Intended Use
The APTIMA® HIV-1 RNA Qualitative Assay is an in vitro nucleic acid assay system for the detection of human immunodeficiency virus (HIV-1) in human plasma. It is intended for use as an aid in the diagnosis of HIV-1 infection, including acute or primary infection. Presence of HIV-1 RNA in the plasma of patients without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection.
The APTIMA HIV-1 RNA Qualitative Assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 antibodies.
This assay is not intended for use in screening blood or plasma donors
Would that test along with a 3rd generation antibody test together being non reactive be conclusive at 28 days after the incident?
No, there are no tests approved to give a conclusive negative test result earlier than 3 months post exposure.
I paid for those test thinking it would be conclusive. Well now I want to get the appropriate test. The problem is that although I have heard people explain how they had a reactive antibody test at only 1-2 months from their exposoure, I also heard people explain they had a non reactive test at 3 months and then test again at 5-6 months with a reactive test. Every single one being generally healthy. Would you consider this true?
Won't even entertain the thought, you were already advised as when to test to obtain your conclusive test result.
Thank you for your advice. It seems I have to wait a while to test again. The truth is that I'm scared and worried.
So the hiv rna aptima is used as an aid for diagnosis of hiv infection, including acute infection and to confirm when reactive. It is not a stand alone test and a negative result does not proclude the posibility of infection.
Would u ever recommend this test and if so in what situation?
Not for normal testing. When a person has had a true exposure an keeps collecting indeterminate results then yes a the APTIMA HIV-1 RNA Qualitative Assay might be considered.
The CDC say the RNA has a window period of 9 to 11 days because it does,it's the most accurate HIV test there is.
Not approved to diagnose HIV by itself and has been stated there is only ONE PCR-RNA test that is approved for supplemental use.
It's a screening test and a confirmatory test aswell
Wrong. READ THE VERY LAST SENTENCE OF THE SECOND PARAGRAPH
Intended Use
The APTIMA® HIV-1 RNA Qualitative Assay is an in vitro nucleic acid assay system for the detection of human immunodeficiency virus (HIV-1) in human plasma. It is intended for use as an aid in the diagnosis of HIV-1 infection, including acute or primary infection. Presence of HIV-1 RNA in the plasma of patients without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection.
The APTIMA HIV-1 RNA Qualitative Assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 antibodies.
This assay is not intended for use in screening blood or plasma donors.
They use the RNA to screen blood donations to the red cross here in Australia--I know that for a fact.
Not approved for screening don't doesn't matter if it's is in Australia or ten buck two.
Thanks rainlover. Thanks teak. There has been a lot of confusion caused by what is stated on the cdc for rna testing. One thing I found out is that the professional porn industry in California is using the hiv aptima to screen their performers. If you google "aphss aptima" you will get the whole scoop. They won't allow anybody with out a recent aptima negative result perform.
Well anyways I'm very interested in what both of u are saying. Rainlover I hope you are right about the rna test being the most accurate. Considering I took it 28 days.
Teak you mentioned there is only one pcr-rna approved for supplemental use. U r talking about the aptima, correct?
Correct, it is the only PCR-RNA test approved to help with diagnosing HIV-1.
and Teak, just for reference, the Aptima PCR-RNA should be taken along with an antibody test anytime AFTER 3 months, right?
reason why im asking is because i didnt see the timeframe on the FDA guideline for when the APTIMA is accurate... other HIV test generally tell you when to test like ORAQUICK ORASURE and others...
If you read through the aptima package insert u will find somewhwhere along the line that it starts to become very sensitive at 30 copies/ml.
i read that it can read 20 copies/ml to 1,000,000 copies/ml
Thats not true at all--an RNA test is a NAAT test which is used to screen blood donations
im not debating that the RNA is a NAAT ... what i am implying is that it is very sensitive that it can read levels as low as 20 copies per ml... sometimes it does give false positives. although false negatives are rare... u can however have undetectable levels as do some HIV+ individuals...
in any sense, my question was about the window period for the RNA test. and please dont give me the 9-11 day BS... give me a from this day to this day answer... like the antibody test is between 2 weeks to 13 weeks...
The window period for an RNA test is 9 to 11 days--thats what the CDC says--take it or leave it.