Mycobacterium tuberculosis Susceptibility First Line Drugs
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| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | MM00204 |
| Day(s) Performed: | Monday - Friday |
| Turn-around Time: | 3-6 weeks |
| Recommended Uses: | To determine the in vitro susceptibility of M. tuberculosis complex organisms to first line antimicrobial agents. |
| Pre-approval: | No |
| Contraindications: | |
| Additional Tests Performed: |
GeneXpert MTB/RIF (MM00261) will automatically be performed on all isolates submitted for 1st-line DST (fee-exempt). Isolates resistant to rifampin or two or more first-line drugs are automatically referred to CDC for second-line drug susceptibility testing (fee-exempt). The first M. tuberculosis complex isolate per patient is automatically genotyped as part of the CDC universal genotyping program (fee-exempt). |
| Preparation for Collection: | |
| Specimen Requirements: | M. tuberculosis complex isolate in broth or solid media |
| Collection Instructions: | |
| Collection Kit/Container: |
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| Requisition Form: |
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| Required Information: | Identification of organism as a member of the M. tuberculosis complex. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier, date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label which is required to have a minimum of two identifiers. |
| Rejection Criteria: | |
| Specimen Handling: | Cultures may be transported to the laboratory at ambient temperatures. Avoid temperature extremes during transport. |
| Packaging Requirements: | |
| Courier Information: | Specimens submitted for surveillance or at the request of a public health department are eligible for fee-exempt courier. Contact Purple Mountain Dispatch at 800-990-9668 for specimen pickup. |
| Specimen Receiving Hours: | Monday-Friday 6:00 AM - 4:30 PM, Saturday 6:30 AM - 12:30 PM |
| Results Include: | M. tuberculosis complex organisms Susceptible, Resistant, or Indeterminate to isoniazid, rifampin, ethambutol using criteria established by the Clinical and Laboratory Standards Institute (CLSI). M. tuberculosis complex organisms Susceptible, Resistant, or Indeterminate to Moxifloxacin at the critical concentration for broth-based susceptibility testing recommended by WHO and promoted by the CDC (World Health Organization. Technical Report on Critical Concentrations for Drug Susceptibility Testing of Medicines Used in the Treatment of Drug-Resistant Tuberculosis. WHO/CDS/TB/2018.5, World Health Organization, 2018; Stafford, C. Mycobacterium Tuberculosis Complex Drug Susceptibility Testing Program: Model Performance Evaluation Program Report of Results, March 2025. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, 2025.) |
| Limitations: | Test can only be performed on pure M. tuberculosis complex isolates. Mixed or contaminated cultures will extend turnaround time significantly and may prevent susceptibility testing if pure M. tuberculosis complex cannot be isolated. |
| Additional Tests Recommended: | |
| Additional Comments: |
| Methodology: | MGIT broth method |
| Includes: | Susceptibility tests of M. tuberculosis complex organisms with two concentrations of Isoniazid (I), one concentration of Ethambutol (E), Rifampin (R) and Moxifloxacin (M). Pyrazinamide (P) testing is currently suspended due to repeated quality control issues with the manufacturer product. |
| Regulatory Compliance: | FDA Approved I, R, E, P |
| CPT Code: | 87188x5 |
| Price: | $300.00 |
| Fee Exempt Eligible: | No |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |