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Avatar universal

HIV Rapid Tests

I've been to several anonymous and confidential clinics. They all use OraQuick Advance HIV1/2 antibody tests. Its standard guideline is 2 weeks to 3 months. However, I've read and have been told numerous times that 6-8 weeks is conclusive.

But the OraQuick Advance package insert confirms that this is not true. The seroconversion panels list instances of plasma that were non reactive until 48, 61, 112 days. I've also read many personal accounts stating that they did not test positive until past 2 months using EIA/Rapid antibody tests. There are also studies that confirm a 6-8 week window period is not sufficient, ie Steckler, Swenson, etc "HIV Testing in a High Incidence Population: Is Antibody Testing Alone Good Enough?". OraQuick Advance guarantees reliability at its stated time frame, not 6-8 weeks.

It is true that a vast majority of people develop enough antibodies to be detectable by 6-8 weeks. If you have normal health, then you probably fall into that category. But if you have autoimmune diseases, chronic skin issues and allergies, and use corticosteroids, you may or may not fall into that category. 3-6 months window period is an extremely agonizing period to wait if you are the anxious type.

If you want more certainty and cannot wait 3-6 months, then you should probably take an RNA test after 4 weeks. It costs $160-$200 out of pocket or via insurance, and you need to go to your doctor. It is a much more reliable indicator on whether or not you are negative. But it also has ~5% false positives, or ~95% true positive. If you believe it's a false positive, that means you have to wait out the 3-6 months, which you would have had to do anyway if you took the antibody EIA/Rapid test.

On the other side, EIA/Rapid is not totally reliable before 3 months, so a false negative can also give you false hope. This can be risky to yourself and to others, especially if you are truly positive and are not practicing safe sex during this window period. OraQuick Advance is used instead of RNA because of its very fast turnaround time, and because it costs about $25 dollars. The lower cost makes a lot more sense if the clinic is on a budget and needs to test many people--it simply cannot afford $160-$200 per RNA test with a week turnaround time.

If you do test positive, it can be very traumatic. But it is not a death sentence anymore, since there is medication available and assistance programs to help finance these drugs, at least in first worlds. HIV positive people in developing countries are not as fortunate to access HAARTs, so please consider financially helping them too if you can afford it.

In the meantime, please practice safe sex if you cannot confirm that you or your partner/partners are HIV negative.

BTW, I am not a health practitioner, but am a scientist by trade. I have only been reading as much as I could on testing and medication material to understand the issue better. So I do have many questions. The one I am really bothered about is the seroconversion panels in the OraQuick Advance package insert.

Does anyone know if the relative day of bleed begins from the infection point or the first day of test (which may be many days beyond the infection day)?

Thanks.
26 Responses
Avatar universal
The information that you posted is incorrect.
1. A conclusive test for OraQuick Advance is 3 months like ALL HIV TESTS.
2. PCR-RNA will not give you a conclusive test result. They are supplemental tests used in conjunction with an antibody test.
Avatar universal
Read the OraQuick Package insert. It shows an instance where the test is non-reactive at 112 days and is repeatedly reactive at 121 days.
Avatar universal
Are all negatives true negatives?
A Non-Reactive (negative) test means that anti-HIV antibodies were not detected in the specimen. This test result is interpreted as Negative.

It is possible to get a negative screening test if the infection is very recent. This may be because there is a window period of several weeks when a person may be infected but antibodies to the virus have not reached a concentration that is visible. Therefore, if a person has certain risk factors, or thinks they may have been exposed to HIV, they should be retested in three months to be certain of a negative result.

