OH NO...got paperwork back of VL...JMJM???

[mkeela]

I can't beleive this. I don't know what to do. I am so confused. I was told that they did a PCR and I was UND over the telephone. Thats not what the paperwork says. It says they did a HCV QN by bDNA. The "cheap" one? Anyway, it says, serum <615.
The Assay dynamic range is 615 IU/mL to 7,692,310 IU/mL. i am very discouraged. Can anyone tell me what this means?

[mikesimon]

It means that according to the sensitivity of the test<615 you are undetectable. Mike

[desrt]

<615 means less than 615. Looks undie to me, but call the doc again just to make sure.

[mikesimon]

If you're still worried you could have another more specific test but, in my experience, when one relapses the viral load jumps and everyone I know who relpased tested way beyond 615 so my guess is you're in good shape. Mike

[jmjm530]

That's cool. At others have said, you are non-detectible, so congratulations !!! No need to call doctor IMO.

BTW the bDNA is not a "cheap" test, in fact probably more accurate than a more sensitive PCR.  Forgot if this is post treatment or during treatment and what week?

-- Jim

[mkeela]

Good Grief. I guess I am just throwing a tantrum, because I thought they did a PCR...at least they could have done a TMA. I just researched all of them so I guess I got my answers. Sorry for panicking and posting like I did. I just hate it that we can't know for sure that this virus is completely gone. I hate this. Sorry for freaking out. Thanks all and blessings to ya, Mkeela

[mkeela]

UND at week 10.(my hepa people only do VL at 12 weeks, but I complained till the finally did one..hee hee)Did shot 11 last night. Only have to go 24weeks because of the VL. My bloodwork looks amazingly good so far, just suffering from itchyness, tiredness, flu like symptoms, and mood swings. I feel bad for feelin sorry for myself now..LOL...I love you guys.

[jmjm530]

If it were me, I'd test again at week 12 per normal protocol. That would be the day before your 13th shot. A good test to ask for would be "Heptimax" by Quest Diagnostics. It is very sensitive and goes down to 5 IU/ml. In fact, any further tests should be senstive tests like Heptimax. It's not unusual that the doctor gave you the test he did. Just not the best test IMO. And certainly the wrong test from here on out since you are below its limit. But as Mike said, not to worry. Chances are that you will also be non-detectible with the more sensitive test.

Be well.

-- Jim

[jmjm530]

Alternatively, you could ask them to run a more sensitive PCR or TMA on the same blood, assuming the lab still has enough left. If you go this route, make sure whatever test they run has a sensitivity of at least 50 IU/ml and preferably 10 IU/ml or under.

[GrandOak]

Good suggestion Jim.  When I scheduled to have next week's PCR drawn, I checked around to find out what test would be used and it's sensitivity before I made the appointment.

I would have prefered the <5 but settled for the <50 at this point as all I need to show, according to the statement at my last follow-up, is a 2 log drop over the 12 wks of 1400 mg of riba from my original baseline of 72,000,000 last January.  I figured UND <50 certainly is more than the 720,000 required for the 2 log drop, and if it is UND, then I can pursue a <5 test for a more precise measurement.

[desrt]

Another good <2/<5 test(depending if you're talking copies or I.U.) is the 'Quantasure' from LabCorp.

[GoofyDad]

As I understand it, bDNA is the most accurate at measuring what your viral load is, if you have a viral load, and it is higher than 615.

TMA is the most sensitive at detecting the absence/presesence of virus, but is doesn't measure what it finds.

If you expect to find virus (like at baseline) bDNA is a good choice. If you expect you may be UND, TMA is a good choice. My doc will usually tag a bDNA onto the TMA even when UND is expected, presumeably as a redundancy. I prefer TMA over PCR because I've read a number of published studies on it's accuracy. Sensitive PCR may be just as good though. Google 'tma residual viremia'.  

As Jim says, Heptimax is another good way to go.

[jmjm530]

A PCR <50 is considered sensitive and should be fine. In fact, as of the last time I checked, that was the most sensitive test used in the European trials --  in other words <50 was considered non-detectible for all practical purposes.

