PCR tests

What PCR tests are most sensitive?  Thanks.

[spectda]

The labcorp ngi quantisure-2 iu/ml (takes a really long time for result)
quest heptimax -5 iu/ml

[willbb]

Susan..  Labcorp..NGI QuantaSure

..https://www.labcorp.com/pdf/HCV_QuantaSure_LabFacets_1259.pdf

[Susan_1a_CC]

Thanks - especially glad to know about result time on the ngi quantisure although at 2 iu/ml it does look definitive.

[Susan_1a_CC]

Thanks to you also - we must have posted at same time.

[willbb]

You & Spectda   type faster than me  :)   Hope all is well with you.
Will

[elpasolady]

I go for my 4 week test next week sometime.  Which test is best for me at this stage?  I can pretty much ask for whatever tests I want from my Dr ,and she agrees.
Thanks!

[lynda607]

Depends on how long you want to wait.  The Labcorp NGI QuantaSure or Quest Heptimax are the most sensitive but the results take longer.

Labcorp offers the Hepatitis C Virus (HCV), Quantitative, Real-time PCR.  Test #550080.

The limit of detection of this assay is 7.1 IU/mL for HCV genotype 1, and the quantifiable range of the assay is 43 IU/mL to 69,000,000 IU/mL.  IMO, that is a sensitive test although it will not pick up HCV RNA below 7.1 IU/mL. The results are usually back within 3-5 days.  If HCV RNA is detected under 43 IU/mL (between 7.1 IU/mL and 42 IU/mL) they will not be able to quantify it but at least you will know the futility rule does not apply.

[working dog]

my 4 week was between 7 and 43 so i have to do 48weeks...good luck....billy

[Bali05]

How does the LabCorp Test# 550080 get reported when the result is 7.1 IU/mL and 42 IU/mL ?

[elpasolady]

The only VL tests I have ever had were from Quest..  all were the same.....and that test was  the   HCV  RNA Quantitative  Real Time PCR

I won't know until tomorrow when I see my Dr. but I assume this will be the one she has me take again.  From what I am reading, you all think  this test is not the best and I should ask for the Quest Heptimax or the Lapcorp NGI ?

Should I not trust the RNA Quantitative Real time test?  I am a bit confused right now...  I thought if we were under 43 it was a good thing, meaning we could be on our way to only a 24 week treatment.  According to Billy, he now has to do 48 weeks and he was btw 7 and 43.  I think I need to go back and refresh my research and my mind!

[GoofyDad]

What PCR tests are most sensitive?

I'm not sure but I once got one from Labcorp that started balling before I event got the envelope open.

[GoofyDad]

Or would that be bawling? I guess balling would be more  "randy" not "sensitive".

[lynda607]

Under 7.1 IU/mL -  HCV RNA NOT DETECTED

Between 7.1 IU/mL and 42 -  HCV RNA DETECTED (Unable to calculate result since non-numeric result obtained for componet test.

43 IU/mL and above HCV RNA DETECTED and a numeric number is assigned.

[elpasolady]

Ur too funny  Goofy Dad....glad to always see your humor thrown in from time to time.

So...I feel like an idiot, BUT does undectable mean just that?  They show NO virus at all...not even 2 IU/ml?

bottom line is that I want to know for sure ( like the rest of you do) if I will be eligible for the 24 week treatment and don't want any errors.

[Bali05]

Thanks.
Just curious , where did you get this info ?
Also do you happen to know how Quest reports their  HCV PCR Quant < 43 IU ?

b

[lynda607]

I think it's a matter of comfort zone.  If you are uncomfortable with the level of detection that Labcorp R/T Cobas or Quest RT PCR's offer then go with a more sensitive test such as Quantasure or Heptimax.  I am not familiar with Quest so I don't know what the actual level of detection goes down to.  Maybe 10-15 IU/mL?

[lynda607]

From LabCorp.  As stated above, I'm not familiar with Quest and I do not see any level of detection on the Quest under 43 IU/mL test.  Perhaps a phone call to Quest would clarify.

[Bali05]

I called LabCorp and Quest I don`t know how many times on this and never got an answer.

thanks
b

[nygirl7]

So...I feel like an idiot, BUT does undectable mean just that?  They show NO virus at all...not even 2 IU/ml? "

There is no test to determine if you are technically and really UND that is why although we might test to UND we treat longer, otherwise we could all assume we didn't have 1 per IU but.....it's not only your blood stream that needs to be clear how do we really know if any are hiding in the fibrosis in our livers etc.

