PONE-D-24-01686TITLE: Optimising instructional materials for Covid-19 Rapid Tests for Self-Sampling and Testing: Mapping the optimisation process of manufacturers Instructions for Use for self-testing RDT's intended for low-literacy contextsPLOS ONE

Dear Dr. Kumwenda,

Thank you for submitting your manuscript to PLOS ONE. I thank you for your interest in this field of work and following up with a great report. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. There are several comments from the reviewers which I agree and recommend to be responded appropriately. Correction of the English writing for grammar and typographical errors are therefore needed. Overall I think your report is interesting, novel and very useful. I hope you could refine it as suggested and return at due time.    

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Bachti Alisjahbana, MD, PhD

Academic Editor

PLOS ONE

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Reviewers' comments:

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Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

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Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: N/A

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: General overview

This manuscript provides a relevant insight into a crucial aspect of incorporating self-administered test kits for infectious diseases. The findings should provide a reliable guide for manufacturers in developing instructions for use (IFU) that can be easily understood and applied by its intended users. I suggest the following revisions to improve the quality of this manuscript.

2. Section-by-section review

2.1. Introduction

“Clearly, simple, and innovative diagnostic technologies that could rapidly deployed and put to scale were needed to circumvent these underlining barriers.” (lines 83-85). This sentence needs grammatical editing, e.g. clear instead of clearly and adding be between rapidly and deployed, or rephrase the entire sentence to improve clarity.

2.2. Methods

To comply with COREQ, more information about the characteristics and reflexivity of the research team is needed. Additional information about whether there is non-participation (and why) should also be provided.

2.3. Results

"Four broad themes emerged from the analysis...” but the sentence listed five themes (lines 229-235). Please revise accordingly.

Moreover, theme #3 (incoherence between description within instructions and actual contents of a test package) and theme #5 (diminished clarity in the wording of text instruction) conceptually overlaps so some redefining is needed. The choice to use the word “Contradictions” in the heading of section 3 of results (line 309) felt imprecise as the findings and quotes described in that section presented inconsistencies or lack of clarity in the instructions rather than contradictions. The term "incoherence" used previously is more precise.

Reviewer #2: Although Moses Kelly Kumwenda and coworkers' manuscript is in a field between scientific and social fields, it is of great interest, considering that rapid tests in low-literacy contexts could save lives.

Therefore, in the discussion section, the low number of participants is no problem. In my opinion, this is a driven study for future application on other rapid tests. In fact, my advice is to include the possibility of having an "optimizing instructional material" not only for COVID-19 rapid tests but for all commercially available self-sampling and testing tests.

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Reviewer #1: No

Reviewer #2: Yes: Erika Cione

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TITLE: Optimising instructional materials for Covid-19 Rapid Tests for Self-Sampling and Testing: Mapping the optimisation process of manufacturers Instructions for Use for self-testing RDT's intended for low-literacy contexts

PONE-D-24-01686R1

Dear Dr. Kumwenda,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Bachti Alisjahbana, MD, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Author

Your manuscript has importance in such that it would emphasis the need for better conduction of rapid test in primary care setting. Therefore I would suggest to accept this manuscript for further progress in Publication

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #3: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: (No Response)

Reviewer #3: Partly

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

Reviewer #3: N/A

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: (No Response)

Reviewer #3: Yes

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: (No Response)

Reviewer #3: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

Reviewer #3: (No Response)

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #3: No

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