Test Code MTBRIF Mycobacterium tuberculosis Complex PCR with Rifampin Resistance

Additional Codes
Software | Test Code |
---|---|
Label Text | MTBRIF |
EPIC | LAB9429 |
Performing Laboratory
NorDx Laboratories - Scarborough Campus
Useful For
Rapid detection of Mycobacterium tuberculosis complex DNA from respiratory specimens.
Presumptive detection of rifampin resistance based on the presence of resistance-associated mutations.
This test should not be used to determine bacteriologic cure or to monitor response to therapy.
This test is not intended for the detection of latent tuberculosis and must not be used as a substitute for tests intended for detection of latent tuberculosis such as the tuberculin skin test or an interferon gamma release assay.
Method Name
Real-Time Polymerase Chain Reaction (PCR)
The Cepheid Xpert MTB/RIF assay utilizes sputum or decontaminated and pelleted sputum sediment. Specimens are inoculated directly into single disposable test cartridges, which contain both DNA extraction and target amplification material. The assay amplifies a 192 base-pair segment of the rpoB gene for Mycobacterium tuberculosis complex identification as well as rifampin resistance profiling. The Cepheid Xpert MTB/RIF assay is a closed polymerase chain reaction (PCR) system that greatly reduces the potential for false-positive results due to specimen cross-contamination as compared with traditional open-system PCR methods.(Package insert: Xpert MTB/RIF. Cepheid; GXMTB/RIF-US-10, rev D, 03/2016)
Reference Values
Negative
Days and Times Test Performed
Monday through Sunday
Report Available
Up to 2 days
Specimen Type
Sputum
Preferred Container
Screw-Capped Sterile Vial – Sputum
Preferred Volume
7 - 10 mL Sputum
Minimum Volume
Collecting minimum volumes can result in a need for sample recollection, and/or a delay in results. Minimum volumes are subjective and cannot account for all aspects of specimen and testing needs. Refer to the Preferred Volume section for optimal volumes for laboratory specimens.
Acceptable Alternative Container(s)
Lukens collection device
Specimen Collection and Handling
- Collect sputum aseptically using system policies and procedures
- Forward specimen to testing location without opening container
- If container must be opened due to additional orders, specimen must be opened aseptically using a BioSafety Hood.
Specimen Stability Information
Specimen Type | Temperature | Time |
---|---|---|
Sputum | Refrigerated | 7 days |
Ambient | 72 hours |
Add On Capable
Yes
Advance Beneficiary Notice Requirements
No ABN Required
CPT Code Information
CPT Code | CPT Description | CPT Disclaimer |
---|---|---|
87564 | Mycobacterium tuberculosis, rifampin resistance, amplified probe technique |
LOINC Code Information
89371-9
Rejection Information
Sputum is the only validated specimen source. All other sources should use this test offered by Mayo.
All universal media transport will be rejected. Examples include:
Clinical Significance
Mycobacterium tuberculosis is a highly transmissible bacterial pathogen and is the causative agent of tuberculosis, a disease causing significant worldwide morbidity and mortality. Each year, M tuberculosis accounts for 1.6 million deaths and is responsible for 10.6 million newly diagnosed cases of tuberculosis worldwide. M tuberculosis is spread from person to person via respiratory transmission and has the potential to become resistant to many of the antibiotics currently used if not treated appropriately. Therefore, rapid and accurate detection of M tuberculosis in patient specimens is of paramount clinical and public health importance.
Conventional culture methods can generally detect M tuberculosis in 2 to 3 weeks, although up to 6 weeks of incubation may be required in some instances. This qualitative molecular assay utilizes polymerase chain reaction-based nucleic acid amplification for the direct detection of M tuberculosis DNA within respiratory specimens without relying on culture growth, leading to more rapid diagnosis and appropriate patient care. This assay also detects the presence of mutations in the rpoB gene that have been documented to confer more than 95% of cases of rifampin resistance.
Performing Location
NorDx Laboratories