My heptimax came back pretty quickly, didn't take any longer than a regular PCR (but I was at Dr. Jacobson's office and well he's not a typical doctor).

[willbb]

If this is your 4 week test you might give thought to having your results in a couple of days.vs. waiting up to 3 weeks for them. If you were Det above the limit of the futility level (odds are that will not be the case) then knowing sooner rather than later would be beneficial..
Will

[lynda607]

I did not personally speak with LabCorp.  The clarification was given by the director of the  lab to the physician.   The option for clarification on any test LabCorp offers is available if your doctor is willing to do it.

[Bali05]

Just called Quest again for the hell of it....
The customer care rep put on hold to talk to the tech
when she came back she said they will only disclose that info to the doctors office.
In the meantime I asked my hepatologist months ago and they simply did not know.

One of these days (years..)  I am going to find out how exactly Quest reports their HCV PCR Qt <43.

It just happend to be my first UND test.

b
8wks post

[Susan_1a_CC]

For those who've been through multiple testings does anyone have experience of reports of being undetected and then "less than the limit of test" and then reported und. etc?  And is there the possibility of having just a few (under test limits) and then the bodies immune system knocks them out?  If so, does this go on through the years - having just a few but not hundreds or thousands, or millions?

[willing]

I don't believe there have been any changes to what Labcorp/Quest have been reporting for some time. However, the big difference is that, with the arrival of triple tx,  the decision to cut  tx short (use RGT) hinges on a VL under 10 or so 4w after adding the PI. Drs are continuing to prescribe the PCR test  they have used in the past, however the Labcoro test reports enough information to make this decision whereas the Quest report does not.

Both  LabCorp test 550080 and Quest test 35645  use the CAP/CTM test kits sold by Roche diagnostics. The FDA insert for that test kit is here
http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060030c.pdf

The linear range for that kit is 43 to 69,000,000 and LOD varies depending on version. For  Labcorp it is 7.1.

The important point is that the  Quest report  does not distinguish between a result under the limit of quantification (43) and one under the limit of detection (10 or lower). This information is available from the Roche CAP/CTM output. Quest simply does not report it (my hunch is they want pts to pay the extra money for the heptimax).  

Bottom line is that if you are on triple tx and your Dr. is using Quest make sure the more sensitive Heptimax is ordered, not the CAP/CTM-based 35645. Making a decision to shorten tx time based on a Quest-reported result under 43 when both boce/tela require a value under 10 is risky.

[nygirl7]

Back in 'the day' you were lucky if they tested you to <315.

That was pretty much considered the common test when I started (my doc ordered the older <615 but I threw a fit thank God because I was stuck at 411 at week 4 and with the older test of 615 would have 'thought' I was UND when I was not.

[Bali05]

I believe the  Quest test# is 110114R

    :-)

b

[working dog]

tomorrow i have my eight week test ..i'm at 9.5 weeks now.....i'll be sure to find out exactly what test their doing on me and why they want me to do 48 weeks..i was 2/2 to start with 10 mil vl.....billy

[GINGERPAL]

My doctor told me that I would be getting Heptimax TMA Viral Load testing done - he said that the test is done in 2 parts.  If the Heptimax which goes to 43 is negative, then the test automatically does the TMA test which has a more sensitive level down to 5.  (If the Heptimax is positive...with a number of 43 or more , then the test does not do the more senstive part).  Is anyone familiar with this test?  I have not started tx yet, so  I have not had this done yet.

[willing]

the Quest test codes, unlike LabCorp's, vary by region. The 35645 code is the one used for my local region (central CA) but may vary elsewhere. In any case the test can be easily identified by its description:

Hepatitis C Viral RNA, Quantitative Real-Time PCR
35645
CPT Code(s): 87522
Linear range: 43 - 69,000,000 IU/mL 1.63 - 7.84 log IU/mL

any test reporting quantification in the linear range 43-69,000,000 will be based on Roche CAP/CTM test equipment. You can confirm that Labcorp reports the LOD (7.1) whereas Quest does not by looking at the test menu on the corresponding web sites.

all: a footnote to the above is that if you *are*using Labcopr with triple tx there is no need to use a higher sensitivity test. The Quantasure is nice but not required.

