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Avatar universal

more sensitive pcr

i went to labcorp a few months ago to get the more sensitive test
(down to 2) but i didnt do my homework and did not have the actual test code number
for their computer. they automatically just gave me the quantasure plus which only has a sensitivity down to 10.
what a disappointment. quantasure plus, this is their version of the heptimax except only half as sensitive  but same price range. in search of the better test i finally got through to someone at their office and they found the test
listing, its called NGI quantasure, code # 140639. its range is small, 2 million to 2. it is designed for tissue transplant testing. hepatitis patients and their docs dont normally ever request this. it is also twice as expensive a $714. if this exact code is not specified by your doc you will not get this test. maybe ill make it in this week
to get it and if im lucky i can say im more undetectable than you regular blokes!
in the practical world i dont know if this is justified or even meaningful but i know it would make me feel better so thats good enough by itself. it might also be interesting and revealing to see fluctuations between 4, 3, 2 and less then 2. especially towards the end of the shot cycle were the interferon has dissipated from our system. ive never seen anyone on the forum with these test results and they might show us things we can never see from the heptimax down to 5.
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Avatar universal
LOL!!! Hope your back is getting better and Happy Holidays!

jasper
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Avatar universal
Getter: other than cost what is the better test/tests to get through out treatment in your assessment?"
-------------------------

Best to answer two ways -- because to be honest, if I were new to treatment I wouldn't have a clue what most of this thread is saying, including most of what I wrote previously in the thread.

So the first option I'll call the "simple solution" and the second the "more complicated solution". But frankly, not sure if at the end of the day, if  one solution is any better than the other in terms of treatment decisions, which is the main concern for us.

I'll also add that the following is just how I see things, and I'm sure would be answered in part differently by other members here. For more discussion, simply read this thread in its entirety.

The third option, of course, is simply to let your medical team order what tests they're comfortable with. If you're seeing a good hepatologist this should not be a problem, although personally, I think that looking over their shoulder isn't a bad idea. Mistakes are probably made in every office, even the good ones.  

SIMPLE SOLUTION

In spite of what I've learned in this thread, I'm go back to my previous opinion that
HEPTIMAX by Quest Diagnostics is way to go if you don't want to make things too complicated. You can order it before treatment, during treatment and post treatment.

HEPTIMAX has a very wide dynamic range 50 million iu/ml -to 5 iu/ml and is as sensitive (or more sensitive) as any of the tests being used in trial situations that I'm aware of.   It's a test many here have used, including myself. Although not a bad idea to specify a test code,  no test code really required. Just have your doctor write HEPTIMAX on an rx form (along with a diagnosis code) and bring it to any Quest Center -- or if your doctor has a Quest account, they can draw blood in the office and have it picked up.

MORE COMPLICATED

Pre treatment you have many choices, including Heptimax, LabCorp's quantasure plus PCR (LC# 550027), and even the less sensitive bDNA's that only go down to 615 IU/ml. What you want pre-treatment is a test with a very wide dynamic range. Sensitivity is less of an issue because most will have a pre-tx viral load above 615 IU/ml. For this reason I would not recommend LabCorp's HCV  N G I  quantasure quantitative, PCR LC#140639  pre treatment as it only goes up to 2 million IU/ml,  and it's extreme sensitivity (2 IU/ml) is not needed pre-treatment, not to mention the cost.


Early in treatment, you want to forget about the bDNA type tests that only go down to 615 IU/ml and switch over to something more sensitive like the other tests mentioned in the above paragraph. HR feels that LC 140639 would be the way to go regardless of viral load during treatment, but my opinion is that you'd want to wait until viral load gets under or starts approaching 2 million IU/ml before using that test.

Later in treatment/EOT and post treatment --  once UND, you have more choices. You can use Heptimax, LabCorp's 140639, or you can start using a Qualtiative like Quest's HCV RNA TMA QUALITATIVE OR LabCorp's HCV NGI ultraqual LC#140609. My opinion here would be to go with either of the two Qualitatives because all you really need at that point is confirmation of UND or not. I happened to switch from HEPTIMAX to Quest's HCV RNA TMA QUALITATIVE post treatment based on a conversation with one doctor who suggested less false positives solely based on a couple of patient stories, but have no reason to know whether this is true.
In the case of LabCorp, it's important to always specify the test number, not just the name.  

So, Jasper, hope this helps some, although I understand I still haven't picked " best test" which was your question, but maybe this will help or not.

