Quick VL test question for another

[Lady Lauri]

My 'pro' friend isn't online :)......can someone refresh us on this...I forgot!


4 week PCR - 'almost UND'  at <15IU.

Isn't that UND? it wasn't a qualitative PCR she said ? but with no time to archive it.....can someone answer that?

THANKS!

[epiphiny]

Thanks for your warm welcome, I've been lurking here a bit trying to get the courage to say hi to all and it's nice to be given such a lovely welcome.  

Last time round on the tx (pegasys/riba in early 2004) they didn't do a 4 week PCR, only at 12 weeks and it was qualitive not quantitive.  At the end of treatment all they said to me was that I was a non-responder but as they never did a viral load test I have no idea what kind of response, if any, I had.  

Sometimes I feel we are a little in the dark ages down here in NZ, esp when I read about how people are having their treatments tailored overseas esp in the States.

I really applaud your determination to get the system to play ball with the 4 week test.  I got mine because of the study (as I mentioned, getting on a trial was the only way for me to get treatment here) but when I was trying to get one back in 2004 noone wanted to know it wasn't accepted protocol.  Protocol, schmotocol!!

It feels like the battle happens on many levels down here in NZ - first you have to fight to get treatment, and then you have to fight to get the right tests, and then you have to fight the damn virus!  Phew!  

Thanks again for your welcome :))

[Kristina538]

I've spoken with 2 other ladies on tx in NZ and they both believe there isn't a more sensitive test here, although one of them said she thought the words "undetectable" were on her form.  I'm ringing her later this week.

When did you last do the combo??  Was it with pegasys/riba or pegintron/riba?  And I'm wondering whether they did a 4 week PCR last time?

I was adamant about needing to know whether I was RVR at 4 weeks;  if I wasn't responding at all I couldn't see the point in doing 24 weeks without a PCR.   At the moment I'm just hoping my WBC, neuts etc will hold long enough to get me though, and am very much looking forward to my 8 week bloods :-).

I've added you as a 'friend' and will send you a note..... lovely that you posted and big congrats on your RVR - if you got that on a trial I would've expected SOC to be able to hold it, but I gather your nervousness if you were a non-responder last time (nb - there's a bit difference between being a 'non-responder' and a 'relapser' - if you got the 4 week RVR it shows that you are responding.... that's what my medic team were celebrating.  A non-responder has the chance of 'not responding again', whereas a relapser may have a better chance on stronger meds.   That's my understanding.

Talk soon epiphany - sounds like you're going strong - GO GIRL :-)!!!!!!!!

[epiphiny]

Hi, I've been following this thread avidly as I also live in NZ, am G3A previous non-responder to 24 weeks combo tx and I am retreating now, currently heading towards my 14th shot.  The only way I could get tx in NZ is by taking part in a trial and I paid for my previous treatment 4 years ago.

I have exactly the same results as you at Week 4 (using PaqMan) and was told by my Nurse that I was considered RVR and PCR negative.  In other words, the virus was undetectable to the lowest limit of that particular test and that I could be zero.  They kept stressing that I was considered negative.

I also questioned getting the <2 test but was told that they don't do that here in NZ.    To be honest I don't know if I'm being told the truth or fobbed off and I would be very interested to know how you get on with requesting the more sensitive test.  I also asked about getting the test done o/seas but pretty much hit a brick wall.

Also, I want to extend treatment to 48 weeks because of my previous non-responder status but I will have to fight for it and pay for it again.  Still no Pharmac funding for me as I don't have enough liver damage!  I am Grade 2.

There is so little info out there about G3A non-responders that I have been looking at re-treatment options for G1 non-responders as a guideline.  The other thing that complicates my situation is that I took a study drug and I think that is what caused the major drop in my viral load, so I am not feeling all that confident about the SOC therapy and I would really hate to waste all my hard work thus far only to relapse and find out later that if I had stayed on longer I would have beat it!  I also feel that if I treat for 48 weeks then I will know I have done my absolute best.  

Anyway, I would love to know what progress you make with these two issues.  Congrats on your RVR and keep on fighting the good fight!!!

M.

[Lady Lauri]

.......You are RVR .........

OMIGOD! DUH!  Can't believe those 3 letters didn't come to my mind either!!

Thanks, LL

[Lady Lauri]

Comeagain....it's not just you, my post are either not posting or just parts ?? Getting off of here tonight!

jmjm, sure you got this by now, but it's just Kristina's pcr we're questioning. I wanted to ask you pro's as I wasn't sure, for her.And  I also think they should do more VL testing thru out tx also. (just my opinion, hint, hint)

Zazza, thanks to you too for all your input. I actually understand most of this, math being NOT my forte.

