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Article
Peer-Review Record

Development and Clinical Performance of InteliSwab® COVID-19 Rapid Test: Evaluation of Antigen Test for the Diagnosis of SARS-CoV-2 and Analytical Sensitivity to Detect Variants of Concern Including Omicron and Subvariants

Viruses 2024, 16(1), 61; https://doi.org/10.3390/v16010061
by Mark J. Fischl 1,*, Janean Young 1, Keith Kardos 1, Michele Roehler 1, Tiffany Miller 1, Melinda Wooten 1, Natalie Holmes 1, Nicole Gula 1, Mia Baglivo 1, Justin Steen 1, Nori Zelenz 1, Antony George Joyee 1, Vincent Munster 2, Zack Weishampel 2, Claude Kwe Yinda 2, Kevin G. Rouse 3, Cathy Gvozden 4, David Wever 5, Giralt Yanez 6, Marc Anderson 7, Song Yu 8, Brian Bearie 9, Stephen Young 10 and Jody D. Berry 1add Show full author list remove Hide full author list
Reviewer 1:
Reviewer 2:
Viruses 2024, 16(1), 61; https://doi.org/10.3390/v16010061
Submission received: 28 November 2023 / Revised: 22 December 2023 / Accepted: 26 December 2023 / Published: 29 December 2023
(This article belongs to the Special Issue Recombinant Variants of SARS-CoV-2)

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This is a paper for analytical and clinical peformance of RAT for COVID-19 and Omicron variants. I attached the word file for the peer review. 

Please be careful to use a scientific terminology.

Comments for author File: Comments.pdf

Comments on the Quality of English Language

Quality of English is excellent, but illustration of Fig and Tables are not good enough. 

Author Response

Please see attachment

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The article represents the study well however I recommend that Authors describe the methods in detail further. Moreover it would be better if the authors can discuss the results presented further. Few comments are below:

1. Authors should include more discussion regarding Figure 1. The stain behaviour observed in Western Blot analysis of variants with mAb 1 and mAb2 should explain in detail

2. Samples from a total of 165 symptomatic individuals were tested on InteliSwab®. The overall positivity for COVID-19 in this study was determined to be 37% (61/165) based on RT-PCR results. The InteliSwab® showed positivity in 52 out of the 61 RT-PCR positive samples. Autohrs should discuss the reason behind the positive and negative errors. Among the 104 RT-PCR negative samples, 102 samples were negative by InteliSwab®.

3. The LOD for the parental strain, Beta, Delta, Lambda, Mu, and Omicron (BA.1) variants (Table 4) was determined to be 0.469 ng/mL. For Alpha strains, Gamma, and the Omicron subvariants, BA.2, BA.4, BA.5 and BQ.1 the LOD was found to be 0.313 ng/mL. Authors should mention how they calculated the LOD values.

Author Response

Please see attachment

Author Response File: Author Response.pdf

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