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more sensitive pcr

by cruelworld, Dec 20, 2007 01:21PM
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.
Member Comments (123)

by jmjm530, Dec 20, 2007 01:50PM
To: Cruel
In two years here, with all the folks taking Heptimax, I've never seen a VL reported between 10 IU/ml and 5 IU/ml, nor anything reported between 5 IU/ml and 2 IU/ml, although probably only a small minority here have taken Quantasure. I guess what I'm saying is that if you are UND by Quantasure Plus (<10 IU/ml) then I think you can rest easy that you're UND. That said, maybe I've got things mixed up but I though you were still HCV positive and off treatment? If so, why would you need such a sensitive test?  

Also, one problem with Quantasure -- and possibly why it's not ordered as much -- is it's more restricted dynamic range, as opposed to Quantasure Plus and Heptimax. Quatasure Plus no doubt was meant to compete with Heptimax (or perhaps vice versa don't know who came first) in that both tests have a very wide dynamic range combined with a low end sensitivity (10 and 5 IU/ml repectively) which allows them to be a sort of "one for all" test that can be prescribed both before, during and post treatment. If you have a very high viral load pre-treatment, Quantasure may not  capture the exact load as its top limit is 2 million IU/ml. However, once you get down below that number, as for example when treating or post treatment, it seems a reasonable test to order.

-- Jim

by Proactive, Dec 20, 2007 02:20PM
along the same lines of more sensitive testing, had an appointment with my hep doc's np today, and she mentioned to me they have done away all together doing the "in House" 615 pcr..They now do one down to 50 in house..of course my taqman in sent off to the Mayo lab....but thought it was interesting.......

by cruelworld, Dec 20, 2007 02:59PM
To: jim
to refresh you of my status: im in round one, week 53 of 72  as a type 1 slow
responder. ive been getting the heptimax  >5  test all along. ive always wanted this other more sensitive test (> 2) just for peace of mind.
this is a rundown of the tests, from your response you might be confused as
to which one is which.


company:    quest diagnostics
test:             heptimax (50 million to 5)   $375
this is their most sensitive test, they of course have many other less sensitive tests.



company:  labcorps
test #1      quantasure plus (100 million to 10)     $439
test #2      ngi quantasure   (2 million to 2)       $714 (designed for tissue transplant screening)

these are their 2 most sensitive tests.

i will be getting the most sensitive test from now on, the one down to 2, do you think we will see any fluctuation between  5 and 2 iu?  i have been less than 5 iu  for 7 months now.

by jmjm530, Dec 20, 2007 03:17PM
Cruel: do you think we will see any fluctuation between  5 and 2 iu?
----------------
No. I'd be very surprised. Never seen a viral load here of let's say 3 IU/ml.

That said, if you're going to go with LabCorp, I see no reason (other than the money) not to order the Quantasure. Other than being sensitive, HR favors this test because of the very strict procedures in place to help eliminate false positives. But regardless, it's a very good idea to test periodically during tx with a very senstive test. Monthly is what my doc and a number of others now recommend.

Curious, what was your pre-treatment and week 12 viral load and when did you get UND.

-- Jim

by cruelworld, Dec 20, 2007 03:18PM
To: pro
as you can see from the prices these more sensitive tests can get pricey.
sometimes the 615 is all thats needed for a particular situation but obviously
the more sensitive the better, at least once you are nearing the low rage anyway.
this brings me back to my original question,  when does more sensitivity become
meaningless?     at 10?  at 5?  at 2?  jim sort of answered this question above
when he said that if you get to 10 or 5 you can be reasonably sure youre und. by virtue of the fact that docs never order this extra sensitive test down to 2 we might assume that it will reveal nothing to help in our treatment. i should have results
in a few weeks.

by jmjm530, Dec 20, 2007 03:21PM
To: Cruel
As an aside, these prices are often negotiable, especially if you don't have insurance. At one point, I thought a test might not be covered -- it ended up being covered -- but I found Quest very willing to negotiate the price on the phone in that I would be personally paying for it. Not sure how that might work with LabCorp. Also, you should know that doctors have their own "discounted' prices for these tests and in many cases will not mark up the test costs to their patients who have to pay out of pocket. Something you could discuss with your doctor - just offer to reimburse the office for the test discounted test cost up front.

-- Jim

by cruelworld, Dec 20, 2007 03:29PM
To: jim
started at 1.6 mil    
week 9     1280
week 18        89
week 19        >5
interim weeks >5
week  51       >5

if no one on the board has ever taken this super sensitive test (ive never seen it)
then none of us have ever seen a vl of 3. have you ever seen this test at all? if so what was the result?
the argument can be made that if tissue transplant samples are required to be less than 2, then logically we would want that reading at the eot. is a viral load of 3 enough to cause relapse? an interesting question to say the least.

by Proactive, Dec 20, 2007 03:34PM
To: cruel
I tend to agree with you on the sensitivity issue. I can see using the 615 or 50 for pretreatment vl...But IMO, let's say you are clear to 30 @ 4 weeks, what possible adjustments could be made to tx if say your actual vl was 29? Seems like there are dimishing returns at some point...Of course if insurance will cover it, I'd say get the best you can...But, I felt 10 was fine for me..

by jmjm530, Dec 20, 2007 03:41PM
Well, you appear to have had an EVR (> two logs by week 12) and were UND by week 19 via sensitive TMA, so 72 weeks sound about right. And you're smart to keep testing during treatment using a sensitive test.

As far as "Quantasure" is concerned, no, we've had people use it here, quite a few in fact, but maybe not as many as Heptimax. And again, I've never seen a "3" although I'm sure it could happen. For you, it would be an excellent test to continue on with. But at the end of the day -- either Quantasure, or Heptimax or one of the Qual's should be fine at this point.

-- Jim

-- Jim

-- Jim

by jmjm530, Dec 20, 2007 03:43PM
I'm assuming those arrows (">") are pointing in the wrong direction.

by Hepatitis Researcher, Dec 20, 2007 05:50PM
To: cruel,jim
The test to use if extreme sensitive UND status is desired, is the Labcorp test called HCV NGI ultraqual LC#140609. It has the same >2 iU cutoff, but is only a qual test. pos or neg. But that is really all you need at this point.It is of course cheaper than the NGI quantasure. This test is identical with the NGI ultraqual, it is just started with a NGI HCV Superquant and continued with Ultraqual, if below 40 IU, the limit of the NGI Superquant. You can trust me on these issues, since i am actually the inventor of all these NGI tests. But to be clear there is absolutely NFI of mine in these tests.


And Jim, if you are close to or at EOT, and you hand an even more sensitive test (than this above), and it would show you that you are not really UND with this, but UND with the less sensitive tests,
THEN
you could start thinking  of killing the remaining virions by extending UNTIL you finally are much more UND.
Remember your stance GONE, NONE, NADA, DEAD, NISCHTA ,KAPUTT implies that if you still have some real virus circulating, that your chance to become a relapser are actually HIGH.
All this sensitivity issues were nicely detailed in the Berg abstract that you recently posted, I was actually there and heard him.

So a very big decison  (to extend SOC, maybe to add Alinia, Vertex, etc) could be made at a critical time, when it might matter most  ( the virus is already very very low, but just not DEAD YET) and paid the most dividends to do so - to push a real UND.



by wyntre9, Dec 20, 2007 05:57PM
To: HR
I'm confused.  (so what else is new?)

Like Cruelworld, I have also been getting the Labcorp <10 test for the past 13 1/2 months.

Do you think I should request the HCV NGI ultraqual LC #14069 for the last few tests?  Like CW, I've been UND since week 17.

wyntre

by mremeet, Dec 20, 2007 06:06PM
To: HR
"You can trust me on these issues, since i am actually the inventor of all these NGI tests."

HA! I love it, do we have street cred here at medhelp or not??? We have the actual inventor of the NGI test on hand, how can that be beaten?? LOL

And HR you mention above "...if you are close to or at EOT, and you hand an even more sensitive test (than this above), and it would show you that you are not really UND with this..."

Just out of curiosity are you suggesting using a test even MORE sensitive to 2 IU/ml EOT, or just make sure you get the 2 IU/ml EOT?? I didn't know anything below 2 IU/ml is commercially available to anyone outside of a research environment...unless you mean sending a sample to castillo in spain etc??

