Amplicor HCV Test version 2.0

[hipps]

I have done my last PCR using Amplicor HCV Test version 2.0. This PCR is 1 year after tx. At 6 months I was svr. Now, first non oficial results are in "grey zone". First I was freaked out, but this PCR will be repeated to confirm or deny this odd results. Now, I am searching all over the net in pursuit for some explanation of "grey zone". Please, please could you help me with some additional advices and knowledge of yours?
Thank you guys, thank you a lot,
cheers, hipp

[marso]

hi mike! ite me again. how are you doin, you seems to be busy those time i dont see you posted, hope you're fine!

i find hard time to post a question so that all will be able to join but i wont waste time that's why i just try to look for your post im pretty sure you wont hesitate to give me some advice.

i just wanted to ask about my hubby's situation, most of the time he's experiencing something like fever or hot around inside his stomach due to that he also has bumps inside his mouth & tongue, those staff really made him upset all the time. the dr. prescribe zantac to take every time he feel some hot in his stomach & mouthwash like lestirine for the bumps. but all those things doesnt work at all, we're just waisting money for those staff.

hope you may find time giving me some advice regarding these matters, thanks a lot again!!!

God bless you :-)

= Mitch

[jmjm530]

Thanks Mike. My doctor and nurse tend to agree with your thoughts regarding very early relapse. When most people say "I relapsed at six months" what they really mean is they were positive on the six month test. In fact, they likely were positive in the first couple of weeks after treatment.

For this reason, I can't understand why doctors wait so long to test post treatment. The argument that only a six-month negative is predictive of SVR means little, because any positve PCR -- 2 weeks, 4 weeks, whatever -- is 100% predictive of relaspe.

Wouldn't many folks like to know a relapse status sooner than later so they can make future plans, perhaps incorporating re-treatment into them. I certainly would.

Anyway, my 2 or 3 week negative (3 weeks from the peg shot) took away about all of my immediate anxiety but I understand that the 3 and 6 month will tell more of the story. I may do one in a few weeks (that would be a six-week) as well. Personally, I do have to make some business and other plans should I know I'm re-treating -- not to mention researching and keeping on top of newer trials, etc --  so for me, the sooner I know the better.

-- Jim

[mikesimon]

I've been busy and not been around much so I just now saw your early Heptimax results. I think it bodes very well for you Jim. I know that it's early but I went from undetectable to 6.8 miliion IU/ML in about the same amount of time(26 days post) so the virus can and often dose replicate fast. This doesn't seem to be widely known because so few people test this early. The fact that you don't show any virus at all is a positive predictor, I think. Good luck. Mike

[jmjm530]

Miss said: His reasoning was that it really wouldn't matter because it "wouldn't change his treatment plan
-------------------------------------------------------
Another arrogant doctor, par for the course :) What about YOUR plan? Not important, I guess.

Maybe you'd like to know earlier, to get your ducks in a row if you need to re-treat? Like insurance, job and other financial issues. Or, maybe you'd like to know earlier, so you can plan that trip around the world you promised yourself if you're non-detect. Or, maybe you just want to know because not knowing is going to stress you out. Or, maybe you DON'T  want to know for quite some while like one of our former members, Willing who waited two years.

The point is, it's YOUR treatment and should be YOUR decision as long as what you're asking for is reasonable. Reasonable to me these days is a four-week, 3-month, 6-month and 1-year sensitive PCR or TMA. A one-month negative correlates around 90% with SVR, the 3-month around 98-99%.

If your doc, absolutely won't do a PCR before six months, I see no reason, why you can't find another doc who will -- perhaps your PCP?

Again, the issue isn't if you NEED a PCR before 6-months, the issue is that if you reasonably want one, you should have it.

-- Jim

[MissMiss]

Thanks Jim.  All good advice and I will take it to heart.

Oh, the molar.  Dang, you got good eyes!

miss

[jmjm530]

Seriously though. I think if you tell him you have important plans financial/work plans hinging on whether you clear or not -- and therefore want to know ASAP versus waiting six months -- hopefully he will go along. If he says the early tests are non-conclusive for SVR, tell him an early positive test is 100% conclusive for relapse. It may be hard, but try not to smirk when you say it :) Some of these docs are such jerks. Fortunately mine is even more test crazy than me. A match made at Quest labs :)

-- Jim

[jmjm530]

Miss said: Were you just inside my head and found all that reasoning jumbled all around
---------------------------------------
No. But I did find a cracked molar that may need a filling.

[jmjm530]

Do you know the sensitivity (level of detection) of your Quest TMA? The only one I could find had a level of detection of 10 IU/ml. It was called "Hepatitis C Viral RNA, Qualitative TMA" Also, how long does it take you to get the results back?

