Detectable or undetectable - borderline!

[zazza]

I am genotype 1a, baseline viral load 120000 IU/ml, week 4 viral load 2900 IU/ml (-1.62 log). Got my lab results today Taqman HCV/RNA (sensitivity 15 IU/ml). Results are confusing. They call it borderline, doctor says there is "a signal" of virus but it is unmeasurable because below 15 IU/ml. What does this mean: detectable or undetectable? Should I extend to 72 weeks or stop at 48 weeks? Or perhaps add 36 weeks if truly undetectable at week 16, when my next Taqman test is due? My ALT/AST levels are consistently normal, I have had the disease for 25 years, not been able to do biopsy because of medical reasons, ultrasound okay. Please help me understand the confusing lab report.

[nygirl7]

Exactly that is what I have been wondering.  It's really a "are you really UND or not" question.

Unfortunately with this stupid disease it can be hiding out and pop back up. I guess we never really know - that is why I fought it so proactively. I mean I didn't WANT to do 72 weeks but I figured it was better to do it once and not have to do it again.

I hope.

:)

[jmjm530]

As long as we're on the topic of re-testing, one protocol that many doctors follow is never make a treatment decision on a positive viral load that follows a negative without re-testing. We've had more than one member who has had a false positive.

[zazza]

Interesting point you made about how sensitive test has each study actually been using? Tried to find this in a report I had, no luck. Is this usually not stated? Otherwise there is no way to know what undetectable actually means in each study. So if I have a sensitive enough test I might do 72 weeks, while using a less sensitive test thinking I was then undetectable I would do 48 weeks. Not knowing what tests the studies are based on, there is no way to know which is the right road to travel.

[jmjm530]

LOL. And I will get you back :)

But on a serious note, for those new here, what Goofy is referring to is the fact that I got PCR's weekly from week 1 until I was non-detectible at week 6 and then every 2-3 months after that which was actually less than my doctor wanted which was once a month. Early and frequent PCR testing is the trend now among many hepatologists as it provides more information that can better direct treatment. That topic is mentioned in several of the newer modules over at the Clincal Options site. Think of how much confusion could be have adverted to some in this forum if everyone had very sensitive weekly viral load tests until non-detectible and monthly tests after that. The big secret is that your insurance company probably covers as many PCR's as your doctor writes you a prescription for, although for some reason many doctors or NP's imply otherwise. You can always check with your insurance company to make sure.

-- Jim

[GoofyDad]

Just to keep thinks in context, if it *were* Jim he would have retested regardless of whether it was positive, negative, somewhere in between, or if it said he had goats cheese coursing through his veins. In fact, the only reason they put him on procrit was because he lost so much blood by having PCRs drawn. LOL :)

[spcecst2]

You have plenty of time to decide on 72 weeks, but maybe you might think about shorter times between shots to increase your chances!

[GrandOak]

I know my orders were drafted to use a PCR  < 50 and if it should me UND, then and only then run the more sensitive, and costlier, < 5 test.

For what good it did me, they could have run the < 600 and saved the HMO some cash.  I'm guessing that based upon my lab orders that there is not as much of a price break in running the < 600 or < 50 but it is more significant if the < 5 test is run.

[Pdilly]

Mine was a linear range of 1-20,000.000.   I have heard about the 5 test but not sure if LabOne has it.  I am going to request the Heptimax that Jim suggested post tx. I still wonder if my grade and stage was right at the beginning but I guess there is no way to know for sure.  I have always been a worry wart.

[jmjm530]

As hard as it is to believe -- and I shake my head every time I read something similar -- this wouldn't be the first time a doctor doesn't know how to read a simple lab test for Hep C. At first glance, sounds to me like you are NON-DETECTIBLE to a sensitivity of 15 IU/ml which is excellent per the way the result was presented and also the fact that I believe 15 IU/ml is the sensitivity of that test. That said, in order to really know what is what, call the lab -- speak to a supervisor, not who answers the phone -- to confirm. Also, you can post your lab report here and some of us can probably figure it out.

Don't panic yet, your doc may be wrong, it happens all the time.

All the best,

-- Jim

[mblessed]

hope I'm not rude but i am struggling with the same topic may i ask a question about myself?

[GrandOak]

Sounds like doctor is saying that at wk 12 the virus is detectable just not measurable.  Thus, you may want to consider the 72 wk therapy.  Another option is to go for the more sensitive < 5 IU/ml PCR test to see if an accurate count can be obtained.  I'm guessing that if the < 15 detects a presence, then the < 5 could possibly give you a count lying somewhere between 5 and 15.

