Confusion about UND

[jankar]

What does UND really mean?

I had a result of UND<15 at week 4, someone else a UND<10 at week 4.  Is this result sensitive enough to base a decision on 24 weeks or 48 weeks?  Another suggested we needed weekly or daily tests in the first four weeks to make a decision, another suggested that those results are still detectable and if present at week 12 in the same levels, needs to result in 72 weeks treatment.

Thanks for all the research responses - I am particularly interested in results for 1b on Pegaysus 2a and Ribavirin as those results differ I think to the results from all Geno 1's and Pegysus 2b

[Deb_c430]

UND means undetecatable! They do differ in timing, but und is und!

[Proactive]

jankar, it appears you are undetectable to the extent of the test, which tests down to 15 iu/ml...congrats!!!
It was me who suggested the multiple tests, but as I stated, it really isn't practicle, and was more of a hypothetical statement on my part, sorry for the confusion.
I believe Zazza posted information pertinant toany shortening of tx decision..

[geterdone]

A geterdone moment here, at twelve and thinking 24, yeah buddyet! Danced around that fire then too. Slap, Slap. Ok, not big on gold digging here but Und at 4 weeks and being a 1b with a 244k and no damage pushing 24. I would get a Labcorp or hepamx pcr that goes down to <2 the next PCR and go from there and if you want the “insurance” split the last 24 and push for the 36 week middle ground and if you make it that far what the hell what's 12 more weeks at that point. Either way you’re going to… get er done!

jasper  

[epiphiny]

Can't get lower sensitivity test than "less than" 15IU/mL in NZ.  Considered trying to push to get my blood exported for more sensitive test but it seemed very tricky given blood is classed as a biohazard.

Wow, going for 24 weeks only sure is tempting given what you are trying to juggle. I notice you do have the low VL pre tx BUT only one of those so it's not a confirmed low VL as per the guidelines published in the other thread.

I know you want research and facts, rather than opinions but I gotta say shortening to 24 seems to be a pretty big gamble in my mind.  I can honestly say things got easier after the first 24 weeks and with a reduced stress/workload 48 might be more doable than you think at present.

Like jasper says, the most important thing is to get er done, and dusted!  Ex-nay the vi-ray!!  No coming back again....

[comeagain]

In sweden we use taqmantest <15 iuml or in log <1.18 what I have heard is that this test its sensetive enough and getting a more sensetive is just overdo it I guess there are exceptions when its motivated.

Whether you shall shorten your tx or not could be a good question to dr D if hes still answering any questions, or maybe you can consult another skilled hepatologist and ask what he, she, they think.

Anyway congrats to the very good result!!

ca

[Kristina538]

I got the same result at week 4 but am a G3.  

I was HUGELY disappointed not to be given a 12 week PCR which would have made me feel more confidant that the <15 coming in 'twice' was more significant of an UND result.    I questioned the same and my nurse said it was "as good as it gets" so I agree with Epiphany, that it's our lowest sensitivity test.

I would push hard to get more PCR's done during tx.   At least then, if you have to reduce your riba or peg during tx,  you will be able to make more informed decision on how it will affect your outcome.   A lady I know was on a trial (G1) and got the same result at 4 weeks but continued for the 48 weeks (she's 12 weeks post and recovering well).   Another lady (G1) is doing 48 weeks despite still being detectable at week 12.  Unfortunately the 48 weeks does seem pretty standard here for G1's and I'm wondering if your specialist has advised you of a possible cut down to 24 weeks (it would not be like NZ to be a forerunner - but thus far it seems you've had better treatment than in Auckland for testing etc!!)

However, weekly does get easier and I know that weeks 10, 12 and 16 were turning points in improvements on some levels for me, including my confidence levels on how my body was reacting to the meds.   Good luck Jankar and congrats on getting such an awesome result by week 4!!!

[copyman]

i think you can safely rely on that test that goes down to 15. The chances of having a VL under that number would be really unusal. I would get the more sensitive "qualative" test 4 , 12 & 24 weeks after stopping tx, this will simply tell you if you have HCV or not, no VL. I agree with the other posters that you look like the perfect cadidate to tx only 24 weeks and spare your body an extra 24 weeks of these harsh drugs. Like I have posted before I believe the permanent damage from these drugs come in the 2nd half of tx. The longer you subject your body to them the better chance of permanent damage. Best of luck

[zazza]

I had a detectable but not quantifiable reading at week 12 with the Taqman <15 IU/ml. The laboratory doctor told me this meant I had somewhere between 5 and 20 IU/ml. This sounds to me that in reality even virus below the stated sensitivity can get detected. Anyway my doctors tell me that it does not matter if we use <15, <10 or <2. They are equally good. Anybody ever here of anyone having a viral load of 4 or 7 IU/ml, for example? They just don't come that low.

[jmjm530]

I may be reading it wrong -- and perhaps your Taqman test does indicate positives below the quantifiable limit of 15 IU/ml.

That said, in general a test will not detect below it's stated sensitivity. For example, if a test states it's sensitivity as 10 IU/ml, it will not pick up a viral load of 5 IU/ml. It won't quantify it and it won't even mention it. Heptimax, for example has a lower limit of 5 IU/ml. It will not quantify or qualify below that limit. As to tests picking up a "4" or a "7", this is possible with a test like LabCorp's Quantasure which goes down to 2 IU/ml. I don't think it will quantify that low but it will qualitate similar I imagine to what your doc said, except that the lower limit of the range is 2 instead of 5.

