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Can I trust the OraQuick home HIV test?

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Posted on Sat, 23 May 2015
Question: Please assess my situation (I need the answer from an HIV Specialist);
9 months ago I have an unprotected sexual relation with a girl that I didn’t know. 28 days later I went for a routine check out with my doctor and I asked for an HIV test. The result of this test was:
•     ICMA Abs: Reactive >1.49
•     QUAL Abs: Abnormal-Repeatedly Reactive
•     Supplemental Multispot HIV TEST (Differentiation Test HIV-1/2): NON Reactive for Both HIV1/2 (I was told the labs in the USA don’t use the western blot any longer)

The recommendation was for me to get an RNA Viral Load Test. I couldn’t find a place to perform the RNA test at that time, so a week later (35 days) I did the following test:
•     ECLIA COBAS HIV Test: NON-Reactive
At this time I was ok and I heard it was a false positive. But later I start having pain on the neck on the nodes and also I got obsessed with a white tongue. So I went and did the following test at 161 days:
•     RT-PCR-RNA Test: <20 Copies/ml

Then I still concerned and feel like I still having weird symptoms on my body so I went and did the following tests:
•     ORAQUICK Home Oral Swab Test (180 days): NEGATIVE
•     ORAQUICK Home Oral Swab Test (181 days): NEGATIVE
•     ORAQUICK Home Oral Swab Test (189 days): NEGATIVE
•     ORAQUICK Home Oral Swab Test (280 days): NEGATIVE
I still concerned. Here are my questions I need answered:
1)     Does my first test was a false POSITIVE?
2)     What is the window period for the Multispot Test and how good it is?
3)     What is the ECLIA test? Is this a 4th Generation or 3rd Generation Test?
4)     Does the RT-PCR-RNA test reliable and accurate?
5)     Can someone have detectable viral load at 161 days?
6)     What the <20 copies/ml means? NEGATIVE?
7)     How accurate is the ORAQUICK Home Oral Fluid Test?
8)     Can I trust the ORAQUICK Home HIV Test?

Thanks
doctor
Answered by Dr. Sheetal Verma (5 hours later)
Brief Answer:
As for now you are negative. Repeat test at 6 months.

Detailed Answer:
Hi,

Thanks for your query at HCM. I understand your concern and situation. I am a microbiologist experienced with infection and HIV. Therefore I shall take this XXXXXXX to address your questions.

Yes it seems your first test was false positive. The Reverse transcription of RNA, followed by real-time polymerase chain reaction (PCR amplification of cDNA Reportable range: 20–10,000,000 HIV-1 RNA copies/mL (1.30-7.00 log copies/mL). As in your case it is negative as copies are below the detectable levels. PCR has higher sensitivity 99.99% after 6 weeks than other tests which you have got done which have sensitivity 97% and above after12 weeks. Multispot test detects HIV 1 and 2 antibodies. It is rapid test less sensitive than PCR and 4 th generation ELISA. More reliable after 3-6 months. ECLIA test is 4 th generation ELISA which detects both p24 antigen and antibodies for HIV. It is reliable after 12 weeks about 97% sensitive and sensitivity increases with days maximum after 3 months. Yes RT PCR is a very reliable test 99.99% after 6-7 weeks. Yes people can have detectable loads at 161 days. Less than 20 copies means negative. Oraquick is rapid format tests which is not as reliable as PCR and ELISA. According to international guidelines any suspected patient even with non reactive results must be confirmed at 6 months with 4 th generation ELISA. For skin and tongue infection they can be related to STD and you can visit a dermatologist. Practice safe sexual practices in future. Eat healthy and protein rich balanced diet with multivitamins and calcium supplements.

Hope I have answered all your questions. Let me know if I have missed any of your questions.
Take care
Best of health

Dr. Sheetal Verma
Above answer was peer-reviewed by : Dr. Prasad
doctor
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Follow up: Dr. Sheetal Verma (3 hours later)
Thanks, for answering Dr.

So I am at the 9 months mark and starting at 6 months I have 4 negatives Oraquick tests all away to 9 months, does this not enough?

Questions:

1) I though 4th generation tests were conclusive after 28 days because it detects the P24 antigens before IgM and IgG antibodies?

2) If the first test was a real positive at 28 days, and since it was a third generation, then the Eclia tests at 35 days should be positive also. Is this correct?

3) what are the possibilities of having 4 Oraquicks false negatives after 6 months? And what could cause this false negatives?

4) I though the international guidelines and CDC says that after 3 months any HIV negative tests is conclusive. Why you are suggesting another 4th gen test now at 9 months?

