Home › Forums › Main Forum › Patient Stories › Threads best left unread, containing things better left unsaid › QUANTITATIVE PCRs with LLOQ missing – UK
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2 March 2016 at 12:31 am #13060dointime wrote:
Thanks for this
dtYou’re welcome!
EDIT: It seems that they are doing only qualitative!
HCV since I don’t know. Diagnosed in 2010.
GT1b, F0/F1, VL 9M, ALT 44, AST 42, Tx naive,
started 12 wks Twinvir on 06.12.2015. Feeling great and grateful 🙂
virus not detected 06.02.2016 & SVR24
isaing4@gmail.com2 March 2016 at 12:35 am #13061Qualitative PCR
15 HCV RNA IU/ml to 6.90E+07 IU/mlNow I’m confused – If it’s ‘Qualitative’ PCR – doesn’t mean it’s there or not? so how can they say up to <15? Isn't that similar to 'Quantitative'?
confused.com !This debate goes on forever !!
Thank-you for your investigations DT & Isaing
I have one test approved by NHS, but I want another one .
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC2 March 2016 at 12:46 am #13063Hi all, I asked Dr James about this because the assay range on my first test was 30-1000000000
I came in at <30
No it wasn't UND
I wondered why a huge public hospital only had such a threshold
All my questions, those you ask here were answered
I also talked to Emilio
A week after the hospital result I saw my GP armed with the information from James and Em and my GP rang around the path labs here.
He located the most accurate lower limit quantitative testing lab and the best qualitative
He ordered the PCR RNA and the regular VL
This second test did show an assay of 15-100000000 and the qualitative csme in as UND
Well nothing showed anywhere
Maybe you can ask for your doc to ring around too?
I'm my GPs first DAA patient and he defers to the info from Dr J and my prescriber, a specialist in another state from me! The hospital had just written more of the same original test I mentioned for my 8 weeks anyway!
So yesterday I rang them, explaining that I had an UND via private path and of course had to put up with the third degree but hey, I don't have to do the three hour round trip plus waiting for hours there plus paying a stupid amount for parking this Friday yay! I'm just going in for my appointment next Friday the 15th end of week 9, and the nurse said any follow up bloods can be done that day if necessary.
It seems that good GP support was the key for me to avoid this frustration you are discussing.
Cheers from Ariel hope you get what we all need re bloods xxxx2 March 2016 at 12:47 am #13064It seems that they are doing only qualitative!
Confirmatory Diagnostic Qualitative PCR
Test ” Levels of Detection are not reported for confirmatory testing ”
HCV 15 HCV RNA IU/ml to 6.90E+07 IU/ml
HCV since I don’t know. Diagnosed in 2010.
GT1b, F0/F1, VL 9M, ALT 44, AST 42, Tx naive,
started 12 wks Twinvir on 06.12.2015. Feeling great and grateful 🙂
virus not detected 06.02.2016 & SVR24
isaing4@gmail.com2 March 2016 at 12:48 am #13065Here’s the thing –
I did the PCR test via Medichecks, one of the private blood test services that does not require you to have a doctor’s request. They advertise the test as an HCV QUANTITATIVE test. Now on looking at The Doctors Lab website found by isaing4, all I can find is the QUALITATIVE PCR test.
So ideally, and for the sake of LG and those with the same requirements, I still want to know if Medichecks is simply advertising their test wrongly, or if there is also a QUANTITATIVE test done by The Doctor’s Lab that isn’t showing up on their website? I hate to phone and get a jobsworth on the line. Just too frustrating.
One thing for sure – it’s not OK to pay for a QUANTITATIVE PCR test, and the one that is run is QUALITATIVE. The figures that isaing4 found should not apply to the test that I ordered.
My report from Medichecks says quite clearly that it is QUANTITATIVE.Watch this space ………
dt2 March 2016 at 12:53 am #13066I still don’t understand? Why can’t you get path sorted at your GP
I’m missing something here, I wrote about how I handled this in Oz
Was simple once I had the info, is this another issue in the UK and US
Hope you sort it
Ariel xxx2 March 2016 at 12:57 am #13067Quantitative VL tests are done using a few different ways of counting. Some LLOD are <12, <15, and <25. It depends on the exact quantitative test used. That is why they are supposed to put the test criteria on there. Usually it is right below the result.