And thanks again for inventing the technology that helps prevent us from failing treatment (for the reasons you specified). Considering what tx puts you through, my god that's manna from heaven!

by cruelworld, Dec 20, 2007 06:07PM
To: wyn
hp's answer is yes. the more sensitive the test, the better chance you have try to and do something to  prevent a relapse. the implication is that once you determine that you still have virus left (with the extreme test), you can extend even further or increase dosage or add alinia to kill the last virons. he is clearly recommending this extreme test towards the end of treatment.

by desrt, Dec 20, 2007 06:08PM
To: hr/cw
hr
Thank you for your inventions.

cw
As far as I can remember, all my PCR quants, except one, were the <2 Quantasure (good insurance). Oh yeah, and one PCR qual at 3.5 yrs post-tx.

by wyntre9, Dec 20, 2007 06:17PM
To: cruelworld
Thanks.  I absolutely don't trust my eyes anymore, not to mention the ole brain.

I'm going to bring this to the attention of my gastro next month.

Only thing is, I remember he did write a script for the <5 test, after Jim mentioned it on forum and I requested it, and when i got that month's results it was with the original <10 parameters.

The Dr. said labcorp had said they didn't DO the more sensitive test.  Maybe it depends on the location of the Labcorp?  I dunno.  But I will try.

Can you request and get that test where you are?

wyn

by g2bMan, Dec 20, 2007 06:26PM
To: cruel, jim, HR
Hi all.  Long time lurker, first time poster.
I am a geno 2b and had an initial VL of 1.6 million IU/ml before starting TX.  I took the NGI Quantasure test LabCorp #140639 and my results were a VL of 2 (yes, only two) IU/ml.  This was for my 4 week PCR taken on 7/19/2007.  I would like to blow it off as a false positive and think UND, but after seeing HR's post elsewhere on this forum regarding the test's sensitivity (2 iU - 2 million iU), reliability and resistance to false positive issues, I will accept the fact that the results are probably accurate.  Sooooo, do I still qualify as RVR with an actual virion count of 5 copies/ml?  I am guessing no and will live with the fact that I took the test with the highest sensitivity available.  I took the same test at 12 weeks and was UND with less than 2 IU/ml so I am remaining optimistic in achieving SVR. I just received my 24 week results today and I am still UND at < 2 IU/ml.  I will be doing another NGI Quantasure test at 8 weeks post TX on 2/1/2008.
I would also be curious to know if HR has seen any other test results of 2,3 or 4 IU/ml at the NGI Los Angeles, CA lab with any regularity.

by cruelworld, Dec 20, 2007 06:27PM
To: hr
with the obvious simplicity of the concept and your confirming its relevance, why have we never seen this approach by all the  so called top hep docs? also, from your
message i assume that we are guaranteed to see readings of  5, 4, 3, 2 iu in some patients at eot. is this assumption correct? i would also guess that a test which only
goes down to 10 should not even be trusted at all at eot.  from what i have seen, many patients around here never have a test more sensitive than 10 even at eot. i guess its all a matter of money and practicality and the slowly moving medical community.  just a few years ago svr's were declared at a sensitivity of 50!
maybe a few more relapses can be prevented by going this extra mile.

by Hepatitis Researcher, Dec 20, 2007 06:29PM
To: wyntre
Labcorp wil only perform  the more sensitive test if you do specify it  EXACTLY by name and labcorp number, otherwise it will default to their quantasure. The regular "quantasure" is easier to perform and likely has  a slightly higher profit margin, so it is the preferred test, from the companys point of view. I guess we have to understand these views as well, but you can get the better test, if you specify EXACTLY. I have given these numbers and explanations several times here, but everything gets diluted and forgotten.



by wyntre9, Dec 20, 2007 06:40PM
To: HR
Oh, thank you for clarifying.

I never saw your explanation but someone else had posted everything EXCEPT the #140639 and so I gave the info to my gastro WITHOUT the reference you mentioned.

Now that i know the specific name and number of the test, I will request it once again.  My gastro had no problem ordering it but I guess because i hadn't mentioned the code,  the results I got for that month had defaulted to the <10.  I'd assumed that was the only test i could get from labcorp, which is my insurance company's lab.

I really appreciate the clarification.

wyn

by cruelworld, Dec 20, 2007 06:43PM
To: g2bman
super cool dude, youre on the really paved road to svr. so glad you came out of the woodwork, you lurkers scare me! (just kidding) apparently this extreme test matters most at the end and you got the best possible reading. i had always wondered about increasing dosage at the very end to smash the last virons, after all its your last chance. this would make logical sense. your first test results are interesting and answer many of my questions.
you actually could have had a lower reading of >2  but you didnt ,you scored 2 iu.
your next test did hit the lower limit of less than 2. and then again same result at week 24.  did your hep doc get you on this track or did you request this extreme test on your own? its use has to be pretty rare. thanks for the info wily lurker.

by jmjm530, Dec 20, 2007 06:48PM
To: HR
I recommended LabCorp's Hepatitis C (HCV) QuantaSure because that is the test you recommended if you remember the last time we had this discussion, but I agree that at certain points in the process, you mine as well go to the Qual with equal sensitivity but less cost -- but perhaps there is confusion because that discussion was not EOT which brings me to the next point...

One reason I often recommend "Heptimax" is because it's less confusing than to keep switching tests and as you can see here, even the doctors are making mistakes ordering.

The other way, for example, you might have to order the Quatasure Plus initially (if very high pre-tx viral load) THEN the Quantasure (once viral load gets down some) THEN the Qual (once vl is down to save some money).

Also, wasn't sure of the "GONE, NADA, NUNCA" paraphrase from me previously. Are you saying that 5 IU/ml isn't sensitive enough to monitor during treatment VL? It was pointed out to me during tx otherwise. Lastly, in your post above to Wyntre, don't you mean the "otherwise it will default to their Quantasure PLUS" I thought that is what you had said previously -- that it's the "NGI Quantasure" being the more expensive test that must be specified. But maybe I misunderstood.

-- Jim

by g2bMan, Dec 20, 2007 06:48PM
To: cruel
LabCorp gave me the NGI Quantasure by mistake at 4 weeks.  After that I made sure my gastro ordered it by LabCorp's specific reference number.

by jmjm530, Dec 20, 2007 06:52PM
To: HR
This is in par what "Cruel" wrote in his opening post"...

"..They automatically just gave me the quantasure plus which only has a sensitivity down to 10.what a disappointment..."

That's why I said it appears that the default is the less sensitive Quantasure Plus, not the more sensitive NGI Quantasure per your last post..

by cruelworld, Dec 20, 2007 06:52PM
To: g2bman
what a lucky freak accident. my god man, you should hit the casinos
while you are still on a streak!

by Hepatitis Researcher, Dec 20, 2007 06:59PM
To: mremeet
"Just out of curiosity are you suggesting using a test even MORE sensitive to 2 IU/ml EOT, or just make sure you get the 2 IU/ml EOT?? I didn't know anything below 2 IU/ml is commercially available to anyone outside of a research environment...unless you mean sending a sample to castillo in spain etc??

You picked up the hint in seconds as expected.

Now a few facts about the NGI ultraqual that are pertinent to this specific question:

The serum workup is done on one complete ml of serum, that is ultracentrifuged under special proprietary conditions, so that all HCV virions will go to the bottom of the tube, even a single one. It takes hours to collect these guys, if they happen to swim close to the surface of the vesdsel and some have more of a lipid coat than others, so that has all to be taken care of.
One extremely important feature of the NGI PCR evaluations is the use of real Southern blotting to detects -after the thermocylcing PCR amplification - even the tiniest amount of PCR product, up to 10000times more sensitive  in this step, than regular post PCR evaluations. This is technically extremely tedious and requires axtually hundreds of additional steps, that could not possibly done using human labor. My machines have totally automated all of these using many unique inventions inside these processes as well.

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.

The rest is kindergartenlogic: If you would take 10ml of serum at a time before EOT, and split the draw in 10 1ml tubes, and send them in separately ( say for insurance purposes), then a fulll 10 ml get systematically investigated for the presence of one or two lousy virions. If you are not UND at all these 10 you do still have virus and the sensitivity is now 0.04 iU!!!! About 100 times better than the Heptimax, hell of a lot of money, but what piece of information to have.

