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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.
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.
A lot of the questions here seem to be directly related to CSW and bath house accidents. If a person has enough money to afford to visit them, there should also be enough to afford contributions to HIV research, awareness, and assistance.
I have more commentary on the issue of early testing.
RNA testing is not conclusive, as earlier stated. Journals have published studies that show less than 5% of HIV infected individuals are naturally able to suppress viral loads to undetectable levels without the use of medication. So even though viral loads are generally higher during the acute infection period, it is NOT conclusive. An antibody/EIA test is still the most affordable and reliable method of testing. And it does make sense to take an HIV test at 6-8 weeks IN ADDITION to one at 3-6 months.
Why do I keep supporting the early testing position? Several journals have shown that up to 40% of new transmissions were from people within the acute infection period (ie window period) vs the latency and later stages. Other publications have also shown that during the acute infection period, transmission is 8 to 10 times more likely.
There is currently no known cure for HIV. And HAART therapy is extremely expensive (without insurance/financial assistance) and often inaccessible to people in developing countries. Hopefully these will change soon, but there's no telling when.
For now, it's important to send a consistent message that, even though early testing is by no means conclusive, early antibody/EIA testing at 6 weeks, in addition to 3-6 month repeat testing, should BOTH be recommended to help lower the transmission rate statistics. This is because newer, common tests are more sensitive and can earlier detect positive cases. And because it is not yet curable, preventative measures are a very sensible alternative.
Please do consider financially supporting organizations that do HIV research and assistance. If you don't want to give money, there are also some interesting programs where you can donate computer free time to help HAART research (http://fightaidsathome.scripps.edu). The software is horrible and is like a screen saver, but it's the goal that's important, not the software itself. There are others.
Here are some backup references:
http://www.gsu.edu/~wwwche/Hiv.ppt
http://gazette.kb.inserm.fr/hic/doc/madec_CID05.pdf
http://www.journals.uchicago.edu/doi/pdf/10.1086/510755
https://www.hivma.org/assets/0/18/312/924/1B93C3A7-4828-41D0-878A-D1FC5A483059.pdf
http://www.sfaetc.ucsf.edu/docs/CIDBranson.pdf
RNA testing is not conclusive, as earlier stated. Journals have published studies that show less than 5% of HIV infected individuals are naturally able to suppress viral loads to undetectable levels without the use of medication. So even though viral loads are generally higher during the acute infection period, it is NOT conclusive. An antibody/EIA test is still the most affordable and reliable method of testing. And it does make sense to take an HIV test at 6-8 weeks IN ADDITION to one at 3-6 months.
Why do I keep supporting the early testing position? Several journals have shown that up to 40% of new transmissions were from people within the acute infection period (ie window period) vs the latency and later stages. Other publications have also shown that during the acute infection period, transmission is 8 to 10 times more likely.
There is currently no known cure for HIV. And HAART therapy is extremely expensive (without insurance/financial assistance) and often inaccessible to people in developing countries. Hopefully these will change soon, but there's no telling when.
For now, it's important to send a consistent message that, even though early testing is by no means conclusive, early antibody/EIA testing at 6 weeks, in addition to 3-6 month repeat testing, should BOTH be recommended to help lower the transmission rate statistics. This is because newer, common tests are more sensitive and can earlier detect positive cases. And because it is not yet curable, preventative measures are a very sensible alternative.
Please do consider financially supporting organizations that do HIV research and assistance. If you don't want to give money, there are also some interesting programs where you can donate computer free time to help HAART research (http://fightaidsathome.scripps.edu). The software is horrible and is like a screen saver, but it's the goal that's important, not the software itself. There are others.
Here are some backup references:
http://www.gsu.edu/~wwwche/Hiv.ppt
http://gazette.kb.inserm.fr/hic/doc/madec_CID05.pdf
http://www.journals.uchicago.edu/doi/pdf/10.1086/510755
https://www.hivma.org/assets/0/18/312/924/1B93C3A7-4828-41D0-878A-D1FC5A483059.pdf
http://www.sfaetc.ucsf.edu/docs/CIDBranson.pdf
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.
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.
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?
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.
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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.
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.
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..
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.
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.
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.
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.
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.
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
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
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).
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).
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.
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.
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.
What I said was more certainty/more reliability. That is different from conclusive.
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."
"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."
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).
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.
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
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
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