[MissMiss]

Well put.  Thank you.  Were you just inside my head and found all that reasoning jumbled all around?  lol

Thank you.  I will be a bit more aggressive at the next visit.

miss

[Mister beagle bailey]

I'm in Fl. but will turn to NY on Mon.  The results are in NY but it took 5 days to get the test back.  I could be wrong but I don't remember seeing the word TMA mentioned.

Having a problem today.  My right ankle is swollen, have used a ice pack and took a mild water pill today.  Do you have any feed back?

Beagle

[GoofyDad]

PCR is <50 and TMA is <5-10. Would have only done the TMA, but I was stressing, and the PCR comes back quickly. Feeling more mellow now that abdominal pangs are mostly gone and enzymes were relatively low.

Interestingly, glucose was a bit high. I've seen that before. I guess with a whacked liver, abnormal blood sugar comes with the package.

[jmjm530]

Sounds like Quest? Is the TMA a qualitative, meaning it will only give a positive or negative?

That particular combination -- sensitive PCR with very sensitive qualitative TMA is an excellent choice post-tx and probably has some advantages over Heptimax, including being processed sooner, with one doctor telling me he thinks the Quest qual TMA has less false positives than the tma portion of Heptimax.

I still continue with Heptimax mostly for consistency and because it's on my docs req forms. If your tests are Quest, can you post the Quest test codes if easily available. Tired of waiting 1-2 weeks for my Heptimax results.

-- Jim

[Mister beagle bailey]

As I posted before, my dr. wouldn't do the heptimax as he felt there was a chance of false / positive results which he saw a few years ago with a test that was out for a while and was discontinued because the test was not consisitent.
He uses Quest but the qualitative one only.

Beagle

[GoofyDad]

The codes I have are not Quest proprietary codes, they are printed on the Clinic's in-house lab order form.. I think the coding is standardized accross the industry though.  

TMA: 21485 (Bayer)
PCR: 20015

My PCR takes a few days, TMA takes about a week.

[MissMiss]

I gotta say my heart goes out to those relapsing.  That has to be very, very tough.  D*** this virus has taken enough of our lives.

As long as we are talking about PCR's, etc. my doc told me at 24 weeks that he would not order another pcr until 6 months after treatment end.  I am on about week 30 of 48 now.  I don't really now feel comfortable with that.  His reasoning was that it really wouldn't matter because it "wouldn't change his treatment plan".  Any comments would be appreciated.

miss

[GoofyDad]

My TMA goes down to 5-10 iu. Its qualitative. I thought they all were.

[Mister beagle bailey]

My test had the positive or neg. which is the qualitative by Quest.

beagle

[jmjm530]

Not all. The Heptimax uses TMA technology in its second phase but is quantitative. In other words, you can get a real number between 5 IU/ml and 50 IU/ml -- as opposed to just a positive or negative. The link to Quest's menus I posted above showed a TMA qualitative that goes down to 10 IU/ml -- I assume then that's what you're using.

[jmjm530]

That's the problem -- all the docs have their own special codes that don't seem to match up to the ones on Quest's site.

Do either of you know the sensitivity of your TMA? Also is it a true qualitative meaning just a positive or negative result, or do you end up with a number as in Heptimax where the TMA is quantitative but uses TMA technology?

Maybe Quest's Hep C menu will help. As you can see, there are quite a few.
http://www.questdiagnostics.com/hcp/topics/heptimax/files/hep_c.pdf


-- Jim

[hipps]

Thank you & god bless you...all for your support and help.
Cheers.

[jmjm530]

No. It doesn't mean you have any virus at all.

I'm pretty sure what it means is that they simply have to run the test again for a technical reason, which apparently happens a lot.

If the repeated test comes out negative -- which I'm sure it will -- then that means you absolutely do not have the virus, are not contagious and therefore cannot spread it to your family or anyone else.

And the fact that you then would have tested negative at both 6 and 12 months means your chances of remaining undetectible are close to 100%.

I know from experience it's tough to wait out a test result, but I really don't think you have anything to worry about.

-- Jim

[hipps]

Does it mean I have some viral load (small amount of virus)? This small amount of virus will remain forever? I ask you this because I have family and now I am considered about spreading it :-( ...
Thanks again and again...

[jmjm530]

It sounded to me that it's just part of the protocol, where a certain per cent will always test grey. Not an error. But again, your chances statistically of being positive at one year after negative at 6-months is maybe only 1%. In fact, the definition of SVR is non-detectible at 6 months and some people never test further.

[jmjm530]

Curious, what is the range then of your PCR and TMA respectively? Also, is there a reason your team doesn't use Heptimax which does the same thing -- combo PCR and TMA.