[jmjm530]

To clarify, I'm not  contradicting your doctor and have no reason to believe that is how your result should be interpreted for your particular test.  My point(s) are that most tests do not work like this in terms of lower limit sensitivity as I read your inference, although I may have read it wrong.  The way they work is that if the lower sensitivity of the test is "x" then any virons present below "x" will still give an UND result, i.e. nothing will be picked up below the detection limit whether that limit be in a quant or qual test.

-- Jim

[Deb_c430]

Sometimes when you a person is having a  quandry about something, you find the answer, Thanks!  

[zazza]

You are reading me correctly. And this doctor is a very knowlegeable hepatitis specialist. I am certain he knows what he talks about.

I have not read up on this myself, but I figure that it might be that they can not guarantee they will pick up viral loads below 15 IU/ml, so they set the limit there. I understand it to be that so low viral loads as 5 and 15 IU/ml do not differ so much in test appareance, so it actually becomes difficult to tell them apart. And I don't think it matters what test you use.

[orleans]

UND at<15 is considered UND indeed(except for the rarest of cases} If you could get the <2 test that would be great (publicly funded health care does have it's own set of costs) My point is that <15 is widly accepted as sensitive enough. jerry ps Proactive was right in clarifying his first remark as wishful. Read the studies you can find on this subject. If you are married and / or have very involved friends have them help you wade thru them.     "The truth is out there" the X files!

[jmjm530]

Without knowing what version Taqman you took (for example there have been three versions in the U.S. within the last 18 months) and if it was pared with other tests, it's really difficult to ascertain exactly what your doc (or lab) guy had in mind when they suggested they picked up a viral load below the sensitivity of the test. And once again, I'm not contradicting or challenging your medical team, just furthering a discussion you opened up for both my understanding and that of the discussion group.  If you have your own hard copies of results including the exact test(s)/versions given it would be useful. If not, so be it. But again, in general, tests by their very description do not pick up virons below their detection limit and that's why they list a detection limit. That said, some tests can pick up virons below their quantifiable limit, but they still have a stated detection limit.

-- Jim

[Proactive]

Actually, it appears the tests can detect the virus well below their stated limits, just not 100% of the time...some down to very low single digit iu/ml numbers.
"The ASR detected 100% of the replicates containing greater than or equal to 40 IU/ml and 73% of the replicates containing the lowest concentration tested, 4 IU/ml. "

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=497598

[kciav]

I am confused on this also.

Directly from our lab report from Mayo Clinic at 4 week test the report states:

"HCV RNA detected, but less than 10 IU/mL (1.00 log IU/mL)
This assay cannot determine an accurate titer below this level.
Dynamic range of this assay is 10 IU/mL to 50,000,000 IU/mL (1.0 to 7.70 log IU/mL).
Testing was done by PCR method using the TaqMan HCV analyte-specific reagents.
Analyte Specific Reagent
This test was developed and its performance characteristics determined by Laboratory Medicine and Pathology, Mayo Clinic, Rochester MN. "

It looks like it is not UND yet but since the HCV RNA is detected or will it always show this?

[Proactive]

My opinion is, virus was still detectable below 10 iu/ml, but the test can't make that detection below 10 iu/ml 100% of the time. It can only detect 100% of the time down to 10 iu/ml. But verify with the lab--call the number on the lab slip where it was preformed.

[Proactive]

this was the same test given me throughout treatment, also sent to Rochester...call there

[Proactive]

Here is how one of mine reads
"HCV RNA Detect/Quant results: negative iu/ml
HCV RNA not detected"

so, the bottom line, you are within a knat's *** and are most likely undy as we speak!!

[kciav]

Thanks, that is what we are hoping for at the upcoming 12 week test, actually will be 13 weeks .  Wish they would do a test between weeks 4 & 12.
Congratulations on your test results!!

[Proactive]

Your son's journey is looking great so far!!! I was fortunate and did get tests monthly and then some, throughout treatment. I still was hanging on to 52,000 at wk 4, a bit over 2000 at wk 8...and unfortunately, 254 at wk 13...I had to take the long boat to China, but in the end, claimed my svr.
I wish your son the best,
Pro

[zazza]

My 12 week test (translated from Swedish):

Examination and test type:
DETECTION OF VIRUS RNA
EDTA-plasma

HCV RNA (Taqman)       BORDERLINE VALUE
(Measuring range 15 IU/ml - 69 million IU/ml)
Repeatable borderline value

General message from the laboratory:
With real time PCR for hepatitis C the earlier high sensitivity for qualitative PCR is combined with a large, quantifiable measuring range. In the same analysis is seen whether hepatitis C infection is ongoing or not, and if it is ongoing, current viral load expressed in International Units (IU/mL). Method comparison with earlier bDNA technique shows good linearity but that Roche new technique gives 0.5 log units (3 times) higher values in IU/mL.

[zazza]

My 15 week test:

HCV RNA (Taqman)      UNDETECTED
(Measuring range 15 IU/ml - 69 million IU/ml)

[jmjm530]

The results clearly state that HCV is detected, just below 10 IU/ml where it appears the test cannot quantify. No, the results will not always show this, assuming you get UND. In that case it will say "HCV Not Detected" or something like that.

Unfortunate that so many of  these tests are presented by the labs in such a confusing manner that even docs and NP's can't read them half the time.

One of the things I like about Quest's "HCV  TMA QUAL TMA" -- other than the fact that it can detect down to 5 IU/ml -- is that the results are reported simply in one of two ways. The results either say "Virus Not Detected" or "Virus Detected". Even a doc or NP can understand that!

-- Jim