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Comparative performances of seven quantitative Reverse-Transcription Polymerase Chain Reaction assays (RT-qPCR) for detecting SARS-CoV-2 infection in samples from individuals suspected of COVID-19 in São Paulo, Brazil.

作者信息

Fukasawa Lucila Okuyama, Sacchi Cláudio Tavares, Gonçalves Maria Gisele, Lemos Ana Paula Silva, Almeida Samanta Cristine Grassi, Caterino-de-Araujo Adele

机构信息

Centro de Imunologia, Instituto Adolfo Lutz, Coordenadoria de Controle de Doenças, Secretaria de Estado da Saúde de São Paulo, SP 01246-902, Brazil.

Laboratório Estratégico, Instituto Adolfo Lutz, Coordenadoria de Controle de Doenças, Secretaria de Estado da Saúde de São Paulo, SP, Brazil.

出版信息

J Clin Virol Plus. 2021 Jun;1(1):100012. doi: 10.1016/j.jcvp.2021.100012. Epub 2021 Apr 5.


DOI:10.1016/j.jcvp.2021.100012
PMID:35262000
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8019594/
Abstract

INTRODUCTION: Brazil is the second largest country with COVID-19 positive cases worldwide. Due to the potent spread of the virus and the scarcity of kits and supplies, the Brazilian Ministry of Health has granted authorization for the use of kits available during this emergency, without an accurate evaluation of their performance. This study compared the performance and cost-effectiveness of seven molecular assays/kits available in São Paulo, Brazil, for SARS-CoV-2 diagnosis. MATERIALS AND METHODS: A total of 205 nasopharyngeal/oropharyngeal samples from suspected cases of COVID-19, were tested using the following assays: (i) GeneFinder COVID-19 plus RealAmp kit; (ii) 2019-nCoV RNA PCR-Fluorescence Probing, Da An Gene Co.; (iii) in-house RT-qPCR SARS-CoV-2 IAL; (iv) 2019-nCoV kit, IDT; (v) molecular SARS-CoV-2 (E) kit, Bio-Manguinhos; (vi) Allplex 2019-nCoV modified Assay, Seegene Inc, and (vii) Biomol one-step COVID-19 kit, IBMP. The criteria for determining a SARS-CoV-2 true positive result included the cycle threshold cut-off values, the characteristics of exponential/linear curves, the gene target diversity, and a positive result in at least two assays. RESULTS: The overall sensitivity of the assays listed were GeneFinder 83.6%, Da An Gene 100.0%, IAL 90.4%, IDT 94.6%, Bio-Manguinhos 87.7%, Allplex 97.3%, and IBMP 87.7%. The minor sensitive gene target was RdRP. Although all assays had a Cohen's Kappa index ≥0.893, the best tests used multiplex assays identifying -gene and/or -gene targets. CONCLUSION: All assays tested accurate for diagnosis, but considering cost-effectiveness (cost, time consumption, number of samples tested, and performance), the in-house IAL assay was ideal for COVID-19 diagnosis in São Paulo, Brazil.

摘要

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本文引用的文献

[1]
Genetic Diversity Among SARS-CoV2 Strains in South America may Impact Performance of Molecular Detection.

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[2]
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Euro Surveill. 2020-1

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Emerg Infect Dis. 2004-2

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