[flcyclist]

Given the choice between the Labcorp NGI QuantaSure (2 IU/mL)  and Quest's TMA test (5 IU/mL), I'd choose Labcorp due to the lower sensitivity.  Unfortunately, my insurance only uses Quest’s lab.  

Instead of doing the Heptimax test which is a 2 part rollover test for my second PCR, I decided to do only the second part, the more sensitive (5 IU/mL) TMA test.   The Heptimax test combines the HCV RNA Quant RT-PCR and the TMA test as a two part rollover. If the RT-PCR is < 43 IU/mL, then the second part, the TMA test is completed.  

You can just request to do the TMA test to save time and money.  I had my results back in less than 5 days.

HCV RNA Quant RT-PCR   -   Linear range of the test is: 43 to 69,000,000 IU/mL.

Quest's more sensitive TMA test, Hepatitis C Viral RNA, Quantitative TMA, the lower detection limits is 5 IU/mL.  The Linear range of this test is: 5 to 7,500 IU/mL.
  
http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_HCV_RNA_QuantPCR.htm

http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_HCV_RNA_QuantTMA.htm

http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_Heptimax.htm

http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_HCV_RNA_QuantPCR.htm

http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_HCV_RNA_QuantTMA.htm

http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_Heptimax.htm

[flcyclist]

links doubled up? not sure why.  Ignore the last 3.

[Bali05]

"the Quest test codes, unlike LabCorp's, vary by region"
Did not know that......

the way Quest put it to me today is , as if when doing the <43  the Dr.
could call in for additional info as to wether detected but not quantifiable.
Kind of hard to do when the test was done over a year ago.....

Maybe someone currently treating around here will find out for sure
me thinks... :-)



b

[his3707]

the only thing I can tell you from recent experience, is the test you get must say on the test "UNDETECTED'  or DETECTED for you to be sure.  The four week test is the most important in determining how long you treat.  I would do the quantisure or heptimax.   If you get the test that only goes to <43, then you cant be sure.  Be very careful.  I got the quest realtime pcr <43 and it came back in range.  my study did another more sensitive test and it showed I was detected.  I also did the Quest <5 TMA and It came back in range.  I thought I was undetected.  The study test said I was detected.  I have to do 48 weeks because I cant rely on mine.   Good luck  

[elpasolady]

Lots of valuable information here!   Once again, I bow down to you all as I can now go into my Dr office tomorrow more knowlegeable and know which test to request.  
We ALL really need to be our own health advocate!!!

Thanks AGAIN....to you all and to this forum!
~Debbie

Just to be clear....if both triple therapy drugs ( I am on INCIVEK) require a VL value under 10, does that mean that is considered UND?  OR....do you have to be zero or less?
I realize from what NY Girl said, that we really never know, but what is UND based on?

[elpasolady]

One more question....if I started my baseline with Quest, do I need to stay with Quest for consistency reasons?

[spectda]

We can never know if we are truly UND because there is no test that will measure below 2 iu/ml. I would guess that is the reason that quest does not commit by saying und on their tests just <43, or <5, (the lower limit of their test). Of course other companies say und but qualify it with the limits of their test. Obviously the lower the test sensitivity the better the chance that you are truly und.

Okay I am going on a limb here and hope I remember this correctly from bill1954 and some reading. Hopefully one of the truly knowledgeable will help me out if I am wrong. I believe that 1 genome copy of hcv in one infected cell equals about 3-6 iu/ml. IU/ml is a standard designed to compare apples to apples because genome copies are different with different tests.

An average person probably has about 5000 ml of blood in their body so if you have 1 iu/ml which is undetected by any test available you still may have between 15,000-30,000 copies of the virus in your body. A person with a viral load of 100,000 iu/ml (low) has about 1.5-3 billion copies of hcv rna their body and a person with 1 million iu/ml (sort of average) has 1.5-3 trillion copies of hcv in their blood.

If you are UND at 24 weeks post tx you are likely really und, but some will even argue that.

[spectda]

It's not necessary to stick with the same test.

[GoofyDad]

UND = undetectable = below the level the test you took could see. Some tests can reach lower lower for undetectible/undetectible (tru/false) and can only accurately measure or "quantify" when virus is present at higher levels.

UND should not be confused with zero. UND does not mean zero. UND means lower than the sensitivity of your test.
  
