[Question #4152] need closure

32 months ago
First off thank you Dr HHH and Hook . I have followed you two for years fighting my HIV phobia.  I couldn’t thank you enough for being here for all of us when we have questions.  Here is my situation.   I have taken a couple of Oraquick in home oral swab HIV tests.   I have always tested negative in 20-40 minutes.  On two tests I took them out of developer solution and threw them away, however anxiety got the best of me and I looked at them the next day and both times they would have line/grayish area in T zone.  I figured this is overdevelopment as stated in instructions.  However both times just to be sure I went and had 4th generation lab based blood tests.   They were always negative.   What I am confused by is on CDC algorithm it says “ Laboratories should use this same testing algorithm, beginning with an antigen/antibody immunoassay on all serum or plasma specimens submitted for testing after a preliminary positive result from any rapid HIV test conducted in a CLIA-waived setting ”.  The Oraquick oral swab test falls into that CLIA waived setting category right ?  Then the algorithm says “ None of the assays in the updated recommended algorithm are FDA-approved for use with oral fluid or dried blood spot specimens. Laboratories should follow the 1989 recommendations for using the HIV-1 immunoassay and HIV-1 Western blot approved by the FDA for these specimen types.”   Is that just saying if you want to take a 4th generation lab test you have to use plasma or serum ? I’m just scared that since I had them oraquicks overdevelop and they are Oral fluid tests, that all my 4th generation negative lab tests after don’t matter because I didn’t take the oral western blot .... Can you please give me some help and answer my concerns ?  1) Was my oraquicks just overdeveloped ? 2) Does the Oraquick oral swab rapid test fall into the CLIA waived setting category so therefore the way to confirm is through 4th gen plasma serum lab blood test ? 3) Am I for sure HIV negative ?


Edward W. Hook M.D.
Edward W. Hook M.D.
32 months ago
Welcome to our Forum.  I found your questions a little hard to follow so if I miss the point, please use your up to two follow-up questions to clarify your questions and I will try again.  You don't mention what sort of exposures you are worried about and since different sorts of contact are associated with different sorts of risk for infection, if you'd like to describe your risks I can comment on this as well.  HIV is far, far harder to catch than most people think.

Your first question appears to deal with the accuracy of the OraQuick tests.  These are antibody only tests which, as a generalization are very slightly less sensitive than other tests which use serum or plasma for testing and, because antibody levels may be slightly lower in oral fluid than serum or plasma, tend to take a bit longer, 8-12 weeks to become positive than other types of HIV tests. 

In addition, in the situations you described, that they may have had a line or grayish area in the T zone the day after the test was initially performed is meaningless and represents over-development, NOT infection.  Your negative tests are strong, reliable evidence that you do not have HIV. 

Finally, the instructions that you mention for further testing apply ONLY to situation sin which the OraQuick test is positive.  Since yours were negative (twice !), this recommendation does not apply to you. 

Question 2.  Yes, the OraQuick test is a CLIA waived tests. This designation means that it is easy for a lay person to perform and get accurate results.

Question 3.  Yes, based on the information you have provided, you are HIV negative.

I hope this information is helpful.  EWH
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32 months ago
Thank you Dr. Hook.  It is a true pleasure to hear from you, especially being I have always used your replies from MedHelp to here when I would get in situations.  I truly know I am HIV negative and have anxiety and its just a phobia of catching HIV.   I just got a couple more questions to help me understand.   Lets just say someone did have a true positive Oraquick oral swab in home hiv test, with the new recommendations from the CDC the correct way to confirm now is to go for a blood 4th generation lab based test.  If that is negative , it confirms that the Oraquick rapid oral swab hiv home test was a false positive ?  Is this correct .. I have read the recommendations and I believe that is correct, however it just was concerning because it says " none of the tests in the recommended algorithm are FDA approved for dried blood spots or ORAL FLUIDS ".  So that just had me thinking that since the Oraquick is an ORAL FLUID test that someone couldn't use the new recommended algorithm with a 4th Generation Blood test.  I just want to make sure I understand that right.  So my questions are as follows and if I understand this correctly I will move on because I trust you more than you will ever know.