This type of UND  at EOT will probably fish 90% of prospective SVRs from prospective relapsers. I say of course probably.

The other aspect that makes this ultrasupersensitivity  possible is the absolute  lack of false pos  PCR, achieved with the mile  ultrastrict  physical separation of the pre and post PCR labs and personnel, that I introduced frrom the very day on when I realized that in the ultrasensitive world, THIS IS THE ONLY REAL SOLUTION. When you use an electron microscope, you have to be ultraclean, clean, clean............

I am sure mremeet you understand in full now.

by cruelworld, Dec 20, 2007 07:07PM
To: desrt
how did you  find and request the extreme test?

by Hepatitis Researcher, Dec 20, 2007 07:10PM
To: jim
Jim
"I recommended LabCorp's Hepatitis C (HCV) QuantaSure because that is the test you recommended if you remember the last time we had this discussion, but I agree that at certain points in the process, you mine as well go to the Qual with equal sensitivity but less cost -- "


It has to say HCV  N G I  quantasure  LC#140639, NOT   "LabCorp's Hepatitis C (HCV) QuantaSure " that is the small but important difference, these two tests are entirely different, done 3000 miles apart.
Dont ask me why it was named so very similar.......
Or for the qual part only  the " HCV NGI ultraqual" LC#140609 can bve used, same sensitivity, same
process, same test, just the quant PCR on the front end is left out.

Using the LC# is very important to avoid mistakes.

by jmjm530, Dec 20, 2007 07:17PM
HR: t has to say HCV  N G I  quantasure  LC#140639, NOT   "LabCorp's Hepatitis C (HCV) QuantaSure " that is the small but important difference, these two tests are entirely different, done 3000 miles apart....Dont ask me why it was named so very similar.
------------------------------------------------------------
LOL. As someone who has spent a lot of his adult life in marketing, may I suggest -- assuming you exert some influence over there -- a name (or a couple of) name changes.

Now take a look at LabCorp's own web page here:]
http://www.labcorp.com/clinicaltrials/what/breadth_of_molecular.html

Do you see where it says "Hepatitis C (HCV) QuantaSure™" like I have posted? Well, according to what you say, if the test was ordered like that you would end up getting the less sensitive test. Someone really should simplify thing up for the consumer !  

But thanks for the clarfication, so next time I post I will know the correct way. Could you once again simply list the correct way to write/order all three LabCorp tests (with the numbers) 1 (The quant to 10 IU/ml); (2) The quant to 2 IU/ml; and (3) The Qual to 2 IU/ml.

Also, again for my clarification -- I'm assuming that 2 and 3 are identical in terms of sensitivity and intergrity (lack of false positives) but the difference is simply the obvoius -- one a quant and one a qual.

Thanks.

by Hepatitis Researcher, Dec 20, 2007 07:21PM
To: jim
jim "otherwise it will default to their Quantasure PLUS" I thought that is what you had said previously -- that it's the "NGI Quantasure" being the more expensive test that must be specified"

Yes, there is interesting wording acrobatics at work here ( not on your part) you just assumed  understandably, from the PLUS  that this is the test. Should someone ask in futuro, please give the LC# with the name.

by cruelworld, Dec 20, 2007 07:22PM
To: hr
are you saying that if you order 10 ngi ultraqual tests at the same time or from the same sample their mathematical summation or averaging translates into a higher sensitivity of .04 iu?
can anyone off the street order it this way?

hundreds of steps, thousands of concepts, 10 of thousands of automated machinery parts, millions of cracks and crevasses to get lost in, im glad
some one on this planet can figure all this out!

by willing, Dec 20, 2007 07:31PM
To: HR - more questions
re "a safe margin of 5 has been officially designated" could you please amplify a bit on what the resulting error rate is ? Since the issue of false positives (or more frighteningly false negatives) regularly comes up here it would be useful to have some insight into how reliable the error rate estimates are (see "spontaneous" thread below).

Also any thoughts on the merits of the different amplification technologies (rt-pcr vs bDNA vs TMA ) used by different test manufacturers?

by cruelworld, Dec 20, 2007 07:38PM
To: hr
i think i understand it now, if you get back all ten samples as und/neg then for practical purposes
you have proven  .4 iu divided by ten = .04iu.   of course this will not be written down
anywhere as a lab test result, you will just have a stack of reports from the same sample showing und/neg.

by Hepatitis Researcher, Dec 20, 2007 07:44PM
To: cruelworld
Yes, if you examine a larger volume of blood with a test than can catch individual virions, you add proportional sensitivity. Checking 2mls for the presence of HCV will find more than one, and 10 more than 2 etc. Just imagine rare fish in your pond, take out a larger volume of water, what are your chances of finding one of them?
Serum, once drawn, can be stored frozen and sent in sequentially, this might be a practical way to get it paid.

Each of these 1ml samples has to have/use a separate order sheet, otherwise there is confusion in their organisation pattern of things. There is no multiple test  under one test number.

So if you get  one out of 10 back POS it means you have approx 2 virions ciculating in 10mls of serum, or , since we have about 18000mls of extracellular liquid and 2600mls of plasma/serum circulating, you have still about 500 to 3000 actual HCV virions circulating AND BEING PRODUCED IN YOUR liver. Hopefully still shrinking day by day, and some of them already crippled......but probably worth considering hitting a little harder or longer, if found at "EOT" - and while sooo low...
  

by CJ807, Dec 20, 2007 08:00PM
To: all
So by using this: HCV NGI ultraqual LC#140609 >2 iU cutoff, you are actually "more cured" than using  >10 test?

How about if you are at 150k VL at start of Tx (and popping Alinia) and hoping for RVR, would it make sense to use the more sensitive test (at week 4) for the peace of mind that you did the best possible to kill the virus making SVR look a lot closer at 24 weeks?

I mean You don't need to know your VL if you started low, and if it's >2, take the other test at 8 weeks to see where you stand.  

by Hepatitis Researcher, Dec 20, 2007 08:01PM
For the purpose of our FDA license to test the blood donations in pools of 512 samples, the sensitivity has to be periodically documented. The licensed test for the plasma donations for the plasmaproducts industry uses  exactly the same amount and methodology, all the way through. The standard that is used as a pos control is determined in the following fashion:
In the high range - above 1million - b DNA is a very precise direct test.So the "to be" standard is multiply measured this way, then diluted to the extent that less than one copy per sample/tube is expected (Limiting dilution). Then a large number of these tubes are exposed to this ultraqual type PCR, and the resulting spotty positives are counted. After a Poisson distribution correction, the viral load number so determined times the dilution factor must be equal to the number obtained with the bDNa number by a factor of maximal 2, in order to be accepted. Please understand  that futher technical detail can not be given here. I am sure you see that this is an excellent periodic validation of this extreme sensitivity claimed here.

by Hepatitis Researcher, Dec 20, 2007 08:02PM
To: willing
Sorry this last post was directed to willing.

by cruelworld, Dec 20, 2007 08:17PM
To: hr
ive always guessed that 5000 to 10,000 remaining virons was low enough for svr.
if i understood it, 5000 to 15,000 virons in your entire blood supply could loosely translate into 10 iu. and you are saying that we need all ten samples to come back und for a fairly sure svr.  and this translates to less than than .04 iu or well below 500 to 3000 virons.
what a reassuance to get this info before one quits dosing. i do hate the fact that ive
missed all this info if youve posted it before. thanks for taking the time to rehash it.

again, thousands of twists and turns, millions of chances for error, billions of maddening details, keep up the good work maestro!

by cruelworld, Dec 20, 2007 08:32PM
To: cj807
the first question is kind of a trick question. if you test to less than 10, then, your number could be 2 or it could be 9. you dont know for sure. 9 spells less cured and 2 spells more cured. to be more sure of the actual number, do the more sensitive test
and be sure you are less than 2.
this is very critical to determine at the end of treatment but before you quit dosing.

as far as all the other earlier tests throughout treatment,  let you money supply
and insurance help you decide. you are mostly just buying peace of mind
at these earlier stages. but any test that returns a result above 2 could warrant extra dosing or other measures to bring it down to less than 2.

by jmjm530, Dec 20, 2007 08:40PM
To: Cruel
Cruel: the first question is kind of a trick question. if you test to less than 10, then, your number could be 2 or it could be 9
----------------------------------------------
The number could also be 0 IU/ml. But let's assume you used Heptimax verus the more sensitive Quantasure. How much more security do you think you're really buying with the 3 IU/ml difference? I say this because of couse the possiblity always exists that the actual viral account would be below the limit of both tests. And again, at least here, I've never seen viral loads below 10 IU/ml with either Heptimax or the more sensitive LabCorp test. I'm sure it happens but with what per cent? Of course all this could easily be tested by sending "x" number of vials to both labs and then doing an analysis including such things as what per cent of UND via Heptimax are actually detectible via the sensitive LabCorp test. It would be interesting.

