Mycobacterium tuberculosis Complex, Molecular Detection and Rifampin Resistance, PCR, Sputum
Use
The test is used for the rapid detection of Mycobacterium tuberculosis DNA from respiratory specimens for the diagnosis of pulmonary tuberculosis. It also provides presumptive detection of rifampin resistance based on the presence of resistance-associated mutations, helping in making timely and appropriate therapeutic decisions.
Special Instructions
Not provided.
Limitations
The test detects nucleic acid from Mycobacterium tuberculosis and does not distinguish between viable organisms and residual DNA from prior infections. Negative results do not rule out disease due to potential low levels of bacteria below the detection limit. Rifampin resistance results are preliminary and require confirmation by sequencing or phenotypic susceptibility testing.
FDA ApprovedNew York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
Mycobacterium tuberculosis
MicroorganismNo genes
Gene
LOINC Codes
- 89371-9 - MTB and RIF resistance Pnl Islt/Spm
- 31208-2 - Specimen source
- 88874-3 - M TB Cmplx DNA Islt/Spm Ql
- 89372-7 - MTB rpoB RIF resist mut Islt/Spm Ql
Result Turnaround Time
0-1 day
Related Documents
For more information, please review the documents below
Specimen
Sputum
Volume
3 mL
Minimum Volume
1.5 mL
Container
Sterile container
Collection Instructions
If a single specimen is being shared between mycobacterial culture, acid-fast smear, and/or M tuberculosis PCR, a minimum volume of 3 mL is required. Clearly indicate on the container and order form that the specimen is a digested specimen if treated with NALC/NaOH.
Storage Instructions
Refrigerated (preferred) 7 days/Ambient 72 hours
Causes for Rejection
Specimen received greater than 7 days from collection will be rejected due to delay.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 7 days |