Once you reach a hypothetical zero in the bloodstream, there is still probably unmeasured virus replicating in the liver. Some research suggests very low levels of replication even after SVR.

[Susan_1a_CC]

I had no idea about the actual number of virus that are represented by a viral load number - very interesting.  Thanks for the information.

[Susan_1a_CC]

First, thanks for the earlier post which gave me a chuckle.  Second, you wrote:

"Once you reach a hypothetical zero in the bloodstream, there is still probably unmeasured virus replicating in the liver. Some research suggests very low levels of replication even after SVR"

Do you have any information on how or why replication stays low after SVR?  I'm just wondering why I could have generated so many - more than the national debt - and then, maybe have a few running around but not enough to go back to detected.

[Aaron57]

"UND should not be confused with zero. UND does not mean zero. UND means lower than the sensitivity of your test.
Once you reach a hypothetical zero in the bloodstream, there is still probably unmeasured virus replicating in the liver. Some research suggests very low levels of replication even after SVR."

This is the issue ... as far as i understand , until now no one can explain why folks are able to relapse ... even after the newer recent and quite sensitive PCR's show UND , sometimes starting from wk. 4 .. throughout the Tx duration.

[Bali05]

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.

A forum friend of mine has a constant viral load of 2 IU for months that is not going
anywhere . He would be UND by all other commercially available PCRs.

b

[spectda]

UND can mean zero, but we don't know since we can't measure zero whether it's in the blood or the liver. There is a lot of speculation about occult hcv.

http://hepatitiscnewdrugs.blogspot.com/2011/03/hepatitis-c-can-we-use-c-word-with.html
"Over the past 20 years, clinical experience has revealed that achievement of SVR is highly durable and corresponds clinically with cure."

"As the next chapter of HCV treatment unfolds, it is important to define goals for treatment and clarify misconceptions regarding virologic relapse for clinicians and patients. Although it will be important to verify the durability of SVR in the protease inhibitor era, among patients who achieve SVR, virologic relapse is extremely rare. There is no evidence to suggest that they should undergo serial liver biopsies or molecular testing of PBMCs or other extrahepatic compartments to search for “occult” HCV infection; rather, they should be monitored serially for clinical complications if they have evidence of advanced fibrosis or cirrhosis. The presence of HCV RNA in liver samples and PBMCs has not been shown to correlate with the durability of SVR, and instead could represent defective virions or residual nucleic acid from prior infection. Thus, for patients who have attained the coveted SVR, irrespective of the route taken, the concept of clinical cure of infection with HCV is valid, and merits strong reinforcement to our patients."

"A review of the literature, however, suggests that the prevalence of hepatic and extrahepatic reservoirs of HCV among patients who achieve SVR is significantly lower than that suggested by Castillo et al6; furthermore, even if they do exist, the presence of HCV RNA reservoirs seems to have little clinical relevance. In an analysis of 934 patients who achieved SVR after enrollment in 18 studies from 1994 to 2008, including that led by Castillo, the overall rate of hepatic HCV RNA detectability was 5%.10 The isolated presence of hepatic HCV RNA has not been associated with an increased risk for virologic relapse or disease progression. Indeed, several studies reported an improvement in liver histology even among those with isolated hepatic HCV RNA.6, 11 In addition, there have been no case reports of HCV transmission from a patient with isolated hepatic HCV RNA. The low prevalence of hepatic HCV RNA among patients who achieve SVR, coupled with the lack of clinical relevance, would seem to undermine the credence of viral reservoirs as a major contributor to relapsing disease."

[GoofyDad]

If you're UND, you could be at zero, but UND only means that virus was not detected down to the level of sensitivity of the test. As tests have become more sensitive, the distinction looses some significance but there is a difference in my view.

In cases where there is viable virus replicating when the tx drugs are stopped, your imune system in theory has the upper hand  and is ready to stan d on its own. It has been trained and is hopefully in top fighting form for keeping the virus at bay. There's a critical handoff that occurs where either the imune system keeps up the good fight, or looses ground againsts the enemy. When it looses ground, that when we see relapse.

[flcyclist]

I find this discussion very interesting and informative.  Thanks to those for sharing.  

[Susan_1a_CC]

As flcyclist just said, very informative answers.  Thanks to all as I now have a much better understanding of what the tests say and what I am looking for and feel somewhat calmed by the information.  All I can say now is "come on immune system!" and keep my fingers crossed...

