Aa
Just Received Lab Results - Comments Welcome (and needed)
Profile:
Female
Age 51
Dx with Fibromyalgia in March 2005 (Symptomatic with fatigue, pain, sleep disurbance, lowered cognitive functioning since November 2004)
Was out of work last year for 12 weeks due to above symptoms and am currently out again since Oct 6 for 12 weeks - symptoms above have increased plus nausea, lack of appetite and weight loss (40 lbs) since May.
Learned of Hep C Infection after donating blood in August, 2006.
First visit with Infectious Disease Specialist October 23, 2006.
Following are the results of the Labs done that day:
Protein, Total, Serum 7.8
Albumin, Serum 4.4
Bilirubin, Total 0.5
Bilirubin, Direct 0.16
Alkaline Phosphatase, S 78
AST 33
ALT 35
Genotype 3
V/L 1,930,000
When I saw the specialist he told me that if I was Genotype 1a or 1b he would order a liver bx (I took this to mean that if it was any other type there would be no bx).
He also said if V/L was more than 2,000,000 - would treat, if less than 2,000,000 would not treat. The V/L is very close to 2,000,000 so I don't know how he will interpret it.
I have been so prepared to come back as Geno 1a or 1b that I haven't even looked at Geno 3 so I'm off to do some research. My next appt is November 20th.
Any information you all have would be very helpful!
Female
Age 51
Dx with Fibromyalgia in March 2005 (Symptomatic with fatigue, pain, sleep disurbance, lowered cognitive functioning since November 2004)
Was out of work last year for 12 weeks due to above symptoms and am currently out again since Oct 6 for 12 weeks - symptoms above have increased plus nausea, lack of appetite and weight loss (40 lbs) since May.
Learned of Hep C Infection after donating blood in August, 2006.
First visit with Infectious Disease Specialist October 23, 2006.
Following are the results of the Labs done that day:
Protein, Total, Serum 7.8
Albumin, Serum 4.4
Bilirubin, Total 0.5
Bilirubin, Direct 0.16
Alkaline Phosphatase, S 78
AST 33
ALT 35
Genotype 3
V/L 1,930,000
When I saw the specialist he told me that if I was Genotype 1a or 1b he would order a liver bx (I took this to mean that if it was any other type there would be no bx).
He also said if V/L was more than 2,000,000 - would treat, if less than 2,000,000 would not treat. The V/L is very close to 2,000,000 so I don't know how he will interpret it.
I have been so prepared to come back as Geno 1a or 1b that I haven't even looked at Geno 3 so I'm off to do some research. My next appt is November 20th.
Any information you all have would be very helpful!
thanks for your reply, though perhaps I didn't put my question clearly. I was hoping you might give us some insight into a question that has been puzzling patients on this forum for some time. There is a growing discrepancy between on the one hand researchers who have reported detectable HCV RNA (+ and - strand) in liver, PBMC, macrophage and other cells extracted from patients who were UND in serum tests (either SVRs or treatment naive) and other researchers who dismiss such results as spurious/insignificant. There seem to be about a dozen recent papers in the former camp, including the Radkowski one linked above and others by Pham, Castillo, etc. The camp that is skeptical that serum-UND infection represents true infection seems to reflect prevailing opinion and includes prominent names in the field (eg Pawlotsky who you mentioned above).
Among the reasons given for dismissing serum-UND infection as true infection perhaps the most puzzling one, and the one I hoped you would give us your opinion on, is the reliability of the measurement protocols. The only differences seem to be that those reporting serum-UND infection examined cells rather than serum and that quantification was based on real-time PCR. However neither of these differences of themselves would seem to make their findings questionable. Perhaps the findings can be dismissed as contamination, but given the number of independent confirmations that seems an unlikely explanation. (Of course the "clinical significance" of serum-UND infection is a separate issue from its existence).
Among the reasons given for dismissing serum-UND infection as true infection perhaps the most puzzling one, and the one I hoped you would give us your opinion on, is the reliability of the measurement protocols. The only differences seem to be that those reporting serum-UND infection examined cells rather than serum and that quantification was based on real-time PCR. However neither of these differences of themselves would seem to make their findings questionable. Perhaps the findings can be dismissed as contamination, but given the number of independent confirmations that seems an unlikely explanation. (Of course the "clinical significance" of serum-UND infection is a separate issue from its existence).
