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      Evaluation of Two Rapid Antigenic Tests for the Detection of SARS-CoV-2 in Nasopharyngeal Swabs

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          Abstract

          (1) Background: In the current context of the COVID-19 crisis, there is a need for fast, easy-to-use, and sensitive diagnostic tools in addition to molecular methods. We have therefore decided to evaluate the performance of newly available antigen detection kits in “real-life” laboratory conditions. (2) Methods: The sensitivity and specificity of two rapid diagnostic tests (RDT)—the COVID-19 Ag Respi-Strip from Coris Bioconcept, Belgium (CoRDT), and the coronavirus antigen rapid test cassette from Healgen Scientific, LLC, USA (HeRDT)—were evaluated on 193 nasopharyngeal samples using RT-PCR as the gold standard. (3) Results: The sensitivity obtained for HeRDT was 88% for all collected samples and 91.1% for samples with Ct ≤ 31. For the CoRDT test, the sensitivity obtained was 62% for all collected samples and 68.9% for samples with Ct ≤ 31. (4) Conclusions: Despite the excellent specificity obtained for both kits, the poor sensitivity of the CoRDT did not allow for its use in the rapid diagnosis of COVID-19. HeRDT satisfied the World Health Organization’s performance criteria for rapid antigen detection tests. Its high sensitivity, quick response, and ease of use allowed for the implementation of HeRDT at the laboratory of the University Hospital of Liège.

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          A Novel Coronavirus from Patients with Pneumonia in China, 2019

          Summary In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing. (Funded by the National Key Research and Development Program of China and the National Major Project for Control and Prevention of Infectious Disease in China.)
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            Interrater reliability: the kappa statistic

            The kappa statistic is frequently used to test interrater reliability. The importance of rater reliability lies in the fact that it represents the extent to which the data collected in the study are correct representations of the variables measured. Measurement of the extent to which data collectors (raters) assign the same score to the same variable is called interrater reliability. While there have been a variety of methods to measure interrater reliability, traditionally it was measured as percent agreement, calculated as the number of agreement scores divided by the total number of scores. In 1960, Jacob Cohen critiqued use of percent agreement due to its inability to account for chance agreement. He introduced the Cohen’s kappa, developed to account for the possibility that raters actually guess on at least some variables due to uncertainty. Like most correlation statistics, the kappa can range from −1 to +1. While the kappa is one of the most commonly used statistics to test interrater reliability, it has limitations. Judgments about what level of kappa should be acceptable for health research are questioned. Cohen’s suggested interpretation may be too lenient for health related studies because it implies that a score as low as 0.41 might be acceptable. Kappa and percent agreement are compared, and levels for both kappa and percent agreement that should be demanded in healthcare studies are suggested.
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              The Architecture of SARS-CoV-2 Transcriptome

              Summary SARS-CoV-2 is a betacoronavirus responsible for the COVID-19 pandemic. Although the SARS-CoV-2 genome was reported recently, its transcriptomic architecture is unknown. Utilizing two complementary sequencing techniques, we present a high-resolution map of the SARS-CoV-2 transcriptome and epitranscriptome. DNA nanoball sequencing shows that the transcriptome is highly complex owing to numerous discontinuous transcription events. In addition to the canonical genomic and 9 subgenomic RNAs, SARS-CoV-2 produces transcripts encoding unknown ORFs with fusion, deletion, and/or frameshift. Using nanopore direct RNA sequencing, we further find at least 41 RNA modification sites on viral transcripts, with the most frequent motif, AAGAA. Modified RNAs have shorter poly(A) tails than unmodified RNAs, suggesting a link between the modification and the 3′ tail. Functional investigation of the unknown transcripts and RNA modifications discovered in this study will open new directions to our understanding of the life cycle and pathogenicity of SARS-CoV-2.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                J Clin Med
                J Clin Med
                jcm
                Journal of Clinical Medicine
                MDPI
                2077-0383
                24 June 2021
                July 2021
                : 10
                : 13
                : 2774
                Affiliations
                [1 ]Department of Clinical Microbiology, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium; jheylen@ 123456student.uliege.be (J.H.); c.fontaine@ 123456chuliege.be (C.F.); francois.maclot@ 123456chuliege.be (F.M.); c.meex@ 123456chuliege.be (C.M.); mphayette@ 123456chuliege.be (M.-P.H.); julie.descy@ 123456chuliege.be (J.D.)
                [2 ]Biostatistics Unit, Department of Public Health, University of Liège, 4000 Liège, Belgium; anhnguyet.diep@ 123456uliege.be (A.N.D.); afdonneau@ 123456uliege.be (A.-F.D.)
                Author notes
                Author information
                https://orcid.org/0000-0002-2499-2038
                https://orcid.org/0000-0001-5134-3220
                https://orcid.org/0000-0002-9025-6493
                Article
                jcm-10-02774
                10.3390/jcm10132774
                8267731
                34202731
                d0a8d8a5-1de9-474c-bddc-5d20f569e525
                © 2021 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( https://creativecommons.org/licenses/by/4.0/).

                History
                : 07 June 2021
                : 16 June 2021
                Categories
                Article

                rapid diagnostic test,antigen detection,sars-cov-2,covid-19

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