Aa
Multiple tests...
Hello... I am a relatively safe, heterosexual male. I was with my last girlfriend for just over 3 years. Towards the end of our relationship this past January/February, I was made aware that she had been cheating on me. I have not been intimate with anyone since her, the last time being January 31st, 2009. So I thought before seeing anyone else seriously that I would get tested. Last week, I got a full panel of UTI/HIV/Syphilis. The HIV test was a DNA by PCR, and it came back reactive. I went back in, and they drew more blood. Another PCR was done, as well as an ELISA. Both reactive. A Wester Blot confirmation test is being done, and I am waiting on those results. The counselor there went over my history with me, and suggested that I get tested at another facility that used a different lab, as he couldn't see this sounding quite right. I have a blood draw scheduled for tomorrow, but I took a Uni-Gold from Trinity Biotech with finger ***** today. It was negative. How does this make any sense? As I mentioned before, I am getting another blood draw ELISA tomorrow at a different facility and different lab, but any info or insight you could provide would be most appreciated.
They are FDA approved tests but not for diagnosising HIV. Now go back and read them then move on.
My goodness you can be infuriating...
I copied those DIRECTLY from the FDA web site. The point was contending your position that "PCR-DNA test and they are not approved for diagnostic use anywhere in the world."
I think I PROVED you wrong, as they obviously are.
My original question was, and still is... DOES ANYONE KNOW what can cause such divergent results as those expressed in my original post? Does anyone know where I can find more information on this?
If you don't know, THEN MOVE ON to something less complex. It is ok if you don't know the answer. If and when I get an answer to my question, I will "move on." But as I have not gotten a single answer from anyone, let alone a sound piece of advice on where to obtain an answer, I consider this post unanswered.
I copied those DIRECTLY from the FDA web site. The point was contending your position that "PCR-DNA test and they are not approved for diagnostic use anywhere in the world."
I think I PROVED you wrong, as they obviously are.
My original question was, and still is... DOES ANYONE KNOW what can cause such divergent results as those expressed in my original post? Does anyone know where I can find more information on this?
If you don't know, THEN MOVE ON to something less complex. It is ok if you don't know the answer. If and when I get an answer to my question, I will "move on." But as I have not gotten a single answer from anyone, let alone a sound piece of advice on where to obtain an answer, I consider this post unanswered.
VERSANT HIV-1 RNA 3.0 Assay
The VERSANT HIV-1 RNA 3.0 Assay (bDNA) is not intended for use as a
screening assay for HIV infection or as a diagnostic test to confirm the diagnosis
of HIV infection
Abbott RealTime HIV-1 Amplification Reagent Kit
This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test
This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease
progress for the clinical management of HIV-1 infected patients. The Test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.
It would help if you knew what the tests were approved for. MOVE ON..
The VERSANT HIV-1 RNA 3.0 Assay (bDNA) is not intended for use as a
screening assay for HIV infection or as a diagnostic test to confirm the diagnosis
of HIV infection
Abbott RealTime HIV-1 Amplification Reagent Kit
This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test
This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease
progress for the clinical management of HIV-1 infected patients. The Test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.
It would help if you knew what the tests were approved for. MOVE ON..
So again, I am unsure how you are saying I am wrong, let alone how you have proven it. I am not saying I was correct. I WAS ASKING FOR MORE INFORMATION, AND/OR CLARIFICATION. You gave, and continue to give, insults and threats. I think you need to MOVE ON.
From (http://www.stdtestexpress.com/select-tests/)
This DNA test uses a sophisticated diagnostic technology called PCR to detect HIV DNA in blood cells. As it can pick up HIV as early as 28 days from an exposure with an 95% accuracy rate, this is an Early Detection test.
From (http://www.onlineuha.com/hiv-stds-risk-panel/hiv-1-dna-pcr-5.htm)
Stay healthy by early detection of virus by testing HIV-1 DNA PCR test. HIV can be detected within 14 - 28 days. Prevent the spread of HIV virus by testing HIV-1 DNA PCR test.