http://www.orasure.com/products-infectious/products-infectious-oraquick.asp#faq5
Avatar universal
And you're right that an RNA test is not conclusive. I never said it was. I said it is a much more reliable indicator of a person's status after 4 weeks compared to an antibody test.
Avatar universal
There are definitely false negatives. But 112 days is beyond the 3 month mark, so the 3 month mark is not conclusive, according to OraQuick data. BTW, OraQuick is reportedly nearly as good as 3rd generation EIAs (lag indicator of ~3 days).
Avatar universal
This is what you said,
"If you want more certainty and cannot wait 3-6 months, then you should probably take an RNA test after 4 weeks. It costs $160-$200 out of pocket or via insurance, and you need to go to your doctor. It is a much more reliable indicator on whether or not you are negative."
Avatar universal
What I said was more certainty/more reliability. That is different from conclusive.
Avatar universal
Wrong. MOVE Along.
Avatar universal
The CDC currently states that ninety seven percent will develop antibodies in the first 3 months following the time of their infection. In very rare cases, it can take up to 6 months to develop antibodies to HIV. NOWHERE in the guidelines does it say that 3 months is ABSOLUTELY conclusive nor does it say WHAT group of people fall in the other 3% that will take longer than 3 months to seroconvert. So you're wasting your time arguing with people on this forum about what is and isn't conclusive. Time and time again you see people saying "people in chemo and people that are long time IV drug users are the other 3 %" but I guarantee you that you cannot and will not find anything in writing by the CDC that says that.  
Avatar universal
Please explain and point me to data/studies that suggest that an RNA test is less reliable than an antibody test during the window period. That would help me understand you and the issue better. I may change my mind, or I may not.

My understanding is that if you believe you have ARS, then there should be sufficient quantities of HIV in the blood. An RNA test looks for specific parts of HIV material rather than antibodies that develop after an infection. From the window point of view, copies of HIV RNA can reach high levels (http://en.wikipedia.org/wiki/File:Hiv-timecourse.png). So in this case, I believe a test that looks for HIV material makes more sense than a test that looks for subsequent antibodies.


Avatar universal
Yes, I agree with you.
Avatar universal
What you believe and what is fact is two totally different things.

Avatar universal
Yes, I mostly agree with you about the time frame when using the commonly used antibody tests, such as OraQuick Advance. My understanding is that these tests are much more sensitive than they were 15 years ago. These tests can detect antibodies on a vast majority of people by 6-8 weeks, which would have not have been detectable using older tests. The OraQuick package insert manual, however, still shows that there are still cases beyond 3 months.

I want to add that HIV testing/treatment R&D definitely progresses, and that newer testing methods (that I've read about) have significantly shortened the 3-6 month waiting time. Abbott, for example, recently got FDA approval for a p24/antibody combo test for earlier detection (~3 weeks, I think). And there are others. Once these become common, I think CDC guidelines may also change to reflect newer technology.

Also, Red Cross uses RNA testing as well as antibody testing to screen its blood donation supply. The RNA testing is used to reduce the window period between infection and antibody testing. The RNA/antibody combo testing gives higher confidence that the supply used for transfusion is HIV negative.

The drawback is the higher cost and wait period when using this combination. Places such as anonymous clinics that use tax funding probably don't have the budget to support this type of testing until the costs go down for free testing. You usually have to go to a doctor to request duo testing and pay out of pocket or bill it to insurance (for the fortunate ones who have insurance or are able to pay--many cannot).


Avatar universal
http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/UCM216314.pdf

Page 27
Current methods for the detection of HIV may not detect all infected individuals. An ARCHITECT HIV Ag/Ab Combo test result that is nonreactive does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. Nonreactive results in this assay for individuals with prior exposure to HIV-1 and/or HIV-2 may be due to antigen and antibody levels below the limit of detection of this assay.

Post-test discussion

The need for a repeat HIV test if still within the window period after a specific exposure should be discussed. Although fourth generation tests shorten the time from exposure to seroconversion a repeat test at three months is still recommended to definitively exclude HIV infection.

http://www.bhiva.org/documents/Guidelines/Testing/GlinesHIVTest08.pdf

Avatar universal
From BHIVA pdf recomendations:

The recommended first-line assay is one which tests for HIV antibody AND p24 antigen simultaneously. These are termed fourth generation assays, and have the advantage of reducing the time between infection and testing HIV positive to one month which is one to two weeks earlier than with sensitive third generation (antibody only detection) assays [22].

