PONE-D-20-10369

Interlaboratory comparison for the Filovirus Animal Nonclinical Group (FANG) anti-Ebola virus glycoprotein immunoglobulin G enzyme-linked immunosorbent assay

PLOS ONE

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PLOS ONE

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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: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

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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: Yes

Reviewer #2: Yes

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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: 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: Line 22: first sentence of the abstract is long, consider breaking up into 2 points about the West African outbreak and then additionally the ongoing outbreak in DRC

Line 27: mention that the anti-EBOV GP IgG ELISA is the FANG assay here

Line 54: again I think at least initially (even though your cite it) you should say that the ELISA is the FANG assay.

Some of the information in the Introduction sounds more like study design which should be part of the Methods. I would like to see more of a background here in the Introduction section perhaps on the development of the assay initially, why this assay was chosen, rationale for doing the study, etc. I think a bit more context for the study is needed in this section.

I would like to see more expansion on the implications of the results in the discussion section. For example spell out the implications of the lower observed concentrations at Lab D and the variability of results in Lab B1. What do these results mean for the use of this assay moving forward?

This manuscript provides important information on assay validation of the FANG assay, an anti-EBOV GP IgG ELISA. These studies are needed in order to ensure robust assays and provide confidence in interpreting data between and within laboratories. My main concern with this manuscript is that more information is needed in both the Introduction and the Discussion to better understand the context of this assay and why the study is warranted. I think it is very much warranted but would like to see more of this information presented in the text.

Reviewer #2: Anderson et al provide data examining the performance of the FANG IgG EBOV ELISA across multiple sites. The study was intended to assess inter and intra-laboratory performance of the assay. The resulting data suggest that the assay is relatively robust, but does highlight a few limitations that the authors claim tend to be laboratory specific. The study has value for assessing preclinical/clinical samples for vaccine development across multiple institutions and clinical sites; where uniformity and agreement among analytical methods are critical for evaluating performance of a given countermeasure, in this case, vaccines targeting the EBOV GP. The paper was digestible and fairly straight forward.

A point of clarification:

Abstract, line 26: One vaccine is fully licensed and not considered investigational, the other is investigational at present.

Please go through the article and verify issues with spelling and grammar throughout to ensure clean readability.

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Reviewer #1: No

Reviewer #2: No

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Interlaboratory comparison for the Filovirus Animal Nonclinical Group (FANG) anti-Ebola virus glycoprotein immunoglobulin G enzyme-linked immunosorbent assay

PONE-D-20-10369R1

Dear Dr. Anderson,

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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Kind regards,

John Schieffelin, MD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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

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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)

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

Reviewer #1: (No Response)

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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)

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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)

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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)

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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