From (http://www.thebody.com/Forums/AIDS/Meds/Current/Q202369.html)
Shortly after an exposure the HIV ab test may not have time to turn positive. Usually the earliest would be by 2 weeks and most will be positive by 6 weeks. We repeat the testing for 3 months to be sure to catch all positives.
The HIV PCR test should be positive by day 36, usually at a high titer. We generally would not run this test unless a person had symtoms of seroconversion (fever, swollen glands, rash, sores in the mouth, etc). In that circumstance it should be postive and would be highly unlikely to be "false negative" The one caveat would be if you took post-exposure prophylaxis for 4 weeks which might delay the virus growth in the blood and make the PCR low/negative.
From (http://www.aim-med.org/library/articles/1194375471/)
The HIV/PCR DNA qualitative test will detect early HIV infection by looking for the inhibitory substance of the HIV virus itself. This test typically will find HIV between 10 and 14 days after exposure.
Currently approved by the FDA tests:
PTIMA HIV-1 RNA Qualitative Assay
Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic)
Tradename: APTIMA HIV-1 RNA Qualitative Assay
Manufacturer: Gen-Probe, Inc, License #1592
Date: October 4, 2006
Indication: Qualitative detection of human immunodeficiency virus type 1 (HIV-1) in human plasma. It is intended for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection.
VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Product: VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Applicant: Bayer Corporation, Berkeley, CA
PMA number: BP000028/0
Indication for Use: for the direct quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma of HIV-1 infected individuals
Approval Date: 9/11/2002
Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay
Proper Name: Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay
Tradename: None
Manufacturer: BioLife Plasma Services, L.P, License #1640
Date: January 31, 2007
Indication: Detection of Human Immunodeficiency Virus RNA in Human Source Plasma samples by PCR
Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
Applicant: ABBOTT Molecular, Inc
Product: Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
PMA number: BP060002 / 0
Indication for Use: Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers
Approval Date: 5/11/2007
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
Applicant: Roche Molecular Systems, Inc
Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
PMA number: BP050069/0
Indication for Use: Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers
Approval Date: 5/11/2007
From (http://www.stdtestexpress.com/select-tests/)
This DNA test uses a sophisticated diagnostic technology called PCR to detect HIV DNA in blood cells. As it can pick up HIV as early as 28 days from an exposure with an 95% accuracy rate, this is an Early Detection test.
From (http://www.onlineuha.com/hiv-stds-risk-panel/hiv-1-dna-pcr-5.htm)
Stay healthy by early detection of virus by testing HIV-1 DNA PCR test. HIV can be detected within 14 - 28 days. Prevent the spread of HIV virus by testing HIV-1 DNA PCR test.
From (http://www.thebody.com/Forums/AIDS/Meds/Current/Q202369.html)
Shortly after an exposure the HIV ab test may not have time to turn positive. Usually the earliest would be by 2 weeks and most will be positive by 6 weeks. We repeat the testing for 3 months to be sure to catch all positives.
The HIV PCR test should be positive by day 36, usually at a high titer. We generally would not run this test unless a person had symtoms of seroconversion (fever, swollen glands, rash, sores in the mouth, etc). In that circumstance it should be postive and would be highly unlikely to be "false negative" The one caveat would be if you took post-exposure prophylaxis for 4 weeks which might delay the virus growth in the blood and make the PCR low/negative.
From (http://www.aim-med.org/library/articles/1194375471/)
The HIV/PCR DNA qualitative test will detect early HIV infection by looking for the inhibitory substance of the HIV virus itself. This test typically will find HIV between 10 and 14 days after exposure.
Currently approved by the FDA tests:
PTIMA HIV-1 RNA Qualitative Assay
Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic)
Tradename: APTIMA HIV-1 RNA Qualitative Assay
Manufacturer: Gen-Probe, Inc, License #1592
Date: October 4, 2006
Indication: Qualitative detection of human immunodeficiency virus type 1 (HIV-1) in human plasma. It is intended for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection.
VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Product: VERSANT HIV-1 RNA 3.0 Assay (bDNA)
Applicant: Bayer Corporation, Berkeley, CA
PMA number: BP000028/0
Indication for Use: for the direct quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma of HIV-1 infected individuals
Approval Date: 9/11/2002
Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay
Proper Name: Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay
Tradename: None
Manufacturer: BioLife Plasma Services, L.P, License #1640
Date: January 31, 2007
Indication: Detection of Human Immunodeficiency Virus RNA in Human Source Plasma samples by PCR
Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
Applicant: ABBOTT Molecular, Inc
Product: Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
PMA number: BP060002 / 0
Indication for Use: Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers
Approval Date: 5/11/2007
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
Applicant: Roche Molecular Systems, Inc
Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
PMA number: BP050069/0
Indication for Use: Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers
Approval Date: 5/11/2007
Well you did open your mouth without be able to back it up.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091626.htm
http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm093317.pdf
Now move on.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091626.htm
http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm093317.pdf
Now move on.
. The AMPLICOR HIV-1 MONITOR® Test, v1.5 is not intended to be used as a screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection. NOW MOVE ON.
http://molecular.roche.com/diagnostics/virology/products_virology_02.html
http://molecular.roche.com/diagnostics/virology/products_virology_02.html
Let me first address the "nickname" comment. I have no idea what you are talking about. I have only one account on this forum, and prior to a couple days ago, I have never visited here before. So threaten me all you like.
As to the PCR-DNA... The HIV-1 DNA by PCR test looks directly for the proviral DNA. The HIV-1 DNA by PCR test has been an industry standard test in high risk professions for many years. This test may detect the presence of HIV before seroconversion.
The first FDA prognosis DNA test was given to ROCHE in 1999. Here is a list of FDA approved tests (http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm080466.htm) and here is the link to the Roche press release.
(http://www.thefreelibrary.com/AMPLICOR+HIV-1+MONITOR+Test+first+to+receive+FDA+approval+for...-a018352582)
So while I may not know what I am talking about, I do NOT open my mouth if I cannot back it up. If I am somehow mistaken, and this information is incorrect, please let me know. But insulting me is completely unnecessary.
As to the PCR-DNA... The HIV-1 DNA by PCR test looks directly for the proviral DNA. The HIV-1 DNA by PCR test has been an industry standard test in high risk professions for many years. This test may detect the presence of HIV before seroconversion.
The first FDA prognosis DNA test was given to ROCHE in 1999. Here is a list of FDA approved tests (http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm080466.htm) and here is the link to the Roche press release.
(http://www.thefreelibrary.com/AMPLICOR+HIV-1+MONITOR+Test+first+to+receive+FDA+approval+for...-a018352582)
So while I may not know what I am talking about, I do NOT open my mouth if I cannot back it up. If I am somehow mistaken, and this information is incorrect, please let me know. But insulting me is completely unnecessary.
I did read his profile. I am not doubting anything he has said. The problem is, he hasn't said anything. I am just looking for more technical information. If someone cannot provide me with more technical information here, that is fine. Just say so.
For someone to say I don't know what I am talking about, when I am here saying "I don't know what I am talking about, can you help?" Is rather insulting. I am not a doctor, nor have I been dealing with this for 25 years. That is why I am here, to get more information.
I am not attacking anyone, or discounting anyone's information. I still haven't been given any information, so there is nothing to discount.
For someone to say I don't know what I am talking about, when I am here saying "I don't know what I am talking about, can you help?" Is rather insulting. I am not a doctor, nor have I been dealing with this for 25 years. That is why I am here, to get more information.
I am not attacking anyone, or discounting anyone's information. I still haven't been given any information, so there is nothing to discount.
just for the record...teak has been living with hiv for 25 years. read his profile ! ! !