-- Jim

-- Jim

by CJ807, Dec 20, 2007 08:43PM
To: cruelworld
who's on 2nd?

I understand... if no response, up the dose... then Procrit.. then Prozac, maybe Provigil... then Ambien etc., etc.

by willing, Dec 20, 2007 09:19PM
To: HR
thanks!

by tedinoregon, Dec 20, 2007 09:49PM
To: all
So I've been UND since week 4 (week 12 now and still UND), but the test the hospital lab uses is the Cobas HCV TaqMan ASR Assay, lower sensitivity limit of 25 IU/mL.  Should I be worried that I'm not actually UND since this is not the most sensitive test available?

by CJ807, Dec 20, 2007 10:23PM
To: Ted
You'll probably want to hear it from  the more seasoned folks, but you're undetected. W/geno 2 and RVR and high prob for SVR (w/2 and RVR) you can rest easy, I'm sure.

We're splitting hairs here.....almost wrote spitting hair! Man, I almost laughed out loud (LOL, jeez am I 12?)  

by cruelworld, Dec 20, 2007 10:30PM
To: jim
hr seems to be saying that you are buying tons of predictive value for svr (relapse)
if you go to the extreme test. 10 vials.
with the  less sensitive test at "und" down to 10, its true that you might actually be at 0 iu and good for you if you are a gambler because you are still in the dark and you dont know "for sure". the other possibility says  that if you test "und" in a test down to 10 you could be sitting on a 9 and have a high chance for relapse. again, with insensitive tests its all a blind play with relapse as the punishment for losing the gamble.

if you are a scardy cat like me
you want to know "for sure" that you at 0 iu or less before you stop the medicine or reach end of treatment. hr seems to be saying that 0 iu or less is a fairly safe zone to
predict svr. he may have even said that you need less than  .1 iu. anything much higher is a risk zone. this is what i understand anyway.
after what he said, if i found i had 3 iu near eot i would extend and increase dosing until i got it down lower. the 10 vial test probably costs $5500 but if you or your insurance has the money it might be well worth it. this test could diagnostically
help you to reach a level of less than .1 iu, a really super "safe" zone. when i consider all the money im losing on these two years of inability to work it looks pretty cheap!

this is a strong argument against the less sensitive tests.  if hr is right, then, if everyone took these sensitive tests at eot we would know "beforehand" who was going to relapse. this is more than just a statistic, its realtime diagnostic info that we could use continue and alter therapy for all those with too high a number at eot.  we could adjust treatment until the number was low enough to finally end treatment. we could prevent at least a few relapses if not quite a few. on the other hand, just because we can determine our
"exact" viral load doesnt mean that we could successfully get the number down to 0 iu in all patients. some virons will be resistant and those patients would go on to relapse no matter what we try.
but many others might only need a slight extra push to kill off the last little wave of virons.
for many years svrs were being passed out at a vl sensitivity of 50 and many of those went on to relapse. everyone at the time thought it was enough sensitivity. turns out they were wrong. today the accepted numbers are 5 to 10 sensitivity. but the relapse rates are still far too high, isnt that clear evidence that the sensitivity is not good enough? from what i understand according to hp the new standard for sensitivity should be near 0 iu. the medical world moves slowly and these things cost money but maybe we will see a 2 level sensitivity as the new standard in a few years. its just like the riba serum level dilemma, we have to fly so
much of this journey blindfolded its no wonder the cure rates are so low.
the question we are asking today is for me  the ultimate diagnostic question
for hepatitis treatment.  whats the max number for viral load that can remain in our
blood and yet we still achieve svr.  if i could tell everyone on this board who was going to relapse i might not be very popular but everyone would know my name
and stay on good terms with me. of course, this is all oversimplified and would never be perfect but i bet as time marches on the use of these more sensitive tests can make a big difference. in the mean time people like me and others around here who can access the money might derive an immediate benefit. the biggest unanswered question
is this, is 8 iu good enough for svr? is 5 iu good enough for svr? is 1iu good enough?
we may never have the answer but if we can use tests to get as close to .1 as possible we know for sure that that is a real good number and alot better than all the others. if you can achieve it why wouldnt you?

by desrt, Dec 20, 2007 10:36PM
To: cruelworld
It wasn't my request. My gastro was part of a geno 1 / geno 4 study (for S-P I assume) and I'm guessing since I had top of the line insurance he ordered the same high $ testing for me he was using for his study patients.

by CJ807, Dec 20, 2007 11:21PM
To: willy
"whats the max number for viral load that can remain in our
blood and yet we still achieve svr."- Willy

VL is simply a number and can't ever determine svr. The holy grail would be, more in terms of identifing a remaining virus family and know what last dose of pills would be best to kill that species.
If bill Gates had hcv he may attempt it. I may be way off base.      

by CJ807, Dec 20, 2007 11:28PM
To: willy
what I'm trying to say is if you're not zero, there will always be a chance for relapse, right?

by CJ807, Dec 20, 2007 11:35PM
To: cruel/willy
I'm sorry, should be cruel's quote not willy's

"whats the max number for viral load that can remain in our
blood and yet we still achieve svr."- cruelworld

by geterdone, Dec 21, 2007 05:07AM
To: hr/jm/all
Good morning, been reading through these threads and trying to understand the concept of the different test to determine eot vl or possible detection below the 10,5,3,2 virions per ml of blood. Sorry, but rowing the boat with one ore here, 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.

I understand that there are two different scenarios working here, one is RVR and the other is a slow responder but either way at the end of tx, be it after 48 or 72 weeks and these different blood test are completed and both show traces of the Super Virions left even down to 2 what would be the course of action at that point?

If left to the bodies own immune system to eradicate, (which I don’t think will happen) imo, because these left over’s would probably be the ones that started the chain reaction in the first place because they were able to overcome the immune system and in time had built up its own resistant to the present soc as they evolved over the course of treatment.

The xv950 trials did not point out its usage at the eot or if it did I did not see it.

HR, is there or will there be an on going research pertaining to the discussion here?

Meaning, the Super Virions at the end of TX, using the most sensitive test to present date, are there any on going research as to what makes up these SV or identifies the chemical components of these virions and what is the most dominant structure with in the virus to allow it survival.  

I’m not as passionate as most here on the subject but a inquiring and (slightly out of focus mind) is a busy one. Hope all this is not redundant.

jasper

by jmjm530, Dec 21, 2007 07:35AM
To: Geter/HR
Getter, This discussion has gotten somewhat away from the every day clinical application for the average patient, and into the research lab -- because I don't see people ordering ten different tests (vials) from their doctors and insurance companies each time they do a viral load during a normal treatment, at least if I read things correctly.

I also don't think it a fair comparison to compare ten vials of of one test against one vial of another test. I suppose one could also do similar using ten vials of Quest's HCV RNA TMA QUAL and also go below the 2 IU/ml limit. Still a very interesting and educational discussion.
-------------------------------------

HR, Thanks for helping to clarify how to order some of the test discussed, but I'm still unclear on a few issues.

1. Earlier you said: "t has to say HCV  N G I  quantasure  LC#140639, NOT   "LabCorp's Hepatitis C (HCV) QuantaSure " that is the small but important difference, these two tests are entirely different, done 3000 miles apart."

