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SEASUN BIOMATERIALS va lancer le test moléculaire rapide COVID-19
  • Polska - Polski


News provided by

SEASUN BIOMATERIALS

Apr 29, 2020, 06:23 ET

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SÉOUL, Corée du Sud, 29 avril 2020 /PRNewswire/ -- SEASUN BIOMATERIALS a annoncé le 1er mai qu'elle s'apprêtait à lancer son deuxième test COVID-19 « AQ-TOP COVID-19 Rapid Detection Kit » juste après l'achèvement de l'EUA de la FDA (27 avril) de son kit de détection en temps réel U-TOP COVID-19.

SEASUN BIOMATERIALS, AQ-TOP COVID-19 rapid detection Kit
SEASUN BIOMATERIALS, AQ-TOP COVID-19 rapid detection Kit

La sensibilité et la spécificité analytiques des méthodes moléculaires conventionnelles ont été améliorées grâce à la technologie AQ-TOP, qui combine l'amplification isotherme et la sonde de détection de l'ANP (acide nucléique peptidique), dont l'efficacité de liaison à l'acide nucléique cible est très précise.

Ce kit cible le gène ORF1ab du SRAS-CoV-2 avec un gène RNase P humain endogène de contrôle. Le kit a obtenu le marquage CE-IVD en mars, et les examens d'une autorisation d'exportation du MFDS (ministère coréen de la Sécurité alimentaire et pharmaceutique) et de l'EUA FDA sont en cours.

Le PDG Hee-Kyung  Park a déclaré : « Les clients ne doivent pas acheter de matériel supplémentaire. L'instrument PCR en temps réel existant, qui est fréquemment utilisé pour le diagnostic COVID-19, peut être utilisé tel quel. Le nombre moyen d'échantillons qui peuvent être testés par unité (12 heures par jour) est de 3400, ce qui est 5 à 6 fois plus rapide qu'auparavant. Actuellement, étant donné que COVID-19 se répand rapidement dans le monde entier et qu'une réinfection est fréquemment signalée, nous produirons plus de 200 000 tests par jour pour livrer le plus rapidement possible. Dès que l'autorisation pour le kit de détection rapide AQ-TOP COVID-19 aura été obtenue, le kit sera fourni à l'échelle internationale et avec l'avantage que le diagnostic rapide de COVID-19 contribuera à un suivi rapide. »

SEASUN BIOMATERIALS distribue actuellement son « U-TOP COVID-19 Detection Kit » basé sur PCR en temps réel qui a obtenu le marquage CE-IVD, le certificat de vente libre de MFDS (en février) et le FDA-EUA (le 27 avril), à l'étranger, y compris en Europe et dans les pays du Moyen-Orient.

À propos de SEASUN BIOMATERIALS

SEASUN BIOMATERIALS est une entreprise de diagnostic in vitro qui développe des plateformes de diagnostic moléculaire des maladies infectieuses, du cancer ainsi que des troubles génétiques et épigénétiques.

Nous développons et commercialisons des plateformes de diagnostic innovantes basées sur PCR en temps réel grâce au développement de nos technologies propriétaires afin de fournir des services de diagnostic moléculaire plus avancés.  

www.seasunbio.com

Photo - https://mma.prnewswire.com/media/1161106/3.jpg

Related Links

www.seasunbio.com

SOURCE SEASUN BIOMATERIALS

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