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TOPIC: QUANTITATIVE PCRs with LLOQ missing - UK

QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12132

  • LondonGirl
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meanwhile.... we are still trying to find a decent private and affordable lab in England that does what it says on the tin :whistle:
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 HepC
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12136

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Many HCV tests in the central and eastern U.S. are sent to this lab for analysis. This is probably typical:




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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12138

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Gaj,
You elegantly made the point my fog addled brain was trying to convey earlier. Thanks...
HCV 35 yrs G1a F3 Tx naive
started Lesovir-C 15/12/2015
pre tx: VL 5,250,000 ALT 374 AST 208
FIBROSCORE 10.4

4 weeks tx ALT 29/ AST 33. VL < 12 UI/mL
8 weeks tx ALT 29/ AST 34. VL UND
4 weeks after tx UND. SVR4. ALT 24/AST 18
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12152

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Thanks to Mike for posting his PCR lab report where you can clearly see that the LLOQ is stated as 15.
Sir, I don't understand why you can't grasp the point that this information should be on a PCR lab report.

By starting this thread DT has Again tried to confuse everyone hoping to make them as
anxiety ridden as he is.

Sir. Maybe you should think about who is the one who is actually confused and anxiety ridden in this scenario?

dt
Last Edit: 3 years 8 months ago by dointime.
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12154

  • LondonGirl
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LG. Yes, if you reach UD before EOT you have a 97% chance of SVR.

Thanks, that's hopeful indeed.
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 HepC
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12155

  • LondonGirl
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and although I would never want to get involved in any disagreements with you lovely people, I would agree that if a Lab is charging £150 for a test, it would seem right to me that they would add the information required before you part with the dosh !
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 HepC
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12156

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I'm not trying to argue here but I suspect we are asking the wrong question in a way that the Lab cannot understand which is why their answers appear unhelpful to us. They aren't being difficult or secretive or anything like that, just talking a different language and not experienced in answering proactive patients who want as much information as possible.

I suspect the point Mike is making is similar to mine in that he has shown us examples of two tests both of which are Quantitative Reflex. If you look at the test titles it is the same test type but in one sample the result is Undetected and in the other case the result is <15.

Those are the results of the test. They do not mean the range of the test. That is not stated as it also wasn't for DTs test result. I think the confusion is caused by comparing them to something like an ALT test which shows your result against a normal range for most people. There is no normal range for viral load, 'normal' is zero!

What DT is asking for is the accuracy of the VL test but note that the ALT test also doesn't state how accurate it is. That is never quoted in the test results.
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
:cheer: :cheer: :cheer:
Last Edit: 3 years 8 months ago by Gaj.
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12157

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Hey Gaj, From my point of view, I am just wondering what the Labs test is before I pay for it ie <15 < 12 etc etc Ariel had one <30 and changed Lab eg . That's about it really. Shopping around looking for details :)
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 HepC
Last Edit: 3 years 8 months ago by LondonGirl.
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12159

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I can understand your concern.
My labs posted earlier were my 4 and 8 week tests. the GI said, in my case, she saw no need for another test until 12 weeks post tx-the "biggie".

So, I imagine different labs in different countries have different protocols. It seems with my lab, its:
1. Qualitative-Is HCV RNA present? If its not-end of test. "Negative"
If "Positive", go to step 2:

2. Quantitative- If the v/l is below the concentration level needed to measure, in my case, <15, then thats it. the notice from my PCP's nurse said my first test result was "unmeasurable" in her email. That was the same as "undetected" to her, but not to me. Unmeasureable is a great result, but the word I was waiting to see was "Negative".
I know it makes no sense, but there is something about it. Negative-not present. Undetected-not found.
They should get a big red stamp that says "Shit's Gone" and stamp it diagonally across all Negative/Undetected results.
M
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
Last Edit: 3 years 8 months ago by mgalbrai.
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12160

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Hi LG,

So the question to the lab is: "Which (brand/model) assay test do you use for your quantatative PCR RNA test?" You then need to look up the manufacturers specifications for that particular test and determine if it meets your needs.

But be aware that while Ariel's original <30 test is was an older standard (she then retested) the newer <10, <12 and <15 tests are all defined by slightly differing accuracy standards so not directly comparable. We are talking really, really, really tiny differences here.. i.e. They are all just as good for our purposes so choose the most convenient/cheapest/fastest based on whichever of those points is most important to you and don't worry.

edit: yes, as Mike says the test is: Is virus present? yes/no and if the answer is no then you can't test for quantity (well I suppose you could but it's pointless and the answer will be none!) if it is present then you test for quantity.
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
:cheer: :cheer: :cheer:
Last Edit: 3 years 8 months ago by Gaj. Reason: Corrected tense per Ariel's later comments
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12162

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They should get a big red stamp that says "Shit's Gone" and stamp it diagonally across all Negative/Undetected results.
:lol: - Love it M !
So the question to the lab is: "Which (brand/model) assay test do you use for your quantatative PCR RNA test?"
Great - Thanks Gaj the word 'assay' is helpful

Didn't know tests could go down to 10 , I doubt they have that here, local hospital is 12, so pretty good. Private companies have to be checked out, last test I did through one I spent hours on phone chasing results. It seems the way....They take the money and you do the work!

The thing is, we may seem like we moan here in England, but the truth is, regarding services of any kind, it seems to be the way of late, that there is plenty to moan about - Unfortunately. God knows how elderly people cope with it all.
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 HepC
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12163

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Those are the results of the test. They do not mean the range of the test. That is not stated as it also wasn't for DTs test result.

