MPEP Mycobacterium Tuberculosis Drug Susceptibility Testing – Reports

Acronym Definition

 

Abbreviations and Acronyms
AMK amikacin
AP agar proportion — performed on Middlebrook 7H10 or 7H11
Bp base pair
CAP capreomycin
CDC U.S. Centers for Disease Control and Prevention
CIP ciprofloxacin
CLSI Clinical and Laboratory Standards Institute
CYS cycloserine
DNA deoxyribonucleic acid
DST drug susceptibility testing
EMB ethambutol
ETA ethionamide
FQ fluoroquinolones
INH isoniazid
KAN kanamycin
LEV levofloxacin
MDR multidrug resistant
MGIT BACTEC MGIT 960 – Mycobacteria Growth Indicator Tube
MIC minimum inhibitory concentration
MOX moxifloxacin
MPEP Model Performance Evaluation Program
MTBC     Mycobacterium tuberculosis complex
Nt nucleotide
PAS p-aminosalicylic acid
PZA pyrazinamide
OFL ofloxacin
R resistant
RBT rifabutin
RMP rifampin
RNA ribonucleic acid
S susceptible
Sensititre Thermo Scientific Sensititre MYCOTB AST plate
STR streptomycin
TB tuberculosis
VersaTREK Thermo Scientific VersaTREK Myco susceptibility
XDR extensively drug resistant

The following information pertains to the tables and figures for each MPEP panel’s Final Report.

  • First-line and second-line drugs have been separated into individual tables for each isolate. Streptomycin is classified as a second-line drug for this report.
  • Separate tables for molecular testing are included.
  • Laboratories that use more than one DST method are encouraged to test isolates with each of those methods at either CLSI-recommended or equivalent critical concentrations. Some laboratories have provided results for multiple DST methods. Consequently, the number of results for some drugs may be greater than the number of participating laboratories. This report contains all results reported by participating laboratories.
  • The Trek Sensititre system allows determination of a minimum inhibitory concentration (MIC) for each drug in the panel. Laboratories using this method must establish breakpoints to provide a categorical interpretation of S or R.
  • For participant result tables for first- and second-line DST that have drug-method totals equal to 0, results were not received or the test was not performed.

(Concentrations listed as µg/ml)

Agar Proportion

Agar Proportion
First-line Drugs 7H10 agar 7H11 agar
Isoniazid 0.2 and 1.0* 0.2 and 1.0*
Rifampin 1.0 1.0
Ethambutol 5.0 7.5
Pyrazinamide Not recommended Not recommended

NOTE—Critical concentrations as indicated in CLSI M24 document [1]
*The higher concentration of INH should be tested as second-line drugs after resistance at the critical concentration is detected.
†CLSI critical concentrations for RMP differ from revised WHO recommendation of 0.5 µg/ml published in 2021 [2].

 

Agar Proportion
Second-line Drugs 7H10 agar 7H11 agar
Streptomycin 2.0 2.0
Amikacin 4.0 Not determined*
Capreomycin 10.0 10.0
Kanamycin 5.0 6.0
Levofloxacin 1.0 Not determined*
Moxifloxacin 0.5 0.5
Ethionamide 5.0 10.0
Rifabutin 0.5 0.5
p-Aminosalicylic acid 2.0 8.0

NOTE—Critical concentrations as indicated in CLSI M24-A2 document [1]
*Breakpoints for establishing susceptibility have not be determined.

 

Broth Based Media

Broth Based Media
First-line Drugs MGIT VersaTREK
Isoniazid 0.1 (and 0.4*) 0.1 (and 0.4*)
Rifampin 1.0 1.0
Ethambutol 5.0 5.0 (and 8.0*)
Pyrazinamide 100.0 300.0

NOTE—Critical concentrations as indicated in applicable manufacturer package inserts
*The higher concentration of INH and EMB should be tested after resistance at the critical concentration is detected.
†CLSI critical concentrations for RMP differ from revised WHO recommendation of 0.5 µg/ml published in 2021 [2].

Broth Based Media
Second-line Drug MGIT VersaTREK
Streptomycin 1.0 (and 4.0*) Not available

NOTE—Critical concentrations as indicated in applicable manufacturer package inserts
*The higher concentration of STR should be tested after resistance at the critical concentration is detected.
†Revised WHO recommendations provide LEV and MOX critical concentrations for MGIT published in 2018 [3].