If I were treating all over again, I'd probably stick stick with the Quest Tests (Heptimax and the QUAL) but my decision would be as much emotional as anything else because it's a test I'm familiar with and that all my treatment doctors and consultants use on a regular basis. That said, HR makes a very good case for the slightly more sensitive LabCorp tests. But if you really want to get belt and suspenders, you can do what I did and order multiple tests at the same time. For example, I ordered both Heptimax and Quest's HCV RNA TMA QUAL at EOT and once post tx.

All the best,

-- Jim
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Avatar universal
So, the point you were trying to get to and did and what are the best blood test to get at the various stages of treatment and the correct code number for each and to eliminate the confusion because of the similar titling (at least with Labcorp) and some of the differentiating degree of how the test are performed, and as it has turned out there is not too much difference between the two if they both accomplish the same thing with the exception of the NGI ultraqual which take the vl load down to 2-3 IU/ml and the Heptimax only takes the vl load down to 5 IU.

Other than Cost what is the better test/tests to get through out treatment in your assessment?

Thanks!
jasper


(A) Best test to use pre-treatment if pre-tx viral load is high would be:
HCV Quantasure Plus,LC# 550027  Quantitative PCR (10-100 million)
test #1 quantasure plus PCR (10 to 100 million)     $439

(A) Covers all the bases in the beginning to find exact Viral Load of patients and if UND by week (4) continue this test through out treatment and maybe at week 32 suggest getting HCV NGI quantasure which will show any remaining virons down to 2 per 1 ml.

Or if, non-UND by week (4/8) but had lowered the VL to below the 2 million threshold use this test and start consulting with team/doc about extending treatment because of slow response to combo.


(B) Best test to use during tx once viral load lowers would be:
HCV  N G I  quantasure quantitative, PCR LC#140639 (2 to 2 million)
No Price given:

(B) Covers slow responders with low starting VL or unable to lower vl beyond the threshold and consult with team/doc about upping the INF and or Riba or both to lower the vl after the initial quantasure plus test at week (4/8).


(C) Best test to use during tx once viral load is UND via previous tests:
HCV NGI ultraqual" LC#140609   (2-3 IU/ml)
test #2 ngi quantasure   (2 to 2 million)       $714 (designed for tissue transplant screening)

(C) If UND at week 4/8/12 and at other specified time frames during treatment and remained UND, at week 44 have this NGI ultraqual test “to check for any hidden virons in the blood supply, organs and or scar tissue of the liver” which would make perfect since to me, if this is what your line of questioning was originally.


5. Quest Lab Choices per above:

So, this would be a one bag cover all, all the way through treatment?

A. Best test before treatment regardless of viral load--
"Heptimax" (5 IU/ml to 50 million IU/ml)
test: heptimax (50 million to 5)   $375


B. Best test during treatment -- "Heptimax"

C. Best test post treatment or after UND during treatment: Either "Heptimax" or
the "HCV RNA TMA QUALITATIVE" (5 IU/ml)
Price?
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Avatar universal
Sh*t! pay no attention to the man behind the curtain. Thought I copied something else but got distracted. O’well just thoughts, sorry.

jasper


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Avatar universal
The important thing to understand is, that in most cases, the actual sensitivity is higer than "2iU", that is five copies of actual HCV virions. Typically a single HCV virion in the ml of serum submitted can be reliably detected, but sometimes a *** "floater" does not come down, or molecular accidents happen, so a safe margin of 5 has been officially designated***. So you understand what this , in practical terms mean: better than 1U in most cases, as good as less than .4 iU in many cases. Thats what a NEG /UND will mean here.

That is if I’m understanding HCV correctly. There are few master printers in the early stages of this disease that have adapted and overcome the immune system and any other defense systems during its evolution with in a specified host and have become quite unique to the chemical make up of that host. As it replicates and replicates and the master printers absorb the blue prints of the compounds being replicated and has built its own immune system to fight the bodies own immune system and using the host to do so. Lipid coating and floaters at the top during the centrifuge process? The last to be detected because of the buoyancy of the coating to keep it from being pushed to the bottom of the tube.


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Avatar universal
I suppose an alternative that would take into consideration all concerns -- cost effectiveness and a numeric positives -- would be to order the UltraQual with a reflex to the NGI Quantasure (if UltraQual is positive). Indeed, this may exist on LabCorp's menu's -- didn't check.
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Avatar universal
No quibbles with that statement -- and in fact I might do the same if using LabCorp. I was just giving HR's take on the matter, per his post to "Cruel" and myself, somewhere way up there in the thread.