[GrandOak]

I could be wrong, but I believe the Heptimax is the Quest name for their TMA test.  It is the TMA method of testing which yields the more sensitive result than the usual PCR method used in most other tests.

It was developed by Gen-Probe and is described fairly well at:

http://www.everythingbio.com/glos/definition.php?word=Transcription+Mediated+Amplification+(TMA)

[zazza]

Yes, my doctor did not understand the lab report when he first called me. He had to call the laboratory and ask them and then call me back. The test's sensitivity is 15 IU/ml, and so they say I am not above 15 IU/ml, but in some way the test has still "made a signal" that virus is present. Can a test with the sensitivity of 15 IU/ml tell if there is a lower viral load than that? I have asked for more sensitive tests, but got the answer there exists none in this part of my country at least.

[jmjm530]

I really don't know what "signal" they are talking about. You might want to speak to the lab yourself for clarification. Meanwhile, if it were me, I'd re-test at a local Quest Diagnostic's lab. You can find the nearest location here:
http://www.questdiagnostics.com/hcp/psc/jsp/hcp_psc_index.jsp
Simply tell your doctor you want a prescription for their "Heptimax" test. That's all he has to write is "Heptimax". It goes down to 5 IU/ml.

-- Jim

[mremeet]

It could be that you have a two stage test like they use for the drug trial I'm in. My trial uses a test that will give a numerical viral load if it's equal to or above 30 IU/ml. If the viral load falls anywhere between 10 and 29 IU/ml, then the test will simply report a "29". Not because it really is "29", it simply means there is virus detected sosmewhere between 10-29 IU/ml. Anyway, your test may have a similar format. It may be that it will quantify your VL if you are above 15 IU/ml, but will only give you a positive or negative result (i.e. qualitative) if the result was between, say, 5-14 IU/ml.

Hope that helps, although I suspect it'll just confuse matters!

[nygirl7]

I'm curious to know now...of the people who are UND - what was the medium sensitivity of the test?

I know mine wasn't a TMA when I first got my "UND" so really ... was I?  Interesting point to think about when there are so many variables that we try to use to get the best chance of SVR.

And also - what did the STUDY base it's "UND" on?  If they based it on an older test (I'd assume) then were THOSE people really UND by week 24 as well?

OR are we using stricter tests now. That would be in our FAVOR when determining odds.

[zazza]

I asked to have a written copy of the lab results sent to me ASAP. Will give you the details you asked for as soon as I get them. Thanks for your support!

[mremeet]

Can you read exactly word for word, symbol for symbol what it says off of the lab report? Unfortunately many viral load lab reports are written in a manner so that only a Phoenician scribe specializing in Eygptian hieroglyphic legalese can understand it. Therefore, both your doctor, your nurse and their secretaries are all unqualified to reliably interpret it.

Seriously though, most lab results are formatted and worded by utter retards. Dorks with poor communication skills who spend their entire day zoning off into space silently watching an HPLC machine tick away and away while the autosampler takes care of everything.

Reading off the lab results verbatim might help us determine if you're detectable or not. Also, if you can give the specific name and/or code number of the test used, that would be helpful.

[zazza]

Sorry, I missed saying my lab results today were of week 12! So the borderline result is as of week 12! I don't understand if I am considered detectable or undetectable. I live in Europe, thereof the Taqman tests week 4 and week 12. Grateful for any input that helps me understand!

[nygirl7]

If you have ONLY had a 4 week test you do not have to extend a thing. The extension is for people who are not UND at week 12 - but ARE at week 24.

Well first off - people here have many different valuations of tests and so some people that may say they are UND at week 4...might have had a test to 315 or 600 only.

For example I had a vl of 411 on my first test. So I was not und at week 4. However if I'd had the older test of 600+ it would have APPEARED I was und.

you had a very sensitive test (to 15). Had you had a test to 50 you would have gotten an UND.

Most people don't have a very sensitive test in the beginning I don't think. We have usually PCRs which I believe are to 315.

I never had a TMA (to 5) until week 46.

Do you see what I am saying?

I extended treatment because I had a VL of 411 at week 4 and still had 419 at week 12. I was "UND" at week 24. But my doctor gave PCRs and NOT anything more sensitive.