To help clarify could you please give me the test number for "Labcorp's Hepatitis C (HCV) Quantasure" , above. Also, is it the same test as mentioned here that has also has a lower limit of 2 IU/ml?
http://www.labcorp.com/clinicaltrials/what/breadth_of_molecular.html

2. What is the test number for the "HCV Quantasure Plus" (See link above) and is this the same test you refer to earlier in the thread as "Quantasure"?

3. From a previous post of yours in '06, there seems to be a gap in test LC#140639 where the PCR starts (39 IU/ml?) and the detectibility level of the QUAL (2-3 IU/ml)
Could you elaborate a little and give the names and test numbers for the two respective tests that appear to make up #140639. From what the thread infers, there seems to be some scenarios where you would not be able to quantify very low viral loads caught between the gap, as opposed to "Heptimax" where there seems to be a continum  from 5 to 50 million IU/ml.
http://www.medhelp.org/forums/hepatitis/messages/43901.html (See post(s) to "New2This"

4. This is where I come out for the LabCorp tests, please confirm:

(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)

(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)

(C) Best test to use during tx once viral load is UND via previous tests:
HCV NGI ultraqual" LC#140609   (2-3 IU/ml)

(D) OR ... if the above is too confusing/complicated for you and/your medical team --  just order "HCV Quantasure Plus,LC# 550027 " as a single test solution.

5. Quest Lab Choices per above:

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

B. Best test during treatment -- "Heptimax"

C. Bes test post treatment or after UND during treatment: Either "Heptimax" or
the "HCV RNA TMA QUALITATIVE" (5 IU/ml)

OR ... if that is too confusing/complicated for you and/your medical team --  just order "Heptimax" as a single test solution.

Lastly, I hope you didn't think I was being disrespectful in a previous post, but as a non-professional/consumer (and marketing person)  I did get a chuckle out of what I still consider to be a complicated ordering Matrix with all too similar names. But levity aside, just  trying to get some clarity for myself so I can pass it along.

And while hopefully this discussion has been education for all, I think it also points out the problems many (including some of our doctors) are having ordering and understanding what tests to order. And again, that's why it's often easier to suggest one of the "one-tests-for-all" phases such as either "Heptimax" or LabCorp's
HCV Quantasure Plus,LC# 550027. And indeed, at least with Quest, if you read their materials, the company was well aware of this confusing landscape in the way they market this test as a one test solution.
-----------------------

by cruelworld, Dec 21, 2007 12:33PM
To: cj geter all
i  think one can logically assume that a vl of  0.1 iu  at eot is
better than a vl or 5 iu or 2 iu. i dont thing many could or would argue against this
piece of common sense.  the degree of "betterness" is the question.  maybe it guarantees you a much greater chance at svr or maybe it doesnt help much at all.
i agree that the existence of just a few super virons "could" negate everything.

most of this hepatitis business today is still fairly blind as science slowly finds the answers. in the meantime, it never hurts to use every trick weve got to win, even though some of those tricks will ultimately be proven ineffective. hr is one
person in the crowd we respect who seems to think that a super low vl at eot
really does have a strong positive predictive value for svr. maybe he is right.

by wyntre9, Dec 21, 2007 12:46PM
To: ALL
And I thought I was confused before!  *LOL*

But I'm cutting and pasting this thread coz with 18 more weeks to go, 5 more PCR's, I definitely am gonna try to get the super sensitve labs for the last 3 at the very least.

thanks for the fantastic info.

wyn.

by cruelworld, Dec 21, 2007 04:09PM
To: jim
now i am beginning to understand your point that with the common tests we never see these "in between" readings of say 7 or 9 or 22. it seems like its always at least 30 and up
or less than 5. so maybe this shows that if the drugs get you to below 30 you are actually fairly guaranteed to be very close to 1 iu or less. if this is true the > 2 test wont mean that much in practice. the 10 vial test could show 10 times less vl which would be reassuring at least but maybe nothing more than that. of course you wouldnt have to do 10 vials maybe just 2 or 3 for a little more sensitivity.
it is very interesting the hr has confidence that the 10 vial neg reading would  "probably" be a 90% good indicator for svr. i dont know if this belief would be contrary to the research community or not. i dont think there is enough study of this for anyone to really know. but it would be highly significant if its true. i just called labcorps
and asked them about all this and they confirmed everything hr said about these sensitivity issues and multiple vials. (of course they would confirm, i guess he taught them everything they know!).  they suggested a more meaningful result if you
spread the vials out on different days. they also said that you (obviously) want all the vials to come back neg or undetectable to be sure of the very very low vl. the particular tech i spoke with didnt believe personally that the ultra low vl was that strong of an indicator for svr. but did agree that lower would always be hypothetically better.

by Hepatitis Researcher, Dec 21, 2007 04:47PM
To: jim
Jim
" This is where I come out for the LabCorp tests, please confirm:

(A) Best test to use pre-treatment if pre-tx viralAcute hiv infection
Common cold
Croup
Hepatitis a
Pharyngitis - viral
Viral arthritis
Viral lesion culture
Viral pneumonia load is high would be:
HCV Quantasure Plus,LC# 550027  Quantitative PCR (10-100 million)

(B) Best test to use during tx once viralAcute hiv infection
Common cold
Croup
Hepatitis a
Pharyngitis - viral
Viral arthritis
Viral lesion culture
Viral pneumonia load lowers would be:
HCV  N G I  quantasure quantitative, PCR LC#140639 (2 to 2 million)

(C) Best test to use during tx once viralAcute hiv infection
Common cold
Croup
Hepatitis a
Pharyngitis - viral
Viral arthritis
Viral lesion culture
Viral pneumonia load is UND via previous tests:
HCV NGI ultraqual" LC#140609   (2-3 IU/ml) " End of quote as copied from above. Some glitch in the medhelp software, I guess, cannot copy text for reference.

Well Jim that is what I copied from your above post. This is the third time I am writing it and that is the limit.

You have these test numbers correct.

If you believe that the changes within the very high VLs are important, then you order the test with the high upper end..

I believe that the lower sensitivity/ lower end has more clinical relevance.

I have nothing to do with naming these test/ or marketing them at all.

by Hepatitis Researcher, Dec 21, 2007 04:58PM
To: cruelworld
Have you seen jims thread way below regarding Thomas Bergs presentation at the AASLD re the importance/differential information of two tests with different sensitivities for the prediction of SVR? That presentation was next right after the Alinia trial results.

If you stop treatment  (EOT) and have still detectable virus circulating - real virus not false positives- then you have to assume that these viruses are now too crippled /mutated or under actual effective control of the immune system  so that they cannot restart the infection=relapse.

So is there a situation where a superlow VL will not really restart, because this remnant HCV has aquired some new quality , so that it can now be controlled.

by jmjm530, Dec 21, 2007 05:13PM
HR: This is the third time I am writing it and that is the limit.
--------------------------------------------------------------------------------------
Frankly, I never would have asked had you not seemed upset that the LabCorp tests were not included in some of my previous posts. The last thing I wanted to do was post the wrong test numbers since there was some confusion as evidenced by this thread and others. Maybe I'll just leave the LabCorp stuff to you and others from now on.

-- Jim

by Hepatitis Researcher, Dec 21, 2007 05:47PM
To: jim
This was not directed negatively towards you at all . I tried to respond to your - very proper and carefully worked list - to avoid confusion in a confirming way, but the software glitched three times.

by merryBe, Dec 21, 2007 05:58PM
To: HR and jim
I just grateful for both of you and all these tests and great info!!!

Is it just me, or is this season a stressful time for many of us??
I'm current wrapping presents...wrap one, collaspe for 20 minutes, wrap another!!!

MAybe after I get my dear son to get all his test records, we can figure out together what test he'll need next!!!!

by the way, he just got "Blue Badge" status at Intel, after 3 years as a temp.
they laid him off two weeks ago...scary
and hired him right back permanent at a higher salary w/benefits,
cool huh,
so the timing could not be better....to keeping a watch on his health!!!

