It is really annoying not being able to find out excactly how the test works. I called the lab once more and spoke to someone that runs the test but she did not know the LLOD but she said if the test came out UND she "sees it" as less then 1.
I was not satisfied with that so I also spoke to a doc connected to the lab who answers questions for treating doctors. She too could not say what the LLOD was, neither could she tell me the specifik version of the Cobas Taqman test used. She described the term limit value as a weak positive reaction below LLOQ <15.
It is all very confusing, when you google different Taqman test it also seems that at least the older test could vary in sensitivity between genotypes with a tendency to over estimate VL of certain genotypes and the opposite for others.
I too find some version of TAQMAN that seem to have the same LLOD and LLOQ, I wonder if that test can come out either DET<15 or UND<15?
i believe that the"Lower limit of quantification" of the Cobas Taqman (if it is the v2 test is 15 as well as the "Lower limit of detection" also 15 in this particulatr test
And if it states <15 for all intents and purposes this means UND..however as I posted previously I have never heard or seen the term "limit value"
It is my opinion it is prudent for your doctor to advise you to carry on to week 24 as this is the stoping point as I mentioned prev .. if there are still virons Det. .
However at the end of the day the term 'limit value" must be totally understood by your treating physician or as advised by some above to possibly do re -testing at another manufcturer.
Best of luck..
Will
I have got some labcopies now. The 4 w UND and the 16 w limit value.
I was also tested w 12 and 14 but nurse said they were the same as w 16 so not necessary to make copies of them. Not much more info except the type of test that was used.
Week 4: HCV RNA (Taqman) Not detected (Intervall 15IU/ml - 6.9E7 IU/ml.
Week 16: HCV RNA (Taqman) Limit value (Intervall 15IU/ml - 6.9E7 IU/ml.
(Maybe borderline value is a better translation than limit value.)
Still not know the LLOD though.
I have heard that Quest's Heptimax test reports uses words like UNDETECTABLE, although I have not had that particular test done - my health insurance prefers us to use Labcorp if we want to have "in-network" patient responsibility out-of-pocket costs (that's why I went with Quantasure test that uses the less direct verbiage). But Heptimax and Quantasure are both very sensitive tests.
And for daroga, LLOQ = 15 isn't too bad, in my unprofessional opinion, but knowing what is the LLOD would be helpful for you.
we had a thread many months ago, with the same issue. the OP checked with her dr and was told she was und with tests below the limit. they used a very sensitive test, i think it was under 7. maybe using a test that has a higjher lloq would be better. since it would have to state und/det
I think a sensitive test is the only way you are going to know for sure. I do know that Quest and Labcorp both offer several "sensitive" PCR tests. Keep in mind blood has to be kept frozen for a PCR test. Would have to ship with dry ice.
Hi copyman,
I too have been thinking in this direction. I would have liked to have another test done in w 20. But my treating doc has already told me he sees no point in testing further until w 24. I could speak to my GP but I doubt that they would like to interfer with an ongoing tratment elsewhere. And where I come from we have no possibility to pay for a test out of our own pocket.
I have been trying to figure out if I could find a more sensitive test but the web pages from different labs here shows no info on sensitivity of the test.
Maybe I will contact my GP, maybe they can charge me only for drawing blood and help me send it to Labcorp and Labcorp could charge me for the test? Not likely though. The webpage at Labcorp is down at the moment.
At least I can start by finding out the lower limit of detection for the tests I already got.
Is there any way you can try a different test from different lab? Perhaps a PCR test that measures virons down to at least <5 would be best. Here in the states several labs offer different tests. Labcorp has one test that measures down to <2. I think this would clarify if you have an active virus.
Best of luck
This study sure looks promising. I will keep my fingers crossed for good final results for you and everybody else participating in this study.
I do have to quit smoking, I am thinking about it everyday. It feels absurd trying to fight HCV while maybe lung cancer is knocking on your door.
I don't touch alkcohol and I've made big changes in eating habits since diagnosed a couple of years ago, lost maybe 13% of my body weight. Although it has been more difficult eating healthy during treatment. Especially while on Telaprevir it was difficult to eat anything at all. But I have kept my weight, not gaining, not losing.
I don't know anything about these other treatments, sorry. All I know is what treatments, that included PI's, didn't work for me, and how well my clinical trial appears to be doing now.
From my endless web-surfing on this subject matter, I haven't gotten the impression that performance of single DAA therapies have been all that stellar for us g1 folks, particularly for PI-experienced and Tx-experienced folks in general.
I was part of Gilead Sciences ION-2 trials and was assigned to the "sofosbuvir plus ledipasvir without ribavirin for twelve weeks" group. I am g1b, and in 3Q2011, liver biopsy had me at stage 3 grade 4. As I said in my first post here, my prognosis at this instant in time is looking encouraging. I think ION-1, ION-2, and ION-3, which are all phase 3 SOF+LDV±RBV, have anticipated completion dates of Dec 2014. If a very high percentage of trial subjects' outcomes with this duo-DAA therapy are as good as my interim status appears to be right now, I could imagine this regimen being fast-tracked for FDA approval in 2015. Feels like a long way off if you're the poor SOB waiting to get a duo-DAA therapy, but at least there's a light at the end of the tunnel and hopefully it's not the bright light that you see while lying on your deathbed (yeah, I'm beginning to hate that phrase "there's light at the end of the tunnel"-- that one's a bad light).
With regards to your quitting smoking and would it help your treatment, I don't know but I doubt that it would improve the efficaciousness of your HCV treatment. However, you might feel better overall and I would claim that you should give some serious thought to doing as much as you can to keep everything else as healthy as you can. If you were to forgo that habit, if nothing else, your wallet would certainly start putting on some weight!
