Peer Review History
| Original SubmissionJuly 9, 2020 |
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PONE-D-20-21272 Evaluation of plasma anti-GPL-core IgA and IgG for Diagnosis of Disseminated Non-tuberculous Mycobacteria Infection PLOS ONE Dear Dr. Lertmemongkolchai, 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. 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. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please clarify what type of consent you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. 3. Please provide the catalog numbers for the anti-GPL core IgA ELISA kit and all antibodies used in the study. 4. Thank you for stating in your Funding Statement: "This study was supported in part by the Japan Agency for Medical Research and Development (AMED) (Grant number: JP20fk0108129, JP20fk0108139) to MA. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." Please provide an amended statement that declares *all* the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now. Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement. Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf. 5. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. [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: Partly ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ********** 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 ********** 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 ********** 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: Manuscript Review: PONE-D-20-21272 Evaluation of plasma anti-GPL-core 1 IgA and IgG for Diagnosis of Disseminated Non-tuberculous Mycobacteria Infection Arnone Nithichanon, Waraporn Samer, Ploenchan Chetchotisakd, Chidchamai Kewcharoenwong, Manabu Ato, Ganjana Lertmemonkolchai Key Results: In the manuscript the authors attempt to determine the efficacy of an anti-GPL-core ELISA kit, originally developed for detection of Mycobacterium avium species, in disseminated lymphadenopathy patients positive for non-tuberculous Mycobacteria (NTM) and anti-interferon gamma autoantibodies. Since the typical diagnosis of NTM does not have good sensitivity and is time consuming, this technique would improve the detection of NTM in patients in this region of the world. 137 plasma samples from a hospital in Khon Kaen, Thailand were analyzed along with control blood samples positive for M. tuberculosis, B. pseudomallei or healthy individuals. The study determined that the detection sensitivity of NTM was approximately 91% and specificity was 70%. Of those samples analyzed, results showed that only patients infected with NTM were positive for anti-IFN gamma autoantibody. Furthermore, anti-GPL-core IgA and IgG levels of NTM patients, including test sensitivities, were also higher than the control groups. When trying to determine if the test was able to distinguish between slow or rapid growing Mycobacteria, the study found that it was only able to distinguish between the two when immunoglobulin levels were at moderate levels; high levels showed no distinction. Overall, the study determined that using the kit does indeed improve the detection of NTM over current methods. Validity: Based on the methodology used in this study, I find the manuscript to be valid. Originality and Significance: I find the data presented in this study to be original and significant. If this study were to be expanded to other regions of the world and have the same results, it may shift the way testing for the infection occurs. Data and Methodology: This manuscript presented a straightforward data analysis based on data collected through analysis of blood samples. The methodology presented is commonly used and appropriate. Appropriate us of Statistics: Appropriate statistics were used throughout the study. Proper statistics were conducted, and variables were adjusted for when needed. Conclusions: Based on the statistics presented in the study, the conclusions appear to be valid and reliable. Suggested Improvements: None References: The references are valid. Clarity and context: The abstract, introduction and conclusions are clear, concise and appropriate. Scope of expertise: This manuscript is within the scope of my expertise. Reviewer #2: The aim of the manuscript was to evaluate surplus plasma samples from Thai patients suspected of disseminated NTM with an anti-GPL-core IgA kit and the modified kit to also detect IgG to compare the diagnostic potential of both isotypes. The authors' approach is interesting, however serology IgA-GPL has some limitation, that is import for clinicians. As described by the authors and others GLP is present in MAC, RGM, including M. abscessus, and IgA-GPL core ELISA cross-reactivity between MAC and RGM in pulmonary cases is reported. It is well known that the drug treatment regime is different for MAC and M. abscessus. However, both IgA and IgG tests failed to distinguish them in disseminated NTM cases. Even significantly higher IgG median reactivity was described for RGM the test weakness remains because the number of tested samples is too small. According to the reference cited by the authors, a meta-analysis study in the diagnostic accuracy of IgA-GPL core in MAC pulmonary diseases was 0.696 (95% CI 0.621–0.761) and 0.906 (95% CI 0.836–0.951), for sensitivity and specificity, respectively. Looking at the results of the present study the IgA sensitivity (61.7) and specificity (95) are similar if use a higher cut off for disseminated NTM cases. This shows the IgA-GPL core accuracy is consistent in pulmonary MAC and disseminated NTM diseases. This discussion is missed. On the other hand, the IgG test showed higher reactivity distribution in disseminated NTM samples, but the other infections disease and control also showed dispersion and cross-reactivity. As the number of MTB and BP samples is too small, thus may cause bias in the test specificity. How do the authors explain this cross-reactivity? All this makes the authors' assumption “Taken together, the application of anti-GPL-core antibody detection provides a novel additional option for clinicians to diagnose and manage disseminated NTM infected patients” speculative. The authors should discuss what can be the role of the biomarkers-based assays for the diagnosis of disseminated NTM and treatment management considering the limitations of the test. The major limitation of the study is the sample size of MTB and BP cases. With few subjects included is difficult to really assess the role of the IgG test, although for IgA the accuracy was consistent for both MAC pulmonary disease and disseminated NTM. Other comments: Line 104-104 - Consider to change: To detect anti-GPL-core IgG, the antigen adsorbed plate of the IgA kit was used to perform the modified test. Briefly, ..... Line 107 - Biotinylated ....anti-human IgG (BD Biosciences, USA). It was made in what animal? Line 112-113 - ... Results were analyzed with in-house standard curve and reported as arbitrary unit/ml (AU/ml). How did you that? Did you use the software? Manual mathematics calculation? Which plasma reference was used? Line 128 – 129 - --- biotinylated anti-human IFN-γ (BD Biosciences, USA). The conjugate was titrated? Seems that it was used surplus plasma samples of suspected disseminated NTM cases from a Hospital bio-repository and the control was freshly collected. However, the authors did not comment on the storage condition of the samples. This is an important issue in serology because Ab degradation can alter the ELISA results. Line 159 - .....plasma samples from routine assay were collected from storage at..... Inform the storage condiction (temperature? suffered freeze-thaw?) ********** 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: No [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 |
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Evaluation of plasma anti-GPL-core IgA and IgG for Diagnosis of Disseminated Non-tuberculous Mycobacteria Infection PONE-D-20-21272R1 Dear Dr. Lertmemongkolchai, 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, Frederick Quinn 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 Reviewer #2: All comments have been addressed ********** 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: Yes Reviewer #2: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ********** 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: Yes ********** 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: The authors addressed all of my comments in the previous version. I have no additional comments to add. Reviewer #2: The authors answered the questions clearly and appropriately. Rewrote parts of the original text and improved the discussion ********** 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: No |
| Formally Accepted |
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PONE-D-20-21272R1 Evaluation of plasma anti-GPL-core IgA and IgG for Diagnosis of Disseminated Non-tuberculous Mycobacteria Infection Dear Dr. Lertmemongkolchai: 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. Frederick Quinn Academic Editor PLOS ONE |
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