I really appreciate this info....boy will I get red flagged when I show up armed with all this!!! : )))))

by jmjm530, Dec 21, 2007 06:00PM
To: HR
Sorry, Words on the internet have a unique way of being misinterpreted with eye contact and inflection lacking -- and was wondering what "croup" and "HIV" had to do with it, unless test #140639 was a lot more versatile than originally thought. Not to mention currently being on ice in a  Mobic/Valium haze due to a recent back spasm. BTW be more than happy to help LabCorp come up with clearer and catchier names for their test, assuming they have the budget.

by jmjm530, Dec 21, 2007 06:05PM
To: MB
MB: Is it just me, or is this season a stressful time for many of us??
-----------------------------
Oh, no, it's the season to be merry. Why just within the last 24 hours, my computer crashed, Firefox won't start, the bookmarks appear to be lost, my back went into spasm and instead of hitting my head on the wall all day like I wanted, I had to do last minute holiday shopping. But I'lll stop complaining because you my dear are really going through some hard times. Just not sure how they will react when you ask for ten vials of blood to be drawn :) Maybe first see if they will at least give you the weekly tests. LOL.

-- Jim

by jmjm530, Dec 21, 2007 06:09PM
To: MB
Forgot to mention I seem to having the same problem HR has with my Cache. Everytime I try and copy and paste too much data comes out, or sometimes it just doesn't copy unless I reboot the system. Maybe time to switch to Mac.  

by mremeet, Dec 21, 2007 06:18PM
To: jim
If you highlight text on posts and attempt to copy and paste it (as a quote) into your response, it will also copy the contents of the underlined "hypertexted" words. Like "viral" is a hypertext word that if you move your mouse pointer over it (after medhelp underlines it) you'll see all the same stuff that showed up in HR's attempted response to you. He was getting frustrated trying to be precise and quoting you in his response but it automatically copies all that additional sh!te whether you want it to or not. So he gave up trying, and I don't blame him, it's an annoying and sh*tty feature and they should disable it.

Also, why do you keep haranguing him over a damn test name or number? Like he said, he didn't name the test, he doesn't run Quest labs, and he doesn't get compensated for the indivualized use of the test. If you've got a gripe about how they're confusingly categorized, then take it up with Quest. Bottomline is that everyone should get the most sensitive test available (2 IU/ml) be it from Quest or LabCorp (as I did), and if you're willing to go the extra distance arrange for a higher frequency of sampling. If not then take your lumps (or not) 6 months after EOT - simple as that. I don't get the OCD-isms you're presenting over the names of the tests, and I don't get why you're persistently grilling a man who's not responsible for those names.

by merryBe, Dec 21, 2007 06:19PM
To: jmjm530
LOL and giggle.....oh heck, you got the good stuff for your spasms!!!!!!
at least there's that...
i'm just on ice packs and half and ativan!!!  and sitting down in the middle of store isles...ain't that a ho-ho-ho moment...not!

but at least my laptop still works.
reminds me..time to back things up........would hate to lose files now....not with the non-search engine in here!!

I think they finally have gotten the idea I'll be the weekly high maintainance type.
the ones I feel for are those who can't or won't ever know what to ask for, and who in too many cases will be not well served.

yeah, for me I'll leave the ten draws out......for Sonny Boy, I think this info will keep us ordering ala carte and off the menu.

by jmjm530, Dec 21, 2007 06:29PM
MR: and I don't get why you're persistently grilling a man who's not responsible for those names
----------------------------
Apparently you're the only person who thinks I'm "grilling" HR, please read his last post to me, he doesn't appear to.  In fact, I was simply making a point why people here are oft confused combined with some kidding with HR -- as both of us (HR and myself)  have done with each other in the past. Next time I'll ask your permission if I want to have some fun with HR.

by mremeet, Dec 21, 2007 06:34PM
To: jim
You don't need my permission jim, we're all grown ups here. That's also why it's appropriate for me to harangue you on why you're repeatedly haranguing HR about Quest's dumb PCR naming/numbering scheme.

by jmjm530, Dec 21, 2007 06:41PM
Maybe when you stop taking yourself so seriously you'll understand why others can kid each other and still remain OK with each other. And for the last time, the reason I'm bringing up what you term "Quest's dumb PCR" naming scheme, has nothing to do with HR, other than to offer him an explanation why I often recommend an easier to order test, that's out of of "respect" and 'courtesy" to him -- you might want to look up those two words in the dictionary. And my last comment, about offering up my services to LabCorp - that wasn't humor nor haranague -- frankly I'm damn good at marketing these things are currently could use the dough.

by merryBe, Dec 21, 2007 06:44PM
To: all
children STOp....here, have some of my tuiti fruiti non candied fruit cake....
we all need some egg nog!!

by Hepatitis Researcher, Dec 21, 2007 06:44PM
To: jim and mremeet
Peace to all the good ones. 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,

BTW jim, my main computer crashed 4 times today already. My experts say it is a virus, will be fixed after xmas.

by jmjm530, Dec 21, 2007 06:56PM
To: HR
Thanks for waving the white flag in proxy. I accept. We already know that a certain per cent of PCR negatives at EOT are TMA postive and they all will relapse. No reason to believe that they weren't TMA positive in the weeks/months prior. So it does make sense that even a more sensitive test might bring more information to the table, but we need the studies. As to what to do with the information - certainly extendng, tweaking ior addng s one option. Another is to smply stop at a certain point. Agan, more studies would be helpful especally in the area of what interventions might be useful past week 24.

As to computer crashing, you have me beat today, but I did somehow corrupt my FireFox browser which will not restart even after reinstallng it -- plus all my bookmarks, so I hope no one asks me for any references soon cause a lot of them were there. LOL. Maybe I'll run an antiviral program tonight.

-- Jim

by cruelworld, Dec 21, 2007 07:01PM
cant help but love all the tireless "givers" busting their @sses to bring all that useful technical info to us uneducated masses. i hope i speak for most of us when i say
"we appreciate it"

hr,
a virus eh? the irony, the mockery ,the sarcasm, the anger, how could we get through life without every last little bit of it?

jim, hr, or anyone,
im unable to find the post that hr refers to with the AASLD thomas berg info on this subject.  can anyone help me find it?

by Bill1954, Dec 21, 2007 07:06PM
To: Jim, HR
Schering-Plough makes a nifty antiviral device replete with PC board applicator tip (28 ga) for those difficult to reach areas.

Merry Christmas to all of you-

Bill

by mremeet, Dec 21, 2007 07:08PM
To: jim
Jim, maybe you shouldn't take both yourself and something as fairly trivial and esoteric as what Quest calls its PCR tests too seriously. Or if you do, redirect your PCR test naming nerd over-loadisms towards the source of the naming (that being Quest labs in this case). And in your last few posts, yes you've emphasized levity (appropriately), but frankly I've seen you drone on about this before and certainly did more of it earlier in this thread. If you wish to now clarify that you were just joshin' with HR, that's fine and I'm glad that's the case. But FYI, it wasn't apparent that you were joshin' earlier, it almost appeared to be a harangue of one sort or another. Especially after it became clear (early in this thread) that HR simply invented the NGI, and is not involved with it's naming or marketing in any way (as he clearly specified). And as far as the "respect" and "courtesy" you mention, that has nothing to do with the test one should request jim. I requested my Labcorp 2 IU/ml just fine without being confused (and so did Charlotte or "prettydamnscared") and many others do too. You can go on LabCorp's website and look it up right there. Print it out, display it to your doctor, and get the lab requisition form filled out - done deal. Also, just out of curiosity I went on Quest's website, and just like LabCorp's they have them all listed there including their sensitivities along with their corresponding CPT codes. So, dumb naming schemes aside, what's all the fuss and muss about?

