Intended Use
This test is a semi-quantitative, in vitro diagnostic test for the detection of extensively drug-resistant tuberculosis (XDR-TB). It identifies MTB DNA and mutations linked to resistance against INH, ETH, FLQs, and SLIDs.
Specimen Required
Respiratory Specimens, CSF, Pleural Fluid, or Tissue
Patient Preparation
- Specimen preparation: Place each specimen in an individually sealed bag.
- Unprocessed Specimens: Transport 5-10 mL respiratory specimen, CSF or pleural fluid (Min: 1 mL) in a sterile container, or tissue large enough to be ground. Label as unprocessed
- Processed Specimens: Transport 2-5 mL digested/decontaminated respiratory specimen, CSF, pleural fluid, or tissue in a sterile container. (Min: 1 mL)
- Storage/Transport Temperature: Refrigerated
- Unacceptable Conditions: Blood, Paraffin blocks, Stool, Swabs, and Urine
- Remarks: Specimen source required; For processed specimens, identify method used for digestion and provide smear results.
- Stability:
- Unprocessed: Ambient: 3 days; Refrigerated: 1 week; Frozen: 1 month
- Processed: Ambient: Unacceptable; Refrigerated: 1 week; Frozen: 1 month
Methodology
The test is performed semi-quantitatively using nested real time PCR on Cepheid GeneXpert Instrument Systems.
Sample Received to Report Turnaround Time (TAT)
Twice in a week (Scheduled Test)
Reference Interval
–
Interpretive Data
Refer to the Report.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report