Cepheid Xpert MTBXDR

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Disponible desde:

SPD SCIENTIFIC PTE LTD

clase:

Class C IVD

Fabricado por:

Cepheid AB

Área terapéutica:

Microbiology

indicaciones terapéuticas:

The Xpert MTB/XDR test, performed on the GeneXpert Instrument Systems, is a qualitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of extensively drug resistant (XDR) Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples, concentrated sediments prepared from sputum, or BD™ Mycobacterial Growth Indicator Tube (MGIT™) culture. In specimens where MTB is detected, the Xpert MTB/XDR test can also detect isoniazid (INH) resistance associated mutations in the katG and fabG1 genes, oxyR-ahpC intergenic region and inhA promoter; ethionamide (ETH) resistance associated with inhA promoter mutations only; fluoroquinolone (FLQ) resistance associated mutations in the gyrA and gyrB quinolone resistance determining regions (QRDR); and second line injectable drug (SLID) associated mutations in the rrs gene and the eis promoter region.

Resumen del producto:

Models: Xpert MTB/XDR - GXMTB/XDR-10, Assay Definition File (ADF) - Assay Definition File (ADF)

Fecha de autorización:

2023-03-09