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El test de COVID-19 de Seegene con recogida de muestra de saliva ya está disponible en Europa
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News provided by

Seegene Inc.

Jan 13, 2021, 23:25 ET

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SEÚL, Corea del sur, 14 de enero de 2021 /PRNewswire/ -- La compañía de biotecnología de Corea del sur especializada en diagnóstico molecular Seegene Inc. (KQ096530) dijo el martes que ha certificado CE-IVD la aplicación de test de saliva para el Allplex™ SARS-CoV-2 Assay y el Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, y que los productos con esta función ya están disponibles en Europa. La nueva incorporación de la función de recogida de muestra de saliva para profesionales sanitarios en las primeras líneas de la pandemia de COVID-19.

Con la nueva función recientemente añadida, el test de recogida de muestra de saliva puede utilizarse intercambiablemente con el test de recogida de espécimen nasofaríngeo, normalmente utilizado para test PCR en tiempo real multiplex para explorar el nuevo coronavirus. La firma de diagnóstico molecular líder de Corea dijo que su test de recogida de muestras de saliva ofrece una opción adicional para la muestra sencilla, segura y cómoda sin tener que comprometer la sensibilidad y especificidad del test.

Independientemente, un estudio realizado por el Children's National Hospital de Washington DC en el periodo de julio a septiembre de 2020 mostró que el Allplex™ 2019-nCoV Assay de Seegene, una versión anterior del test de diagnóstico de la COVID-19, fue la más adecuada entre los cuatro ensayos COVID-19 PCR aprobados por la FDA EUA para especímenes de saliva recogidos de los participantes. Añadió que la sensibilidad de la detección viral era equivalente a la de los especímenes nasofaríngeos cuando se probaba en el Allplex™ 2019-nCoV Assay de Seegene.

La función de recogida de muestra de saliva de Seegene también puede eliminar la necesidad de materiales y trabajo asociada a la extracción de ácido nucléico, como el test realizado directamente desde la saliva natural recogida de los participantes. Un representante de Seegene dijo que la función de recogida de muestra de saliva, junto con la aplicación sin extracción, también certificada CE-IVD en diciembre, permitirá a los laboratorios realizar test masivos. La aplicación sin extracción permite a los laboratorios sin equipo de extracción, previamente un requisito previo para test de diagnóstico molecular, y estuvo recientemente disponible en Europa para el Allplex™ SARS-CoV-2/FluA/FluB/RSV.

Presentando el primer test de recogida de espécimen de saliva de la compañía, un representante de Seegene dijo que la nueva función se considera un método eficiente de recogida de gran volumen de especímenes, especialmente en un momento en el que el coronavirus mutante en Europa ha provocado recientemente la alarma global. 

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SOURCE Seegene Inc.

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