Reviewer's report
Title:Excellent superiority and specificity of COBAS TaqMan HCV assay in an
early viral kinetic change during pegylated interferon-alpha 2b plus ribavirin
treatment
Version: 2Date:7 July 2009
Reviewer: Peter Ferenci
Reviewer's report:
The authors partly incorporated my comments into the revised version.
By rereading the revised manuscript, I realized that the paper contains a major
mistake. Since samples were diluted 1:10 for the Monitor assay, the LOD is
certainly not 50 IU/ml (in fact the authors give a lower value of 3.7 log IU). Thus
the basis of the whole paper is simply wrong. The authors should give the
Taqman data for all patients who were neg by Monitor but pos by TaqMan.
Furthermore following points were not covered:
1. Surprisingly, 60% of Taqman neg pts. at week 12 did not an SVR. This calls
for a discussion on compliance and drug exposure. Were all TaqMan neg. pts.
really negative or just unquantifiable? Even more unclear is why all non SVR pts.
were undetectable by the Amplicor assay. This study compares the more
sensitive TaqMan assay with the older Amplicor (see also my comment above)
2 A more useful analysis would be the time to first undetectability (see Ferenci et
al, J Hepatology 2005 – this paper describes the time dependency of SVR for the
first time) and its relation to the end of treatment response, relapse rate and SVR
3. Fig. 1 should have the same units for the ordinate and the abscissa – to
highlight the fact that values with the Taqman assay are higher than with the
Amplicor assay.
Assessment:
1. Is the question posed by the authors well defined yes
2. Are the methods appropriate and well described - questionable
3. Are the data sound –depend on the validity of the diluted Monitor assay
4. Does the manuscript adhere to the relevant standards for reporting and data
deposition yes
5. Are the discussion and conclusions well balanced and adequately supported
by the data questionable
6. Are limitations of the work clearly stated No
7. Do the authors clearly acknowledge any work upon which they are building,
published and unpublished - incomplete
8. Do the title and abstract accurately convey what has been found yes
9. Is the writing acceptable yes
Recommendation: REJECT
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
'I declare that I have no competing interests'
Reviewer's report
Title:Excellent superiority and specificity of COBAS TaqMan HCV assay in an
early viral kinetic change during pegylated interferon-alpha 2b plus ribavirin
treatment
Version: 2Date:7 July 2009
Reviewer: Peter Ferenci
Reviewer's report:
The authors partly incorporated my comments into the revised version.
By rereading the revised manuscript, I realized that the paper contains a major
mistake. Since samples were diluted 1:10 for the Monitor assay, the LOD is
certainly not 50 IU/ml (in fact the authors give a lower value of 3.7 log IU). Thus
the basis of the whole paper is simply wrong. The authors should give the
Taqman data for all patients who were neg by Monitor but pos by TaqMan.
Furthermore following points were not covered:
1. Surprisingly, 60% of Taqman neg pts. at week 12 did not an SVR. This calls
for a discussion on compliance and drug exposure. Were all TaqMan neg. pts.
really negative or just unquantifiable? Even more unclear is why all non SVR pts.
were undetectable by the Amplicor assay. This study compares the more
sensitive TaqMan assay with the older Amplicor (see also my comment above)
2 A more useful analysis would be the time to first undetectability (see Ferenci et
al, J Hepatology 2005 – this paper describes the time dependency of SVR for the
first time) and its relation to the end of treatment response, relapse rate and SVR
3. Fig. 1 should have the same units for the ordinate and the abscissa – to
highlight the fact that values with the Taqman assay are higher than with the
Amplicor assay.
Assessment:
1. Is the question posed by the authors well defined yes
2. Are the methods appropriate and well described - questionable
3. Are the data sound –depend on the validity of the diluted Monitor assay
4. Does the manuscript adhere to the relevant standards for reporting and data
deposition yes
5. Are the discussion and conclusions well balanced and adequately supported
by the data questionable
6. Are limitations of the work clearly stated No
7. Do the authors clearly acknowledge any work upon which they are building,
published and unpublished - incomplete
8. Do the title and abstract accurately convey what has been found yes
9. Is the writing acceptable yes
Recommendation: REJECT
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
'I declare that I have no competing interests'
Please review this paper.
user
Reviewer's report
Title:Excellent superiority and specificity of COBAS TaqMan HCV assay in an
early viral kinetic change during pegylated interferon-alpha 2b plus ribavirin
treatment
Version: 2Date:7 July 2009
Reviewer: Peter Ferenci
Reviewer's report:
The authors partly incorporated my comments into the revised version.
By rereading the revised manuscript, I realized that the paper contains a major
mistake. Since samples were diluted 1:10 for the Monitor assay, the LOD is
certainly not 50 IU/ml (in fact the authors give a lower value of 3.7 log IU). Thus
the basis of the whole paper is simply wrong. The authors should give the
Taqman data for all patients who were neg by Monitor but pos by TaqMan.
Furthermore following points were not covered:
1. Surprisingly, 60% of Taqman neg pts. at week 12 did not an SVR. This calls
for a discussion on compliance and drug exposure. Were all TaqMan neg. pts.
really negative or just unquantifiable? Even more unclear is why all non SVR pts.
were undetectable by the Amplicor assay. This study compares the more
sensitive TaqMan assay with the older Amplicor (see also my comment above)
2 A more useful analysis would be the time to first undetectability (see Ferenci et
al, J Hepatology 2005 – this paper describes the time dependency of SVR for the
first time) and its relation to the end of treatment response, relapse rate and SVR
3. Fig. 1 should have the same units for the ordinate and the abscissa – to
highlight the fact that values with the Taqman assay are higher than with the
Amplicor assay.
Assessment:
1. Is the question posed by the authors well defined yes
2. Are the methods appropriate and well described - questionable
3. Are the data sound –depend on the validity of the diluted Monitor assay
4. Does the manuscript adhere to the relevant standards for reporting and data
deposition yes
5. Are the discussion and conclusions well balanced and adequately supported
by the data questionable
6. Are limitations of the work clearly stated No
7. Do the authors clearly acknowledge any work upon which they are building,
published and unpublished - incomplete
8. Do the title and abstract accurately convey what has been found yes
9. Is the writing acceptable yes
Recommendation: REJECT
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
'I declare that I have no competing interests'
assistant