Mycobacterium tuberculosis Complex, Molecular Detection, PCR, Paraffin, Tissue
Use
This test is intended for the rapid detection of Mycobacterium tuberculosis complex DNA in formalin-fixed, paraffin-embedded tissue specimens. This method is preferred due to its ability to promptly identify M. tuberculosis complex, which is crucial given the organism's capacity to develop antibiotic resistance if treatment is delayed. Rapid identification allows for timely clinical intervention, vital for public health due to the contagious nature of tuberculosis spread via respiratory transmission.
Special Instructions
Not provided.
Limitations
The PCR assay detects M. tuberculosis complex nucleic acid, thus cannot differentiate between viable organisms and DNA from prior infections. Negative results do not rule out M. tuberculosis, as concentrations may be below the detection limit. The assay does not distinguish between species within the M. tuberculosis complex. It has not been studied for use with specimens from patients undergoing antituberculous treatment and is not suitable for monitoring treatment response. Sensitivity is approximately 63% from FFPE tissue, and repeated negative results may necessitate additional specimens.
New York Approved
Methodology
PCR-based (qPCR)
Biomarkers
Mycobacterium tuberculosis complex
Microorganism
LOINC Codes
- 38379-4 - M TB Cmplx DNA Spec Ql NAA+probe
- 31208-2 - Specimen source
- 38379-4 - M TB Cmplx DNA Spec Ql NAA+probe
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Tissue block
Collection Instructions
Submit a FFPE tissue block to be cut and returned.
Causes for Rejection
Any non-formalin-fixed, paraffin-embedded tissue block (FFPE), FFPE slides, FFPE body fluids
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Ambient (preferred) |