This supports that the 4-8 week testing period, using newer p24/antibody tests, does give highly predictable results (for 90+%, vast majority) that should be confirmed after 3-6 months. BHIVA states 3 months for confirmation, as you pointed out.

And more common tests, such as OraQuick Advance, used in the US, show IN ITS OWN DATASET that a 3 month hard line is not always true, and that it does happen to a very small number of people who do test positive.

But like I said before, the hard line 3 month mark depends on several things, such as test sensitivity, antibody production, and (importantly) cutoff confidence. If a confirmation at 3 months means 99.98%, then there is still a 0.02% error. To get to 99.99%, the confirmation period might have to extend to 5 months to cover that additional 0.01%. And the confirmation period might have to extend from 5 months to 6 months to cover an additional 0.005%. So newer tests seem to have shifted the time to test positive window for a vast majority to a shorter period.

It's important to have earlier detection, and that's the way tests are going.

Avatar universal
And I want to be clear to say that, from what I have been reading, detection is shifting to earlier with highly predictive confidence. But confirmation testing at a later point in time is just as important, because there's still a small chance that newer testing methods don't pick up everything.
Avatar universal
thanks mememe2010947, your comments were stimulating, I appreciate someone who uses common sence and intelect as opposed to just someone who memorizes what the cdc says. I would encourage you to frequent this site often and weigh in.
Avatar universal
Yes 6-8 weeks is probably conclusive based on the new tests but until the FDA approves that, we wil never recommend testng before 3 months.
Avatar universal
Plz if u can answer my question which I have been searching and not able to find confident   Answer.. Are HIV 4th gen antibody test are capable of detecting different antibodies produced by diff HIV stains.. @ 3month mark.. I will b thankful if u can comment on this..
Avatar universal
Common antibody tests also list the subtypes being tested, and it looks like most of the major subtypes of HIV-I are covered. For example, OraQuick Advance package insert lists testing for I subtypes A-G, O, and II.

If you're in the Western and Asian countries, the most frequently occurring ones are HIV 1 in the major group, specifically subtypes B, C, F. Common antibody tests are mostly likely checked against these. Check the antibody kit manual if you are concerned about a specific subtype. If you're from Africa or have reason to believe someone else was from Africa, then HIV 2 may be possible. HIV O is an outlier type that's found a lot less commonly from West Africa. Mainly people who are diagnosed with HIV-2 or subtype O in the Western world seem to be direct immigrants or have been in contact with direct immigrants from Africa.

In the future, there will most likely be new subtypes, since the HIV does evolve. Testing technology will probably be updated to reflect that.

If older generation tests check against the most common subtypes, most likely 4th generation tests will cover more than the older ones. For example, with the Abbott test mentioned earlier, the manual lists at least the same subtypes listed in OraQuick Advance. It does seem like common tests are comprehensive.
Avatar universal
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Avatar universal
Thank for putting some light on it.. well i am from india... The only thing what i know dat i was tested on HIV duo 1&2 4th Gen antibody kit (CMIA) from Dr Lal path lab's.. When i asked them on what kit i was tested they refuse to disclose it. They said its a latest HIV test which is avaliable in market.


Avatar universal
Does it matter what test I got? Should I have ask for a specific type of test? I don't even know what kind I had done. Should I find out?
Avatar universal
Thanks. But I'm still learning about these issues myself. Reading the posting replies from these experts and health practitioners, studies, CDC, package inserts were very, very helpful in educating me. Many of the questions I had were already answered from this material, and they're mostly consistent across web sites. I took a lot of time to read through them.

My post was only pointing out some inconsistencies in the testing period, and was trying to explain why this was so. I continue to rely on expert (such as Teak) and doctor comments, and official guidelines and publications when I don't understand something. They're very helpful.
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