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SML Genetree reçoit de la FDA l'autorisation d'utilisation d'urgence de son kit PCR en temps réel Ezplex SARS-CoV-2 G avec la possibilité de regroupement des échantillons
  • USA - English
  • Polska - Polski


News provided by

SML Genetree

Jan 14, 2021, 11:22 ET

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SANTA CLARA, Californie, 14 janvier 2021 /PRNewswire/ -- Aujourd'hui, SML Genetree a annoncé que la FDA des États-Unis lui a accordé une autorisation d'utilisation d'urgence pour son kit Ezplex SARS-CoV-2 G. Il s'agit d'un test de diagnostic moléculaire pour la détection qualitative de l'ARN du SRAS-CoV-2 au moyen de prélèvements nasopharyngés, oropharyngés et d'expectoration. Cette autorisation permet aussi l'utilisation d'échantillons groupés de patients contenant jusqu'à 5 échantillons prélevés par écouvillonnage des voies respiratoires supérieures. Les échantillons doivent être prélevés par un professionnel de la santé à l'aide de flacons individuels contenant des milieux de transport.

Le regroupement des échantillons est un outil de santé publique important parce qu'il permet à un plus grand nombre de personnes d'être testées rapidement en utilisant moins de ressources de dépistage. Les tests groupés sont les plus efficaces dans les régions à faible prévalence, ce qui signifie que la plupart des résultats devraient être négatifs. « Grâce au protocole de regroupement, nous pouvons aider les laboratoires à répondre à la demande de résultats de tests moléculaires précis et à grand volume, s'est réjoui M. Jihoon Ahn, le PDG de SML Genetree. Nous sommes ravis de pouvoir proposer le test Ezplex au marché américain. »

Le kit Ezplex SARS-CoV-2 G est conçu pour fournir des résultats sensibles et précis en détectant deux régions différentes du virus SRAS-CoV-2 : les gènes RdRP et N. Les résultats sont disponibles environ 2 heures et demie après l'extraction de l'ARN. Le test est autorisé dans les laboratoires des États-Unis certifiés en vertu des Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C., § 263a, pour effectuer des tests de grande complexité.

Pour obtenir de plus amples renseignements sur le test Ezplex CoV-2 G, visitez le site www.smlgenetree.com.

À propos de SML Genetree 

SML Genetree est reconnu comme l'un des principaux concepteurs de technologies moléculaires multiplex et de diagnostics cliniques multiplex en Corée du Sud. SML Genetree est une filiale de Samkwang Medical Laboratories (SML), l'un des plus grands laboratoires commerciaux de diagnostic en Corée depuis 1985. SML fournit des résultats de diagnostic à ses clients dans 3 000 institutions médicales gouvernementales en Corée, dont l'administration du personnel militaire (MMA), les hôpitaux universitaires et les établissements médicaux locaux. Pour obtenir plus d'informations, veuillez consulter le site www.smlgenetree.com.

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SOURCE SML Genetree

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