Mycobacteria Genotype, Resistance Markers

Test Code

14439

CPT Codes
87999<br>Limited Access Code<br><strong>This test is not available for New York patient testing.</strong>

Preferred Specimen

Visable growth of the isolate on solid media or an isolate sent in ≥3 mL of broth

Instructions

An identified isolate is required for testing.

• This test can be ordered on a clinical specimen that has been sent to our laboratory for isolation and identification of mycobacteria. See specimen requirements for culture of mycobacteria from a clinical specimen.
• This test can also be ordered on organisms identified elsewhere. Pure mycobacterial isolates should be sent in solid media such as a Middlebrook slant (7H10 or 7H11), Lowenstein-Jensen (LJ) slant, or in broth (7H9, MGIT, MP BACT/Alert, VersaTrek). Isolates should be pure; if contaminants are identified, an attempt will be made to isolate the AFB and an additional charge will be applied.

Note: Isolates can be sent ambient on solid or liquid media.

Transport Container

See Collection Instructions

Transport Temperature

Room temperature

Specimen Stability

Room temperature: ≤ 3 days from collection
Refrigerated: ≤ 7 days from collection

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Cultures received with incomplete identifiers • Mixed cultures; Note that prior to rejection, attempts will be made to isolate organisms. A re-isolation charge will be applied in these cases • Cultures containing mold • Solid media with insufficient growth • Cultures submitted on agar plates • Liquid media with < 2 mL • Leaking specimens

Methodology
PCR-based methods are used. PCR/MALDI-TOF mass spectrometry assay is used as the primary method for NTM drug resistance markers; line probe assays are used as a alternative method. Line probe assays are used for MTBC isolates.
See Interpretation for when various line probe assays are applied.

FDA Status

This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics of this test have been validated by Advanced Diagnostic Laboratories at National Jewish Health. This test has not been cleared or approved by the U.S. Food and Drug Administration.

The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This laboratory is certified under the Clinical laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.

Setup Schedule

Set up: Mon-Sat; Report available: Resistance gene testing by line probe is typically within 72 hours

Reference Range

See Laboratory Report

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.