Thank you for your reply. I will try to get the copies and find out the lower limit of detection for the specific test used in my case. I just know the lower limit for quantification wich was <15.
As I understand it now my week 4 result of UND was in fact not NEG, it just means that the virusload was too small for this test. An UND does not necessarly means true NEG. But several UND after each other increase the likelihood of true NEG.
As for the future - who knows. I had a rapid progress from Fibroscan 9.6 in May 2012 to Fibroscan 12.4 in Feb 2013. One can only hope. I am genotype 1a, TT.
I know that the combo Sofusbovir/INF/Riba will only be for GT 1, treatment naive. Is this because studies has already shown that this combo will not render good enough results for more difficult to treat groups? Maybe they already know that treatment experienced will need a combo of several DAAs to have a good chance of SVR.
And what about Simeprevir? This is also under approval, right? But I have not seen anything about for what group of patients this will be used. Or is Seimeprevir also a protease inhibitor so not possible for those who has been on Telaprevir/Boceprevir?
It would help you to have copies of all your viral load lab reports. Not all labs will say UND. They will use vague wording. For example, I had a viral load test performed several weeks ago and it said:
! Hepatitis C Quantitation
L5COPY Copies/mL *1
Less than 5 Copies/mL.
! HCV log10 UPTCAL Log10copy/mL (X)
Unable to calculate result since non-numeric result obtained for
component test.
! HCV Quant (IU/mL) "Result Below..."
RESULT: Less than 2 IU/mL. IU/mL
! HCV IU log10 UPTCAL Log10 IU/mL (X)
Unable to calculate result since non-numeric result obtained for
component test.
! PCR Amplification + Detection
Performed *2
! Test Information See report *3
PCR assay performed using National Genetic Institute's validated,
proprietary methodology. Results greater than or equal to 5 Copies/
mL of HCV RNA indicate the presence of virus-specific nucleic acid
sequence.
Note that it did not say UND. Note that it did not say DET, either. What it said is that I was less than 5 copies/ml and that results greater than or equal to 5 Copies/mL of HCV RNA indicated the presence of virus-specific nucleic acid sequence. The lower limit of detection on this particular test was 5 copies/ml. So they didn't see any.
Why they just don't say UND I don't know. Probably because a corporate lawyer suggested that they not say that. So look over your lab reports and compare what they report for your test results to what they say is the lower limit of detection of the test and what they say is the lower limit of quantification of the test.
On the other hand, partial responder wouldn't surprise me, though. I had viral breakthrough between weeks 8 and 12 on PEG/RBV/BOC therapy. (I am at where I am today because of some new drugs in the clinical trial pipeline. I am still in followup monitoring on that trial. The trial won't declare my individual success or failure until 24 weeks after treatment and that's still 12 weeks away. I, personally, won't declare individual success or failure until at least 52 weeks or more after treatment.)
If you are indeed a partial responder, hopefully, you are in good enough health to hold on for the new stuff; at this point in time, the new stuff looks very promising to me.
I'll try to get the lab report Monday or call the lab again for a better answer and keep you posted about the outcome.
Monday will also be my first day at work after 6 w of vacation, not looking forward to it but I guess I'll manage.
Yes you are right eRVR means UND week 4 and 12. Sorry about that. I guess I am wondering about the labs after week 4 since there does not seem to be a definitive response at this time. The doctor saying things are not going well is persuasive and scary. Still, not having copies of the labs along with him stating he "is under the impression" does not exactly inspire confidence.
I am not sure about the context of the term "limit value" but apparently your doctor is. To me it seems like there would be a term indicating over or under a limit value (???).
I have seen false positive lab results happen on here however since there is uncertainty to how the results are phrased I am not sure how we can speculate if this is the case.
I hope you follow through on this thread and let us know how things are going.
Thank you for your answers, both of you. I will try to get the hard copies and/or call the lab again. I already asked my doc if the lab did both a qualitative and a quantitative test and he said that he was "under the impression" that they first did a qualitative test and if positive went on to a quantitative test. But if so, how come it might be false pos as they said at the lab? I sure feel that I need to know exactly how to understand it, although it most likely means detected.
By the way, I was never eRVR, only UND w 4.
I second everything Will says.
You seriously need hard copies of your labs.
You were eRVR so if it were me I do not think I would stop talking my Peg and Riba until I had answers (you have come this far).
I see in your profile that you are in Sweden so I am not sure what your options are at this point in time but as soon as you have the chance you need to post exactly what the test says so we can see the word in context? I hope you have been keeping copies of your labs. I cannot tell you how many times on here a nurse or some other well meaning employee at a doctor's office misinterpreted lab values. It can be very stressful.
If they can't fax see if you can drop by or if they will scan it and email you.
You have come a long way on these heavy duty meds and you deserve answers.
"low amounts below the limit for quantification, <15" sounds like paraphrasing by someone who does not know what to look for.
Hi there..
I have personally never seen or heard of the term "limit value" on an " HCV quantatative" lab report"
If the LLOQ (lower limit of quantification is 15 and it states <15,then any report I have knowledge of would state DET. or UND.
If your doctor has verified with the lab that indeed at weeks 12,14, and 16 there is still DET virus,then he is correct when he says "it is not going well.
Given that you are finished the INCI and and are just taking the combo PEG/RIBA there would be no harm to continue on ,however he would be correct in assuming that if at week 24 you are still DET. then there would be no point continuing as this is the period at which the drug company has initiated a stopping rule
The lab telling you that this was either a "false positive " or lower limit than quantification" did not really give you the defeinitive answer if you are DET or not .
Personally I would want to see the hard copy of the lab ,as it is surprsing how many times we hear that many of these treating physicians also are not up to speed even yet of reading these reports properly
best of luck
Will