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Test ID TB2LN Susceptibility, Mycobacterium tuberculosis Complex, Second Line, Varies

Infectious

Useful For

Determination of Mycobacterium tuberculosis complex minimal inhibitory concentrations to second-line antimicrobial agents

Additional Tests

Test ID Reporting Name Available Separately Always Performed
STV2 Susceptibility, Mtb Cx, 2nd Line No, (Bill Only) Yes

Testing Algorithm

When this test is ordered, the additional test will always be performed at an additional charge.

Reporting Name

Susceptibility, Mtb Complex, 2 Line

Specimen Type

Varies


Additional Testing Requirements


CTB / Mycobacteria and Nocardia Culture, Varies or CTBID / Culture Referred for Identification, Mycobacterium and Nocardia, Varies must also be ordered and will be charged separately unless identification of organism is provided. 



Shipping Instructions


1. For shipping information see Infectious Specimen Shipping Guidelines.

2. Place specimen in a large infectious container and label as an etiologic agent/infectious substance.



Necessary Information


Specimen source and suspected organism identification are required. 

 



Specimen Required


Specimen Type: Organism

Supplies: Infectious Container, Large (T146)

Container/Tube: Middlebrook 7H10 agar slant

Specimen Volume: Isolate

Collection Instructions: Organism must be in pure culture, actively growing.


Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Refrigerated 

Reject Due To

Other Agar plate

Clinical Information

The Clinical and Laboratory Standards Institute (CLSI) provides a consensus protocol for the methods, antimycobacterial agents, and critical concentrations of each agent to be tested in order to permit standardized interpretation of Mycobacterium tuberculosis complex susceptibility testing results. CLSI guidelines suggest that second-line agents should be tested when an isolate of M tuberculosis complex is resistant to rifampin, is monoresistant to the critical concentration of isoniazid and the physician intends to use a fluoroquinolone for therapy, or is resistant to any combination of 2 first-line agents.

 

This test uses a broth microdilution method for susceptibility testing of M tuberculosis complex against second-line agents. Agents tested are amikacin, ethionamide, kanamycin, moxifloxacin, ofloxacin, p-aminosalicylic acid, rifabutin, and streptomycin. In contrast to other M tuberculosis complex susceptibility methods which test 1 or 2 critical concentrations of a drug, this method examines a range of drug concentrations and produces a minimal inhibitory concentration result.

Reference Values

Interpretive criteria and reporting guidelines are followed using the Clinical Laboratory Standards Institute (CLSI) M24S document.

Interpretation

Results are reported as minimal inhibitory concentrations in mcg/mL.

 

This test is used as an alternative to TB1LN / Antimicrobial Susceptibility, Mycobacterium tuberculosis Complex, First Line, Varies when reagents are not available to perform the TB1LN test. Ethambutol, isoniazid, and rifampin agents are not routinely reported with this test.

Cautions

Consensus guidelines for interpretive criteria using this method are not available at this time. Breakpoints were established by Mayo Clinic by comparison to the critical concentration for each drug and are considered tentative until consensus guidelines are established.

 

In vitro susceptibility does not guarantee clinical response. Therefore, the decision to treat with a particular agent should not be based solely on the antimicrobial susceptibility testing result.

 

Drug susceptibility testing should be performed on pure culture isolates of Mycobacterium tuberculosis complex.

Clinical Reference

1. Hall L, Jude KP, Clark SL, et al. Evaluation of the Sensititre MycoTB plate for susceptibility testing of the Mycobacterium tuberculosis complex against first- and second-line agents. J Clin Microbiol. 2012;50:3732-3734

2. Centers for Disease Control and Prevention. Treatment of Tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR 2003;52(No. RR-11):1-79

3. Woods GL, Lin S-Y G, Desmond EP. Susceptibility test methods: Mycobacteria, Nocardia and other Actinomycetes. In: Versalovic J, Carroll KC, Funke G, et al. Manual of Clinical Microbiology. 10th ed. ASM Press; 2011: 1215-1238

4. CLSI. Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia species, and Other Aerobic Actinomycetes. First edition CLSI supplement M62. Clinical and Laboratory Standards Institute; 2018

Method Description

This test utilizes the MycoTB broth microtiter dilution plate (Trek Diagnostic Systems, Inc.). Antimicrobials included in the assay are tested according to the Clinical and Laboratory Standards Institute guidelines. The plate contains lyophilized antimicrobials which are rehydrated prior to testing. A standardized suspension of the Mycobacterium tuberculosis isolate is added to the plate wells and the plate is incubated at 36° C in 5% to 10% carbon dioxide for up to 14 days. The first drug-containing well with no visible growth is determined to be the endpoint.(Clinical and Laboratory Standards Institute (CLSI). Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes. CLSI standard M24. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes. CLSI supplement M24S; Hall L, Jude KP, Clark SL, et al. Evaluation of the Sensititre MycoTB plate for susceptibility testing of the Mycobacterium tuberculosis complex against first- and second-line agents. J Clin Microbiol. 2012;50:3732-3734; Thermo Scientific Sensititre MIC Susceptibility Plates for Mycobacterium tuberculosis. Product Insert. 011 - MYCOTB - CID9502. Revision Date: 09/07/2016)

Day(s) Performed

Monday through Sunday

Report Available

21 to 30 days

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87186-Susceptibility, Mtb Cx, 2nd Line

NY State Approved

Yes

Method Name

Minimum Inhibitory Concentration (MIC) by Microtiter Broth Dilution Method

Specimen Minimum Volume

See Specimen Required