1) If someone was to have a positive Oraquick oral swab hiv in home test, the correct way to confirm since the new CDC algorithm came out in 2014 is to go have a blood based serum/plasma 4th generation lab test and if it is negative , it indicates that the oraquick rapid test was a false positive and they can consider themselves Negative without any further testing. 

2) When they say " The test in the recommended algorithm is not FDA approved for oral fluid or dried blood spot specimens , that just means that when using the 4th generation test , you have to use serum/plasma specimens ? 

Thank you so much Dr Hook , I look forward to your reply. 


Edward W. Hook M.D.
Edward W. Hook M.D.
32 months ago
1.  Correct, a positive OraQuick test should be confirmed using a second test such as a 4th generation, combination HIV antigen/antibody test. If the confirmatory test is negative, the OraQuick test is likely a false positive.

2. Correct.

EWH
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32 months ago
Ok I know I’m on my last question but please verify.   I know I am negative and my oraquicks were just overdeveloped.  However I was asking just to get clarification about if someone was to have a positive Oraquick oral swab hiv home test..  The CDC says if the 4th generation is negative after a positive result from any rapid test , then no further testing is needed and the rapid test would be false positive ...

I value your answer but could you please verify what you meant by the Oraquick would “LIKELY” be a false positive if the 4th generation blood test is negative ?

I’m sure it’s just my anxiety stuck on the word likely but I’m so close to having this final question answered and me being able to finally breathe.  I just want to make sure that the Oraquick would for sure be considered a false positive rapid test if the 4th generation blood test is negative after someone receives a positive Oraquick oral fluid swab home test  .. 

 1).  If it would only LIKELY be a false positive Oraquick after a  receiving a negative 4th generation blood lab based test, what would it take to be SURE the Oraquick is a false positive so they could move on knowing they are HIV negative... 

Thank you Dr hook for your time.  I truly hope you can explain that for me. I know this is my last reply per your rules , so thank you for your time.  I will be waiting patiently for your reply.  

God Bless, 


32 months ago
Sorry I never told you my risk which was just unprotected vaginal sex.  I am a male.   This episode was in late 2015.  The overdeveloped oraquicks were in 2016, then were followed by the 4th generation blood tests from 2016 till 2018 ( many of them... All 4th generation lab blood  tests were negative )    Like I said Doc, I know I’m HIV negative but it would just help me out a lot to make sure that “ IF someone had a real life positive Oraquick oral swab home hiv test , the Oraquick would definitely be considered a false positive rapid test if they went on and took a lab based 4th generation blood test and that was Negative?   Then no more testing would be needed ?? ... just want to make sure I understand.....The word LIKELY just had me a little concerned.    Sorry for writing again but I just seen where u asked about my exposure so wanted to fill you in.   I’ll pay extra if I broke the rule.  I just wanted to make sure I answered your question I didn’t see at first about what my exposure was.  
But the only question I need answered is 

 1).  If it would only LIKELY be a false positive Oraquick after a  receiving a negative 4th generation blood lab based test, what would it take to be SURE the Oraquick is a false positive so they could move on knowing they are HIV negative... 

God Bless.  
Edward W. Hook M.D.
Edward W. Hook M.D.
32 months ago
Thank you for the additional information.  It is helpful and as not present in your earlier questions.  With multiple follow-up negative 4th generation tests, you can be confident that you were not infected in the low risk encounter that you describe. 

Your follow-up question was repetitive.  When you asked " I was asking just to get clarification about if someone was to have a positive Oraquick oral swab hiv home test..  The CDC says if the 4th generation is negative after a positive result from any rapid test , then no further testing is needed and the rapid test would be false positive." I said this was LIKELY to be correct.  and that is the answer.  In your case, I am confident that his is the case but when you ask a general question, you will get a general answer.  In unusual circumstances (but not yours) such as in persons who took PEP after exposure, further testing MIGHT but would not usually be needed.  I will presume that this repetitive, anxiety-driven question is a manifestation of your phobia.   You need to believe your test results.

This ends this thread which, as per Forum guidelines, will be closed later today without further replies.  Take care.  EWH


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