That said, what lab are you using? If it's Quest, you can have the PCR reflexed (automatically re-tested) to a qualitative or quantitative TMA if the PCR shows <50. That way you only have to get stuck once :)

Good luck and be well.

-- Jim

[l-horn]

Heptamax is the only way to go, imnho. Why would you even USE any other test ?

[cuteus]

mkeela, are you genotype one?

[jmjm530]

LOL. I love it. Brand loyalty :)

Seriously, Heptimax is an excellent test and I used it during treatment and for my week 6 post treatment test.

Then I switched to Quest's HCV RNA Qualitative TMA that uses Bayer Versant Technology for my 12 and 24 week VL tests. Like Heptimax, this TMA also has a sensitivity of 5 IU/ml.

The latter, as it's name suggests is a qualitative and gives the results as either "non-dectible" or "detectible" without a VL number. This type of qualitative is also an excellent choice once you've become non-detectible via a less sensitive test. LabCorp also has a very sensitive PCR that goes down to 3 IU/ml, I believe.

If GO uses Quest, one option would be to have his PCR reflexed to the Qualitative TMA mentioned above. In essence, this would be Heptimax with a "twist". The actual Heptimax is a two-part test that uses a real-time PCR with sensitivity of 50 IU/ml. If negative, the test is automatically reflexed to a quantitative TMA with a sensitivity of 5 IU/ml.


-- Jim

[l-horn]

I'm hoping one of their reps will read it and cut me a discount. I don't have insurance and it is a kinda pricey test.

I'm willing to wear a logo T-shirt.

[jmjm530]

I heard it the same as GoofDad regarding Bdna as the most accurate.

However, I was told that a real time PCR is more accurate than a TMA in the sense of false positives or false negatives due to contamination or other reasons, since there is so much amplification involved with TMAs.

To tell you how neurotic I was, at week 12 post treatment I had both Heptimax and a qualitative TMA. Since Heptimax is actually two tests --  in effect I had three tests -- a quantitative PCR, a quantitative TMA and a qualitative TMA. Fortuantly the results were consistent or I would have had one big headache. If I were over the top neurotic, I might have added in a bDNA to the mix. Actually thought about it. LOL.

-- Jim

[mkeela]

Nope, 2b...I stopped feeling sorry for myself earlier, thanks all for reminding me of my personal blessings.   :)

[jmjm530]

LOL. How about "I'm sensitive" for the front of the shirt :)
-------
Seriously, I hear you can "negotiate" with Quest on prices if you're paying out of pocket. I think the insurance companies only pay a fraction of the "list" price. Always best to speak to one of their supervisors.

-- Jim

[jmjm530]

Actually, if you're paying out of pocket, once you test non-detectible by Heptimax, you might just want to use their
Quest's HCV RNA Qualitative TMA for all future tests, assuming the qualitiave costs less.

[sunspot]

The Mayo has a Super Quant that tests down to <10.

[l-horn]

Well I've learned a few things about that. For 'whatever' reason, my hep doc doesn't have an account with Quest. So he just gives me a sheet with the tests he needs and I go directly to a Quest 'outlet' and have the test done and pay on the spot. Heptamax is $475. Initially, when I had the genotyping and all the tests it was nearly $1500. So I go to my Primary Physician and he tells me, 'Don't do that. I have an account and get a discount. Still, it's $225 with him, but that's better than $500.

Hep doc @ $150 a whack, blood test running about $350/mo. Even with the free meds, I'm still talking $500/mo out of pocket.

I was thinking about a T-shirt with 'What's YOUR viral load ?'

[mkeela]

What is the difference between IU/mL and copies as desrt mentioned in C10? I can't navigate through the archives and find the threads that I remember seeing the discussion in.

[jmjm530]

I-Horn: I was thinking about a T-shirt with 'What's YOUR viral load ?'
---------------------------
I like it but not sure it will get you many dates :) $225 sounds like a good price indeed, but maybe you could do better with just the qualitative TMA. Then your T-shirt could read "Detectible ?" on one side and "Non-detectible?" on the other. Still probably not a great date shirt.

