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Oraquick Test Results accuracy
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Oraquick Test Results accuracy

hi everyone. i wanted to know if any of you had seen the latest hiv rapid test study done in seattle, wa in regards to the accuracy of the oraquick hiv rapid test? was this study concerning the oral rapid test or the blood test? the report was not really clear in which test this study was done on. dr. hhh mentioned he thought it was the blood test. but after reading the report again, it would appear that the study was in regards to the oral test. can i trust my test results of negative. i tested out to about 11 months negative. my tests were rapid blood tests. can i trust the results? please help.. thanks
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Avatar_m_tn
just called orasure. the spokesperson i spoke with informed me that this study from seattle was in regards to the oral test and not the blood rapid test. he also noted that the study and its results were from an isolated case. i must say that the study report that was written by bloomberg was poorly written. it never stated anything about whether the study was about the blood rapid or the oral rapid. thanks bloomberg for giving thousands of people anxiety and doubt regarding their tests.
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Avatar_m_tn
The study is available online.  It is linked to in a Kaiser report on the study.  If you google it, and you have powerpoint you can view it.
On p 4 of the study it says that they used both fingerstick and oral fluid.  The authors do not differentiate between the two.  Later in the study (p9) they use "frozen sera" to test.  Im pretty sure this could only refer to blood and not oral mucosa.  So the spokesperson was not giving accurate info.
Remember, Bloomberg is a financial publication, and they are probably looking at this study more in terms of how this data will affect the company's sales and share price, and not how it will affect public health.
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Avatar_m_tn
It only concerns oral part of the test, not the use of blood.
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Avatar_m_tn
If you read the report (see p 4), and look at Dr HHH comment on the study, you will see that is not correct.  It also is talking about the fingerstick test.
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Avatar_m_tn
If you had read the report from the FDA you would have known it does not apply to the blood part of the test. You would have also known it was nothing new and it only applies to OraQuick Advance not any of the other oral tests.
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Avatar_m_tn
Please take a look at the report from the people who performed the study at the Seattle clinic. They say they used the fingerstick.  This is DR HHH's clinic and he stated on his discussion that this is regarding the blood test.  Here is the link to the study.  If the link is taken down from my post do a search for oraquick on the Kaisernetwork website.  This is new information.  The study was just reported on Sep 5.  You dont have to believe me, it is all online from a reputable organization.  I have given you the link.  If you link to the FDA report Id be happy to take a look, but Im pretty sure they have not said anything substantive since the Seattle info came out.
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=54297
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Avatar_m_tn
Take a look at the the FDA report that holds more clout than just the collected data from one Health Department.
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Avatar_m_tn
Im not sure that clout really matters.  I think that the FDA reports are done by the manufacturer of the tests themselves.  This is an independent study that shows that the rapid tests miss 8% of infections that a regular ELISA would pick up.  It might not be enough to change nationwide testing recommendations, but it is surely interesting information about testing.
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Avatar_m_tn
It's not enough to pull the test from being used.
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Avatar_m_tn
I agree, but it is probably enough to keep people up at night.
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Avatar_m_tn
What, like those that come on this forum thinking they had a risk from fingering, kissing, contracting HIV off toilet seats and protected sex? The people that didn't need to test to begin with?
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Avatar_m_tn
don't forget oral sex as well...
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Avatar_m_tn
Heh.  I agree that most who come are nutso.  Dont know how you deal with them without going off on them.  If there was no such thing as HIV they would probably find something else to obsess about.  My favorite phrase that ive seen so far on one of those questions was about "insertive masturbation."  That just cracked me up.  
Anyway......  Im just saying there are some who come with a real risk situation, and this study indicates that a non-rapid test might be better.
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Avatar_m_tn
sorry guys to be so late in replaying back to this post... I had to work... i also called the location that conducted this study (King County Health Dept.)and the phone number was 206-205-7837. the person I spoke to told me that this study was in regards to the ORAL VERSION only. NOT the blood test version. teak, you are correct. The gentleman on the phone told me that I had nothing to worry about since my tests were the blood fingerstick version of this test. He knew all about the study and everything about it. Teak, you are correct. Thanks for all of your help. I also read the PPT version of this  test and mentioned something about early infections being caught, nothing beyond the 3 month window period date. I also saw something about Dr.HHH thinking it was the blood test, but I called Oraquick and they knew about the study and said it was only in regards to the oral fluid version and that they had determined that the study was in relation to isolated case... I am not discounting Dr.HHH,  but I think he must have made a typo or something when he said he believed it was the blood test version..Anyway, I tested many times and I do feel pretty confident in my results.. How could multiple tests all be wrong out to 18-19 months after risky business?
