Does NOt detected necessarily mean UNDetected (4 Week Labs)

[Idyllic]

HCV RT-PCR, Quant (Non-Graph)
Hepatitis C Quantitation   HCV Not Detected IU/mL   
HCV log10        
Unable to calculate result since non-numeric result obtained for component test.


The quantitative range for this assay is 25 IU/mL to 69 Million IU/mL using a combination of Taqman real-time PCR (LLOQ 43 IU/mL) plus reflex to another Taqman assay (LLOQ 25 IU/mL) for low viral load samples that were detectable by the original Taqman real-time PCR assay but not quantifiable. The limit of detection of the assay is 7.1 IU/mL for HCV Genotype 1.

Question: Does this mean my VL is lower than 25 IU/mL or 7.1 IU/mL & I am technically not UND yet, right?

[melame63]

I regret to say I realized I was hepititis c positive when I was pregnant I was worried sick and still am he is now 21 months and I know as embarrassing as it was all my doctors were aware and notified about the issue and my concerns with giving birth they made me believe he would be fine and natural birth was the way to go I wish I had more information then but anyway my sons test results say antibodies positive for hepititis I realize this can be present from the mother until 18 months he is 21 months and further testing indicated hepititis c RNA detector qual. His results were detected (not detected) A . I just would love any information it makes me sick to think he could be sick because of me and I am praying it just isn't but his atl and ast are elevated his AST is 52 in a range of (<40) and his ALT is 53 in a range of (<41) I am having a hard time sleeping eating I would just die to think my little baby with his little body has to start off life in a fight with medications and the possibility of cancer and 20 year prognosis of life or the fact that my little handsome boy has to tell every girl he's with I am infected it just ***** I can deal with myself but not him he's too young it kills me and any information any one can give me I would so appreciate his platelet count and white blood cells were high and his co2 was low and so was his creatinine I just don't know what this all means thank you

[frijole]

The quantitative range for this assay is 25 IU/mL to 69 Million IU/mL using a combination of Taqman real-time PCR (LLOQ 43 IU/mL) plus reflex to another Taqman assay (LLOQ 25 IU/mL) for low viral load samples that were detectable by the original Taqman real-time PCR assay but not quantifiable. The limit of detection of the assay is 7.1 IU/mL for HCV Genotype 1.

I think this is the standard wording to define the test.  If someone is detectible under the 43, then they run thru again to determine if there is detection between 25 and 43.  However, if there is detectible virus which is nonquantifiable, down to 7.1, it would be stated in the first paragraph which is the actual patient result.

Hepatitis C Quantitation   HCV Not Detected IU/mL    -- I believe this is your result.  Since the test can't detect levels below 7.1, you could possibly have viral load under that.  However I would call you undetectible on this test.

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Assays/Interactive%20Virtual%20Presentation/iVP/Presentation.aspx

in this CCO presentation by Dr. Kwo he discusses the difficulty in interpreting the PCRs.  It is an interactive presentation - meaning you answer questions - and I am surprised at the amount of wrong answers on this one

bean

[flcyclist]

I meant function.
Yes, we need one!! ;-)

[flcyclist]

a 10 minute edit fuction would be wonderful.  Can't wait.  

[orphanedhawk]

Emily tells me they 'talk' about getting an edit function.
We need one!

[Idyllic]

Thanks for all this commentary gang. Thanks for the other link brought up in this thread. I found another relatively recent one that discusses this as well:

http://www.medhelp.org/posts/Hepatitis-C/43-IU-mL--but-detectable---I-think-I-finally-get-it/show/1582070

__________________
I sort of got sidetracked and started reading stuff like this to understand why it's like that and where am I getting confused. The explanation in the "Interpretation" portion of this document helped a little:

http://www.airuplab.com/Testing-Information/resources/TechnicalBulletins/Hepatitis%20C%20Virus%20%28HCV%29%20RNA%20Quantitative%20Real-time%20PCR.pdf

________________________---
♫ While I am on a ramble I would like to say:♫

1. I really appreciate recent thoughts and analysis on common and routine questions. I realize it may get frustrating sometimes but thoughts and ideas get wiser, more refined & precise as they evolve. Plus, I often have to read something several times before it sinks in. Usually it is the same thing is said in different ways.


2. The Search Function is easier and more fruitful when people use "Tags." So sometimes it's not that I really don't use the search function before I ask a question.

