Cepheid Xpert MTBXDR

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Pieejams no:

SPD SCIENTIFIC PTE LTD

Klase:

Class C IVD

Ražojis:

Cepheid AB

Ārstniecības joma:

Microbiology

Ārstēšanas norādes:

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.

Produktu pārskats:

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

Autorizācija datums:

2023-03-09