by jmjm530, Dec 21, 2007 07:11PM
Couldn't find the post with this d*mn Explorer browser I know have to use, but did go to the AASLD site and will paste what I think was the study. If the chart doesn't format, you go to AASLD 2007, then find the "online viewer" and search under "Berg"
----------------------------------------------
The exact estimation of early virologic response rates in the course of antiviral therapy is an important goal in order to improve individualized therapeutic strategies in HCV infection. The sensitive TMA test could provide better advantage to distinguish at early stages sustained from non-sustained responders. We evaluated HCV type 1 patients who took part in a prospective study asking whether the application of TMA in bDNA-negative patients may be a better indicator to predict long-term outcome of the HCV infection. Methods 433 patients were randomized to receive either 1.5ug/kg PEG-INFa-2b plus 800-1400 mg RBV for 48 weeks (n=225, group A) or an individualized tailored treatment duration (n=208, group B). In the latter group treatment duration was calculated by the time required to become for the first time HCV RNA negative as defined by bDNA assay (detection limit 615 IU/mL) multiplied by the factor 6. HCV RNA levels were quantified weekly until week 8, at week 12 and 24. For all those patients who were bDNA negative the more sensitive TMA test (detection limit 5.3 IU/mL) was also prospectively assessed. The different response groups were classified according to the HCV RNA levels at week 4 and 12 (Table). Results Table shows the relevant data and refers to the relative relapse rates in group A and B at week 4 and 12 in relation to the treatment schedule. There is clear evidence for a high relapse rate in patients with a positive TMA within the first 12 weeks of therapy being more pronounced when treatment duration shortened in the individualized treatment group. In contrast patients shown to respond as early as week 4 evidenced by a negative TMA test had relapse rates below 10% irrespectively from treatment group. Conclusion The application of the highly sensitive HCV RNA tests must be considered to be now mandatory because this new test helps to evaluate in a much more refined way treatment response as well as relapse rates and provides better clues for an individualized tailored treatment strategy. Thus our study clearly indicates that patients even with a minimal amount of HCV RNA detected at week 12 can suffer from relapse rates greater than 50%. These patients may indeed benefit when their treatment duration is adapted to their individual needs.


response groups  relative relapse rate (%)  
      
week 4
response  >= log decline,
bDNA positive  36%
(all patients)  19%
(group A) 63%
(group B)
bDNA negative,
TMA positive  38%
(all patients)  22%
(group A) 49%
(group B)
bDNA negative,
TMA negative  4%
(all patients)  0%
(group A) 8%
(group B)
week 12
response  >= 2log decline,
bDNA positive  77%
(all patients) 78%
(group A) 75%
(group B)
bDNA negative,
TMA positive  64%
(all patients) 56%
(group A) 69%
(group B)
bDNA negative,
TMA negative  20%
(all patients) 9%
(group A) 32%
(group B)



by cruelworld, Dec 21, 2007 07:18PM
To: jim
firefox has an internet feature. its called foxmarks i think. (other exist as well)
it keeps all your bookmarks on a remote internet location so you never can lose them.
and you can always access them from any computer. and if your system goes down or you get a new computer its all still there. try it out ,youll never go back. in the meantime i just looked through the firefox application folder and didnt see an obvious file that contains your bookmarks but its there somewhere. ill try to
find out where it is. a normal reinstall shouldnt wipe it out. carefully uninstall the old one and reinstall. eventually  you may have to move that old mozilla somewhere else and try to reinstall without traces of the old one but save the old one and we should be able get your bookmarks back.

by jmjm530, Dec 21, 2007 07:19PM
To: Mre
Mre: but frankly I've seen you drone on about this before and certainly did more of it earlier in this thread. If you wish to now clarify that you were just joshin' with HR, that's fine and I'm glad that's the case. But FYI, it wasn't apparent that you were joshin' earlier, it almost appeared to be a harangue of one sort or another.
-----------------------------------
I just re-read the thread and couldn't find any "harangue" at all, unless you consider good natured riddlng (which HR has done to me as well) harangue. In fact, I went out of my way to show no disrespect. But that aside, if I want to rag on about Quest's test methology -- or anything else for that matter (like for instance how you keep droning on about Alinia or any of your pet issues) so what? I have every right to speak my mind on issues that interest me as you do on issues that interest you. As they say, if you're not interested, then stop reading.

by jmjm530, Dec 21, 2007 07:20PM
And lastly, why don't you simply butt out of other people's business, like you seem to relish in. Whatever disagreements HR and I may have had in this thread was over an done with before you started in. He made a statment that I took the wrong way, he clarified it, I apologized. What's your problem

by jmjm530, Dec 21, 2007 07:28PM
To: Cruel
What's happend is that Firefox woldn't start it. The screen comes up, it tries to load, but then it's lke it can't connect. Then I made a copy of bookmarks and renamed them on the desktop. Then did a reinstall. Same problem. Are you sayng that I should uninstall and then reinstall? I figured the reinstall would do the trick. Also, did a system restore to a week ago in XP Home. That didn't help ether. Not a happy camper using IE. LOL.

by mremeet, Dec 21, 2007 07:30PM
To: jim
"Other people's business?" Sorry I thought the discussion concerning PCR testing and sensitivities was something everyone was participating in jim (being that this is a public forum). If you wish to claim it's just "your business", ok go ahead and do that - but FYI, it's not. Other than that I don't have a problem, hopefully you don't either. In the meantime merry x-mas and happy holidays...and pass the friggin' fruit cake while you're at it. ;-)

by jmjm530, Dec 21, 2007 07:37PM
To: Mre
Hey, we agree, it is a public forum and it is ALL our businesses, even if we disagree with each other, and even if we actually disagree with HR on an issue here or there. So the end. A mery x-mas to you as well and actually could use some fruit (or something sweet) right now and just may go out and get some. Best post I think was whoever volunteered for a full transfusion for more accurate testing -- I think that was Willing :)

-- Jim

by cruelworld, Dec 21, 2007 07:46PM
To: jim
can you see all your bookmarks in your backup file on your desktop if you just click on it
without firefox? is so, make sure and reimport that file back into firefox first. if that doesnt work. your next choice is to do a complete uninstall first then a fresh install.
if that fails, then  uninstall again  and move or delete the mozilla folder located in the program file folder and do another install. try to use a new install file from their site.

by CJ807, Dec 21, 2007 07:49PM
"You can go on LabCorp's website and look it up right there. Print it out, display it to your doctor, and get the lab requisition form filled out - done deal. Also, just out of curiosity I went on Quest's website, and just like LabCorp's they have them all listed there including their sensitivities along with their corresponding CPT codes...  " -mremeet

I see how some threads just take on a life of their own...

folks wanting to go a different way than what's standard would best be served by simply going to the web site and printing as suggested above. That would be good advice.

by jmjm530, Dec 21, 2007 07:58PM
To: Cruel
When I click on my backed up bookmarks file, it tries to open Firefox (which won't open) therefore I don't know if the bookmarks have been lost or not. I'm not too hopeful because the size of the bookmark file is only 6.97 KB (7,138 bytes) which leads me to believe I've lost them. I did try and import the file into IE and only got what probably came with Firefox. Is there a way to open the file without using Firefox? Hey, thanks for the advice, I'll probably play around with it tomorrow. The good news is that the bookmarks are only about a month old as my larger bookmark file is on a backup disk from my major crash last month. LOL. Fortunately, I had "Mozy" online backup running them. Wish I had it running yesterday :)

by cruelworld, Dec 21, 2007 08:18PM
To: while we are at it
lots of people ask which test to take, jim appears to answer the many of them as well as other advice givers.
i think his goal is to be consistent and simple with his answers.  the tests and their names can be confusing.  i looks to me as if he is just trying to make sure hr endorses the advice he gives out in this regard. defering to the higher expert (in this regard anyway) if you will.  now suddenly, we are trying to throw more tests into the mix and this stuff gets messy for the advice givers. as far as looking this stuff up yourself at the lab sites goes,  ill bet that half of the brain fogged treaters would have trouble doing that. and thats why jim, hr and others are here, so they wont have to.
ive been to a labcorps site and i couldnt find the list of tests and im foggy this week. i did find them at quest diagnostics. maybe i was less foggy that day. i think jim is just trying to make sure that
any tests he recommends will be the same tests that hr recommends. this is great
but spells extra trouble for them keeping it all updated and consistent. .

by CJ807, Dec 21, 2007 08:23PM
understood,,,thank you

by mremeet, Dec 21, 2007 08:25PM
To: jim
In regards to the lost faves etc: what you might want to do is get yourself a standalone backup hard drive. They're pretty cheap nowadays, even for one's with significant storage capacity. Usually you simply plug in the USB port and you're ready to backup whatever you want. Or you can even get yourself a simple thumb drive with solid state memory on it, just plug it into the USB port and you're all set. Again cheap, small, super-simple with multi-gb capacity to back up anything you want. Also, on IE you just click file ->import and export> and follow the prompts for exporting to the auxiliary drive (or importing back on later).

