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. 2019 Apr;25(4):403-405.
doi: 10.1016/j.cmi.2019.01.019. Epub 2019 Feb 14.

Standards for MIC testing that apply to the majority of bacterial pathogens should also be enforced for Mycobacterium tuberculosis complex

T Schön  1 , E Matuschek  2 , S Mohamed  3 , M Utukuri  4 , S Heysell  3 , J-W Alffenaar  5 , S Shin  6 , E Martinez  7 , V Sintchenko  7 , F P Maurer  8 , P M Keller  9 , G Kahlmeter  2 , C U Köser  10
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Standards for MIC testing that apply to the majority of bacterial pathogens should also be enforced for Mycobacterium tuberculosis complex

T Schön et al. Clin Microbiol Infect. 2019 Apr.
No abstract available

Keywords: MIC testing; Microtiter plates; Mycobacterium tuberculosis complex; Quality control ranges; Quality control targets.

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Figures

Fig. 1.
Fig. 1.
Diagrammatic representation of a hypothetical MIC distribution for a QC strain and an MIC distribution for a mechanism that confers high-level resistance (HLR). The QC range should optimally encompass ≥95% of the QC distribution and the QC target represents the mode of the QC range. To enable adequate QC, the testing system must include a sufficiently wide dilution range to provide MIC end-points for the QC range, which means that at least one dilution above and below the QC range must be included to avoid truncated MICs (i.e. to ensure on-scale MIC results). For example, if a QC range is strongly truncated at the lower end (i.e. with MICs less than or equal to the lowest concentration tested), it will be difficult to identify systematic shifts towards lower MICs using the QC strain. Normally, the QC strain is chosen to be devoid of resistance mechanisms. This means that the QC range is typically inside the phenotypically wild-type MIC distribution for strains devoid of phenotypically detectable resistance mechanisms (i.e. the upper end of the QC range is equal to or below the epidemiological cut-off (ECOFF) and the clinical breakpoint (CB) for the susceptible (S) and resistant (R) range [2]).
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References

    1. 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]. Available at: http://apps.who.int/iris/bitstream/10665/260470/1/WHO-CDS-TB-2018.5-eng.pdf (accessed 19 December 2018).
    1. Kahlmeter G The 2014 Garrod Lecture: EUCAST ‒ are we heading towards international agreement? J Antimicrob Chemother 2015;70:2427–39. - PubMed
    1. Clinical and Laboratory Standards Institute. M23. Development of in vitro susceptibility testing criteria and quality control parameters. 5th ed Wayne, PA: CLSI; 2018.
    1. European Committee on Antimicrobial Susceptibility Testing. Routine and extended internal quality control for MIC determination and disk diffusion as recommended by EUCAST. Version 8.0. 2018. Available at: http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/QC/v_8.0_EUC... (accessed 19 September 2018).
    1. International Organization for Standardization. ISO 20776-2:2007. Clinical laboratory testing and in vitro diagnostic test systems — susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: evaluation of performance of antimicrobial susceptibility test devices. 1st ed Geneva: ISO; 2007.

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