Cepheid Xpert MTBXDR

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Verfügbar ab:

SPD SCIENTIFIC PTE LTD

Klasse:

Class C IVD

Hergestellt von:

Cepheid AB

Therapiebereich:

Microbiology

Anwendungsgebiete:

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.

Produktbesonderheiten:

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

Berechtigungsdatum:

2023-03-09