With Quest, it's a little different however. Their HCV RNA TMA QUAL(while offereing the same sensitivity as Heptimax)  is not identical to the TMA part of Heptimax, and uses slightly different technology (not to mention it's a qual verus a TMA quant)  as well as usuing a dedicated lab. LabCorp's UltraQual, on the other hand, is identical to the second part of the NGI Quantasure, so as you say, you're getting a little bonus testing thrown in, being a possibly numeric result if detectible.
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Avatar universal
Speaking for myself, I'd much rather get the quantitative test at EOT (unless it was out of pocket, where I might have to compromise). Firstly because my insurance company paid for it no problem, and secondly if I did score + (i.e. >2 IU/ml) I'd want to know just how positive I was. Otherwise you're left hanging, wondering what your VL might be. Then, after being confronted with the ambiguity of the qual + result, you'd probably want to be retested with the quantasure anyway. And then you'd have to be retested, re-submit charges again to the insurance co (which they might deny due to frequency of testing) and then wait to get your results back (mine took a little over 3 weeks, incidentally). No thanks, I'll just get the quant right up front. The magnitude of the VL would factor into the decision to extend tx, add drugs, or maybe take my chances and stopping depending on how I felt at that time (and what level of fibrosis I had, of course).
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Avatar universal
yes, a lot more questions but as you said... "will this research actually be done in such a fast changing treatment landscape or will it probably be eclipsed by the fast moving PI's and other add-ons", so true.

That was the other question I had for hr but may have not been put it point blank.
He has invented these sensitive blood test and has been able to get the vl down to its lowest point at the present time and I am sure he has used the ten vial study or else he would not have mentioned it. So, the next question would be, for me at least, if after 48/72 weeks of std soc what would make these few SV so resistant (or lasting longer than the others) over that time and is he involved in any on going study in connection with his inventions and other researchers as to why these virions are so resistant or what separates them from the others that have been eradicated or mutilated beyond the replication stage.


jasper
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Avatar universal
On the other hand, if some day in the future, they did find viable virions in the serum of SVRs who treated with SOC -- and if newer treatments existed at that time which would wipe out those virons -- and if it was then shown that the treatment to wipe out those virons had some clinical significance  -- and assuming the risks of the treatment (hopefully by this time it will be a couple of weeks of pills) do not outweigh the rewards -- well, I think I will be first on line to get the pills :) Or maybe you might be me there. LOL.

-- Jim
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Avatar universal
Mike: The question now becomes what do we do?"  
I believe in that case we should proceed as if we are undetectable
---------------------------
I agree unless further studies show different.

--------------
Mike: I assume you believe that there is absolutely no trace of (viable) HCV in SVRs (in serum) but I don't agree with that. (Parens mine)

As you know many doctors believe this -- some don't -- and I'd like to believe this. But assuming for sake of discussion that you're correct, I think we both agree that at present there is nothing to be done and therefore I would decline a 10 vial test at this point in my SVR. If positive in one vial, then what? More interferon, I think not :) For now, I will enjoy my SVR and "cure" as was expressed to me by my doc.

Hope this finds you well enjoying the holiday season.

-- Jim
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Avatar universal
Actually -- from what I've learned from HR in this thread (see post above from HR to "Cruel/Jm) -- assuming you already have been tested during treatment by something fairly sensitive -- then at EOT (and post treatment)  a more cost effective (but equally accurate test) would be  LabCorp's HCV NGI ultraqual LC#140609 which is the actually qual portion of the two-part NGI Quantasure linked by Mre.
Link for UltraQual here: http://www.labcorp.com/datasets/labcorp/html/chapter/mono/id003400.htm
(Sensitivity 2-3 IU/ml)

Alternatively, you could take Quest's "HCV RNA TMA QUALITATIVE"
I'd supply the link but not sure if test has national test code numbers so best to order it as writen above. (Sensitivity 5 IU/ml)

