MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)

Dénomination commerciale

MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)

Code d'IUD-ID

06974566304015

IUD-ID de base

B-06974566304015

Numéro de référence/catalogue

PMTB0348

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)is designed for the qualitative detection of Mycobacterium tuberculosis complex nucleic acids in sputum, bronchoalveolar lavage fluid, and bacterial cultures by detecting IS6110 and IS1081 genes. In specimens where Mycobacterium tuberculosis complex is detected, it can also detect rifampin, isoniazid, fluoroquinolone, and ethambutol resistance-associated gene mutations. Rifampin resistance gene mutations are detected by analyzing the rpoB gene's 426–452 region, which includes 27 amino acid codons (81bp, rifampin resistance determining region). Isoniazid resistance gene mutations are detected by examining mutations in the ahpC promoter region (-44 to -30 and -15 to 4), inhA promoter region (-17 to -8), and katG315 codon. Fluoroquinolone resistance gene mutations are detected by analyzing gyrA gene codons 88–94, and ethambutol resistance gene mutations are detected by examining embB gene codons 306, 406, and 497. The product does not specify the exact type of mutation. It can be used for the identification of Mycobacterium tuberculosis complex and for the auxiliary diagnosis of rifampin, isoniazid, fluoroquinolone, and ethambutol-resistant tuberculosis.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105010703MYCOBACTERIAL DETECTION BY NA REAGENTS

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.