-- Jim

[jmjm530]

IU stands for international units. Copies stands for "confusion" in my opinion. Stick with IU's and you'll be OK. FWIW, with most systems, copies are double the IU. In other words, if a test might say it has a sensitivity of 5 IU/ml or 10 copies. Confused yet? I am :)

-- Jim

[mkeela]

HAHAHAHA...ok, now I remember that thread...LOLOL. Yep thanks.

[BThompson4]

I would ask for a more sensitive test.  I was 1430 copies at ten weeks; just got 12-week pcr and it shows 561 copies.  With a test sensitivity of >615, I would have been "undetectable" at week 12.  In reality, tho, I still have a ways to go before I can be very comfortable with tx working [post=transplant; 1a; viral load over 3.5 million pre-tx].  

My numbers are trending toward undetectable [if the vl went up from week 10 to week 12, I would be very worried], but in a lot of relapsers I don't think it is uncommon for the viral load to fluctuate for a lot of weeks after week 12 between undetectable and a few hundred in a lot of genotype 1 people.  Being stuck in the low three digits for a lot of weeks can have big consequences for the success of your treatment, especially involving the decision  to increase doses now and whether to extend tx beyond 48 weeks.

Chances are, you are all the way undetectable and have nothing to worry about.  The more sensitive test, however, can give you more information to act on if you tx has a tendency to stall in the less than 615 range.

[jmjm530]

Not 100% sure because the conversions may vary per test, but if your test had a sensitivity of 615 IU/ml, then you would not have been non-detectible if your result was 561 copies which probably translate to more than 615 IU/ml. They are trying to get rid of "copies" and convert everything to "IU/ml" so there is less confusion. I agree though, a more sensitive test is always a good idea.

-- Jim

[jmjm530]

Just to get things straight, I did state earlier that "Copies" stands for "Confusion" :)

OK, on second look, it's a little more complicated.

"In tests using Polymerase Chain Reaction (PCR) technology: Copies/mL = IU/mL x 2.7 In tests using Branched DNA(bDNA) technology: IU/mL = Copies/mL x 5.2." In other words, one type of test uses one coversion, another type uses another.
Source: http://www.dmt123.com/disease-aids/4673-aids.html

So, assuming that BT's test was a BDNA with a sensitivity of 615 IU/ml...you know what, I'm gonna let someone else answer this question. LOL. There's a reason I always use IU/ml. :)

Here's some more confusing reading on the topic, the first of which also shows TMA conversion:
http://tinyurl.com/8jgya
http://groups.msn.com/HepatitisCComunity/pcrviralloadchart.msnw
http://www.thebody.com/Forums/AIDS/Labs/Archive/Hepatitis/Q136553.htm

[jmjm530]

If that isn't confusing enough, here are additional conversions for other viral load tests. By now you can probably understand why they are adopting IU/ml as a single standard.
http://tinyurl.com/ym3m4c (Table 1)

Table 1: Common viral load measurements converted
from International Units to copies/mL.
Assay
Conversion Factor
Amplicor HCV Monitor v2.0
(manual procedure) ........................1 IU/mL = 0.9 copies/mL
Cobas Amplicor HCV Monitor v2.0
(semi-automated procedure)............1 IU/mL = 2.7 copies/mL
Versant HCV RNA 3.0
Quantitative Assay...........................1 IU/mL = 5.2 copies/mL
Cx HCV RNA
Quantitative Assay...........................1 IU/mL = 3.8 copies/mL
SuperQuant....................................1 IU/mL = 3.4 c

[mkeela]

ok trying not to get technical, BUT, does " / " in IU/mL actually mean  international units divided by milliliter of blood? And then multiply by 2.7 or 5.2 depending on the test used?
Sounds to me its really kinda like Neutrophil Absolutes with lets say 2.3 X 10^3. why don't they just say, 2300??? Anyways, thanks jmjm for all the links...and I think I will stick to the major I was working on before tx...LOL...I hate all this medical stuff. Night and Blessings to ya!!!