Thanks all, we've given Kristina a lot for her tx brain to think on :)

LL

[Kristina538]

I really LOVE you people!!!!   I did get a print out of the form and quoted exactly (and all) that it said on my post above.   I'm ringing later today to see if I can get further clarification.

In the meantime, I know I'm responding (phew) detectable or not, so I have a better chance than I thought, and if my bloodwork lets me, I'll certainly look to extend some or at least taper (and still push for another PCR if this one does turn out to be minutely detectable).

The fact that I got the PCR at all is due to the responses from everyone here... Blessings crew - may your voyages stay smooth to the destinations.

[IAmTheWalrus]

I had a similar experience with Labcorp Quantasure (TMA) test. One entry for the test showed <5 IU/ml and below it had another entry showing =5 in order to diagnose hep C. It left me not exactly sure what the difference between the two numbers was, butI was just happy to be under both of these limbo bars. :)

I didn't know anyone was still using the branched DNA tests. For what it is worth, I would have been considered UND if my any of my PCR tests had come back under the detection limit of 50 IU/ml until I took the Quantasure a few months ago.

As if this water wasn't muddy enough!

[jmjm530]

The reason I often recommend two of Quest's tests -- for those in this country -- are that the results are relatively clear and simple with no grey areas.

Their qualitative TMA "HCV RNA QUAL TMA" gives you only one of two results. The report either says "Virus Detected" or "Virus Not Detected". So simple and clear that even a doctor or nurse can understand it. Their "Heptimax" test is also pretty clear once you understand that it's really two tests if the first shows you under 50 IU/ml. If I remember correctly, at least one of the LabCorp tests has also resulted in some confusion here.

[zazza]

To me it is understanding the test results that actually made tx tolerable. I haven't had so much intellectual stimuli and fun! in years. OK, OK, I admit, I must be some kind of math nerd, I have realized that by now! (Thank you, Medhelp!)

[zazza]

My quantitative was not negative but it is impossible to determine the difference between 5 and 15 IU/ml in these tests. The test result looks the same. It shows you are detectable but there is no difference between a sample of 5 and a sample of 15 IU/ml, since these are below the linear range where the differences in test reactions are so small or rather nonexistant.

I totally agree with you that there are so many test versions available that everybody needs to get their own paper copy and do their own research when getting these kind of difficult to understand test results.

It seems in Sweden they use the term borderline to imply that the virus is there but they cannot quantify it. If it is two parts of the same analysis this terminology does make some sense, even if it is hard to understand. Borderline being between UND and detectable with a quantifiable viral load.

[mikesimon]

Gee, I don't know which I would find harder to do  - endure 72 weeks of treatment or decipher the test results.  
Mike

[jmjm530]

Thanks for the clarification. So what I think you're saying is that your quant (detection 15 IU/ml) was negative but the qualitative was positive meaning you still had a viral load of somewhere between 5 and 15 IU/ml. You would think that there would be something more specific to this (the qual) on your lab slip other than "borderline value".

The question I was raising is whether or not the tests taken by the (one or two ?) other people in the thread is the exact same test combo, or perhaps they just took part of the test, such as the quant? Like I mentioned earlier, my lab has over a dozen different HCV tests and more than that if you count combinations and testing reflexes. And as you suggest, relying on what your medical team tells you orally is not always a good idea. You did the right thing by getting hold of the actual test results and then researching that further. Hopefully they will do the same.

BTW sounds like three tests were used in your case per answer "1"-- a PCR with wide dynamic range, a tma quantitative down to 15 IU/ml and a qual that went lower.
It's easy to see how these thing can be confusing -- there should be a law about lab people writing lab reports -- but you would think that a doctor who charges money to treat people for HCV would at least take as much time and trouble as folks like you and I have to find out exactly what the results mean.

[zazza]

That is, by the way, what "below the linear range" means. When the straight line in a graph that indicates the relationship between viral load and test reaction starts bending off as a curve at low viral load levels, ie below linear range.

[zazza]

The answer to question nr 3 should read:

"3) According to the doctor at the laboratory whom I talked with, who is a researcher on hepatitis C as well, the TAQMAN test giving a borderline result might mean anything between 5 and 20 IU/ml. So apparently the qualitative goes down to 5 IU/ml then."

