Reviewer's report
Title:A Point-of-Care test for facing the burden of undiagnosed celiac disease in
the Mediterranean area: a pragmatic design study
Version:3Date:27 October 2014
Reviewer: Daniela Basso
Reviewer's report:
The study "A point-of-care test for facing the burden of undiagnosed celiac
disease in the Mediterranean area: a pragmatic design study" by Costa et al. is
aimed to demonstrate that new generation POCT for CD diagnosis is
cost-effective.
Major compulsory revision:
Data do not support conclusions.
A reasonable premise and conclusion for POCT use in CD setting regards only
countries without laboratories facilities. It is not true what stated in the
introduction that ELISAs .."are laboriuos and expensive". In well organized
laboratories, CD serum testing is fast, not expensive and, differently from POCT,
is under continuous monitoring for quality control. Moreover, the statement in the
introduction that POCT are ..."easy-to-perform" is contradicted by the results (fig
1 compared to fig 2 and 3): the rate of classification error increases when POCT
are used by different persons suggesting that it is not so easy to perform. The
other statement which is also the leit motiv of the study is POCT low cost, but no
data regarding POCT cost and comparison with standard ELISA are provided.
An ideal diagnostic test should be 100% sensitive and specific, but this rarely
occurs. For screening purposes, as those claimed for this POCT, sensitivity must
be privileged and should be as high as possible, while a low specificity might be
accepted. This does not appears to be the case of this POCT (PPV of about 90%
and NPV of about 98%).
The results presented in table 2 are not clearly described. i.e. are the No CD
found the number of patients with a confirmed histological diagnosis of CD?
A more detailed analysis of POCT results in comparison with standard ELISA
should be presented. In particular was there any association between POCT
results and ELISA tTG levels? In the paper by Raivio et al (ref 16) it appears
clearly from figure 2 that the lowest ELISA value among those with POCT
positive results is about five fold the cut-off. If this is the sensitivity of POCT this
must be defined.
Some considerations on CD prevalence among the different countries studied
should also be taken into acocunt. By POCT CD was identified in Italy in
19/3559, in Slovenia in 7/1480, in Turkey in 1/771. Do these prevalences fit with
data in the literature?
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:A Point-of-Care test for facing the burden of undiagnosed celiac disease in
the Mediterranean area: a pragmatic design study
Version:3Date:27 October 2014
Reviewer: Daniela Basso
Reviewer's report:
The study "A point-of-care test for facing the burden of undiagnosed celiac
disease in the Mediterranean area: a pragmatic design study" by Costa et al. is
aimed to demonstrate that new generation POCT for CD diagnosis is
cost-effective.
Major compulsory revision:
Data do not support conclusions.
A reasonable premise and conclusion for POCT use in CD setting regards only
countries without laboratories facilities. It is not true what stated in the
introduction that ELISAs .."are laboriuos and expensive". In well organized
laboratories, CD serum testing is fast, not expensive and, differently from POCT,
is under continuous monitoring for quality control. Moreover, the statement in the
introduction that POCT are ..."easy-to-perform" is contradicted by the results (fig
1 compared to fig 2 and 3): the rate of classification error increases when POCT
are used by different persons suggesting that it is not so easy to perform. The
other statement which is also the leit motiv of the study is POCT low cost, but no
data regarding POCT cost and comparison with standard ELISA are provided.
An ideal diagnostic test should be 100% sensitive and specific, but this rarely
occurs. For screening purposes, as those claimed for this POCT, sensitivity must
be privileged and should be as high as possible, while a low specificity might be
accepted. This does not appears to be the case of this POCT (PPV of about 90%
and NPV of about 98%).
The results presented in table 2 are not clearly described. i.e. are the No CD
found the number of patients with a confirmed histological diagnosis of CD?
A more detailed analysis of POCT results in comparison with standard ELISA
should be presented. In particular was there any association between POCT
results and ELISA tTG levels? In the paper by Raivio et al (ref 16) it appears
clearly from figure 2 that the lowest ELISA value among those with POCT
positive results is about five fold the cut-off. If this is the sensitivity of POCT this
must be defined.
Some considerations on CD prevalence among the different countries studied
should also be taken into acocunt. By POCT CD was identified in Italy in
19/3559, in Slovenia in 7/1480, in Turkey in 1/771. Do these prevalences fit with
data in the literature?
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:A Point-of-Care test for facing the burden of undiagnosed celiac disease in
the Mediterranean area: a pragmatic design study
Version:3Date:27 October 2014
Reviewer: Daniela Basso
Reviewer's report:
The study "A point-of-care test for facing the burden of undiagnosed celiac
disease in the Mediterranean area: a pragmatic design study" by Costa et al. is
aimed to demonstrate that new generation POCT for CD diagnosis is
cost-effective.
Major compulsory revision:
Data do not support conclusions.
A reasonable premise and conclusion for POCT use in CD setting regards only
countries without laboratories facilities. It is not true what stated in the
introduction that ELISAs .."are laboriuos and expensive". In well organized
laboratories, CD serum testing is fast, not expensive and, differently from POCT,
is under continuous monitoring for quality control. Moreover, the statement in the
introduction that POCT are ..."easy-to-perform" is contradicted by the results (fig
1 compared to fig 2 and 3): the rate of classification error increases when POCT
are used by different persons suggesting that it is not so easy to perform. The
other statement which is also the leit motiv of the study is POCT low cost, but no
data regarding POCT cost and comparison with standard ELISA are provided.
An ideal diagnostic test should be 100% sensitive and specific, but this rarely
occurs. For screening purposes, as those claimed for this POCT, sensitivity must
be privileged and should be as high as possible, while a low specificity might be
accepted. This does not appears to be the case of this POCT (PPV of about 90%
and NPV of about 98%).
The results presented in table 2 are not clearly described. i.e. are the No CD
found the number of patients with a confirmed histological diagnosis of CD?
A more detailed analysis of POCT results in comparison with standard ELISA
should be presented. In particular was there any association between POCT
results and ELISA tTG levels? In the paper by Raivio et al (ref 16) it appears
clearly from figure 2 that the lowest ELISA value among those with POCT
positive results is about five fold the cut-off. If this is the sensitivity of POCT this
must be defined.
Some considerations on CD prevalence among the different countries studied
should also be taken into acocunt. By POCT CD was identified in Italy in
19/3559, in Slovenia in 7/1480, in Turkey in 1/771. Do these prevalences fit with
data in the literature?
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
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