Aa
Guiding myself
I haven't posted since Oct. 11 when I asked for advice about quitting incevik a few days early. I did end up quitting 5days early. I personally, just couldn't handle it. I have posted a few times about issues with my doctor who was really not very supportive through this entire process (and sometimes clueless). Right now, I'm worried about my viral load:
At 4 weeks my HCV RNA IU/ml was <43 and my HCV RNA ,QN, PCR was <1.63 log IU/ML. My doctor told me at the time I was UND and called an early responder. At 12 weeks, it was the same exact number. He told me at the time, those numbers basically mean I'm undetectable. Today I read a post where someone said they were 43 and still not undectable and now I'm really worried if he knows what he is talking about. Any advice? Cyndi
At 4 weeks my HCV RNA IU/ml was <43 and my HCV RNA ,QN, PCR was <1.63 log IU/ML. My doctor told me at the time I was UND and called an early responder. At 12 weeks, it was the same exact number. He told me at the time, those numbers basically mean I'm undetectable. Today I read a post where someone said they were 43 and still not undectable and now I'm really worried if he knows what he is talking about. Any advice? Cyndi
I sure appreciat all the response to the questions I cant start my treatment till Some time in Jan and i need all the inf I can get. I am having a hard time finding the money for the exp meds . I have medical ins but it dont cover drugs. thanks for any inf u can give me.
I'm still struggling to understand the results of these reports, so bear with me. I'll refer only to Cyn's Quest test (HCV RNA ,QN, PCR) to avoid any confusion, since Labcorp uses different LOD and LOQ for their tests.
My understanding for Quest's HCV RNA ,QN, RT-PCR:
Limit of Quantification (LOQ) = 43 IU/mL
Limit of Detection (LOD) = 7.1 IU/mL (although not listed on report)
Therefore, if the test came back to read < 43 IU/mL, Detected, that means virus was found above 7.1 IU/mL, but below the quantifiable level of 43 IU/mL. So if someone had 9 IU/mL in their blood test, then the results would report <43 IU/mL - Detected. If below 7.1 IU/mL, then the result might only report <43 IU/mL.
If Quest's standard RT-PCR can detect virus at 7 IU/mL and above, and report it as detected, is that good enough? Or do we need a more sensitive test to quantify it below that level?
My understanding for Quest's HCV RNA ,QN, RT-PCR:
Limit of Quantification (LOQ) = 43 IU/mL
Limit of Detection (LOD) = 7.1 IU/mL (although not listed on report)
Therefore, if the test came back to read < 43 IU/mL, Detected, that means virus was found above 7.1 IU/mL, but below the quantifiable level of 43 IU/mL. So if someone had 9 IU/mL in their blood test, then the results would report <43 IU/mL - Detected. If below 7.1 IU/mL, then the result might only report <43 IU/mL.
If Quest's standard RT-PCR can detect virus at 7 IU/mL and above, and report it as detected, is that good enough? Or do we need a more sensitive test to quantify it below that level?
********
The facts are not in yet on the PIs. You may think so because of the trials, but the trials were a small group. Much new information will be gleaned from the huge numbers in treatment. So anyone who thinks they know the outcome of this large population and 3x, SVR and the variables, is wrong. We won't know until summer earliest and later when this information is presented.
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I may not know if I am SVR because it is too early and I may not know what the ultimate results of my trial will be next year. But I do know that I am undetectable and have been since week 2. I do know that I have had no major side effects other than a very slight fatigue. I do know that All my blood tests are within normal limits and that my liver function tests are very low normal. I also know that a lot of people here have been very sick going through their FDA approved treatment. I know that I have not been sick going through my also FDA approved (for investigational use) treatment. I don't need to know anymore for now. My anxieties and my liver are taking a rest.
The facts are not in yet on the PIs. You may think so because of the trials, but the trials were a small group. Much new information will be gleaned from the huge numbers in treatment. So anyone who thinks they know the outcome of this large population and 3x, SVR and the variables, is wrong. We won't know until summer earliest and later when this information is presented.
**********
I may not know if I am SVR because it is too early and I may not know what the ultimate results of my trial will be next year. But I do know that I am undetectable and have been since week 2. I do know that I have had no major side effects other than a very slight fatigue. I do know that All my blood tests are within normal limits and that my liver function tests are very low normal. I also know that a lot of people here have been very sick going through their FDA approved treatment. I know that I have not been sick going through my also FDA approved (for investigational use) treatment. I don't need to know anymore for now. My anxieties and my liver are taking a rest.