If we want to go even deeper into this, I think a borderline result is that you can see that there is a reaction to virus being found but not being able to determine how much virus there is. I don't actually think it is two separate tests, but rather two parts of the same analysis. For example, if it were different shades of colors which show the amount of virus present, you might see that there is a change in color which would indicate the presence of virus, but the difference between such low viral loads as 5 and 15 IU/ml is so small that it hardly affects the shade of color at all. Thus you can see the test sample is detectable but not the actual viral load present. At higher viral loads the shades of color vary more. This is how I understood it to be from a discussion of borderline results on the UK hepatitis forum last year. A doctor who has himself been treated successfully for hep C was participating in this discussion and explained it like this.

[zazza]

My regular doctor, who is a senior doctor in the infections clinic, was clueless when he got my borderline result, so he called the doctor at the laboratory when he could not answer my questions. Great, huh? You would think he would have called and found out BEFORE talking to me. Anyway, I was still not satisfied with his answer so I called the laboratory in our second largest city, Gothenburg, and talked to the doctor there.

To clarify, the bDNA test mentioned, is the old kind of tests they used earlier. To my surprise and anguish I realized that my baseline viral load of 120'000 IU/ml was based on such a test from 2005. So not only was my baseline viral load 1 1/2 years old, according to the note on the Taqman test this would equal 370'000 IU/ml with the Taqman test, and thus every comparison during tx with my baseline viral load must have been inaccurate. Oh well, hopefully it is water under the bridge by now.

Anyway, to try and answer your questions about my test results:
1) Two steps are used, one qualitative and one quantitative. In your words, a real time PCR with a wide dynamic range and a quantitative TMA with a sensitivity of 15 IU/ml. The upper limit being 69 million IU/ml.

2) 15 IU/ml is the lower end of the quantitative test. The qualitative test can measure detectability lower than that.

3) According to the doctor at the laboratory whom I talked with, who is a researcher on hepatitis C as well, the qualitative test giving a borderline result might mean anything between 5 and 20 IU/ml. So apparently the qualitative goes down to 5 IU/ml then.

4) I was told I had virus detectable at week 12, but once it comes below the linear range, ie below 15 IU/ml in this case, it is not possible to determine an exact amount. I was recommended to extend beyond 48 weeks, no definite number however. It was my own choice to go the full 72.

Hope this answered your questions, Jim.

[jmjm530]

Help me Im confused about your results and the note on each slip.

First it gives a range of 15 to 69 million. Then it says that a *qualitative PCR is combined with a large cquantifiable measuring range). Then it mentions bDNA later on.

1) Exactly how many different tests/steps are used here? (Quests "Heptimax" for example uses two steps -- a real time PCR with a wide dyanmic range and a quantitative TMA with a sensitivity of 5 IU/ml)

2) Is 15 IU/ml the low end of the quantitative tests or the sensitivity of the qualtiative, assuming we have at least two different tests going on?

3) If the 15 IU/ml is the low end of a quantitative, then is there a qualtitative used with even a lower sensitivity? Because if not, then a result of "<15 IU/ml" would appear to be conclusively UND, at least for this particular test.

4) What values/explanations did they give you on your week 12 test, other than "Borderline". Not sure what that means without number and context.

I agree re getting hard copy and not relying just on what you med team tells you. One of the nurses would ask me what my Heptimax results meant and I cringe to think what she might have told a patient if say the doc was out that day :) For one particular test issue the only way I got a straight answer was to speak to the lab director directly because even customer service didn't have a clue. It's unfortunate test results can't be written in clear English, Swedish, or whatever language one speaks.

[zazza]

For those interested I will copy my test results, so you can see how these are written in Sweden:

HCV RNA (Taqman)
(Range 15 IU/ml - 69 million IU/ml)

Week 4: DETECTABLE. Virus concentration is 2900 IU/ml.
Week 12: BORDERLINE VALUE. Repeatable borderline value.
Week 15: UNDETECTABLE.

Note on each slip:
"With real time PCR for hepatitis C RNA the high sensitivity for qualitative PCR is combined with a large, quantifiable measuring range. In the same analysis it is determined whether there is an ongoing hepatitis C infection or not, and if there is, the virus load present expressed in International Units (IU/mL). Comparison of methods with earlier used bDNA technique shows good linearity but that Roche new technique gives 0.5 log units (3 times) higher readings in IU/mL."

Kristina, I advise you and everyone else to get paper copies of your test results. Ask Sfbaygirl, you can not really trust the doctors to interpret these results correctly. Although I think a doctor would rather call you UND when detectable, than detectable when UND.