-- Jim
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Avatar universal
I suspect that when the tests become extremely sensitive we are likely to find traces of virus remaining in the serum of SVRs. I have been serum undetectable since April 2003 < 5 IU/ml and I test monthly. Yet small traces were found on biopsy. So what does that mean? Can I be distinguished because I am immunosuppressed and a transplant recipient? Perhaps, but I seriously doubt that. Logic seems to suggest that because I am immunosuppressed the virus would more more likely replicate to serum detectability than it would in the general population.
In response to your hypothetical: "And then let's say we did a 10 vial test like HR mentioned and found out we were still detectible but somewhere well below 1 IU/ml. The question now becomes what do we do?"  
I believe in that case we should proceed as if we are undetectable - like we would be with less sensitive tests. I assume you believe that there is absolutely no trace of HCV in SVRs but I don't agree with that. As I have said before, I think there is a type of truce in SVRs between the virus and our immune system. And that's just dandy with me. I got lab results from this Wednesday and my ALT 14/ AST 18/ GGT 11.
I think I'm well even if I do have a few traces of HCV hanging out in my liver.
Mike
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Avatar universal
Thanks! for the link.

jasper
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Avatar universal
First, we're assuming that these super virions (I'll call them "stragglers") will indicate relapse. Studies will have to show this. And yes, do you extend to 72 weeks with a negative TMA but positive ten vial test at week 47 or not? Without study data, you are in unknown waters because: (1) the extension may be unecessary, i.e. you may be SVR anyway; or (2) the extension may still result in relapse because those straggers are in actuality "super virons" like you named them. That said, the extension might result in an SVR in an otherwise relapse scenario. Many more questions than answers.

-- Jim
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Avatar universal
Ok jim, so it’s getting closer to post time here for me and after reading this thread it would be in my best interest to hound the doc about getting the Labcorp test called HCV NGI ultraqual LC#140609 before the end of TX. The reason I will use this, if allowed, is because I have used Labcorp’s HCV Quantasure Plus,LC# 550027 through out treatment and if it means paying out of pocket so be it but the hinge pin will be the doctor.
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Avatar universal
My insurance paid for my labcorp 2 IU/ml test no problem. I only got one test because I was being tested all along as a part of the VX950 trial I was in (so I'm not sure how many more of them they would have ponied up for). In my case I decided to test at week 3. I figured if I was UND by week 3 with a <2 IU/ml test, then that strongly suggested I was getting VX950 (instead of a placebo). If the rest of tx goes well, it could also forecast an SVR with high probability. But ideally you'd want to be tested all along with that sensitivity, especially towards the end prior to stopping. Below is a link to the test I took (i.e. the famed NGI that HR invented). Print it out and take it to your doc, then make sure the LabCorp request form is filled out properly with the code specified. I had to correct my doctor's secretary, so be watchful about how it's filled out and personally see to it that's it's done properly:

http://www.labcorp.com/datasets/labcorp/html/chapter/mono/id004600.htm

And here's the corresponding Quest PCR's (note heptimax has a limit of detection of <5 IU/ml instead of the labcorp NGI <2 IU/ml):

http://www.questdiagnostics.com/hcp/topics/heptimax/files/hep_c.pdf
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Avatar universal
which brings me back to the point made above.

I understand the 4 week test but what about at the end of or close to the end of TX?

so if going by hr’s 10 vile test and all come back negative that is Great! But if say three come back positive out of the ten would this not suggest that the most Hearty of Virions would be left in the blood and if so, why are the strains so resistant, or cleaved up portions of the strains not killed off by the present combo?

I would tend to think that these left over Super Virions would be the focal point of any ongoing studies and maybe they are but it would seem to me that after 48 weeks of tx what purpose would it be to increase dosage at the eot if after the specified number of weeks these few virions are left. Would they not be the Most Resistant, therefor the std combo would be useless at this point.
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Avatar universal
On the other hand, let's say we were RVR by normal TMA (<5) at week 4 and had a projected 90 per cent of SVR. And then let's say we did a 10 vial test like HR mentioned and found out we were still detectible but somewhere well below 1 IU/ml. The question now becomes what do we do? Do we amp up the meds and/or extend assuming we're in that 10% who will relapse? Because there's no data developed, there is no way to make the call. It might be the right strategy, or it might turn out that a significant majority of those who are let's say TMA negative but ten vial positive (tvp) at week 4 will end up SVR anyway. It may even turn out that even out that most are intermittently tvp throughout tx, meaning someone ten vial negative at week 4 may turn out to be tvp at week 8. So, until actual studies are done, hard to know what to do with the data, as I am sure "Willing" will agree if reading this, since that has been his argument against sensitive TMA testing all along -- although now we do have studies to support its use -- normal TMA's that is.

That said, future studies such as using ten vials could turn out to be predictive, and being more predictive of SVR at various points of treatment would be a significant achievement, and in addition to vl test predictors, there are also T-cell predictors that I've heard could also offer the answers, pending more research. Of course, the greatest predictor of all would be a predictor pre-treatment, such as the genetic markers being studied, i.e. pre-treatment, what our chances of SVR are (if any) or how long we might hve to dose.