Thank you for your response and suggestion.
Would you kindly clarify several issues.
Like you said,the NGI Quantasure # 140639 is made up of three portions...Super Quant, Ultra Qual, and Poisson.
I read that NGI was the only Lab in the US to get FDA approval for a test that was used in testing the National blood supply.
This FDA approved test was not approved for commercial use, but NGI uses the same approved methodology in it's Ultra qual, which is part of the Quantasure.
Did I understand this correctly?
Makes me feel better to know that I am having a test done that was sanctioned by the FDA.
-------------------------
Jim
I am beaten up from the biopsy today. I catch you another time at another post.
This thread is filling up, and it's best to leave room for researcher. When a visitor of this caliber comes by, we got to pick his brains before he silently disappears LOL.
He may be gone already.
Ina
Would you kindly clarify several issues.
Like you said,the NGI Quantasure # 140639 is made up of three portions...Super Quant, Ultra Qual, and Poisson.
I read that NGI was the only Lab in the US to get FDA approval for a test that was used in testing the National blood supply.
This FDA approved test was not approved for commercial use, but NGI uses the same approved methodology in it's Ultra qual, which is part of the Quantasure.
Did I understand this correctly?
Makes me feel better to know that I am having a test done that was sanctioned by the FDA.
-------------------------
Jim
I am beaten up from the biopsy today. I catch you another time at another post.
This thread is filling up, and it's best to leave room for researcher. When a visitor of this caliber comes by, we got to pick his brains before he silently disappears LOL.
He may be gone already.
Ina
MEDICAL PROFESSIONAL
Re Sheila Sherlock - yes - historical figure in Hepatology. Was that a chronic HCV biopsy she was looking at?( Sorry, dont know your personal hepatitis data) In Medicine, even the uttermost genius can only build upon the technology available around them. Sometimes it takes new technology to tackle critical problems, like e.g. to measure HCV in the blood of people. The hepatologist has to wait for a molecular biologist to develop such means - then a new world of testing, understanding and treating can unfold. I am deeply interested in the borderline issues of HCV and HBv like intrafamiliar spread, stabiity of SVR, optimization of treatment approaches, speed of progression etc. You are right that everything has to be questioned. But then who has the answers - often nobody -and action ( like some form of Tx) is still a pressing need.
When I spoke at the AASLD to the Echosens people - they are not yet aware for the need to be fasting for reproducible results. It is not part of the official protocol. What I found is the following ; In patients who had regression of fibrosis or cirrhosis it seems to matter more how engorged the liver is because some remnant fibrous strands might get pretensioned by the engorgement that follows a meal ( All the increased intestinal blood flow has to go through the liver!) Then, when the elastic pulse wave hits along such a fibrous strand you get dramatic stiffness. The Fibroscan measures the speed with which this elastic wave propagates which can be very high if local remnant strands are hit. If the liver is relaxed, like in the fasting state, there is no pretensioning and the average collagen content of the parechyma determines wave velocity.
How often to scan: Easy answer to that one: When there is reason to fear that your fibrosis has intensified ( flare up etc) or hope that the treatment has reduced fibrosis you want to know where you stand. Severe fibrosis can develop in several month of intense hepatitis ( or take 20 years to develop in some) Thus it all depends on the circumstances that might have induced a change. Once a year is a good guess some might need more frequent intervals.
The issue of measurement variability in VLs is also important but difficult to discuss in this format. Quality control is the critical issue here and at NGI I introduced four independent PCrs for each sample at different cycle numbers to increase the reliability of quantitation.
Treatment decisions should not be made based on placements of Vl in the midrange. It is after all the inflammatory response to the presence of virus proteins in the liver that causes the damage and stellate cell activation to increase collagen production and fibrosis which impedes diffusion in the Disse space making it harder for the liver to process the portal blood and the distortion in architecture of the lobulus. Vl is not linearly related to inflammation, although there are some connections - because the immune activation in the periphery is caused by virions travelling to these peripheral lymphnode sites.
