Identification Mycobacterium tuberculosis Complex Speciation, PCR (Bill Only)
Use
This test is used for the identification and speciation of Mycobacterium tuberculosis complex, providing crucial information for the detection and identification of Mycobacterium tuberculosis in clinical samples. It is essential for diagnosing and managing infections caused by this pathogen, particularly in patients with suspected tuberculosis. The test supports appropriate treatment decisions and containment measures for tuberculosis control.
Special Instructions
The test is designed for billing purposes only and is not directly orderable. Users accessing the service must be authorized and have an account representative or customer service contact to facilitate the billing process.
Limitations
The test has not been cleared or approved by the US Food and Drug Administration. It is performed under guidelines consistent with CLIA requirements but lacks FDA approval, which may limit its use in certain regulatory settings. Additionally, the test is not orderable in the state of New York, despite state availability indicated, without proper authorization. The results may also be limited by the specimen type and condition, and stability information should be carefully checked to avoid compromising specimen integrity.
New York Approved
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
Not provided
Minimum Volume
Not provided