One question of course is will this research actually be done in such a fast changing treatment landscape or will it probably be eclipsed by the fast moving PI's and other add-ons which may eventually deliver us such significantly better treatments (very high SVR rates in very little time) that all the rest of this becomes academic. In other words, SOC predictors will probably be relevant only with SOC.

-- Jim
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Avatar universal
Pro,

You make some good points, but I think imbedded in the question is a valid call for earlier sensitive viral load treatment where perhaps something more can be done. My guess is that in the EOT study all the EOT PCR negative/TMA positives, relapsed -- y guess is that this sub group was probably TMA positive either all along, or certainly intermittently throughout tx and would have been picked up much earlier with monthly TMA's.

Cruel,

In addition to removing the program, I thought I manually deleted every bookmark, and backup bookmark file from the computer. I didn't just use the "search" function this time but went back through the path you have me -- and other paths, to do the deletion. That only leaves three possiblities: (1) I missed a deletion; (2) Clicking on my re-named bookmark file somehow started Firefox (didn't the first few times) and firefox then somehow accepted the re-named bookmark file as default (I've never seen this happen when clicking on a desktop bookmark file); or (3) Your powers are still intact. Anyway, thanks again for the help, Firefox is working shaper than ever with the reinstall.

-- Jim
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Avatar universal
"The really important question here is, if a VL detected at or close to EOT with a supersensitive test is a valid predictor of upcoming relapse and if such a predictor could then be used to prolong or extend SOC or add some  antiviral pressure to avoid this outcome in a substantial % of so detected patients. How many relapses we could avoid this way of course depends on the means to further suppress and the susceptibility of the remaining HCVs."
This does make sense to me, although in my case, being a 72 weeker already, I'm not sure the benefit is so high. I guess I have no idea what change of course at my eot would be beneficial to my attempted outcome..Would I push on further in weeks? Do a double down dose of tx drugs? Add Alinia? Try and procure a PI and add to the mix? Switch to infergen or change pegs? Unfortunately I wouldn't have many options available..Seems to me that after 72 weeks, you either are or aren't svr period, and there isn't much to be done at that point, but stop and regroup.
granted there does appear to be benefit for deciding to extend past 24 or 48 weeks. Have you had trouble billing insurance co.'s for these >2 tests?
I will see if I can get one for my eot test out of curiosity, but don't see what it will change in my case..
Thanks for all your input here hr
Pro
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Avatar universal
if you asked me to do that a few years ago i could have helped.  i used to have those kinds of powers but naturally i abused them and god took them away.
it was a sad day in the life of cruelworld!
now for the truth (something of which i am not famous for giving out)
im guessing that your reinstall fixed whatever problem you might have had even though it didnt appear to work at first.
these programs have different ways of "starting" or "opening up"  whether you normally started firefox from a desktop shortcut, or an internet address. or the start menu, each one is a different start button so to speak. for some reason the start button you were using was just not working right at that time.
just like trying different "open with" options for the bookmark files
sometimes one works but the other doesnt. you keep trying until one works.
when you double clicked on your bookmark file for some reason it worked as a good start button and firefox started normally and properly. if there were other problems still existing, the program senses them and self corrects. but only if something triggers the program to have at least a 90% proper start.
your backup bookmark files that i took you to see were there all along unaltered and in a safe separate place and never bothered by the reinstalls or other problems. the fact that you went manually to them and looked at them directly and backed them up didnt mean anything. to firefox.
i just wanted you to make sure they were still there and intact.
once the program was able to start properly it went directly to that login profile area and found the right one one and loaded it for regular use. it does this everytime it starts. computers programs can self correct more often than you think and the reinstalls may not have been needed.  if you know the three of four different types of start buttons you can straighten things out pretty easily sometimes. havent you heard the stories of someone coming out and all they did was reboot and it all magically worked.
i dont know much about stocks but does she look good?

cruelworld over and out
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Avatar universal
But seriously, this is the only explanation. The resolution defies all logic. You probably are able to discern my stock portfolio. Can we do something about it? And what about that young lady I was speaking to earlier today. Can you put in  a word.
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Avatar universal
from what you described, i bet it all works like new from now on.
normally, my pyschic powers only bring pain, suffering and annoyance to others, i guess god is punishing me by allowing this beneficial telepathic event to happen, if this keeps up, my reputation here on earth will be ruined forever!
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