"I think Cyn's immediate concern is the fact that the report did not state UND. So the question remains - if the report listed <43 IU/mL, does that equal UND by this test? My unprofessional guess is yes. "
fl -I beg to differ - - this is the issue. With Quest all you know is you don't have any virus over 43. You really don't know if you have detectible virus. However, the only difference in the data submitted to the FDA and that of Quest is the difference between 25 and 43. What I am saying is that in all the testing they did not know if there was detectible virus under 25. UND was assumed but the key word here is assumed. Who knows -- it could be that those you did not clear had virus under the level of detection.
When I previously treated the commonly used test only detected down to 50. I pushed for the QuantaSure, detectible to 2 -- and at 12 weeks I had 40 IUmL ------ and even though I treated for 56 weeks, I relapsed. So I push members here to get more sensitive testing.
frijole
fl -I beg to differ - - this is the issue. With Quest all you know is you don't have any virus over 43. You really don't know if you have detectible virus. However, the only difference in the data submitted to the FDA and that of Quest is the difference between 25 and 43. What I am saying is that in all the testing they did not know if there was detectible virus under 25. UND was assumed but the key word here is assumed. Who knows -- it could be that those you did not clear had virus under the level of detection.
When I previously treated the commonly used test only detected down to 50. I pushed for the QuantaSure, detectible to 2 -- and at 12 weeks I had 40 IUmL ------ and even though I treated for 56 weeks, I relapsed. So I push members here to get more sensitive testing.
frijole
I think Cyn's immediate concern is the fact that the report did not state UND. So the question remains - if the report listed <43 IU/mL, does that equal UND by this test? My unprofessional guess is yes.
I would think the report would have listed "Detectable" if it was detected above the limit of detection (7 IU/mL). And if Quest's LOD is 7 IU/mL, is it really necessary to consider more sensitive tests such as Quest's TMA (5 IU/mL) or Labquest's Quantasure (2 IU/mL)??? Although it might be nice to quantify at this very low level, is knowing whether its 6 or 4 IU/mL going to make any difference? I've done the more sensative TMA test, but I wonder if Quest's standard PCR's LOD is 7 IU/mL, are we just splitting hairs?
Hopefully the lab and/or your doctor can clear some of this up for you.
I would think the report would have listed "Detectable" if it was detected above the limit of detection (7 IU/mL). And if Quest's LOD is 7 IU/mL, is it really necessary to consider more sensitive tests such as Quest's TMA (5 IU/mL) or Labquest's Quantasure (2 IU/mL)??? Although it might be nice to quantify at this very low level, is knowing whether its 6 or 4 IU/mL going to make any difference? I've done the more sensative TMA test, but I wonder if Quest's standard PCR's LOD is 7 IU/mL, are we just splitting hairs?
Hopefully the lab and/or your doctor can clear some of this up for you.
I think the answer is that you do not know and your doctor does not know if you were detectible under the limit of the test which is 43. We had an excellent discussion on this in September and here is the link to that thread.
http://www.medhelp.org/posts/Hepatitis-C/PCR-tests/show/1588597#post_7225640
Posted by 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"
Cyn, if you read the FDA submissions for both PI's the level of detection used for the trials was 25. There was no quantification below that. However when they put it on the market, the only cheap test available had a detection limit of 43 so that is what was used. According to willing, LabCorp goes farther than Quest. Quest stops at the 43 and LabCorp runs another test to determine is there is detectible virus down to 7.1 *but does not count them). Recently LabCorp has added another step which quantifies down to 25 if detection is still found at 43. I personally request the QuantaSures.
If I were you I would have the doctor ask Quest to run the samples to see if there was any detection below 43 or ask them to use your blood samples for both tests and run the Heptimax (detectible to 5)
frijole
http://www.medhelp.org/posts/Hepatitis-C/PCR-tests/show/1588597#post_7225640
Posted by 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"
Cyn, if you read the FDA submissions for both PI's the level of detection used for the trials was 25. There was no quantification below that. However when they put it on the market, the only cheap test available had a detection limit of 43 so that is what was used. According to willing, LabCorp goes farther than Quest. Quest stops at the 43 and LabCorp runs another test to determine is there is detectible virus down to 7.1 *but does not count them). Recently LabCorp has added another step which quantifies down to 25 if detection is still found at 43. I personally request the QuantaSures.
If I were you I would have the doctor ask Quest to run the samples to see if there was any detection below 43 or ask them to use your blood samples for both tests and run the Heptimax (detectible to 5)
frijole
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