3. Gah!  This is the only Forum out of many I have been a member where there is not at least a 10 minute edit function!! Once you post: you post. So, I need to get used to checking my posts before I submit them so thanks for your patience.

[flcyclist]

"Your test had two part test: 1st part had a quantification limit of 25 IU/mL; 2nd with a quantification level of 7.1 (for 1a's).  According to your statement, no HCV RNA levels were detected."

I agree with part of your statement above.

1st part LLOQ - 43 IU/mL - detected
2nd part LLOQ - 25 IU/mL - not detected
The limit of detection (LOD) of the (both??) assay is 7.1 IU/mL

[willbb]

Hmm.  interesting

[willbb]

The test the way I read it means that you were UND.  However what did your doctor say?  He is the one that needs to interpret these tests correctly
.If he is unsure demand that he contact the lab for clarification. That is his job and why he is being paid.

These tests are far to important not tot have concise and quick exact interpretation by the professionals that are paid to inform us correctly..
Best to you..
Will

[flcyclist]

Can I change my answer??? :-) After reading the responses it rattled my memory and reminded me of a previous post that dealt with the same situation.   Fortunately, Eureka helped me see the light :-)

http://www.medhelp.org/posts/Hepatitis-C/Taqman-Clarification/show/1663796#post_7590262

The sample was detectable by the original Tagman RT-PCR, but not quantifiable (LLOQ 43).  Another more sensitive (LLOQ 25) Taqman assay was run and the results were determined "Not Detected".  Therefore, this more sensitive assay is the definitive result of the test.  

What I find confusing is that I thought the limit of detection of the both assays is 7.1 IU/mL.  This stuff continues to mystify me since it shouldn't be that complicated in translating the results.  Hopefully your doctor can help explain this to you.  

[hrsepwrguy]

I was also DET at 4 wks

Roche Ampliprep and Tagman and specifically says

Virus detectable below limit of quantification

[JasmineT]

You should talk to your doctor of course but I just got my week 24 labs last week and they say the same.  I am UND.

My Interpretation, not an expert:
Hcv not detected = UND is my understanding too as stated by suezeeque above

Hcv log10
Unable to calculate...
Think of this as a divide by 0 error.  The software tried to divide your viral load, which had no value.  Since you do not have a viral load number, the software could not calculate a log, it needs a number.

The quantitative range...
This is a description of the sensitivity of the test.  Since it can only measure above a certain level of viral load, it's possible there is some small amount of virus still lurking.  This is why people relapse from und so keep treating.

Not a doctor and can't see your results but believe congratulations are in order.  

[nygirl7]

"for low viral load samples that were detectable by the original Taqman real-time PCR assay but not quantifiable." As stated above, the sample was detectable, but not quantifiable.  That is my understanding. "

I am not sure what tweedle means by undetectible when the verbiage clearly does not say you are not detectible, except over the sensitivity of 25. However; with even one virus present it opens the door to possible reinfection and you must eradicate them all - not just the ones in your bloodwork but others that might be present outside it.

The good news is that you can continue on with the protocol and have an excellent shot at the CURE.  In the end that is the goal you must remember is the most important.

[pooh55811]

Okay, just to compare that detectable test to my undetectable tests, I will include this one which clearly states I am undetectable:

Test: Hepatitis C RNA Detect/Quant
Undetected
Reference Range: Undetected
(Unit: IU/ml
NOTE)
Result in log IU/ml is Undetected
Quantification range of this assay is 43 IU/ml to 69,000,000 IU/ml (1.63 to 7.84 log IU/ml)

Test was performed by the COBAS AmpliPrep/COBAS TaqMan HCV Test (Roche Molecular Systems Inc.).

You can see it is pretty clear that the result of my 4 week test (in the last post) was Detected and the results in the following tests have all been Undetected.

[pooh55811]

You mentioned you wanted to see the results of other people's 4 week tests. I looked at my hard copy of my 4 week VL test and here are the results (word for word).

Test: Hepatitis C RNA Detect/Quant
Detected
Reference Range: Undetected
Unit: IU/ml
HCV RNA detected but less than 43 IU/ml (1.63 log IU?ml)
This assay cannot accurately quantify HCV RNA below this level.
Result in log IU/ml = <1.63
Quantification range of this assay is 43 IU/ml to 69,000,000 IU/ml (1.63 to 7.84 log IU/ml)

Test was performed by the COBAS AmpliPrep/COBAS TaqMan HCV Test (Roche Molecular Systems Inc.).