5) from what I have read, the first marker that appears for the HIV on the blood is RNA, then P24, then IgM antibodies and then IgG antibodies. RNA and IgG are the only ones that stay detectable after 3 months, why are you suggesting a 4th Gen test now at 9 months? You got me confused now.

Thanks.
doctor
Answered by Dr. Sheetal Verma (1 hour later)
Brief Answer:
If non reactive between 3-6 mths by ELISA- Negative

Detailed Answer:
Hi
Well come back.
In your case as 9 months have already passed so there is no need for any test. As in your case the test of 4 th generation ELISA was negative at 6 months it is considered conclusive and no further tests recommended. Yes you are right 4 th Generation ELISA is superior to 3 rd generation ELISA. In the blood firstly RNA appears, then p24 antigen, IgM antibodies and then Ig G. The HIV RNA and Ig G persists thereafter. The 4 th generation cannot be said conclusive at 28 days, they are conclusive after 12 weeks. Yes if you were true positive then both 3 rd and 4 th generation tests would be positive. Oraquick test is a screening test. It needs to be supported by other confirmatory tests. CDC recommends 3-6 months testing after exposure. If you have got 3 or 4 th generation ELISA test done between 3-6 months or beyond and it was negative means that you are negative for HIV.

Take care
Above answer was peer-reviewed by : Dr. Pradeep Vitta
doctor
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Follow up: Dr. Sheetal Verma (48 minutes later)
Thanks for answering.

Does a 2nd generation screening test at 6 months or after is conclusive?

As I understand the FDA approved the ORaquick to be conclusive at 3 months and unless the Oraquick is positive a confirmation test is not needed, Correct?

I did not have any 4th or 3rd Generation Test done at 6 months (I didnt said this), I did have four Oraquick tests (three at 6 months and one at 9 months).

What can cause false positives results? I did get food poison or somekind of virus with bad diarrheas two weeks before the test.

During the first false positive test I also did a CBC and this was the result:
- WBC 8.20 (normal)
- RBC 5.28 (normal)
Everything was normal but the following:
- EOS 7% (high)
- BUN/Ceatine 22 (high)
- Lipase Serum 66 (high)

Anything to be worry about this? Thanks
doctor
Answered by Dr. Sheetal Verma (16 hours later)
Brief Answer:
Take a 3 or 4 th generation test.

Detailed Answer:
I understand your concern and situation.

I must tell you whether you got tested by oraquick it is just an screening method with only 92% sensitivity but specificity is 99.99% meaning that a negative test when tested by confirmatory test is likely to be same result. But false positives can occur due to drugs, autoimmune diseases, cross reactivity with other viral infection, etc. Therefore such tests needs to be confirmed by a 3 or 4 th generation ELISA. In your case as you have not taken the test at 6 months. There is no problem you still can take the tests and clear your doubts. Your reports are normal. No need to worry.
Above answer was peer-reviewed by : Dr. Prasad
doctor
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Follow up: Dr. Sheetal Verma (12 hours later)
Now you got me confused. You said that the RT-PCR-RNA is 99.9% accurate after 6 weeks, if yes, then why I will need more tests???

In addition, I called the Oraquick help line and they told me that if I followed the instructions correctly, the test is 99.9% accurate, and that is the same as having a blood test from a lab. In additon, if the test is NEGATIVE theres no need for a confirmatory test. This will be only for a positive test.

What are the possibilitites of having 4 False NEgatives Oraquick Tests after 6 months and up to 9 months?

What is the accuracy of the MULTISPOT Confirmatory Test at 28 days?? (you did not answer this question on my first set of questions to you)

You got me confused also with the ECLIA 4th Generation test. You saud it is a 4th Generation test. What I have read is that the 4th Generation tests are conclusive at 28 days and beyond becasue it can detect P24 antigens erlier than antibodies.

My first false positive test was a 3rd generation test which only looks for antibodies, so if antibodies are present at 28 days, then they should be present for life. Is this correct??? Then if this is correct, the 4th generation ECLIA test that I took later should also be positive and also all 4 Oraquick tests at 6 months and 9 months.

- 3rd Generation Tests Looks for: IgM and IgG antibodies
- 4th Generation Tests Looks for: p24 Antigens and IgM and IgG antibodies
- 2nd Generation Tests Looks for: IgG antibodies only (Oraquick)

Please answer ASAP. Thanks
doctor
Answered by Dr. Sheetal Verma (45 minutes later)
Brief Answer:
Guidelines suggest 3/4 th generation after 3 months.

