009

Hi Dr. Bob, what's up?

I am in college and my class was recently discussing HIV testing and I said that I would ask you this question!

1)With all the recent reports on Orasure testing, would you say the mouth swab and finger prick methods are still accurate testing methods as long as you test after the window period?

2)Do you recommend using those methods?

Thanks Dr. Bob for educating America on this disease!!!!

Response from Dr. Frascino

Hi,

1. Yes, particularly the new enhanced version with a longer shelf life.

2. Yes.

You're welcome! See below for supporting information about OraQuick tests.

Dr. Bob

Thanks(Breaking news (FALSE POSITIVE ORAQUICK TESTS) Mar 8, 2009

thanks for your info. I would love to know, we you think after you read about it. The news was posting on your site and came from some confrence that just took place. again thank you so much for all u do

Breaking News? (RELIABILITY OF ORAQUICK ORAL TESTS) Feb 28, 2009

Good Morning, Could you please explian to me the Breaking News the HIV- instant test are not relieable? Not sure I understand themeaning of the doctors paper. I am a monthly donor and am so very gratful for your website

Response from Dr. Frascino

Hi,

I'm presently "on the road again" and consequently may have missed the "breaking news" you are referring to. Here is what I can tell you about the recent concerns related to rapid tests (although it hardly qualifies as "breaking news"). There have been scattered reports of higher than expected false-positive tests in certain areas: Seattle, NYC, Boston, etc., when using the oral fluid OraQuick Advance Rapid HIV-1/2 Antibody Test. As with all rapid tests results, these tests results are only considered "preliminarily positive" and require a more sensitive test, such as the Western Blot. Any false-positive rapid test results would be caught by this confirmatory test. Although we still don't know why there was an uptick in preliminary false-positive oral fluid OraQuick rapid test results. However, OraSure Technologies, the maker of the oral test, has gathered data nationwide, which is reassuring regarding the accuracy of the test. It does appear that the specificity of OraQuick rapid tests performed on oral fluid specimens is lower than that of OraQuick rapid tests performed on whole-blood specimens (finger prick). The overall performance of both tests continues to meet Food and Drug Administration (FDA) requirements. Overall, oral fluid rapid tests have performed well and make HIV testing possible in many venues where performing a blood draw or finger stick is impractical or impossible. The CDC is continuing to work with the FDA and the manufacturer (OraSure Technologies) to further investigate the causes and extent of increases in false-positive oral fluid tests and monitor the performance of oral fluid and other rapid tests to ensure that they continue to perform as expected in testing programs. In addition the CDC is investigating other combination-test strategies to minimize false-positive preliminary test results. I'll repost below some information from the archives that discusses this problem. As for newer information or breaking news, I'm heading back home in a few days and will report back at that time, OK?

Thanks for your donation to the Robert James Frascino AIDS Foundation (www.concertedeffort.org).

Be well.

Dr. Bob

Oraquick Mindwhack Dec 11, 2008

Hey Doc...I wrote you a couple of years ago...High Risk Guy was my handle. Your insight and encouragement helped me through a tough time. I have kept up with you and this forum...congratulations on getting married and heave-hoing (?) the Bush disaster. My question: I heard and read (here and elsewhere) that there were some questions about the accuracy of the Oraquick oral rapid advance test (gum swab version) due to some bullshite up in Seattle. Can you update me/us on the status of that test? Is it still reliable? Can I still feel good about my test from May 2006 (which I had eight months after possible exposure)? I have been moving forward in a well-lived life, but would like to get this pesky mindwhack out of the way. Thanks.

Response from Dr. Frascino

Hello,

Welcome back to the forum! Thanks for the congratulations. As for Dubya, January 20th can't get here soon enough!

Can you believe your negative OraQuick Advance test? Yes, I believe you can. The FDA is investigating the accuracy of the test, but the questions centers on the rate of false positives rather than the rate of false negatives.

An assessment of OraQuick Advance was performed between February and October 2007, which included 849 adults who visited the emergency department at Boston's Brigham and Women's Hospital. Of the 849 adults consenting to rapid HIV tests, 39 were found to be reactive (positive). Of those 39 with positive results, 31 agreed to confirmatory testing. Just five have positive confirmatory tests! This rate of false positives is considerably higher than what is suggested by the test's manufacturer. Some researchers recommend the "addition of HIV RNA testing to the confirmatory algorithm for rapid HIV screening tests in the United States."

You can read about the Seattle situation in the archives, as I've discussed it several times.

The bottom line for you is that your negative test should be considered a true negative. If your "pesky mindwhack" persists despite my reassurances, you could get an ELISA. The results will undoubtedly be negative.

Your WOO-HOO is secure, OK?

Be well. (You are indeed well.)

Dr. Bob

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

DR

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

Hello,

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?

Dr. Bob

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).

Response from Dr. Frascino

Hi,

I was back home in the San Francisco Bay Area only very briefly. I'm now at 38,000 feet again, winging my way back across the country and not really looking forward to the winter storms that await me. I do think I now know what you were referring to. It was a presentation at the recent CROI (Conference on Retroviruses and Opportunistic Infections) that took place in Montreal last month. Not surprisingly I was there too! The presentation was given by a fellow San Franciscan, Shelly Facente, the coordinator for evaluation and quality assurance for the HIV Counseling, Testing, and Linkage programs in the San Francisco Department of Health. She was evaluating reports of unusually high false-positive rates for the OraQuick rapid test. She looked at results for 21,000 OraQuick Advance Rapid HIV-1/2 Antibody tests taken between 2005 and 2007 that had a negative result or preliminarily positive result that was proven to be a false-positive following confirmation with a Western Blot (WB) or immunofluorescence assay (IFA). The specificity of the test, according to the manufacturer (OraSure Technologies) is 99.8%. (That means 2 out of 1,000 folks tested would be expected to have false-positive results.) Shelley's study looked at the expiration dates for the test kits (the shelf life is six months) and compared it to when the test was performed. In other words, how close to the expiration date the test was done. What she found was that if she looked at tests performed within one month of the expiration date, the false-positive rate was 98.83%, far lower than the manufacturer's number. In fact she noticed that the closer the expiration date, the more likely it was to get a false-positive test result! This may well explain those clusters of high false-positive test results seen around the country over the past few years. Excellent detective work on Shelley's part, eh?

So what happens next? Well, the FDA recently announced approval for an enhanced version of the OraQuick test that has a much longer shelf life (12 months). Plus there has apparently been some additional quality control measures and changes to the manufacturing process that should improve consistency and stability. These new test kits should hit the shelves this month. Hopefully this will solve the problem.

Dr. Bob



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