Also, re read the study again... it never mentions anything at all about the blood test, it just says
http://www.medicalnewstoday.com/articles/120592.php
"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.
also.........

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."
It appears that this study was talking about the Oral fluid test... it never mentions anything DIRECTLY about the accuracy of the blood test...
Anyway, hope this helps..... If anyone knows anything more, let me know...
I still feel really good about the blood test
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Avatar_m_tn
I also would like to add that I feel this study report ( press release) study, was poorly written and does not specify enough... the only thing that is specified is as I mentioned above and it talks specifically about the oral test, it never mentions directly or questions directly the blood test version.. hence the mentioning of the CDC not changing the recommendations for the oral fluid version and saying that people should not use rapid oral tests if they can avoid it...
Anyway, I hope this makes sense.. I just feel that it was a poorly written press release... I feel the gentleman on the phone at the number I called above and also the person at Orasure knew what they were talking about..What reason would they have to lie about it?
Anyway, I hope this helps out.. I know it is all confusing. goodnight
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Avatar_m_tn
oh yeah, funny thing that the ppt presentation has now disappeared from the website of the study. I have it saved on my hard drive. it was kind of confusing, but never mentions directly about a blood test. It mentions the different types of rapid tests, and includes Oraquick rapid and tells the kind of tests they make..also, it says nothing about false negatives, it mentions false positives..
anyway.. i am not too smart of a person, but reading the conclusion of the test, no matter if it is about the oral or blood, it states.Oraquick may be less sensitive than 1st or 2nd gen EIA's in early infection.. it never says anything about testing outside the 3 month period.. I think that all of us who have tested outside the window period, can feel confident in our results.. but after re reading the study press release again, I feel that they are only talking about the oral test.. at least that is what it seems like to me..
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Avatar_m_tn
Do a google search for "Sensitivity of OraQuick and Early Generation Enzyme
Immunoassay"  There you will find a pdf of the study.
They say:  "OraQuick used finger-stick blood samples or oral fluids, depending on the testing site."
The issue is that Oraquick both oral and blood tests searches only for antibodies to the gp41 protein, while ELISA searches for antibodies to other viral proteins as well.
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Avatar_m_tn
Don't confuse OraQuick, with OraQuick Advance. They are  completely different tests. OraQuick was one of the first rapid tests which was blood only tests for the detection of HIV1. OraQuickAdvance, can be done by oral, blood or serum for the detection of HIV 1 and HIV 2. OraQuick Advance replaced the earlier OraQuick test.  
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Avatar_m_tn
well, I feel wholeheartedly in the fact that Orasure is going to have the best tests possible. Why would they be making a test that only searches for gp41. Do you think that they are gonna be putting out inferior quality tests? Orasure has done study after study and comparisons after comparisons with the EIA test or ELISA test.. heck even the EIA test misses some infections in early stages..Does that mean they need to post a study about the EIA or ELISA and discredit it??? I think what has happened is that a lot of people are looking at a test study that we know nothing about. I called the phone number that I posted above yesterday and the gentleman I spoke to told me that it only involved the oral version of the test, I feel he knows what he is talking about. And besides, like teak or someone else mentioned that this study was for early detection problems.. If one has been tested numerous times, I find it hard to believe that every test would miss an infection. I also do not believe that oraquick is gonna make a test that is not reliable. Also wasn't some of this study done back in 2005... come on..thats a long time ago.. that is 3 years ago..My tests were done in 2007-2008. Anyway, if anyone else wants to know... call the number I posted above and ask them about it. They will tell you it was in regards to the oral test only and also call orasure, they will tell you the same.. teak, you are correct.
