PCR tests

[Susan_1a_CC]

What PCR tests are most sensitive?  Thanks.

[flcyclist]

Yes, Quest has an app (Gazelle) for the smart phones where you can make lab appointments at Quest and get the results.  But your doctor has to know how to do this and give you the proper code to get authorization so you get the results directly.  Mine was not familiar with the process.  It sounds like a great idea if your doctor's office will set you up.

[elpasolady]

Just  an update on my lab dilema....it appears my decision was made for me when I called my insurance co ( Aetna) and was told that LabCorp was out of network, where I have a 6K deductible.  QUEST it is!!!

FYI....Quest has online lab results if you register and get Dr.okay.  I am getting ready to do that.  We should ALL do that who use Quest.

[Bali05]

Indeed the QuantaSure is not something you want to have to pay out of pocket.
My insurance stopped covering LabCorp so TMA is next in line , also a lot faster.....

[Bali05]

Last time I ran the Hepti...  it took 1.5 weeks and I have been running them separate
ever since and it takes 3-4 days.
I get the results faxed straight from the lab when they are ready.
.

[willing]

agreed - the NGI is reassuring but not needed to assess futility whereas  getting off the PI quickly if it's not working is prudent. As a relapser with good past response frijole's is pretty safe on the futility issue, but naives should be more cautious.

[willing]

if you go out of pocket, make sure you don't get burned on the cost. Labcorp charges an insane $778 for the quantasure, $30 for the draw. My insco "adjusted" this down by $766 (also insane, since what's left doesn't even cover the cost of the chemicals). You don't want to get stuck paying list price. A heptimax was around $300 when I  last checked and the TMA only, which is all you'd want as follow up to  a 550080, is likely cheaper.

[lynda607]

Just a thought here.  Since the DAA's are RGT, the QuantaSure NGI takes over 3 weeks for results to return. According to the Victrelis treatment futility if the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW12, then discontinue three-medicine regimen.  Of course, that's the last thing anyone wants to happen but if it does that means the patient will have at least three additional weeks of exposure to the PI which impacts on resistant variant growth.  Same thing applies with Incivek, if the patient has a vl equal to or greater than 1000 IU/mL at week 4 and they have the QuantaSure, they will have had approximately 7 or 8 weeks of exposure to Incivek whereas the 550080 is usually back within 3 - 5 days, tops 7.

To me it makes more sense to use the 550080 with Victrelis for the 12 week PCR and 4 week PCR with Incivek.  All other PCR's wouldn't seem to have that need to know now urgency.

[mikesimon]

How much longer can it take if I got my blood drawn on Friday and had the Heptimax results 2 or 3 days later? Is that long enough to make a difference? I don't think so unless you need them the same day or the day after.

A big to-do about nothing.

[Bali05]

"That makes sense, right?"
Yes

I keep running TMA + PCR also to cover false positives on the TMA.

The Heptimax takes longer because those two tests are done one at a time
instead of at the same time.

b

[frijole]

"One more question....if I started my baseline with Quest, do I need to stay with Quest for consistency reasons? "   ---  you know, there used to be a difference in copies.  However now even if the labs show your vl in copies, they all give them in international units and those are standard from one test to another and one lab to another.  I am glad you  are getting the Heptimax

I just got my lab orders today and the doctor ordered all 550080.  I am okay with that the first time, because I am on the lead in and probably won't be clear.  I am even more okay with it since willing has explained that I will be advised if the test is detectible from 7-43.  However, I have called his med assistant to ask for a couple of orders for the QuantaSure -- even if I have to pay for it -- just so I can see what is happening by sensitive testing.

frijojle

[mikesimon]

I used to get my blood drawn on Friday and I'd have my Heptimax results faxed to me by Sunday or Monday.

I had a Heptimax done every month for over 5 years and I know it doesn't take long to get the results......unless you're getting them from the doctor because some doctors are very slow.

I'd keep it simple and just get a Heptimax every time - if you like Quest Diagnostics.

Mike

[elpasolady]

Can I just ask them to do both tests simultaneously? How did you arrange them to be done together.
FYI...  My Dr office called Quest to see how long the Heptimax test would take and they said 48 - 72 hours.
We talked about just doing the TMA, but she said for the first time, she wanted both to see if by some odd chance my VL load was still over the 7500 limit in that test.  She said if I am low or UND, then the next time we can just do the TMA.  That makes sense, right?

[flcyclist]

oops, crosspost with bali, sorry, same info.

[flcyclist]

If you use the Quest lab and want to save some time and money, you're doc can write a script for the HCV RNA Quant TMA test, rather than do the 2 part Heptimax test.

The Heptimax test, which is a 2 part rollover test, combines the HCV RNA Quant RT-PCR and the Quant TMA test. If the RT-PCR is < 43 IU/mL, then the more sensitive TMA (5 IU/mL) is completed.  

Since my 4 week RT-PCR was UND, I requested the more sensitive TMA for my 12 week test.  I had my results back in less than 5 days.

[Bali05]

FYI
the so called Heptimax is an invention of Quest
they just grouped two Quantative PCRs as a rollover together

first they run the standard <43 Quant at the closest Quest operated lab
and only if that one is negative will they rollover that same sample be tested with
the TMA Quant <5 at Quest`s  Nicols Institute which is a different
location so you are in essence getting two different labs.

The rollover process takes longer than as if you were to run both of
these tests simultaneously which is what I have been doing.
Results back in 3-4 days , sometimes the TMA is ready before the PCR too...