Qualitative tests are either Detected, or Undetected. However, these tests can only see down to just under 5/ml, which is considered undetected. The last time I spoke with Dr Freeman, we discussed this. The rationale is if you have a level of <5, your body will get rid of it on it's own. If you were to get infected with <5, you probably would not go on to even contract Hepatitis. That is why a lot of people are still 'detected' at EOT, but go on to achieve SVR.
Dr Freeman, please clarify if I'm mistaken.
Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000Started generic Epclusa Sep. 23, 2017
4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.Thank you Jesus.
Thank you Dr. James2 March 2016 at 1:21 am #13072Splitdog, I’m in agreement with everything you just explained.
dt2 March 2016 at 1:49 am #13075Exactly, that’s what I was saying DT
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC2 March 2016 at 2:03 am #13076Hey Ariel The thing is, on the NHS they will only do a set amount, so if you want another one eg, some of us would like to be able to pay for one privately. We don’t have that many options here for that, extremely expensive and vague details re the testing. My GP has been very supportive, but I am getting expensive! He wont do anything now without my NHS consultant requesting. So I have to ask her, she writes to him, he has to receive it amid no doubt hundreds of other requests, I then need to call the hospital and hope I can get bloods around the date I require and then wait for results. So , if there is a reasonably priced private test you could do alongside this, that would be really helpful. I mean, look at the last time I went to the hospital, they refused to take my bloods over some small bureaucracy (which I think has annoyed my GP). If that happened again, It would really throw a spanner in the works, I guess it would be good to get a reliable private lab organised as back -up.
(edit) Hey Splitdog
Qualitative tests are either Detected, or Undetected. However, these tests can only see down to just under 5/ml,
Ahh I seee. So the lab in question says it’s Qualitative, but still <15, so you may as well just do 'Quantitative' ? Or you find a lab that does qualitative <5 ?
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC2 March 2016 at 2:16 am #13078I have now found this on The Doctor’s Lab website under “H” but I can’t find any more info on it, ie. the LLOQ.
http://www.tdlpathology.com/test-information/a-z-test-list/h
Please anybody, have a go. Your search skills may be better than mine.Hepatitis C Quantification (Viral Load)
Code Sample Reqs Turnaround
QPCR A 5 daysAt least they do a quantification test and the turnaround is fast. I was beginning to fear that they didn’t, and Medichecks had made a really big blunder and got mixed up with the qualitative test. Still seeking an LLOQ though. That there is one is not in doubt. Getting it ….. something else.
dt2 March 2016 at 2:25 am #13079OK, now I got a code for the test (QPCR) so time to hit the email … and the phone if I really have to (sigh)
dt2 March 2016 at 2:45 am #13081I’ve seen no research that suggests anything other then once you’re UD by week 12 you’ve a 97% chance
of SVR!Is that right? – If so, that’s good news Hang on a sec, is that week 12 EOT or week 12 post tx?
Mind you there is just so much debate about all this, I still think everyone is still learning and data hasn’t caught up yet.I think it is reasonable to expect a company offering tests to let you know what they’re paying for though – They ain’t cheap!
(edit) I also think it’s very hard for those who have previously failed tx – No doubt very traumatic, this whole thing’s traumatic really.
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC2 March 2016 at 2:50 am #13083Hi Sir,
Have you just caught up with this conversation? – a day late and a dollar short, as they say.
Maybe get yourself into the ballpark first, then we’ll have something to talk about.
dt2 March 2016 at 3:05 am #13086Hi all,
There seems to be a bit of confusion here.
LLOQ – is the lowest level they can accurately quantify down to, so if the test assay has an LLOQ of 15 then they can accurately say you had a result of 16 or 19 or 78 etc. Below 15 they can say that you were detected or undetected but if detected they can’t say accurately what it was, just that it was <15. Now at some point below 15 is the limit at which they can detect the virus. But as they can't measure that low they can't accurately tell you what it is. From what I've read it is though to be about 5-6 in the case of <15.
But from what I understand even with a quantitisation test they check first to see if they can detect the virus and if they can't then they don't run the grading process to determine what the actual level is because that would be pointless. So for an UND it is not <15 but rather a really low number well below that where they aren't fully sure of the level. Or equivalent of an UND via qualitisation.Hope that makes sense?
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
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