Peer Review History
Original SubmissionNovember 5, 2020 |
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PONE-D-20-34883 Validation of the COVID-19 Rapid Antigen Test in Vojvodina, Serbia PLOS ONE Dear Dr. Ristić, Thank you for submitting your manuscript to PLOS ONE. 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. Please submit your revised manuscript by Jan 30 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and 2. We note that patients provided oral consent to have a swab taken. Please state whether the IRB or ethics committee waived the requirement for informed consent to participate in your specific study. If patients provided informed written consent to have data/samples from their medical records used in research, please include this information. 3. In the ethics statement in the manuscript and in the online submission form, please provide additional information about the patient records/samples used in your retrospective study, including the date range (month and year) during which patients' medical records/samples were accessed. 4. Thank you for stating the following in the Acknowledgments Section of your manuscript: "This work is a part of the research that was supported by Provincial Secretariat for Higher Education and Scientific Research grant number 142-451-3072/2020-03." We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." Please include your amended statements within your cover letter; we will change the online submission form on your behalf. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. 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: Yes Reviewer #2: No ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No ********** 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: Yes Reviewer #2: No ********** 4. 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: Yes Reviewer #2: No ********** 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: This is a well presented manuscript. The authors do a good job of addressing study limitations and caveats. One point is that the viral transport medium (VTM) used for qPCR is likely not optimal for performing an antigen test. The authors should specify whether or not the any of the swabs were collected in VTM with guanidine or other disruptive agent as this could decrease antigen detection. The authors should also mention the manufacturer of the test in the abstract as there are several and performance will vary. The sample size is limited, which should also be mentioned in the abstract. Reviewer #2: General Comments: The authors evaluated the performance of the STANDARD Q COVID-19 Ag Test among symptomatic patients who presented to health care facilities in Novi Sad, Serbia. Performance of the rapid antigen test was compared with qRT-PCR (the gold-standard diagnostic test recommended by WHO). The authors observed a strong agreement between performance of the rapid antigen test and qRT-PCR. 1. The author acknowledged the importance and novelty of such a validation in their setting and globally; however, it would have been helpful for the authors to set out a well- structured study design, with a well-defined and described study population, and selection criteria. There were major methodological weaknesses making the study design prone to a lot of biases, and hence, interpretation of the results. 2. Overall, there were many grammatical and scientific-writing errors. 3. It would have been helpful for the authors to use the standard manufacturer’s name (STANDARD Q COVID-19 Ag Test) of the rapid antigen test used for this validation. Specific Comments: 1. Abstract: a. The result and conclusion could benefit from review of grammatical and scientific-writing errors. 2. Introduction: a. It would be helpful for the authors to review grammatical and scientific-writing errors. b. Line 88: It would be helpful for the authors to clearly explain or edit sentence stating “no strong evidence to determine the usefulness of these tests in clinical practice”. What is being referred to as ‘strong evidence’? c. Lines 93-94: The use of the words “potential partial replacement of qRT-PCR” appears misleading. The relevance of such a statement could be spelt out, otherwise it is debatable. Most studies have shown that the use of COVID-19 rapid antigen tests, as with many other rapid antigen tests is complementary to qRT-PCR. 3. Study design: a. Lines 97- 99: It would be helpful for the authors to clearly state a specific study design, and to explain what is meant by “retrospective analysis of prospective collected data”. Was it a prospective or retrospective study? b. It would be helpful for the authors to justify reasons for the short duration of the study which is a possible limitation for the generalization of the study; an inclusion of the COVID-19 prevalence would have been an added advantage in interpreting results from PPV and NPV. c. Lines 102-104: The relevance of these sentence should be spelt out or reviewed. d. Lines 106 -107: Inclusion and exclusion criteria should be rigid, specific and clearly stated. Information on these lines appear contrary to Line 100; Including all symptomatic patients could mean both in-patients and outpatients; COVID-19 symptoms are non-specific; hence it would have been helpful for the authors to state the criteria used by these facilities to define who a case suspected of COVID-19 is; and also, using a non-specific age group makes such a study difficult to reproduce. e. Lines 107-109: The authors alluded that “physicians through face-face structured interviews on the day of admission interviewed all included participants”. It would be helpful for the authors to clarify what they meant by ‘day of admission’, as this sentence appears contradictory to Line 100. f. Lines 118-119: The authors made mention of “previously trained medical staff”; the text could benefit from an explanation. g. Lines 120-122: The authors alluded to “available tubes containing a specific viral transport medium with antifungal and antibiotic supplements”; what was the role of the antifungal and antibiotic supplements being referred to here? h. Lines 122-126: It would be helpful for the authors to cite a reference for the laboratory protocol used. i. Lines 128-152: Cite reference(s); this text could be shortened. j. Lines 156-157: Cite reference(s). 