When I spoke at the AASLD to the Echosens people - they are not yet aware for the need to be fasting for reproducible results. It is not part of the official protocol. What I found is the following ; In patients who had regression of fibrosis or cirrhosis it seems to matter more how engorged the liver is because some remnant fibrous strands might get pretensioned by the engorgement that follows a meal ( All the increased intestinal blood flow has to go through the liver!) Then, when the elastic pulse wave hits along such a fibrous strand you get dramatic stiffness. The Fibroscan measures the speed with which this elastic wave propagates which can be very high if local remnant strands are hit. If the liver is relaxed, like in the fasting state, there is no pretensioning and the average collagen content of the parechyma determines wave velocity.
How often to scan: Easy answer to that one: When there is reason to fear that your fibrosis has intensified ( flare up etc) or hope that the treatment has reduced fibrosis you want to know where you stand. Severe fibrosis can develop in several month of intense hepatitis ( or take 20 years to develop in some) Thus it all depends on the circumstances that might have induced a change. Once a year is a good guess some might need more frequent intervals.
The issue of measurement variability in VLs is also important but difficult to discuss in this format. Quality control is the critical issue here and at NGI I introduced four independent PCrs for each sample at different cycle numbers to increase the reliability of quantitation.
Treatment decisions should not be made based on placements of Vl in the midrange. It is after all the inflammatory response to the presence of virus proteins in the liver that causes the damage and stellate cell activation to increase collagen production and fibrosis which impedes diffusion in the Disse space making it harder for the liver to process the portal blood and the distortion in architecture of the lobulus. Vl is not linearly related to inflammation, although there are some connections - because the immune activation in the periphery is caused by virions travelling to these peripheral lymphnode sites.
MEDICAL PROFESSIONAL
RE CONTAMINATION; In the old days we used special pipettes, negative Air rooms and more gadgets to avoid post PCr product to prePCR testing material contamination. When I read that the Mayo clinic had just opened a facility with nice room separations neg, air etc for HCV I was smiling, because I had based NGI on the fundamental concept that there is only one way to really prevent postPCR contamination: Half a mile of city air in between labs, Zero contact between personnel, one way visitors only.
Labcorps Taqman test is not done at NGI and i do not know their precautions in any detail.
You are 9month post tx and neg so far on sensitive tests. That looks good. The proper test for you from NGI/Labcorps menu is LC# 140609 NGI HCV Ultraqual.
Labcorps Taqman test is not done at NGI and i do not know their precautions in any detail.
You are 9month post tx and neg so far on sensitive tests. That looks good. The proper test for you from NGI/Labcorps menu is LC# 140609 NGI HCV Ultraqual.
On a similar note, I heard from very well repected clinician/researcher that he stopped using Heptimax because of what he believed to be some false positives, I assume in the TMA portion of the test. Because of this, I switched from Heptimax to Quest's
HCV RNA Qualitative TMA using the Bayer Versant technology. Actually, I did both (Heptimax and Versant) the first time and then for my six-month post tx test only used the qualitative. Could you comment on false positives and/or accuracy of the quantitative TMA portion of Heptimax versus the HCV RNA qualitative. Both go down to 5 IU/ml. Thanks.
Ina,
Don't know if you saw my post below but broke down and had some soy sauce with my sushi last night :) Been off bread and hopefully all foods containing gluten for about a six days. Not sure if it's helping my stomach other than I'm losing some weight. LOL. Also, been thinking of seeing a doctor of TCM about some herbs for my post tx problems such as skin and digestion.
-- Jim
HCV RNA Qualitative TMA using the Bayer Versant technology. Actually, I did both (Heptimax and Versant) the first time and then for my six-month post tx test only used the qualitative. Could you comment on false positives and/or accuracy of the quantitative TMA portion of Heptimax versus the HCV RNA qualitative. Both go down to 5 IU/ml. Thanks.
Ina,
Don't know if you saw my post below but broke down and had some soy sauce with my sushi last night :) Been off bread and hopefully all foods containing gluten for about a six days. Not sure if it's helping my stomach other than I'm losing some weight. LOL. Also, been thinking of seeing a doctor of TCM about some herbs for my post tx problems such as skin and digestion.
-- Jim
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