Thank you for the response. While I fully understand that these are not MDs (Where is the expert section of this forum BTW?), I was just hoping that someone might have a link to more detailed information. For example, I understand that PCR tests, as well as AB tests, can give false positives, as well as false negatives (though from what i have read, false negatives are much more rare). Is there a place that has hypotheses regarding this phenomenon? Why are there false positives? What postulations are there as to the condition or conditions required to create a false positive? I am just trying to educate myself.
As far as you AB comment: I have now gotten 1 positive AB, and one negative AB. The positive AB was an ELISA, and the negative was the Uni-Gold. A WB is being done on the ELISA, and an additional ELISA draw was performed today, so I should have the results back in a couple of days. The WB should be available tomorrow. How can an ELISA come back reactive, and then 5 days later, a Uni-Gold come back non reactive? They are both FDA approved AB tests.
While I understand that this is not a forum of MDs or researchers, I was hoping that someone would have a reference to these types of questions. They seem valid questions to me, though perhaps a little advanced for this forum. Again, I was hoping that someone would at least have a link to another site with more detailed technical information.
Thanks again!
As far as you AB comment: I have now gotten 1 positive AB, and one negative AB. The positive AB was an ELISA, and the negative was the Uni-Gold. A WB is being done on the ELISA, and an additional ELISA draw was performed today, so I should have the results back in a couple of days. The WB should be available tomorrow. How can an ELISA come back reactive, and then 5 days later, a Uni-Gold come back non reactive? They are both FDA approved AB tests.
While I understand that this is not a forum of MDs or researchers, I was hoping that someone would have a reference to these types of questions. They seem valid questions to me, though perhaps a little advanced for this forum. Again, I was hoping that someone would at least have a link to another site with more detailed technical information.
Thanks again!
from what I have read, it seems that the PCR tests are known to give false positives. I would stick with the AB test from this point forward. It has been well over 6 months since your last exposure, and the results that you receive from any of these FDA approved AB tests at this points are conclusive.
Also, please dont get disheartened by the comments that you read from some of the individuals on this thread. These individuals are not medical doctors and have not had the experience or enough patient exposure in this field to make them experts. If you want more sound advise, you should voice your concerns in the experts section of this forum.
Also, please dont get disheartened by the comments that you read from some of the individuals on this thread. These individuals are not medical doctors and have not had the experience or enough patient exposure in this field to make them experts. If you want more sound advise, you should voice your concerns in the experts section of this forum.
Well thank you! I appreciate your personal opinion. Despite the tone, you are correct: I DO NOT KNOW MUCH IF ANYTHING regarding these issues. Hence the reason for me posting as a question, not a statement.
I am ASKING if anyone here can provide me with reference material regarding these issues, since no one seems to be able to answer the questions I have posed in this forum.
I am not in any way shape or form an expert, or anything close to it. I thought that is why I was asking questions here. If something that I asked, was somehow posed as a statement, it was certainly unintentional, and I can only offer my sincerest apologies.
However, my questions, which I feel are valid and could potentially be of use to at least some people, have yet to be answered. If you are unable to answer them, I would appreciate a reference to someone, or somewhere, that can answer them.
Thank you, and my apologies again if I somehow came across as posing a statement rather than a series of questions.
I am ASKING if anyone here can provide me with reference material regarding these issues, since no one seems to be able to answer the questions I have posed in this forum.
I am not in any way shape or form an expert, or anything close to it. I thought that is why I was asking questions here. If something that I asked, was somehow posed as a statement, it was certainly unintentional, and I can only offer my sincerest apologies.
However, my questions, which I feel are valid and could potentially be of use to at least some people, have yet to be answered. If you are unable to answer them, I would appreciate a reference to someone, or somewhere, that can answer them.
Thank you, and my apologies again if I somehow came across as posing a statement rather than a series of questions.
PCR-RNA are monitoring tests. HIV1 DNA by PCR is used extensively in the United States for rapid results (Exposure after 7 days). The test looks for the DNA signature of HIV. This is not the same as the monitoring tests which is PCR-RNA. HIV1 DNA by PCR is used extensively in the adult entertainment industry as well, and performers in California are required to be tested monthly. They use DNA by PCR, the exact test that I took.