At any rate... I think people are jumping the gun on this "study" I read the PPT and it was hard to understand, but I did gather enuff info from it to know that they only mentioned the oral test in the study press release and also in the PPT file it only mentioned infections missed in EARLY STAGES.. maybe during the window period.. Anyway, the man that I talked to on the phone yesterday understood fully that the press release of the study did not stress that it was in regards to the oral version, but he was going to discuss it with his higher ups on trying to get a correction made.
Anyway, If there are any doctors that frequent this forum and I am sure they do, maybe they can fill us in on some more information...but I am, skeptical when a study is released with information about tests that were conducted in 2005, and that is what this study was in regards to, 2005... a long way back.. In my way of thinking, I would think that it would not involve people who has tests done recently... Like teak said.. there is a difference in Oraquick and Oraquick Advance..
Anyway, I will anxiously await any more responses..but read the study again on the press release.. where does it say anything about the blood tests?? it only mentions the oral test...
teak, I do believe you are FULLY CORRECT.
Anyway, call them and ask them about it...see what they have to say...They will talk to you.. they were very nice at Orasure and the Seattle location I called.
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Avatar_m_tn
hey ther everyone. Just got back home. I wanted to inform everyone that I talked with an HIV specialist at a well known clinic, I will not name names or locations, but it was a popular clinic in the south. Anyway, I spoke with this gentleman at length and just asked him bluntly about that study in Seattle. I asked him if he had heard about it. And he said "yes, I know the study you are talking about"  "he told me the what the entire study revealed, and it is as I interpreted it as being. Here are the facts....

This study was conducted and revealed the Oraquick Rapid test not being as accurate on specimens of people who were not out of their window period... testing too early..such as a few days or a couple of weeks... meaning, that people who were not outside of their window period might not have a difinitive and conclusive result.... well.. that right there tells it all.. patients not getting tested after 3 months..RULES NOT FOLLOWED.... and it also reveals that the test has its limits at picking up early infections.. well.. that is what Orasure and every other rapid test manufacturer states... "you must be out of your window period for an accurate result (3 months)..
I also asked the gentleman on the phone about which test this study was conducted on..I asked him repeatedly... he replied... "The Oral rapid test". He stated that the blood test was a better mode of testing and a more accurate testing means...
Anyway, people, I think this entire study has done nothing but upset a lot of people for no reason at all...
First and foremost.. I have been told by 3 different agencies... the Health Dept in WA that conducted the study, Orasure Technologies and a very reputable HIV clinic in the south that this study was on the oral fluids version of Oraquick...
and also let me add... We also know that from reading the CONCLUSION of the test, the PPT slideshow online that the study was about EARLY INFECTION... or people testing too early before the window period had ended. The gentleman at the clinic today that I called also told me this when he was describing the study...I told him I had tested repeatedly with the blood fingerstick Oraquick and it was up to 18 months... he said, "You are NEGATIVE"

So, to sum up everything.. If you tested outside of the 3 month window period and received a negative result... YOU ARE NEGATIVE... END OF STORY, PERIOD...!! Whether it was an Oral Rapid or Blood Rapid... Orasure is state of the art...and has a 99% accuracy record (IF THE PROPER RULES ARE FOLLOWED (window period 3 months)
I think a lot of this comes up to the general public not being able to read the results of a test study correctly and panicking.. Heck, I didn't even understand the test study either until I read it closely.. of course, I will be the first to say that the press release study story that was released was poorly written and did not give a good enough description of what it was all about.. "Oral test and testing too early"
the veterans of this forum Teak, Lizzie Lou you are all CORRECT..when you tell people to move on...
it is like the man at Oraquick stated yesterday in regards to this study.. and he was correct. he stated " This was an isolated case" well, it makes since when you think about it... Follow the 3 month window period rule and test then, and the test performs properly... You have to follow the rules...
Anyway, we all need to move on from this...if you tested on or after 3 months.. you are fine..anyway, I hope this helps ease some minds.. I am the first one to panic, but after speaking to all the experts I have spoken to on this matter,. I feel 100% at ease now..
If anyone else knows anything else, please add... I hope this helps you guys..