[mkeela]

AH HA!!!! Gotcha!! Thanks for that last comment, makes total sense now. Im gonna copy and print that for future reference! THANK YOU SOOO MUCH!

[BThompson4]

I should have used the iu/ml.  It was 1430 iu/ml at week ten; 561 iu/ml at week 12.  I'm guessing week 12 would have been undetectable with a test sensitivity of greater than 615 iu/ml.  My tests were with the Roche Tagman, or something like that, too tired to look it up, with a sensitivity of 50 to 10,000,000 iu/ml.  So I think the test used by mkeela would have shown undetectable for me at week 12, when it could take a lot more time to actually get there.  Starting vl was greater than 3.5 million iu/ml.  Its kind of frustrating that vl dropped more than 99.95 per cent the first ten weeks and only about about 900 ml/iu in the two weeks after week ten.  I got another pcr done yesterday [end of week 15] and should know the results in two weeks.

[mkeela]

AWE....you're getting there!!! LOOK AT HOW FAR YOU'VE COME!!!
And you are a geno 1 and at week 12 (by use of bDNA) you'd have been UND too!!! THATS AMAZING for A geno1!!!!! (Im a geno 2b) So you said you are also post transplant? WOW...how many weeks do you do tx for? Your story is VERY inspiring...you should let others know that there is much hope. Thanks you for commenting, you've helped me more than you know today...also keeping my mind on all these equations has kept my mind off my "day after shot sx"...LOL. Thanks again, and Blessings to ya!

[ladybug52]

How about a t-shirt that says: Hep doc  $150 a whack,
                               blood test  $350/mo
                               SVR, priceless!

[jmjm530]

MK,

IU/ml means international unit per milliliter of blood. The human body has "X" milliliters of blood in it, so you would have to multiply by "X" in order to get the number of IU/s in the body and then covert to copies to get the number of copies of virus in the body. But not sure why you really would want to do that.  

My suggestion is to forget copies/ml entirely, and just go by IU/ml. Your test reports should be in IU/ml.

BT,

Thanks for clarifying.

[mkeela]

So in other words, at week 12, Bthompson is down to apx. 1122 IU/mL? As compared to 2860 IU/mL at week 10?

[mkeela]

And also that would mean that by the standards used <615 IU/mL then it IS detectable at 1122IU/mL??

[jmjm530]

I think so but I think it depends on how the specific test converts. That's why it's a lot easier to compare IU/ml to IU/ml, in other words apples to apples. Of course I don't know, but I assume somewhere on BThompson's lab report are the results in IU/ml. That's all I've ever looked at.

-- Jim

[BThompson4]

Thanks for the encouraging words, and congratulations again on your undetectable.  

I got my liver in January 2001, but was only allowed to begin treatment in June 2006.  I was not in the best of shape beginning treatment because of waiting so long after transplant.  The tx has really hit hard the last few weeks energywise.  My doctor is shooting for 48 weeks of tx, but if I don't clear fairly soon there is no way that I am doing only 48 weeks.  It is too much of an investment of time and suffering to not go at least 36 weeks after becoming undetectable.  

Also, I have a very healthy respect for the limitations of my body in its fight with hepc, having almost died from sepsis and multi-organ failure in 1999.  When you have been down that far, hepc does not sound like something you can't live with if you have to.  I don't want to sound like I'm ungrateful for how much virus has been killed so far, but I need to get undetectable to start feeling good about this whole process again.  Also, I don't really know with accuracy what my liver was like pre-tx, as last biopsy was June 2004 [grade 2, stage 2], and  post-transplant the virus can do lots of damage very quickly if you don't keep an eye on it.  I worry about killing the virus that hangs out in the damaged liver.  Its all such a huge **** shoot with too many unknowns.

[jmjm530]

It depends on the test. Sometimes the multiplier is not "5.2". See posts "C33" and "C32" above.

-- Jim

[niceguy2007]

jim n mkeela, to get copies, just multiply the IU/ML value by 5.2