[scoleman]

I too am grateful for this particular thread.  I spent Wednesday online looking through the online clinical test catalogues for Mayo and my local hospital for sensitive PCR tests.  I was so tired towards the end of my investigations that I was nearly in tears.  I went to bed.  

When I initially visited my doc, he said he'd be treating me for 48 weeks period.  I like the idea of 24 weeks of treatment if I can be reasonably sure I'm under 10 IU/ml.  

I spent another hour on the phone with a regional lab but I have my PCR tests picked out thanks to all of you who posted.  I wanted two sensitive PCR tests done in 2 different labs in case of a false positive.  I'm getting the Heptimax and NGI Quantasure.  Yup, this is overkill but if I'm going to opt for 24 vs 48 weeks of treatment I want to make sure it's the right decision.  

Thanks everybody,
Sherry

[Bali05]

.......I am cracking up in laughther after reading your last two lines
you made my day  :-)

thanks

b

[Aaron57]

B , great news to hear that your enzymes are that low ! Thats great & hope they stay that way as time moves on ....

Seems effects of Riba can lead one to over think Tx .. just a little bit ...

Hmmm ... obsessing .. no .. not at all ...  not possible : )

[elpasolady]

Just want you all to know that because of this thread, I was able to get the more sensitive test, Heptimax, ordered from my Dr.  She did not even know it existed, or that any test could get to such a low sensitivity. She would have just ordered the normal <43 PCR Real Time test, and I would have let her, if not for all your input.  She concurred that with this new triple therapy, it changes things and that we are learning together..  Because of all of you, I really know more than my  Dr, when it comes to the new triple therapy, which is actually pretty scary for me.  Can you tell, she doesn't have many HCV patients???  I am her first telaprevir patient.
Don't know....but I think a discount would be nice.  Afterall, I am doing her research.  LOL

BIG Thanks, friends!!

[Bali05]

"Still allot of unanswered questions ... "

Definately , if someone gets stuck at a low 2 IU for example and the
imune system is now "trained" after long tx theoretically the VL should
remain at 2 IU once tx is stopped ?

Usually this means cocktail party again.

I presented many of these thoughts and supporting abstracts (incl. occult ect....) to my Dr.
who is very much involved in research and he told me he very much appreciated having a patient like that but he also told me I was overthinking it,,,, (must have been the Riba ...)   :-)

b

btw , now 9wks post my 60wk tx and have the lowest enzymes I have ever seen  (still looking good....)

[Aaron57]

B, I think this is a bit of an oversimplification of the relapse question ..

'When Relapse occurs the virus was never gone in the first place
just supressed into undetectability and after stopping meds it than becomes detectable again."

Can pretty much take the above for granted .. if it is gone .. it's gone  ...

My thinking is a bit closer to the concern:

"My problem with that is that by nature of HCV is mutating and replicating
extremely fast to find away to survive."

Let me re-phrase  ... we have someone with a baseline VL 6 million , ok they get down to 2 IU/ml in 12 weeks , but no further reduction  .. stuck ... how is it that a reduction of over 5 log in that time frame is able to take place , however, not able to reduce VL any further, why not ?

Since we know the virus does not enter the nucleus ...

"also interesting is that HCV unlike HBV does not enter the cell nucleus
to leave a reservoir.

We know the longer Tx duration = higher odds of svr ....

Still allot of unanswered questions ... Not that it matters at the end of the day ... I'm ok with GD's "If its hiding in there like a pantywaist and having the occaissional tea party, I could give a rat's a@@. "

Just as long as it doesn't turn into a cocktail party !    

[Bali05]

Thanks Willing, unfortunately or fortunately I do not have any more appointments
scheduled with Dr. J right now.
I brought this whole thing up again at my EOT meeting and he just made a comment
as if he thought Quest now reports it but I don`t think so. Also I was doing SOC so it
did not come into play as much.
When I ran the Quest <43 it was my wk6 and I did that one on my own with
my GP and I should have done the TMA instead (was still learning on the job so
to speak...) The NGI QuantaSure was shut down at the time because of permit
issues in the state of CA.

BTW, do you think that this information was recorded anywhere ?
Propably not because it was`nt on the report ..... huhhh ?

How about this , if you can pm me the proper wording for the request to  Dr. J
I will email it to him ?

[willing]

I confirmed that  Quest code 35645 at local CA regional lab is the same test labeled 110114R  at the NY lab. In both cases the tests use Roche CAP/CTM  equipment :
"This test was performed using the COBAS®′ AmpliPrep/COBAS®′ TaqMan®′ HCV Test Kit (Roche Molecular Systems, Inc.).".

From page 41 of that FDA pdf linked above ("Interpretation of results") it's obvious the tech who read the post PCR analysis knew whether your  sample was below LOQ or LOD. Though this never made in into the final report, it's possible they keep computer files of the original output from the CAP/CTM device.

I know this is all water long past under the bridge for you, but you could be doing a major service by following up on it with Dr. J. He  presented for Vertex at the FDA approval hearings in May and is the ideal heavyweight to deliver a swift kick in the rear to Quest. A letter from him emphasizing that the omission in the  test report makes their (very widely used) CAP/CTM test unsuitable for triple tx could get them to mend their ways (and help pts who may otherwise think they can safely do shortened RGT when this is not the case)

[GoofyDad]

I think the taper makes sense on the surface but it never got much traction. It's an interesting idea. I recall there have been PCRs done on liver tissue of SVRs and most have virus. So be it.

Because of those who spontaneously clear, we know the native immune system can get the job done. It may be that for most of us it didn't get a quick enough jump during the teeter-totter of infection and so tx gives another shot after it learns the lay of the battle field.