Detailed Answer:
Hi
Don't be confused. It is correct that test HIV PCR TEST has 99.99% sensitivity, ECLIA test is also highly sensitive. Oraquick company definitely claim there test to be highly sensitive. But clinical trials have shown sensitivity of 92%. The international guidelines suggest 3 or 4 th generation tests still for confirmation between 3-6 months. Oraquick is rapid test which is only screening test. If you have taken any ELISA TEST whether 3 or 4 th generation after 3 months then no need for further tests. If not tested another test is recommended. I suggest you to do accordingly. Rest I leave the decision to you.

Take care
Above answer was peer-reviewed by : Dr. Raju A.T
doctor
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Follow up: Dr. Sheetal Verma (22 minutes later)
Dr. I have to pay again becasue you didnt answer all my questions.

Do you read my first post?????

I will repost again:

9 months ago I have an unprotected sexual relation with a girl that I didn’t know. 28 days later I went for a routine check out with my doctor and I asked for an HIV test. The result of this test was:
• ICMA Abs: Reactive >1.49
• QUAL Abs: Abnormal-Repeatedly Reactive
• Supplemental Multispot HIV TEST (Differentiation Test HIV-1/2): NON Reactive for Both HIV1/2 (I was told the labs in the USA don’t use the western blot any longer)

When you test for HIV and have a Repeatedly Reactive test result, the lab is supposed to do a confirmation test before confirming a positive. Since Western Blot is no longer recomended by the CDC, my lab used the new recommendation which is a MULTISPOT test, as you can see above, it was NEGATIVE for both HIV 1 and HIV 2. Now, the next step was for me to do a RNA test, which I did at 161 days and it was NEGATIVE (<20 copies/ml). So I did what is recomended by the Lab and CDC.

What are the reasons (technical and medical) that I need to retest again?

Again, do you know what the MULTISPOT tests is???

HOw accurate it is??? and How is compared to the Western Blot???

also, how sooner than the Western Blot this test will be positive???

I NEED you to answer ALL my questions above.

Thanks.


doctor
Answered by Dr. Sheetal Verma (54 minutes later)
Brief Answer:
Unigold oraquick test recommended.

Detailed Answer:
The Multispot HIV-1/HIV-2 rapid test received FDA clearance on 12 November 2004 for use in the ection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. HIV blood antibody testing is used to diagnose HIV infection by using a two to three-tiered testing protocol. First, a 4th generation screening test for HIV-1and 2 antibodies, and p24 antigen is performed, using a chemiluminescent microparticle immunoassay (CMIA) , or a 3rd generation immunochromatographic card assay is used. If positive, then a second test is done, using a rapid immunoconcentrating assay (Biorad Multispot). The Multispot assay replaces the previously used immunoblot ( "Western" blot). If both the screening test and the Multispot test are positive, then the overall test result is termed positive. The Multispot assay can differentiate between HIV-1 and HIV-2 antibodies, something not possible with the prior Western blot assay. If the Multispot assay is negative or indeterminate then a "deal breaker" nucleic acid amplification ("HIV confirmatory viral load") assay must be performed to determine the final result.The screening tests are highly sensitive and specific in but still can lead to many false-positive tests depending on the chances of the test population being HIV infected, and false-negative tests in very early infection. When a second test is performed on EIA-positive specimens, the combination of both tests being positive is very specific. The nucleic acid amplification test is performed when the screening test is positive and the Multispot assay is negative or indeterminate.
Now coming to your case initial HIV screening was positive but confirmation with HIV MONOSPOT was negative. The diagnostic HIV viral load was less than 20 copies meaning HIV indeterminate. Therefore repeat testing and infectious disease consultation is needed. The repeat testing must be by Unigold oraquick. Therefore I'm recommending you for a repeat test. But if multiple testing with oraquick is negative chances of negative test is high. Therefore for your mental satisfaction I was suggesting you for repeat test. But you can go with your test results if Unigold test not available. I was insisting test as your was a unique case in which initial results were repeatedly positive not once.

Take care.
Above answer was peer-reviewed by : Dr. Neel Kudchadkar
doctor
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Follow up: Dr. Sheetal Verma (30 minutes later)
Dr. with all the respect, you dont know what you are talking about. I will encourage you to visit the CDC website and the WHO latest testing guidelines and get familiar with this information before answering clients their questions:

The current CDC HIV Guideline say that any "repeatedly reactive screening test" should reflect to a confirmation test, in this case Multispot since Western Blot is no longer used. If Multispot is NEGATIVE, then a Deal BReaker, a RNA test is performed. If the RNA is NEGATIVE, the overall result is considered NEGATIVE for HIV and not indeterminate like you said.