Gaj, Mike's PCR report does in fact state the range of the test. It says:
"The quantitative range of the assay is 15 IU/ML to 100 million IU/ML"

This is what I would expect to see on any PCR report. In fact, I've never seen a PCR report that didn't have it, until now.


Anyway, I now have an answer - of sorts - to the issue. Many thanks to those who contributed this information.

The Doctor'sLab (TDL) says that the LLOQ for their test is 12 IU/ML.
The fact that my intermediary (Medichecks) did not put this on my report is because TDL did not provide it to them.
I can't get a satisfactory answer as to why TDL didn't provide it, or if they ever provide it, eg. on their PCRs which show DET rather than UND. It is also not displayed on their website.

So, it is what it is.

There are implications to this for anybody seeking to get a private PCR done in the UK. TDL is a major provider of this test. It is used by several private blood services and private consultants. If you get a private PCR in the UK then the chances are that it will be done by TDL. So - you could, like me, get a report that does not contain the quantitative range of the assay, (no LLOQ).

My understanding is that TDL are a perfectly good provider and their LLOQ of 12 is fine for just about all purposes.
However, I'd urge anybody who wants the LLOQ and doesn't get it on their report, to contact TDL and ascertain for themselves the LLOQ for their test.

dt
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12166

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Good morning
On this debate I seem to have have been misunderstood about the quality of the testing so......
I will restate:
My FIRST path aasay range was 30-10000000
I was <30
NOT GOOD ENOUGH
A week later I had TWO tests performed no NOT assay 30 plus
Lower limit 15 see my blog (Ariel takes the plunge)
Qualitative VL AND quantitative PCR RNA reported
Nothing seen on either

Zero
UND woohoo! Nothing will rock my boat now no talk of test assays etc etc nope

My GP rang labs
He located and wrote up the test request whilst on phone I sat there

I am not worried !!! Don't stress everyone it isn't worth the worry trust is good for the mind

I have even relapsed from Peg/inf I shouldn't have even been on at F0 and VL 400000! But NO I Am not anxious or concerned or worried or confused about the tests I had

I'm STOKED and I hope to hear more Stoke on here than worry
In my case at day 40 (now week 8 here)
The VL shows nothing
The PCR RNA shows UND
I believe I am clear and intend staying clear

I tried to write this in a consice way earlier on this thread but it seems people think I'm being tested still at assay 30+ NO!!!!
Please again reread my notes
I hope you can find a doctor who will assist with explanation
James and I talked about this prior to my second test as I also mentioned
I'm in Oz so I don't know the system in the UK and US but I say get both, and trust the qualitative UND
Ken, yes you made a good point re ranges as during peginf test ranges on my reports were ridiculously high assay eg 600- 10000000 whats the point of that but then that was three to four years ago now
Gosh this is getting way too stressful here !

I'm happy with my testing and quality of care.
At the end of the day ask Dr J to explain why you may see an unquantifiable result such as my first at day 25 (<30)
Then seek out testing as I did with support from medicos, because hell I was getting close and knew from my ALT AST I was going to clear imminently.
Hoping this makes perfect sense
No seeds of doubt in my garden #flower #flower #flower
Gen 1a
Peg/inf/riba 2012(!) stop @ Wk 43 potassium low +issues (rlps week 4 post tx, VL120,000) scnds eg. adenomas.
pre sof/led VL 240,000 Fibsc F0
Day 25 <30
Day 32 UND
Week 10 UND
EOT UND ALT11AST17GGT19
SVR4 UND ALT10 AST16 GGT13
SVR8 UND ALT <9 AST16 GGT15
SVR12 UND ALT14 AST19 GGT12 Bili 5
EOT +18 ALT13 AST20 GGT9 Bili 5
EOT +21 ALT11AST15
Cured SVR12
Dysplasia Adenomas RemvdAug '16
SVR24 UND ALT11AST16
ColonoscopyClear Nov17
LumpectomyClear ‘18
LithotripsyCytoscopyBiopsy 4/18
Last Edit: 3 years 8 months ago by Ariel.
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12173

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At 4 weeks I had a qualitative which came back detected. The same sample was then sent to have a quantatitive test and it came back undetected. The tests didn't have details of LLOQ or LLOD so I was very confused. After reading this thread I guess the qualitative test was more sensitive. I just didn't think that would be the case as I understood the quantatitive test is more complex I assumed it would have a lower detection limit.

It did my head in to be honest but I had to come to terms that either way it was low, which was a good result and that's all that mattered. Edit: just realised you are testing for SVR, so it would be more important to know LLOD.

If I'd had to pay for the test myself I think I would've made more effort to follow it up. Luckily I got the 4 week quantitative results back at at same time as I got a 6 week qualitative test result which was undetected so it put my mind at ease.

So you got undetected? That's great, congrats
3a F0 TX Naive
Started Tx 12/12/2015 Kingswood Sof/Dac

Pre Tx - ALT 71 AST 40 V/L 9 million
Day 11 - ALT 12 AST 15
4 week - LFTs normal - detected (same sample sent for v/l showed undetected) :/
6 week - UND
12 week EOT - UND
SVR4
SVR12
Last Edit: 3 years 8 months ago by Jaz.
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QUANTITATIVE PCRs with LLOQ missing - UK 3 years 8 months ago #12175

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Hi Ariel,

I was aware that after seeking medical advice you had retested with a LLOQ 15 test, my fault for sloppy use of grammatical tense :blush:. I have edited my post to correct that.

You are right about a good doctor being able to explain all this information. Finding one that you trust and making sure you understand their advice (in whichever country you live) should be a far more important area of focus than looking for various tests and test labs by ourselves. :+1: #flower
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
:cheer: :cheer: :cheer:
Last Edit: 3 years 8 months ago by Gaj.
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