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Avatar_m_tn
A few comments:
1)  The actual study said that "OraQuick used finger-stick blood samples or oral fluids, depending on the testing site." I trust the actual study over random people you have spoken to on the phone.  Here is the link to the study abstract.  Please read it: http://www.hivtestingconference.org/abstracts/abstract4.pdf
2)  Oraquick Advance only has one HIV1 antibody in the test (gp41).  ELISA tests include other proteins such as p24, gp120/160 etc.  You can find this info easily online.  Dont assume.  Look it up.
3)  The study compared the Oraquick test to first and second generation elisa (not 3rd) and found even the early ELISA was better.
4)  Teak:  I would think that the study used OraquickAdvance because some of the tests were done on oral fluid.
5)  Timelord:  Studies take more than two years to do.  If a study took less time that would be shocking.  Do you really think testing has changed since 2005?  
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Avatar_m_tn
Enough, it was not a concern enough for the FDA to make a recall. The test is still being used by most Health Departments and Hospitals.
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186166_tn?1385262982
men are soooooo silly!!!  since you think with your "mr willies"...is this post about who is right/smarter...or who has the biggest mr willie????
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Avatar_m_tn
well.... here is the last of what I am gonna say about it. I trust professional people in the field Orasure employee, HIV specialist who had PROFESSIONAL knowledge and interpretation of the study. Also, the health dept where the study was conducted..I would trust a professional ANYDAY over an average joe online trying to understand a study and it's conclusions...
Also, the study conclusion revealed.... and the ONLY thing it says ...and it states from the PPT slideshow online...is that Oraquick is not as accurate in detection of early infection.... hence what the professional told me on the phone at the AIDS clinic in the south concurred.
Now, I can read and understand that much.. Some people are just assuming that it means the test is not as accurate at ANY time... That is not what the study says... it says not as accurate in early infection..
You can slice and dice this up as much as one wants too... but that is what the conclusion says...no matter if it is with the oral or blood... it only mentions accuracy in early infection.. Now, if this applies to you... I am sorry. I had my 10 12 tests way after the window period... If you only had yours close to the window period, I am sorry.. maybe you need to go and retest with a better test or something...
But since you like to quote off the FACTS of the test study.. like I said before.. it only mentions the Oraquick not being as accurate in early infection.. nothing is mentioned in regards to testing in later stages..
Now really... do you honestly think Oraquick is going to make a test that only, kind of detects HIV or only HIV 1 gp41??? Do you think that Oraquick is going to just have a test that will only "kind of find" it.. Give Orasure some credit here..Heck, if you want, I will call Orasure tomorrow and talk to some of their diagnostic scientists if you want me too?? the designers of the test, field representatives...Maybe they can tell us exactly which bands it detects and just how sensitive it is...
And, you also mention the ALL PERFECT EIA or ELISA.. I believe I also saw in that study you quote so much about. I believe I saw that it also misses some early infections as well...Should we all just discredit the EIS or the ELISA well and only depend on the NAAT?
geesh man...lighten up.. the tests are accurate... I don't give a rats patooty about some off the wall study that you nor I am trained to understand fully... but I do know and I learned from past experience.... when a professional tells you something, one should listen to them and MOVE ON...They are trained and know a lot more about it than you and I.  every person that I talked to on the phone knew all about the study and knew what they were talking about.. I would fully trust someone who is trained rather than someone's opinion online. Heck, even Dr. Bob (the body) addressed this issue on his website when he was replying to a fellow poster..
Dr. Bob told the poster..you have been tested 3 times way beyond the 3 month window period.. do you honestly think that all 3 tests were going to miss and infection? Also, Dr. HHH also addressed this with a poster as well.. he said pretty much the same thing... This particular poster had tested multiple times, Dr. HHH also told him, do you think that all of your tests would have missed an infection??
I am finished with this... I trust all of my results.. but my post that I made earlier this evening still stands...everything in it makes perfect sense.. I guess one has to make their own decisions.. but I believe that if I make phonecalls to enough people who are trained in HIV testing and the HIV test device itself, I believe that if all 3 people were telling me the same thing, I would think it would probably be the truth..
you all be good and please accept your test results... if you tested after the 3 month window period, you are fine.. whether it is the oral or blood rapid, you are fine. NEGATIVE


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186166_tn?1385262982
are you trying to take first place????  hehe
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Avatar_m_tn
oh my man.. i just went to the link you gave and read it all... read what it says.... dude it mentions testing at 4 days after exposure... come on.......4 days after exposure to an acutely infected partner?? 4 days??? come on... how can the test be accurate at 4 days after an exposure?  it also mentions something about 9 discordant results with Oraquick...well, how many days after exposure were those tests taken? it doesn't say...
