Examination of SARS-CoV-2 serological test results from multiple commercial and laboratory platforms with an in-house serum panel
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Severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) is a novel human coronavirus that was identified in 2019. SARS-CoV-2 infection results in an acute, severe respiratory disease called coronavirus disease 2019 (COVID-19). The emergence and rapid spread of SARS-CoV-2 has led to a global public health crisis, which continues to affect populations across the globe. Real time reverse transcription polymerase chain reaction (rRT-PCR) is the reference standard test for COVID-19 diagnosis. Serological tests are valuable tools for serosurveillance programs and establishing correlates of protection from disease. This study evaluated the performance of one in-house enzyme linked immunosorbent assay (ELISA) utilizing the pre-fusion stabilized ectodomain of SARS-CoV-2 spike (S), two commercially available chemiluminescence assays Ortho VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Abbott SARS-CoV-2 IgG assay and one commercially available Surrogate Virus Neutralization Test (sVNT), GenScript USA Inc., cPass SARS-CoV-2 Neutralization Antibody Detection Kit for the detection of SARS-CoV-2 specific antibodies. Using a panel of rRT-PCR confirmed COVID-19 patients’ sera and a negative control group as a reference standard, all three immunoassays demonstrated high comparable positivity rates and low discordant rates. All three immunoassays were highly sensitive with estimated sensitivities ranging from 95.4–96.6 %. ROC curve analysis indicated that all three immunoassays had high diagnostic accuracies with area under the curve (AUC) values ranging from 0.9698 to 0.9807. High positive correlation was demonstrated among the conventional microneutralization test (MNT) titers and the sVNT inhibition percent values. Our study indicates that independent evaluations are necessary to optimize the overall utility and the interpretation of the results of serological tests. Overall, we demonstrate that all serological tests evaluated in this study are suitable for the detection of SARS-CoV-2 antibodies.
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Thank you for the time to revise the manuscript to include the Open Data requirement. Congratulations on the publication of this manuscript.
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Whilst your recent changes have fulfilled the original reviewers comments, in-line with the Open Data policy of Access Microbiology, please ensure you include a Data Summary section. The data that underpins your analysis (tables 1-4, figures 1-3) should be publicly available where possible. The Society offer access to FigShare as an option, but you are free to upload data at other such repositories should you wish. Please deposit the data underlying the work in the Society’s data repository Figshare account here: https://microbiology.figshare.com/submit. Please also cite this data in the Data Summary of the main manuscript and list it as a unique reference in the References section. When you resubmit your article, the Editorial staff will post this data publicly on Figshare and add the DOI to the Data Summary section where you have …
Whilst your recent changes have fulfilled the original reviewers comments, in-line with the Open Data policy of Access Microbiology, please ensure you include a Data Summary section. The data that underpins your analysis (tables 1-4, figures 1-3) should be publicly available where possible. The Society offer access to FigShare as an option, but you are free to upload data at other such repositories should you wish. Please deposit the data underlying the work in the Society’s data repository Figshare account here: https://microbiology.figshare.com/submit. Please also cite this data in the Data Summary of the main manuscript and list it as a unique reference in the References section. When you resubmit your article, the Editorial staff will post this data publicly on Figshare and add the DOI to the Data Summary section where you have cited it. This data will be viewable on the Figshare website with a link to the preprint and vice versa, allowing for greater discovery of your work, and the unique DOI of the data means it can be cited independently.
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Comments to Author
"Examination of SARS-CoV-2 serological test results from multiple commercial and laboratory platforms with an in-house serum panel" The research work is interesting Comparisons between various immunoassays are informative. Manuscript is well written and the author provided detailed materials and methods. Minor comments: It will be interesting to know the turnaround time for each assay. 124: Interesting to know the age and gender and precondition if possible. Line 141: Immulon 2 HB 96 well-plates sourced from?
Please rate the manuscript for methodological rigour
Very good
Please rate the quality of the presentation and structure of the manuscript
Very good
To what extent are the conclusions supported by the data?
Strongly support
…
Comments to Author
"Examination of SARS-CoV-2 serological test results from multiple commercial and laboratory platforms with an in-house serum panel" The research work is interesting Comparisons between various immunoassays are informative. Manuscript is well written and the author provided detailed materials and methods. Minor comments: It will be interesting to know the turnaround time for each assay. 124: Interesting to know the age and gender and precondition if possible. Line 141: Immulon 2 HB 96 well-plates sourced from?
Please rate the manuscript for methodological rigour
Very good
Please rate the quality of the presentation and structure of the manuscript
Very good
To what extent are the conclusions supported by the data?
Strongly support
Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?
No
Is there a potential financial or other conflict of interest between yourself and the author(s)?
No
If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?
Yes
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The work presented is clear and the arguments well formed. This is a study that would be of interest to the field and community. Based on the reviewer comments Including the age and gender of the participants will be essential for this kind of studies. Comparing turnaround time for each assay will be interesting.
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Comments to Author
From a careful and rigorous reading of the article entitled "Examination of SARS-CoV-2 serological test results from multiple commercial and laboratory platforms with an in-house serum panel" with manuscript number "ACMI-D-22-00093", I have brought as conclusions : -The objectives of the research were clearly stated and were achieved. -The methods described are sufficiently elucidated and would allow the scientific community to reproduce the experiments conducted. -The methodology is well adapted to the research, thus allowing it to contribute to the diagnosis, epidemiological surveillance, and prevention of the disease. -The results of this study are correctly interpreted and show the importance of serological tests while at the same time demonstrating that the immunoassays compared in this study are …
Comments to Author
From a careful and rigorous reading of the article entitled "Examination of SARS-CoV-2 serological test results from multiple commercial and laboratory platforms with an in-house serum panel" with manuscript number "ACMI-D-22-00093", I have brought as conclusions : -The objectives of the research were clearly stated and were achieved. -The methods described are sufficiently elucidated and would allow the scientific community to reproduce the experiments conducted. -The methodology is well adapted to the research, thus allowing it to contribute to the diagnosis, epidemiological surveillance, and prevention of the disease. -The results of this study are correctly interpreted and show the importance of serological tests while at the same time demonstrating that the immunoassays compared in this study are of crucial importance in the diagnosis. They are suitable for the detection of antibodies binding to SARS-CoV-2. On the other hand, the section dealing with neutralizing antibodies known as the SARS-CoV-2 surrogate virus neutralization kit remains a useful method that could be performed to assess neutralizing antibodies against SARS-CoV-2. This leads us to say that this study represents an advance in the knowledge and understanding of serological tests, evaluating the performance characteristics of these tests and the correlation between the qualitative and quantitative values of each test. -The entire manuscript is well-written and of an appropriate length to meet the 3000-7000 word standard for research papers. The number of figures and tables is appropriate. 1-Details on the age and gender of participants would be important. Since the antibody titer is highly variable from patient to patient and some patients tend to excrete the virus (viral clearance) for longer periods of time, this may lead to differences in sensitivity, especially since plasma levels vary significantly in middle-aged and very elderly patients. 2-The limitations of serological tests may extend to that they can only determine whether a person has produced antibodies in response to SARS-CoV-2 infection or not. These tests are not recommended for the early diagnosis of COVID-19 infection in the first week of infection as opposed to RT-PCR testing. The serological tests also do not determine whether the patient is contagious or not.
Please rate the manuscript for methodological rigour
Good
Please rate the quality of the presentation and structure of the manuscript
Good
To what extent are the conclusions supported by the data?
Strongly support
Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?
No
Is there a potential financial or other conflict of interest between yourself and the author(s)?
No
If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?
Yes
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