Estandarización y validación de una prueba molecular RT-LAMP in house para el diagnóstico de SARS-CoV-2
Autor: | Oscar, Escalante-Maldonado, Margot, Vidal-Anzardo, Fernando, Donaires, Gilmer, Solis-Sanchez, Italo, Gallesi, Luis, Pampa-Espinoza, Maribel, Huaringa, Nancy, Rojas-Serrano, Coralith, García, Eddie, Angles-Yanqui, Ronnie Gustavo, Gavilán, Ricardo, Durães-Carvalho, Jairo, Mendez-Rico, César, Cabezas, Paulo Vitor, Marques-Simas |
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Jazyk: | Spanish; Castilian |
Rok vydání: | 2021 |
Předmět: |
Medicine (General)
Sensitivity and Specificity Vero cell line estudio de validación virus RNA R5-920 Chlorocebus aethiops molecular diagnosis Animals Humans animal human Viral Vero Cells SARS-CoV-2 técnicas de diagnóstico molecular COVID-19 standard valor predictivo de las pruebas Reference Standards reacción en cadena de la polimerasa sensibilidad y especificidad reacciones cruzadas nucleic acid amplification diagnóstico Molecular Diagnostic Techniques covid-19 curva roc RNA Viral RNA Medicine Nucleic Acid Amplification Techniques |
Zdroj: | Revista Peruana de Medicina Experimental y Salud Pública, Vol 38, Iss 1, Pp 7-16 (2021) |
ISSN: | 1726-4642 1726-4634 |
Popis: | OBJECTIVES: To standardize and validate an in-house RT-LAMP test for the detection of SARS-CoV-2, based on laboratory and field assays using samples from COVID-19 suspected patients. MATERIALS AND METHODS: An in-house SARS-CoV-2 RT-LAMP molecular test was standardized, establishing the detection limit with Vero cells of isolated Peruvian strains of SARS-CoV-2, and the robustness to various concentrations of primers. The laboratory validation was performed with 384 nasal and pharyngeal swab samples (UFH) obtained between March and July 2020. The field validation was performed with 383 UFH obtained from COVID-19 suspected symptomatic cases. All samples were tested by RT-LAMP and RT-qPCR. The RT-qPCR was considered as the reference standard test. The concordance measures and diagnostic performance were calculated. RESULTS: The detection limit was consistent in cases with Ct |
Databáze: | OpenAIRE |
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