Intended Use
To accurately differentiates Mycobacterium tuberculosis (MTB) from non-tuberculosis Mycobacterium species (NTM) qualitatively using one-step nested real-time PCR.
Sputum, Tissues (fresh biopsy, paraffin-embedded tissue), Urine (early morning midstream, multiple consecutive days), Aseptic fluids (body fluids (spinal, pleural, pericardial, synovial, ascetic,), bone marrow – EDTA, blood – EDTA, bronchial washings), Stool, BAL, ascitic fluid, CSF, pus, lymph node biopsy, genital biopsy, ocular samples, etc.
- Sample Collection and Specimen Preparation:
- Sputum: Rinse mouth, deep cough directly into sterile container
- Tissue: Aseptically collected, moist with sterile saline if dried
- Urine: Collect midstream early morning
- Fluids: Aseptic collection, add anticoagulants (EDTA top) for clottable fluids
- Stool: collected in sterile container, small sample transferred to new vial
- Storage/Transport Temperature:
- Sputum, Urine, and Other Specimens: Refrigerated
- Biopsy tissue: Store at -15±8°C
- Unacceptable Conditions: Samples with preservatives or fixatives (unless paraffin-embedded with suitable DNA purification); Improperly collected or contaminated specimens.
- Remarks: Proper aseptic technique and sample handling are critical to avoid contamination or degradation
- Stability
- Bone Marrow: Ambient: 1 week; Refrigerated: 1 week; Frozen: 1 week
- Whole Blood: Ambient: 24 hrs; Refrigerated: 6 days; Frozen: 6 months
- Tissue: Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 3 months
- All others: Ambient: 8 hours; Refrigerated: 72 hours; Frozen: 3 months
This assay uses qualitative One-step nested real-time PCR to detect and identify MTBC and mycobacterial genus-specific DNA.
Sample Received to Report Turnaround Time (TAT)
Twice in a week (Scheduled Test)
Positive or negative for presence of MTBC and/or NTM.
Interpretive Data
Refer to the Report.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report