Need some help interpreting HCV RNA by PCR, Qn RFX Geno

[headshop]

Got lab results from new GI, the seem a little more confusing than others. Help
Hepatitus (hepatitis) C Quantitation: 40 IU/ml
HCV log 10:        1.602   log10 IU/ml

The reportable range for this assay is 43 to  69,000,000 UU HCV RNA/ml

HCV Genotype:       Not indicated

Usually the Doctor would explain this to me, but don't have an appt. for a few weeks.

Week 34

Thanks
Headshop

[desrt]

I'm confused too - how do you get a result of 40 on a test that has range of 43 to 69,000,000? Do you have any other info like is it a LabCorp test or Qwest? Is there a reference # or a name like "Quantasure' or 'Quantasure Plus'?

[epiphiny]

Hmmm, this is quite confusing!  I think it's a Taqman Test and I did find this, but it still doesn't really explain the way they have reported results.

"Effective February 2009, NorDx will begin HCV RNA viral load testing on plasma or serum using the Roche COBAS AmpliPrep/ TaqMan® HCV real-time PCR platform.  The reagents have been developed for the quantitation of the six HCV genotypes.  This test targets the highly conserved 5' untranslated region of the HCV.  The reportable quantitative range of the assay is FDA approved at 43 to 69,000,000 IU/ml.  The limit of detection (LOD) is 18 IU/ml.

Result Reporting:  Results are reported as either undetected or positive.   HCV RNA Viral load is reported in IU/mL.  Reportable quantitative range of the assay is from 43 to 69,000,000 IU/ml.  Positive results below 43 IU/ml are reported as:  Positive <43 IU/ml.  The limit of detection (LOD) is 18 IU/ml."

Here is the link, and I also notice there is an email link at the bottom of the document where you can request more information, might be worth sending off an email.

It really does confuse me, as my tests were Taqman also but my limit of detection was 15 and less than 15 was considered UND.

Would love to hear what you find out.

All the best to you.

Epi.

http://www.nordx.org/resource/HCV%20TaqMan%20PCR%20TB.doc.

[willing]

in PCR tests it's much easier to detect RNA than to reliably measure how much RNA is detected, particularly at very low levels.

Thus, I believe the issue is simply that FDA approval restricts  the test's 'reportable quantitative range'  to 43 to 69E6,  that's the range in which quantification is reliable. In this case, RNA was detected below that range, thus though the test claims <40 the FDA's analysis indicated the test could not reliably distinguish say 20 from 30.
  
The lower limit of detection, the point at which the test can distinguish RNA from a glass of water, is 18, so you can assume VL somewhere between 18 and 42.

The larger issue is that detectable VL at w 34 is not good news..though there are reports of SVR even with a breakthrough.
Best wishes.

[jmjm530]

Positive results below 43 IU/ml are reported as:  Positive <43 IU/ml
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If this is the case per "epi's" post above, then your lab report doesn't make sense. Are you looking at it or did someone dictate it to you on the phone?

But, assuming you are positive as "Willing" suggests (and I emphasize the word "assuming") then you can almost be guaranteed that treatment will not be successful. For this reason I would not wait "a few weeks" but get hold of the actual report now and insist on discussing with your doctor to clarify whether you are rna positive or negative at week 34. If positive, I would strongly suggest you consult with a liver specialist (hepatoloigst) before continuing on with the drugs.

-- Jim

[jmjm530]

last paragraph of my last post should have read:
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If positive, I would strongly suggest you consult with a liver specialist (hepatoloigst) to decide if continuing on with treatment is in your best interest.

[jdwithhcv]

I seem to remember you stopped tx for a few weeks, pretty early on.  Is this 34 weeks since you first started or have you done 34 uninterrupted weeks?

[headshop]

I was actually very sick and did have about 6 weeks of no tx, also changing doctors had to get with insurance redo prescript and just feel better, took longer.

my doctor sort of said we'd almost would be starting over, I might could say I am at week 12, they say I am very med responsive both ways.

He did say he would like me to go 6 months more about a month ago.

[jmjm530]

He did say he would like me to go 6 months more about a month ago.
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You owe it to yourself and family to get a second opinion at this point. If you're positive at week 34 then you may be subjecting yourself to these drugs with no hope for a cure. Best person to get an opinion from is a liver specialist (hepatologist). You can usually find them at your larger, teaching hospitals.

[headshop]

I need to call my GI, who made the statement that after the 5 or 6 week layoff, if in his diagnosis was I actually starting over after 22 weeks,

[headshop]

I have a copy of the lab report

[headshop]

This disease and treatment is baffling, I was UND at 5 weeks, taking the riba when I did my injection and at 13 weeks, when I started taking the riba every day, then my bloodwork tanked and here I am.

[GSDgirl]

Are you saying that you only took riba for 13 weeks when you did your shot?  If so why? Wishing you all the best

Denise

[headshop]

I took my interferon every Friday night 180mg, took my riba in the evening and the next morning and that was it. I misunderstood and when I had Dr appts, they asked me my routine on taking the meds and I told them, they didn't question it, until the pharmacy called to set up a riba refill and I told them I still have plenty left, then they called the dr.

Then I started taking the riba twice everyday 1000mg and my blood work immediately started to tank.

Headshop

[GSDgirl]

Doctors!!  You even told them and they didn;t even catch it. Hope it works out for you

[jmjm530]

because of all the missed ribavirin doses your case is somewhat complex and really needs the attention of a good liver specialist (hepatologist ) to sort things out and let you know what is in your best interest. Hepatologists can usually be found at your larger teaching hospitals. for your visit I would gather up all your blood work along with some sort of diary indicating what treatment drugs you took and when. Personally, I would make this a priority.

[headshop]

Maybe I should go back to that dosage.  

My GI and Hematologist tell me that I am very reactive to the meds.

[jmjm530]

going back to 1000 mg of riba will probably guarantee you a relapse. Year-earlier viral decline had to do most probably with the interferon. It's the riba that keeps it from coming back. Take the sound like a broken record, but go get yourself a better medical team. Your case is not an easy one to figure out and you're certainly not good do it on your own.

[nygirl7]

HS

Please do not wait a few weeks for a doctors appointment.  IF your results are that you are positive now and they are considering this week 12 - you need to react quickly to get your ducks in a row. If this is considered week 34 and you are positive that is very bad news indeed and more than likely it is not worth continuing.  

Such a complicated situation surely needs to be addressed right away - not in a month when you are at week 16 and time on the time clock is ticking down.

[headshop]

Yes you are right, I have to drop some stool culture tests by there on my way to get my procrit and neupogen shots at the Cancer Center.

My time is so not mine lately, been working 12 hours with a resurfacing crew and moving stuff from my old house, meanwhile doing a tx Friday, sleeping and other side effects this weekend.
I am trying to save sick time to apply to my time with the City where I can definitely retire July 1.

[headshop]

I was just kidding about going back to the first riba I was taking only once a week.

I like this team I have now, but it might not be a bad idea to check hep