[Bali05]

"In cases where there is viable virus replicating when the tx drugs are stopped, your imune system in theory has the upper hand  and is ready to stand on its own. It has been trained and is hopefully in top fighting form for keeping the virus at bay"

That implies a weakening of the imune system could cause a relapse
even after SVR. However the relapse rate after SVR is almost non exsistent at 1% . I read a study recently where SVRs had to
undergo chemo therapy that drastically weakened their imune system
but none of them relapsed.

[willbb]

Long-Term Follow-Up of Chronic Hepatitis C Patients: Discussion  Medscape


Viral persistence is not specific for HCV. Hepatitis B virus and woodchuck hepatitis virus can persist at low levels in cells of the lymphatic system years after the resolution of liver disease.[32] Many other viruses including Herpesviridae (Herpes zoster, Herpes simplex virurses, Cytomegalovirus, Epstein–Barr virus), measles and the human papilloma virus establish a persistent infection[33] that is maintained for the lifetime of the host and may persist even after successful anti-viral therapy.[34] Interestingly within this context, three patients in our study had borderline-positive HCV-PCR results once within follow-up, but were proven to be HCV-RNA negative in control testing soon thereafter and remained so. Whether these observations represent virus persistence with rare transient-positive PCR results is unknown. However, SVR may prevent development of hepatocellular carcinoma,[6-8] leads to improvements in liver fibrosis,[9] in biochemical markers as well as in quality of life and fatigue.[35] In this study, none of the patients with SVR had evidence for progressive liver disease as assessed by routine biochemisty. As no follow-up liver biopsies were carried out, our data cannot contribute to the discussion of viral persistence in the liver.

In conclusion, no recurrence of HCV infection was seen in any patient with an SVR achieved by an IFN-based anti-viral therapy. Thus, long-term prognosis in chronic hepatitis C patients with an SVR to therapy with PEG-IFN/ribavirin is excellent. The clinical impact of small persistent quantities of virus is yet unclear and has to be investigated in further studies

.http://www.medscape.com/viewarticle/522760_4

[Bali05]

also interesting is that HCV unlike HBV does not enter the cell nucleus
to leave a reservoir. HCV can therefore be completely eradicated.

[nygirl7]

Bali,

Which test is it that comes up most often with a false positive? I remember it was the test they gave me at my 4 week EOT which did pop up at 63 and my doc insisted it was a false pos. and I've tested negative ever since for 5 years.

I remember you discussing this at one point I am sure in your quest to find the perfect test.

deb

[Bali05]

The TMA is more prone to false positives , however when it is negative it is
"golden" as Dr. J put it at my wk12 meeting over a year ago.

b

[Bali05]

He actually had me run 2 PCRs simultaneously in the beginning of my tx
for exactly that reason. The TMA Qualitative as most sensitive with the standard
PCR <43  as back up.

b

[GoofyDad]

"That implies a weakening of the imune system could cause a relapse
even after SVR. However the relapse rate after SVR is almost non exsistent at 1% ."

I'm not sure this is fully understood although there have probably been advancements since I was in the loop. My hepatologist at CPMC described a teeter-totter period and said for example that I should definitely avoid steroids during that hand-off period. It may be that once you get stabilized after the handoff that you're pretty rock solid at that point?

Without looking this up, I'm guessing it's not uncommon for a virus to be beaten to submission without being completely killed off.

I, for one, do not worry one iota about residual viral replication. For all intents and purposes, it's gone. If its hiding in there like a pantywaist and having the occaissional tea party, I could give a rat's a@@.    

  

[Hiking_Tom]

Just to say that the cutoff VL for stopping treatment on Incivek at week 4 and 12 is >1000 - not >10.

[Bali05]

That "teeter-totter" period is also what HR theorized in the archives.
If that is the case than tapering of INF comes to mind again......

My problem with that is that by nature of HCV is mutating and replicating
extremely fast to find away to survive. I find it hard to believe that all of a sudden
your imune system is "trained" to handle that.
If that would really work we should have a vaccine by now.

just thinking out loud....

Cheers

b

[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.  

[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)

[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 ?

[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]

"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....)

[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!!

[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 : )

[Bali05]

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

thanks

b

[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]

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...

[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.

[flcyclist]

oops, crosspost with bali, sorry, same info.

[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?

[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

[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

[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

[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.

[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.

[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.

[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.

[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.
.

[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.....

[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.

[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.