[pooh55811]

"So at this point I think it only matters that my HCV-RNA levles were LESS than 1000 IU/mL "
----------------------------------------------------------------------------------------------------
I am not going to comment on the interpretation of the test. I leave that to the experts on the forum.

I will, however, comment on your statement above.

For the purpose of continuing treatment, you are correct. Your levels were under 1000 so you can continue treatment.

However, if you are/were truly detectable at 4 weeks on Incivek and SOC, you will need to treat for 48 weeks instead of 24. To me (who has to treat for 48 weeks because of detectable virus at 4 weeks) that is a big difference. I was very happy at 4 weeks that I could continue treatment because I was so afraid I might be 1000 or above and have to stop. I am now at 21 weeks and have been undetectable since week 8. I am happy I am undetectable, but I really, really wish I had been undetectable at 4 weeks. So to me it does make a difference in the long run.

If I were you, I would get this test result clarified by your doctor or your lab or both. Hopefully your doc can interpret the test accurately.

I wish you the best.

[Idyllic]

The Incivek page elaborates a little more. It says:

Treatment futility rules in all patients:

Patients with inadequate viral response are unlikely to achieve SVR. Futility rules are therefore in place at key time points during treatment. Discontinuation of therapy is recommended in patients meeting these rules.



Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions. Discontinuation of therapy is recommended in all patients with

(1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or

(2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm

So at this point I think it only matters that my HCV-RNA levles were LESS than 1000 IU/mL


There is a chart about 3/4th way down.
http://www.incivek.com/hcp/treatment-duration-treatment-history

[suezeeque]

I'm terribly confused.

I've seen similar results posted many times.  This one says "HCV Not Detected IU/mL".  Then the standard blurb that seem to follow all of these things.

I can tell you, mine said "DETECTED" and under 25.  It did not say "NOT DETECTED".

[flcyclist]

"for low viral load samples that were detectable by the original Taqman real-time PCR assay but not quantifiable."

As stated above, the sample was detectable, but not quantifiable.  That is my understanding.  

[frijole]

To either can do or idyllic

"Hepatitis C Quantitation   HCV Not Detected IU/mL    
HCV log10        
Unable to calculate result since non-numeric result obtained for component test. "

Aren't these the results of your test and do they not say HCV not detected?  What part of this indicates that you still have viral load under the limit of detection?  I am still confused in reading these tests.  The rest of the information you typed in your post is, I believe, the discussion of the range of the test and there is no personal informaiton on your test in that paragraph.  Is that how you understand it?

[can-do-man]

No your doctor used the correct test, its the same as vertex used in their trials. And as you can see below you are not whats called a null responder which is very good news. You would be a Partial responder so odds are very much more in your favor.


Null Responder: A null responder is someone who achieves little or no decrease in hepatitis C viral load during HCV treatment. Null responders are highly unlikely to respond to re-treatment with an interferon-based regimen.

Non-responder: Often referred to as a "treatment failure," a non-responder is someone who does not have an EVR or, if they stay on treatment for 24 weeks, does not ever have a 2-log (99%) drop in hepatitis C viral load or undetectable HCV RNA during hepatitis C treatment.

Partial Responder: A partial responder is someone who experiences at least a 2-log decrease in hepatitis C viral load during HCV treatment. Partial responders are more likely to respond to re-treatment than non-responders or null responders.

http://www.thebody.com/content/art46371.html

[Idyllic]

Hey..I am pretty sure I spelled as·sess/əˈses/ accurately....
Verb:

    Evaluate or estimate the nature, ability, or quality of:

[Idyllic]

I was just re-reading the Futility Rules and this is what is throwing me off:

For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result.

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm


So, didn't my doctor use the wrong....assay (???) to ***** my condition and apply the Futility Rules? Should I call them? btw I only had a partial response on Peg/Riba Had a 2 Log drop in the beginning and nothing after that so I stopped before 12 weeks

1. Does this make me a Null Responder

[can-do-man]

I can sure understand wanting that 4 week und, but on the bright side you know with under 25 you are having a very good response... So close yet so far away, hang in there, wishing you the very best......