4. Data Analysis: a. Lines 174-176: The relevance of the broad classification of statistical analyses used should be spelt out, otherwise it would be helpful for the authors to indicate specific statistical analyses used. b. Lines 177-178: The authors should review the scientific-writing of statistical tests. For example, it is commonly written Kruskal Wallis test or Kruskal-Wallis ANOVA rather than ANOVA-Kruskal±Wallis H-test; and Fisher’s Exact test rather than Fisher exact test. It would be helpful for the authors to also indicate that Kruskal-Wallis ANOVA was used for ordinal scale variables. c. Lines 184-186: It would be helpful for the authors to clarify whether the accuracy and Kappa values used were derived from validation done by the manufacturer. d. How was sample size determined? e. Any consideration for missing data? 5. Ethical Considerations: a. Lines 190-191: Why was verbal informed consent obtained only at the moment of sample collection? It would be helpful for the authors to explain why informed consent was not sought for the overall conduct of the research which also include, but not limited to data and sample collection. 6. Results: a. It would be helpful for the authors to review the scientific-writing in this section. b. Line 196: The relevance of the information should be spelt out as this sentence appears contrary to Line 100 stating only outpatients were enrolled in the study. c. Lines 196-198: The relevance of the information should be spelt out, otherwise its inclusion is questionable. d. It would be helpful for the authors to explain why fever was not measured. e. Lines 201: The relevance of the information in line should be spelt out. f. Lines 203-204: It would be helpful for the authors to explain the relevance of both a mean period of 9.4 days and a median time of 5. g. Lines 206-207: The relevance of the information in these lines should be spelt out. h. Lines 225-227: It would be helpful for the authors to explain the relevance of the values in the brackets. i. What is the overall observed period in Line 229 referring to? 7. Discussion: a. It would be helpful for the authors to review the grammar and scientific-writing in the section, and by extension interpretation of the results. b. Line 257: The relevance of the information could be spelt out, otherwise its inclusion in this section is debatable c. Lines 266-268: These lines appear contradictory to Lines 107-109 and Line 196. Were patients who presented with symptoms requiring admission excluded because they it was an exclusion criterion, or no patient with symptoms needed admission? d. Lines 271-272: These lines appear contradictory to Line 106 stating all symptomatic patients were included. It would be helpful for the authors to clarify. e. Cite reference(s) for Lines 304-306. f. Lines 324: Cite reference stating the prevalence of positivity g. Was there an explanation for participants presenting to facilities and being tested after ≥ 16 days from onset of signs/symptoms? 8. Tables: a. Table 1: It would be helpful for the authors to consider using figures for “days from symptoms onset”; for example, 0-5 days for the “first five days”. b. Line 215: It would be helpful for the authors to differentiate P values derived from Fisher’s Exact test or chi-square test c. Table 2: It would be helpful for the authors to explain the meaning of NA underneath the table; d. Table 2: Lines 239-240: The title of the table does not reflect the findings; the authors should consider replacing “Similarities and differences” with “Comparison”. 9. Figures: a. Figure 2: The authors should consider indicating what unit is the period between symptom onset and laboratory testing on the Y-axis measured in? ********** 6. 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 #2: Yes: Robert J. Samuels [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.
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Revision 1 |
Validation of the COVID-19 Rapid Antigen Test in Vojvodina, Serbia PONE-D-20-34883R1 Dear Dr. Ristić, 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. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. 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, John Schieffelin, MD Academic Editor PLOS ONE Additional Editor Comments (optional): All reviewer comments have been adequately addressed in the revised manuscript in this editor's opinion. 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 #2: (No Response) ********** 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 #2: No ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) Reviewer #2: No ********** 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: Yes Reviewer #2: Yes ********** 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: Yes Reviewer #2: No ********** 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 #2: General Comments: The authors evaluated the performance of the STANDARD Q COVID-19 Ag Test (a rapid antigen test) against qRT-PCR (the gold-standard laboratory diagnostic test for SARS-CoV2 as recommended by WHO) among symptomatic patients suspected of Covid-19, who presented to primary and tertiary health care facilities in Novi Sad, Serbia. The authors observed a strong agreement between performance of the rapid antigen test and qRT-PCR. The authors acknowledged the importance, timing and novelty of such a validation in their setting and globally. Significant changes were made to the manuscript from previous review. However, this manuscript could benefit from further review for scientific-writing errors. Examples include, but not limited to: 1. Repetition of words with resulting long text – see Lines 85,117, 143, 284 etc. 2. Slightly confusing presentation of results and discussion section – See Lines 212 -214, 217 – 220, 238-241, 257 (which of the two statistical tests was used, or both were used and what is the possible explanation for that), 314 – 318 etc. The study could also benefit from a rigid study design for ease of reproducibility, reduction of bias and generalizability. It would be helpful for the authors to briefly explain how the sample size of 120 was determined. Was this a pre-specified/ determined sample size? The statement in Line 109 should be clarified. Asymptomatic patients were excluded from which “analysis” or were they pre-specified to be excluded from the study as stated in Line 352. Based on what should close contacts (could be asymptomatic or symptomatic) of index cases in families and “collectives” as stated Lines 340- 343 be tested using the RDT, when the study population was only symptomatic patients? It would have been helpful for the authors to also cite reference(s), criteria or case definitions used for the determination of the study population (i.e., patients with mild and moderate signs and symptoms). ********** 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 #2: Yes: Robert Samuels
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Formally Accepted |
PONE-D-20-34883R1 Validation of the STANDARD Q COVID-19 Antigen Test in Vojvodina, Serbia Dear Dr. Ristić: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr, John Schieffelin Academic Editor PLOS ONE |
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