[jmjm530]

I just hope everyone is talking about the exact same test because to the best of my knowledge no one here has seen the actual test report. My lab, for example, has over a dozen different tests for HCV, some of which have almost identical names but not the same sensitivities.

Im still a bit confused if we're talking about one or two different people here who are unsure of their test results -- but if it were me, I'd get hold of the lab results myself, and research it myself. Research would include: (1) call the lab (ask for a supervisor or lab director): (2) Speaking to your doctor direclty: (3) Speaking to another liver specialist if you don't feel your doc is familiar with the test reports which unfortunatly seem to happen from time to time.

Its difficult enough to come to the right decision on whether or not to extend, but if you don't start off with the correct data, it becomes somewhat mute.

[comeagain]

part of the text is disappearing when posted.

I also said that this test cant measure the exact nr but that it is <15iuml ( could also be 20 because the test aint that precise ), so a good guess would be something between 5 and 20.
And as jmjm pointed out either you are UND or your not ( close dosn´t shot a rabbit )

and I meant called not cold borderline result

[comeagain]

The taqmantest start as a qualitative test just determen if there is any virus left and in this case it most probebly was according to the doctors statement.

Then the next fase of the test is quantitative and since there is so little left this test can´t measure the exact nr, but that it is <then 15iuml,( but it can still bee 20 because that exact the test isn´t ) but the qualitaive test has determen that there was virus activ and as jmjm said either there is or their aint.( close dosen´t shot a rabbit ) So they have to quess the nr a good guess is something between 5 and 20.

Its a so cold borderline result.

I´m in a studie for relapsers geno 2 and 3 and when I´ve got that result week 4 borderline my nurse told me theres a reason why i relapsed the first time and this bordeline week 4 result was quite common among relapsers.

Both drofi and smaug got a simular result with a test that was sensitive down to <10iuml.

Take care Kristina your on your way to SVR if you play the cards right that at least what I think.

ca

[zazza]

I think the one way to find out for sure is to research if a test result your doctor would say is UND actually reads "UND" or "<15 IU/ml". I was hoping you would get another test at week 12, because then you could compare the two, but since this is not the case you could call the laboratory and ask to talk to a doctor there and have him explain your test result. That's what I did, and the doctor was most genorous with his time and knowledge.

The thing is that if you were detectable but below linear range it might very well be noted as "<15 IU/ml". As I said above, the only way to find out is to find out how they note UND with this particular test.

And, Kristina, I am actually very happy for your result since I remember you to be a non-responder to the old interferon. I think your result is good indeed considering this. I think Lady Lauri is right that you probably were UND by week 5 or 6. It is, of course, up to you to decide whether you want to try to get an extension or not, being you were so close to UND at week 4. Maybe 36 weeks would be something to consider?


Zazza

[CockSparrow]

The form says as follows (so it looks as though still detectable but small):

HCV RNA : < 15 IU/ml
HCV RNA:   15 but less than 43.

You can get a borderline result like Zazza's which means it is detected at <15 but not quantifiable.

You are RVR which is good thing. Because if you werent then you really would need to consider extending.


Hope this helps
CS

[Lady Lauri]

So happy to see you here posting :)

[Lady Lauri]

Laughing as I type ("taking over the thread"). Yep, it was you, for Kristina. Sorry for the confusion but wasn't mentioning that as she hadn't posted it. I had told her I do believe it's UND and wanted the input here before getting your/her hopes up too much.  I wanted to check my input to you. I also thought the Dr. wasn't being to clear...almost UND wasn't working for my thinking in this either. With jmjm on he should be 100% clear with you.
  As it is started and the input here is so extensive, so many heads thinking together.....
the 'no more VL checks' is an issue also. The Dr. saying that concerns me as well. I have heard of no tx's where once you reach UND (let alone his 'almost UND') where they say "well, we won't need to do any more VL test now" and let you go thru the entire tx. I mean....and not to worry on this as it's not so common....but some actually drop or even reach UND and than the virus reappears, VL actually goes up during tx and that is an urgency in deciding the next step....to extend, stop tx, etc. I realize it's handled in different ways where you are, but tx is tx, no matter what the location and some things I would think would be 'standard practice'. While low chance of that happening for you, IF it did even knowing how early it came back would be important for tx in the future and so on. Sorry if this isn't too clear, 2:30 am and at the falling asleep stage :)

Now aren't you glad we nagged you to get that 4wk. VL test and put all this thinking into the mix :) ? EVERYONE should get that 4 wk VL!

Back in the AM, and thanks to all replies, LL