Teak/Lizze Lou Please Advise Re: Oral Test

Question

Teak, you were kind enough to respond the other day and know exposure (unprotected vaginal).  The question I have now is that I do plan to get a twelve week test. Review I had a 22 day (3wk) and 51 day (7wk) negative blood test followed by 2 OraQuick Advance Oral Swab negatives at 67 days (9+ wks) an 75 days (10+).  My question is that based on the following link I am doubting the Oral Test's reliability.  After my test last week I spoke with a rep from Orasure and she scoffed at any suggestion of it being inaccurate as long as used after 3 months.   http://www.medhelp.org/posts/HIV-Prevention/Accuracy-of-rapid-tests/show/1316320 

I had planned to have a 12 week test done at the same center I had taken the last two and the counselor who has been great suggested I do so (she feels I am safe based on these test results).  However, now I am thinking I should have another blood test.  Are you familiar with Home Access Test, I know it is FDA approved and suggests near 100% accuracy (same as OraSure claims)?  Would this suffice or should I just go back to the original lab I had the 7 week test at which I know is a 3rd generation ELISA after speaking with the lab in Columbus (LabCorp).  Please advise as to your thoughts.  Thank you again for all you do!!!

Teak · Answer

3 months is conclusive oral or blood. 
Oral test is 99.3% Sensitivity 
(98.4-99.7)  99.8% Specificity

veryworried7 · Answer

Uwe, I spoke with both the State of Mass. Hotline and an Orasure Rep and both stated that the oral fluid test was as good as blood and that they use the same technology.  There have been reports of irregularities in S.F., NYC and Seattle but they have not determined a cause.  Some speculation on storage and maybe misuse.  The rep from Orasure scoffed at my question regarding accuracy and stood by the near 100% sensativity number provided use after the window period.  Said if ab's are present the test will detect.  I also read somewhere that the oral test may be 2.5 days behind blood, but can't recall where.  At very least it is a good indicator of status as Dr. HHH said when taken in context with the risk factors many have on here.  For me, it was not enough so I did a blood test this weekend from home access for further confirmation.

Uwe_2010 · Answer

I think people who previously (albeit cautiously) relied on the Oraquick tests are probably looking for more information than 3 months being conclusive. I think it would be helpful if we could find more information on the Seattle study in relation to the timing of false negatives (if that information does exist).

That is, are 6 weeks and 8 weeks still the kind of "magic numbers" or do they too suffer from a potentially 15% false negative rate?

I kind of thought that I might be on to something with the false negatives arising from testing before 4 weeks but maybe not...

Teak · Answer

3 months is conclusive. Period...

Uwe_2010 · Answer

Has this Seattle study been published yet? Do we know the sample size and whether the subjects were testing at all points through the window period?

Obviously, this study has bothered me quite a bit since I tested negative with Oraquick Advance at 47 days. But, then I went back and re-read Dr. HHH's comment on the results of the Seattle study, which comports with Teak's comment above: 

"The concern about sensitivity of the rapid HIV tests, i.e. missing some infections, applies primarily to early HIV infection."

Could it not be then that this 85% rate falls exactly in line with what the good doctors on this forum have already been saying? For instance, I noted that one of the doctors has mentioned that about 90% of the time people will test positive for HIV antibodies - either by mouth swab or by blood - at about 4 weeks.

Could the 85% figure in this study represent a good portion of people who were testing at around 3 and 4 weeks? This would easily explain why there might be around 15% false negatives and it would actually be expected.

If so, it seems that we could still freely rely on the approximate percentages quoted by Dr. Handsfield and Dr. Hook with the use of Oraquick and other methods within the window period (i.e. +/- 90% at 4 weeks, 95% at 6 weeks and 98-99% at 8 weeks)?

Thoughts?

veryworried7 · Answer

Thanks for the information.  I think I will purchase the home access test this weekend and hopefully confirm my previous results.  If so, I think I can put this behind me somewhat and never make such a foolish decision again.  Thanks again and take care.

Teak · Answer

Oral test is 99.3% Sensitivity
(98.4-99.7)  99.8% Specificity

Home Access is: specificity (95% confidence interval 99.6-l 00 %) and 150 of 150 (100 %) of samples were positive in both test algorithms demonstration 100% 
sensitivity (95%confidence interval 97.5- 100 %).

veryworried7 · Answer

Thanks Teak, find it hard to believe the FDA would approve a test only 85% accurate for such an important issue. I know nothing is perfect, but if outside the window period one would expect 97%+ if people's lives are at stake. 84+ days ok for 3 months or would you recommend 90 days? Guess the longer the better, but hate to wait longer than necessary (stress alone has taken several years off my life if nothing else). Thanks again, you are helpful to so many and appreciate your honesty and how you handle yourself.