My concern is that I performed the RNA test 133 days after the first test and I dont know if this will be accurate at this time.

Theres is NO sush test as a "UNIGOLD ORAQUICK" theres either Unigold or ORAQUICK, two different tests.

I dont htink you have any experience with HIV testing or with the related guidelines to be answering this type of questions...

doctor
Answered by Dr. Sheetal Verma (8 hours later)
Brief Answer:
Best of health

Detailed Answer:
Hello again

Your HIV PCR was showing less than 20 copies therefore it is interpreted as indeterminate and not negative. Therefore further tests are recommended. If in your case oraquick was negative so you may consider your case as negative. Sometimes to be cautious we recommend further test. Guidelines are General recommendation. Doctors have the rights to individualize there clients if they feel so. Doctors always want to do best for their patients. Just because of your test results I suggested unigold test. There was some typing error. Oraquick is rapid test. Therefore to be on safer side and your PCR indeterminate I was requesting you for one more ELISA TEST.

I leave the decision to you.

Best of health
Above answer was peer-reviewed by : Dr. Yogesh D
doctor
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Follow up: Dr. Sheetal Verma (1 hour later)
The RT-PCR-RNA test that I did was the COBAS Roche Taqman Version 2. The limit of detection is <20 and my result wa <20. My doctor interpretation and report to me was Negative ad not indeterminate. Please explain why you insist on additional test. How many copies of virus an infected person will have at 5 months without being on treatment. Could be less than 20 copies? My understand is that at 5 months one should have thousands of copies.
doctor
Answered by Dr. Sheetal Verma (10 minutes later)
Brief Answer:
No further test recommended.

Detailed Answer:
I understand that the detection limit of your test done RTPCR was only up to 20 copies in that case there is no need for further tests. Actually now we have RTPCR which can have lower detectable limit. In that case you are HIV negative and no further tests recommended.

Take care
Above answer was peer-reviewed by : Dr. Yogesh D
doctor
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Follow up: Dr. Sheetal Verma (7 hours later)
Ok, thanks.

You didn't answer my question.

Can people with HIV and not in treatment have <20 copies of RT-PCR-RNA at 5 months after infection?

Thanks.
doctor
Answered by Dr. Sheetal Verma (10 minutes later)
Brief Answer:
See detailed answer.

Detailed Answer:
Hi
After building up in the lymph nodes, HIV burst out into the blood stream and infects other parts of the body. The amount of HIV throughout the body (viral load) reaches very high levels (often millions of copies/mL after seroconversion. Sometimes it has been reported few patients seroconversion is delayed in that case they may exhibit low levels.

Take care
Above answer was peer-reviewed by : Dr. Vaishalee Punj
doctor
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Dr. Sheetal Verma

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Practicing since :2001

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Can I trust the OraQuick home HIV test?

Brief Answer: As for now you are negative. Repeat test at 6 months. Detailed Answer: Hi, Thanks for your query at HCM. I understand your concern and situation. I am a microbiologist experienced with infection and HIV. Therefore I shall take this XXXXXXX to address your questions. Yes it seems your first test was false positive. The Reverse transcription of RNA, followed by real-time polymerase chain reaction (PCR amplification of cDNA Reportable range: 20–10,000,000 HIV-1 RNA copies/mL (1.30-7.00 log copies/mL). As in your case it is negative as copies are below the detectable levels. PCR has higher sensitivity 99.99% after 6 weeks than other tests which you have got done which have sensitivity 97% and above after12 weeks. Multispot test detects HIV 1 and 2 antibodies. It is rapid test less sensitive than PCR and 4 th generation ELISA. More reliable after 3-6 months. ECLIA test is 4 th generation ELISA which detects both p24 antigen and antibodies for HIV. It is reliable after 12 weeks about 97% sensitive and sensitivity increases with days maximum after 3 months. Yes RT PCR is a very reliable test 99.99% after 6-7 weeks. Yes people can have detectable loads at 161 days. Less than 20 copies means negative. Oraquick is rapid format tests which is not as reliable as PCR and ELISA. According to international guidelines any suspected patient even with non reactive results must be confirmed at 6 months with 4 th generation ELISA. For skin and tongue infection they can be related to STD and you can visit a dermatologist. Practice safe sexual practices in future. Eat healthy and protein rich balanced diet with multivitamins and calcium supplements. Hope I have answered all your questions. Let me know if I have missed any of your questions. Take care Best of health Dr. Sheetal Verma