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"Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Intended Use", "Value": "Le cobas z 480 analyzer avec logiciel dédié, destiné à des applications de diagnostic in vitro, est un système automatisé d'amplification et de détection des acides nucléiques, dont le fonctionnement est basé sur des plaques. L'analyseur a été conçu pour être utilisé comme système de diagnostic capable d'assurer l'amplification et la détection par PCR en temps réel à partir d'échantillons humains au sein du système.

Les cobas x 480 instrument et cobas z 480 analyzer doivent être utilisés par des professionnels de laboratoire formés.

Les déclarations relatives à l'usage prévu des tests menés sur le cobas® 4800 System sont situées dans les instructions d'utilisation de chaque test réalisé sur le système.", "Language": "fr", "Country": "XG", "Code": "Intended Use" } ] } } ] }

cobas z 480 analyzer

Efficacité. Flexibilité. Confiance.

Country Specific Labeling See country-specific product labeling for regulatory status.
Analyseur cobas z 480
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icône de cible
Performance avérée
  • Plateforme de PCR de débit moyen à élevé
  • Des milliers de laboratoires du monde entier font confiance en sa capacité à fournir des résultats précis
icône de chronomètre
Cycle thermique rapide et précis
  • La technologie unique Therma-Base optimise le transfert de chaleur pour une uniformité maximale et une reproductibilité entre les puits
icône de réactif
Haute spécificité
  • La conception optimisée de l'unité de détection minimise les interférences spectrales 
  • Capture précise du signal de fluorescence pour réduire les artefacts et assurer l’intégrité des données
icône de roue dentée
Résultats automatisés et fiables
  • Vérifie et valide automatiquement la cohérence de la courbe PCR
  • L’algorithme cinétique exclusif réduit l’ambiguïté

Compléter votre menu de tests de diagnostic in vitro (DIV) avec les tests développés et utilisés par votre propre laboratoire (LDT), en tirant parti du logiciel User Defined Functionality (UDF) du système.

icône de l’analyseur cobas z 480

Tests développés en laboratoire

icône d’ordinateur

Logiciel User defined functionality

Algorithme automatisé des résultats

L’interprétation manuelle des données de réaction en chaîne par polymérase (PCR) est associée à la subjectivité. Pour garantir des résultats plus fiables, l’analyseur cobas z 480 applique un algorithme de résultats automatisé avancé qui interprète trois aspects clés des données de PCR :

Growth-Curve-Shape

Forme de la courbe d'amplification

Growth-Curve-Height

Hauteur de la courbe d'amplification (amplitude de la courbe)

Valeur Ct

Valeur du seuil de cycle (Ct)

Référence :

  1. Manuel opérateur cobas 4800, v 4.1, 05/2022

Le cobas z 480 analyzer avec logiciel dédié, destiné à des applications de diagnostic in vitro, est un système automatisé d'amplification et de détection des acides nucléiques, dont le fonctionnement est basé sur des plaques. L'analyseur a été conçu pour être utilisé comme système de diagnostic in vitro ou de dépistage capable d'assurer l'amplification et la détection par PCR en temps réel à partir d'échantillons humains au sein du système.
Dispositif médical de diagnostic in vitro. Classe A
Mandataire : Roche Diagnostics GmbH (Allemagne) – Distributeur : Roche Diagnostics France
Lire attentivement les instructions figurant dans le manuel d’utilisation et les fiches techniques spécifiques à chaque test.

MC-FR-01759 - Mis à jour : 08/2023

Description

Référence produit

Documents techniques

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