Man, all of this is about EARLY INFECTION.. it mentions nothing about 3 month window period...
and again, I stress in the conclusion of the study what does it say???
Oraquick MAY be less sensitive than EIA's in early HIV infection..
Anyway, I am with teak on this one...
Enough...The test study speaks for itself... it tells all in the conclusion and it goes with along with what every professional has told me on the phone.... This study is about early infection detection... nothing is mentioned about the window period..
Anyway, teak has told us, Lizzie Lou has told everyone and the professionals have told everyone... You are NEGATIVE if you tested after the window period....
Just like the test instructions say.... Any test result is not 99% valid or conclusive until after 3 months...
Lighten up... relax, go on with your life... everything is gonna be ok... because you are NEGATIVE!
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Avatar_m_tn
LOL! yeppers... I think I may have hit a home run or crossed the finish line with checkers... LOL!
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Avatar_m_tn
*sigh*
Teak, I apologize for posting again.  I didnt want to, I just wanted to correct misconceptions.  I promise not to make it an extended rant.
Lizzie, Thanks for lightening it up a bit :)
I hope this is my last post about this.
Timelord:  First of all, I am sorry if this situation is causing you anxiety.  And, if you have an 11 month negative I am sure that you can trust that result.  Congratulations on your negative status.
But, the only antibody HIV1 that Oraquick tests react to is gp41.  This is clear from everything I have read.  If you can prove me wrong I will pay you $100.  Of course I will need more proof than you saying you spoke with some company rep on the phone.  Here is one study that agrees with me.  If you find a different reputable study that disagrees I will pay you. http://www.medscape.com/viewarticle/578652.
Also, the "4 day" man you are talking about tested negative on NAAT, ELISA and Rapid.  This result was clearly not surprising.  But, he was not the only person in the study.  Others tested positive on either NAAT of ELISA but not Rapid.  When were they infected?  It doesnt say.  It would have been nice if they did follow up Rapid testing but it does not look like they did.
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Avatar_m_tn
hey man! 100$ sure.. i will take it.. just kidding. man, i amnot having any anxiety over this.. i actually have an 18 month negative result taken this past june... i know that after 9 or so negative rapid tests plus home access neg and negative elisa, i feel that i am negative.. don't ya think one of them would have caught any infection that was there? i cannot get your link to work... i wholeheartedly feel the oraquick test is 99% accurate when the guidelines are followed. orasure has run test after test. study after study... they know their stuff. the only definitive studies have shown some manner of false positives with the oral tests.. but those were found to be human error and isolated cases..anyway, the study above shows one thing.. in my opinion and from what i read.. early infection may be overlooked if the tests are done too early..
we all knew that.. the guidelines state a window period... it needs to be followed..
i now you are a nice guy and you seem to be worried and have some amount of anxiety, but after me reading the study and my phonecalls, i feel that none of this study provides any new information... NOTHING NEW TO SEE HERE...
best wishes...
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Avatar_m_tn
hey man, i got the link to work... my bad.. i read the report you gave a link to, but again, it only mentions the oral rapid test, also...nothing about the rapid blood test... at any rate.. this could all be an isolated case, something with the particular patients blood, chemistry, etc.. it also mentions early infection.. also, we have no idea what his true infection date was... people tend to forget that sometimes, he could have been still having sex...anyway, it is all about early infection and it also mentioned LATE STAGES of infection.. thanks for the read..
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Avatar_m_tn
wow this is scary all my tests were done with oraquick fluid i thought my 3 month was conclusive but now should i re test?
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Avatar_m_tn
You never had a risk. You got a blowjob and even used a condom. MOVE ON.
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Avatar_m_tn
yea the blowjob with a condom was not at all a risk Teak your rite that was my most recent exposure last week... the one i am talking about was 4 months ago i had a real exposure unprotected vaginal with a csw in asia thats when i did the oraquick mouth swab tests that im worried about now
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