"Best post I think was whoever volunteered for a full transfusion for more accurate testing -- I think that was Willing :) "

I guess we now know why willing's moniker is self recognizably apropos. ;-)

by cruelworld, Dec 21, 2007 08:31PM
To: jim
right click on the backup bookmarks file and click
"open with" then find "internet explorer" as the application to open it.
you should see it then, if its not corrupted.

if that doesnt work go through the same steps
and "open with"  the application "note pad"   look for your entries  there, if they are
there, youre good. you may have to manually reenter them in the end but first do your reinstalls first. you probably need to to some updated spyware and virus sweeps
if you or your software are not totally on top of this. system restores can screw you up.
but if all else is ok the reinstalls will work.

by jmjm530, Dec 21, 2007 08:31PM
To: Cruel
Thanks for that. And it's not simply going to the respective web sites and finding the charts, assuming you can find then.

It's knowing which tests actually mean and which are right for someone at a given time in treatment. If you read this thread from top to bottom you will see how simply going to given site will not give you all the info you need. As to why I asked HR for confirmation on the LabCorp test Matrix, I did so because he's intimately involved an knowledgeable about these tests and therefore I wanted anything I (or anyone) might put forth to be accurate.  

That doesn't mean we may have some differences in which tests to order -- for example, the Quantasure or Quantasure Plus (or Heptimax) before tx with a high viral load -- but it does mean that the info he provided will help me and others speak more accurately about these tests.

But frankly, if someone with a nincompoop doctor and themselve having little HCV background, now asks "what's the best test to take", I shudder at how confused this person might get if all the options above are brought out. LOL. While it seems so clear now, it took me quite some time to understand the difference between a quant and a Qual, etc.

by CJ807, Dec 21, 2007 08:33PM
Hey, by the way Medhelp needs a side btn called "personal challenge" so participants can go and air grievances, clarify tone and just generally ***** at each other and then allow other readers to score for say twelve rounds then the loser has to apologize to the winner as to not take up space and make it hard to follow a very important thread.

by jmjm530, Dec 21, 2007 08:41PM
To: Cruel
Thanks. That worked The bookmarks are dust. I don't suppose Firebox makes their own backup copy, other than if you subscribe to the online service? Funny thing was that when is started to partilly open a few hours ago I could see the "tabbed bookmarks" on top. Now they seem to be gone as well. I wonder if it was installing "SpyBot" that did it. The new version seems hooked into the registry. Oh well.

by geterdone, Dec 21, 2007 08:45PM
To: jim
Don’t worry; I have them in a safe place.

jasper

by cruelworld, Dec 21, 2007 08:49PM
To: cj
thats the definition of an imporant thread, impossible to follow!
it would be instant death to the universe if threads couldnt get 200 times removed and totally lost in themselves!
i do like the idea about 12 rounds and stuff though.
seriously, we all hate interrupting a thread and a "side thread button" would possibly
solve the problem but we already have a personal message capability and it is not used as much as it could be. help us remember to use that feature, become a moderator for consistency of thread thought!

by cruelworld, Dec 21, 2007 08:54PM
To: jim
dont give up yet, those bookmarks still have a chance of existing intact in the original
mozilla folder.  i should be able to tell you how to dig them out tomorrow.

by geterdone, Dec 21, 2007 08:59PM
Man, a lot of high "C" notes playing out here tonight, I prefer boxers myself... Lol

jasper

by cruelworld, Dec 21, 2007 09:13PM
To: jim
you are going here  

C:\Documents and Settings\   (your login settings)

            dont cut and paste this address

you have to find it manually, this is how,
when you get to docs and settings you will see the different login names that you use.
if you dont use any and you login as administrator pick that one or pick the one you log in with when you use firefox.
then youll see application data, click on that
then mozilla click on that
then youll see firefox click on that
then youll see profiles click on that
then youll see just one weird one  click on that
then youll see bookmarkbackups and youre there
you will have to view them by using the  "open with"  "internet explorer"
hopefully one of them is still good.

anytime you have a prob like this just go to google and say something like
"i lost my bookmarks" or "i need to recover my bookmarks" usually you get pretty easy step by step answers.




by jmjm530, Dec 21, 2007 09:36PM
To: Cruel
You're a genius! Thanks so very much! I was positive it wasn't going to work since I searched my hard disk using XP's "search" function from the "start" menu. The only bookmark file I could find  was the empty one mentioned before. But when I followed your path, presto, THEY were there -- and when I say "they" -- there were a whole bunch of bookmark files, including multiple back ups. Wonder why they didn't show up when I did the search? At any rate, I copied the file to desktop and renamed it so it will be safe when I reinstall Firefox. I guess the next step is to uninstall and then reinstall. Thanks again.

-- Jim

by cruelworld, Dec 21, 2007 10:21PM
To: jim
see what happens when you put you faith in alien characters like cruelworld.
its a miracle!

now you know how i felt  the many times you gave me good hep advice at a moment of intense rage and exasperation!   all i owe you is about another 500 favors!

many computer search functions never work very well, especially the windows ones.
you really have to be a pretty big expert just to search effectively on your hard drive.
isnt it amazing, it was right there the whole time but windows couldnt find it!
this has happened to me millions, no trillions of times!  
as scattered out as i am, ive had to devote a big part of my life to the art of recovering lost files and info.

by jmjm530, Dec 21, 2007 10:36PM
To: Cruel
Good news is that I have the bookmarks and am actually using them now in Explorer. That's the important thing HOWEVER unistalled Firefox using Window XP's "remove/add" program. Then manually went it and removed anything leftover "Mozilla" or "Firefox related". Then did a reinstall from the Mozilla/Firefox Web site. Still, exactly the same problem. Puzzling, huh. Starts to load, and then it stalls and gets a "Firefox Not Responding" message at top. I also uninstalled "Spybot", but that didn't help. Maybe i'll try and uninstall the Macafee anti-virus, although can't see why that would be preventing it from opening. Anyway, thanks again for helping to recover the important file.

by jmjm530, Dec 21, 2007 10:42PM
To: Cruel
OK. Just clicked on bookmark file again and started browing in IE, only to look up and all of a sudden realize I'm in Firefox. What the? Works just like before. Even all the bookmarks work which seems impossible since I never imported them into the reinstalled version and they were renamed on my desktop.I think I'll just go to sleep at this point not to jinx things. If it's still working in the morning I'll right this off to a bad dream that "CruelWorld" somehow intervened into and fixed.

All the best,

-- Jim

by cruelworld, Dec 21, 2007 11:24PM
To: jim
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!

by jmjm530, Dec 22, 2007 01:05AM
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.

by cruelworld, Dec 22, 2007 04:06AM
To: jim
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

by Proactive, Dec 22, 2007 05:59AM
To: hr/all
"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

by jmjm530, Dec 22, 2007 09:15AM
To: Pro/Cruel
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

by jmjm530, Dec 22, 2007 09:31AM
To: Pro
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

by geterdone, Dec 22, 2007 09:49AM
To: jim
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.

by mremeet, Dec 22, 2007 09:52AM
To: pro
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

by geterdone, Dec 22, 2007 09:54AM
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.

by jmjm530, Dec 22, 2007 09:57AM
To: Geter
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

by geterdone, Dec 22, 2007 09:58AM
To: mr
Thanks! for the link.

jasper

by mikesimon, Dec 22, 2007 09:59AM
To: Jim
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

by jmjm530, Dec 22, 2007 10:20AM
To: Pro/Mre
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

by jmjm530, Dec 22, 2007 10:27AM
To: Mike
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

by jmjm530, Dec 22, 2007 10:33AM
To: Mike
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

by geterdone, Dec 22, 2007 10:38AM
To: jim
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

by mremeet, Dec 22, 2007 10:53AM
To: jim
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).

by jmjm530, Dec 22, 2007 11:02AM
To: Mre
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.

by jmjm530, Dec 22, 2007 11:06AM
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.

by geterdone, Dec 22, 2007 11:20AM
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.


by geterdone, Dec 22, 2007 11:25AM
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


by geterdone, Dec 24, 2007 02:35PM
To: jim
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?

by jmjm530, Dec 24, 2007 04:06PM
To: Geter
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

by geterdone, Dec 24, 2007 08:37PM
To: jim
LOL!!! Hope your back is getting better and Happy Holidays!

jasper
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