Performance evaluation of the diaxxoPCR system for rapid and user-friendly stool-based diagnosis of trichuriasis, ascariasis and strongyloidiasis in Mozambique

PLOS Neglected Tropical Diseases

Dear Dr. MESSA,

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Kind regards,

Angela Monica Ionica, Ph.D.

Academic Editor

PLOS Neglected Tropical Diseases

Jong-Yil Chai

Section Editor

PLOS Neglected Tropical Diseases

Shaden Kamhawi

co-Editor-in-Chief

PLOS Neglected Tropical Diseases

orcid.org/0000-0003-4304-636XX

Paul Brindley

co-Editor-in-Chief

PLOS Neglected Tropical Diseases

orcid.org/0000-0003-1765-0002

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Reviewers' comments:

Reviewer's Responses to Questions

Key Review Criteria Required for Acceptance?

As you describe the new analyses required for acceptance, please consider the following:

Methods

-Are the objectives of the study clearly articulated with a clear testable hypothesis stated?

-Is the study design appropriate to address the stated objectives?

-Is the population clearly described and appropriate for the hypothesis being tested?

-Is the sample size sufficient to ensure adequate power to address the hypothesis being tested?

-Were correct statistical analysis used to support conclusions?

-Are there concerns about ethical or regulatory requirements being met?

Reviewer #1: (1) Could authors please comment on the comparative PCR: is this an in-house developed or commercial assay? Is it fully-validated or accredited? Why was this test used as comparison?

Reviewer #2: (No Response)

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Results

-Does the analysis presented match the analysis plan?

-Are the results clearly and completely presented?

-Are the figures (Tables, Images) of sufficient quality for clarity?

Reviewer #1: The data are well presented.

Reviewer #2: (No Response)

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Conclusions

-Are the conclusions supported by the data presented?

-Are the limitations of analysis clearly described?

-Do the authors discuss how these data can be helpful to advance our understanding of the topic under study?

-Is public health relevance addressed?

Reviewer #1: Minor:

(6) Line 40/41: “demonstrate the performance” in study C needs to be clarified further whether this is analytical performance.

(7) Line 54/55: “low resource laboratory settings”. This needs to be justified – e.g. costing, ease of use etc.

Reviewer #2: (No Response)

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Editorial and Data Presentation Modifications?

Use this section for editorial suggestions as well as relatively minor modifications of existing data that would enhance clarity. If the only modifications needed are minor and/or editorial, you may wish to recommend “Minor Revision” or “Accept”.

Reviewer #1: (No Response)

Reviewer #2: (No Response)

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Summary and General Comments

Use this section to provide overall comments, discuss strengths/weaknesses of the study, novelty, significance, general execution and scholarship. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. If requesting major revision, please articulate the new experiments that are needed.

Reviewer #1: This is a very well-written study examining laboratory validation of a commercial cartridge-based PCR system on helminth detections. It has great relevance to the diagnostics accessibility in resource-limited settings.

I suggest the authors address the following points:

(1) To discuss at the introduction the context of this study in the absence of true “gold standard” (10.1016/j.ijpara.2014.05.009)

(2) Discuss limitations of this study: e.g. monitoring of load or intensity of disease, evaluation of treatment response, shedding dynamics are not in scope

(3) Line 69: “population-based surveys” have not been evaluated in this study, hence should not be included in the conclusion.

(4) Suggest discuss the PPV and NPV in the context of disease prevalence in Mozambique.

(5) Line 457-464: authors many want to consider rephrasing this as a general issue rather than a specific company issue, e.g. “a well-developed instrument support programme is required to ensure sustainable testing in Africa due to limited capability for instrument technical support by individual companies.”

Reviewer #2: (No Response)

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Reviewer #1: Yes:  Chuan Kok Lim

Reviewer #2: Yes:  Manfred Dakorah Asiedu

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Dear DR. MESSA,

We are pleased to inform you that your manuscript 'Performance evaluation of the diaxxoPCR system for rapid and user-friendly stool-based diagnosis of trichuriasis, ascariasis and strongyloidiasis in Mozambique' has been provisionally accepted for publication in PLOS Neglected Tropical Diseases.

Before your manuscript can be formally accepted you will need to complete some formatting changes, which you will receive in a follow up email. A member of our team will be in touch with a set of requests.

Please note that your manuscript will not be scheduled for publication until you have made the required changes, so a swift response is appreciated.

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Thank you again for supporting Open Access publishing; we are looking forward to publishing your work in PLOS Neglected Tropical Diseases.

Best regards,

Angela Monica Ionica, Ph.D.

Academic Editor

PLOS Neglected Tropical Diseases

Jong-Yil Chai

Section Editor

PLOS Neglected Tropical Diseases

Shaden Kamhawi

co-Editor-in-Chief

PLOS Neglected Tropical Diseases

orcid.org/0000-0003-4304-636XX

Paul Brindley

co-Editor-in-Chief

PLOS Neglected Tropical Diseases

orcid.org/0000-0003-1765-0002

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