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Mycobacterium tuberculosis drug-resistance testing: challenges, recent developments and perspectives.

T Schön1, P Miotto2, C U Köser3

  • 1Department of Clinical Microbiology and Infectious Diseases, Kalmar County Hospital, Kalmar, Sweden; Division of Medical Microbiology, Department of Clinical and Experimental Medicine, Linköping University, Sweden; European Society for Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycobacterial Infections (ESGMYC), ESCMID, Basel, Switzerland.

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Summary

Antimicrobial susceptibility testing (AST) for Mycobacterium tuberculosis is crucial for drug-resistant cases. Both phenotypic and genotypic methods have limitations, highlighting the need for complementary approaches for accurate resistance detection and surveillance.

Keywords:
Antimicrobial susceptibility testingCritical concentrationCritical proportionGenetic resistanceHot spot mutationsMinimum inhibitory concentration

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Area of Science:

  • Microbiology
  • Infectious Diseases
  • Molecular Diagnostics

Background:

  • Drug-resistance testing, or antimicrobial susceptibility testing (AST), is mandatory for Mycobacterium tuberculosis, especially in cases of treatment failure.
  • Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis pose a global health challenge, yet AST for M. tuberculosis (AST-MTB) is often resource-dependent rather than resistance-rate driven.
  • Current AST-MTB practices vary significantly between high-income and low-income countries, influencing method selection and accessibility.

Purpose of the Study:

  • To review and compare different phenotypic and genotypic methods for AST in Mycobacterium tuberculosis.
  • To discuss the challenges and complementary roles of phenotypic and genotypic approaches in detecting drug resistance.
  • To emphasize the need for a consensus reference method for AST-MTB to assess in vitro activity and set breakpoints for new anti-tuberculosis agents.

Main Methods:

  • Review of phenotypic (culture-based) and genotypic (mutation screening) methods for AST-MTB.
  • Analysis of method suitability based on resource availability in different settings.
  • Discussion of challenges including false-resistance and false-susceptibility results with genotypic methods.

Main Results:

  • Phenotypic methods are common in high-income countries for confirming susceptibility and detecting resistance in high-risk cases, often combined with genotypic tests.
  • Genotypic methods are favored in low-income countries due to ease of performance and avoidance of culture/biosafety constraints, rapidly detecting common resistance mutations.
  • Genotypic tests present challenges such as false-resistance and false-susceptibility due to mutations not conferring resistance or common resistance mechanisms being missed.

Conclusions:

  • Phenotypic and genotypic AST approaches are complementary, essential for high sensitivity and specificity in detecting drug resistance and susceptibility.
  • Accurate AST-MTB is critical for predicting MDR/XDR tuberculosis cure and for effective resistance surveillance.
  • The absence of a consensus reference method for MIC determination hinders the assessment of in vitro activity and the establishment of breakpoints for novel anti-tuberculosis drugs.