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Diagnostic Performance of Molecular and Serological Tests of SARS- CoV-2 on well-Characterised Specimens from COVID-19 Individuals: the EDCTP "PERFECT-Study" (RIA2020EF-3000)

PONE-D-22-20470

Dear Dr. Fokam,

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PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The manuscript is very well written and shows an innovative tool to monitoring diagnostic performance of molecular and Serological Tests of SARS- CoV-2. The manuscript is clearly written, the set of methods is adequate to the goals formulated.

The topic is interesting, due to a lack of literature dealing with this matter and data support the interpretation of the discussion.

I suggest accepting the paper in his form

Reviewer #2: The authors present a research proposal aimed to implement measures to minimize risks for COVID-19 in Cameroon. The multidisciplinary approach aims to improve the diagnostic performances for COVID 19 by better integrating methodologies, and infrastructures already available to enhance capacities in Cameroon for detecting the infection.

Authors also plan to validate point-of-care SARSCoV-2 molecular assays and to implement SARS-CoV-2 diagnosis with ddPCR-based assays , to validate serological assays to identify COVID-19- exposed persons and follow-up of convalescents.

The prospective, observational study of 24 monthswill be performed in Cameroon by collecting 1,536 nasopharyngeal swabs and sera samples of COVID-19 contacts. Molecular testing will be performed on conventional real-time qPCR, point-of-care GeneXpert, antigen-tests and digital droplet PCR (ddPCR); testing will be performed using ELISA, and antibody-based kits. Sensitivity, specificity, positive- and negative-predictive values will be evaluated.

The dta obtained will contribute to generate the technical and clinical environment required for a better detection of Sars-CoV2- in Cameroon and in Africa in general

The project will achieve several important results which include the technology transfer for conventional and point-of-care molecular assays, the improvement of the turn-around-time for diagnosing COVID-19 infection with low-cost assays, allowing timely treatment. Finally the project will contribute to assess the epidemiology of COVID-19 and the circulating-variants in Cameroon

This project is interesting and timely and will achieve important result for the control pf COVID19 pandemic in Cameroon and in Africa

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Reviewer #1: No

Reviewer #2: No

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