So again, specifically, I took a DNA by PCR and it was reactive. I went back to the same draw station, and had two additional vials drawn. Another DNA, and a ELISA were performed, and both came back reactive. I am expecting the WB tomorrow.
Yesterday however, I took a finger p rick Uni-Gold, and it was negative. Two additional vials were drawn today, at a different location, by a different Phlebotomist, and are being tested at a different lab. I will of course post these result when I have them.
What I was asking is how can these tests have such varying results? What causes these divergent results? Is there one test that out performs another? Is there a possibility that a lab, or draw station, could have in some way been contaminated? Is it possible that the Plasma used in the test kits could be reacting to something in my blood? Are there certain types of supplements (vitamins, minerals, amino acids) that I take that could interact or interfere with these tests? Is there a resource with scientific information available on how these tests are preformed?
So again, specifically, I took a DNA by PCR and it was reactive. I went back to the same draw station, and had two additional vials drawn. Another DNA, and a ELISA were performed, and both came back reactive. I am expecting the WB tomorrow.
Yesterday however, I took a finger p rick Uni-Gold, and it was negative. Two additional vials were drawn today, at a different location, by a different Phlebotomist, and are being tested at a different lab. I will of course post these result when I have them.
What I was asking is how can these tests have such varying results? What causes these divergent results? Is there one test that out performs another? Is there a possibility that a lab, or draw station, could have in some way been contaminated? Is it possible that the Plasma used in the test kits could be reacting to something in my blood? Are there certain types of supplements (vitamins, minerals, amino acids) that I take that could interact or interfere with these tests? Is there a resource with scientific information available on how these tests are preformed?
This question has been asked over and over. PCR-DNA tests are not diagnostic tests, they are monitoring tests for people WITH HIV.
I will most certainly post the results when I get them. Are there any resources available to explain a false positive result? What causes them? Is there possibly something wrong with the lab, or the draw station? Could there be some contamination? Also, what explains a False Positive DNA PCR? I know there are over 3 billion base pairs in the human genetic code. Is it possible that some people's DNA could contain DNA is shared with HIV DNA? I have been unable to obtain any clear scientific answers to these questions. Links are great if you have them. THANKS!
yes mate. Some times life is as cruel as that. I can share your feelings as I had no unsafe sexual life style and yet I was tested positive in two tests and negative in three tests. I consulted three doctors from three different countries and very reliable forums of medhelp, Aidsmeds and The body. All doctors and experienced counselors like Teak, joggen etc declared me conclusively negative based on details of my results. (Teak even asked me to consult mental doctor for my un-necessary worries). False positive are rare but do occur specially in developing countries where testing facilities are not as robust as of USA. Specialists in this forum may like to give reasons of such rare false positive results....best of luck to you.
A positive status is confirmed when both Elisa and WB are reactive
now your chances are good since the uni-gold showed a negative results as false positive is more common than false negative
anyway keep us posted with your results
good luck
now your chances are good since the uni-gold showed a negative results as false positive is more common than false negative
anyway keep us posted with your results
good luck
Also, just in case anyone is interested, as I left it out of the original post, I do not have any symptoms, nor have I had any symptoms, of anything. I am a healthy, caucasian, 5'10", 180lb, 29 y/o male. No weight loss, diarrhea, swollen glands, cough, aches, etc. If this makes any difference, I am not sure. Also, the 2 reactive PCR and the reactive ELISA were all drawn at the same facility, and tested by the same lab.
What would explain 3 false positives? How many people would never think to check again after receiving three positive results? Is this a common issue? What can cause this type of anomaly?
What would explain 3 false positives? How many people would never think to check again after receiving three positive results? Is this a common issue? What can cause this type of anomaly?
if uni gold showed negative you are most probably negative
and the other ones are falls positive
however the Elisa and WB will determine that
good luck
and the other ones are falls positive
however the Elisa and WB will determine that
good luck
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