Lab Matters Summer 2020 | Page 26

INFECTIOUS DISEASES The ABCs of MIC Testing for Mycobacterium tuberculosis complex By Kimberly McCullor, PhD, APHL Antimicrobial Resistance Laboratory Fellow, Michigan Bureau of Laboratories Susceptibility testing for Mycobacterium tuberculosis complex (MTBC) plays a vital role in protecting efficacy of available therapeutics and in identifying drug resistant cases to help with epidemiological efforts to stop transmission. Testing for MTBC drug susceptibility is commonly performed by methods such as agar proportion and rapid broth culture systems, using fixed antibiotic concentrations based upon critical concentration breakpoints. Critical concentration is the lowest concentration of drug inhibiting 95% of growth of wildtype isolates. The presence or absence of growth is then used to classify isolates as resistant or susceptible. Microbroth dilution testing differs from other tests because it is used to identify the minimum inhibitory concentration (MIC), or the lowest drug concentration within a tested range that is required to inhibit growth of an isolate. Although widely used for susceptibility testing of other pathogens, it is only utilized by a small number of laboratories for MTBC. The Case for MIC In a clinical setting, MIC provides susceptibility data that can aid physicians with drug dosing and management of complicated cases. MIC data are an essential component to therapeutic drug monitoring efforts that ensure appropriate concentrations are achieved within the patient, mitigating the potential for treatment failure and development of drug resistance. Pre-made or customizable microtiter plates by Sensititre TM are available and include both first- and second-line antimycobacterial drugs, excluding pyrazinamide (PZA). Cost per plate ranges from $30.00 to $50.00 and requires minimum orders of 100 to 500 plates, which may limit utility for sites with lower testing volumes. Pure culture isolates are required for testing (with observations of better results using inoculum from solid media). Plates are generally read at seven, 10, 14 and 21 days, with many showing sufficient growth after 14 days. While this causes a delay in reporting for first line drugs—the recommended CDC benchmark is 17 days post MTBC culture identification—the advantage is both first- and second-line drugs are reported simultaneously. Finding a Balance with MIC Isoniazid, rifampin and ethambutol are the only drugs with MIC breakpoints for MTBC. MIC testing for the identification of lower levels of resistance is beginning to be better understood and has provided important results to improve patient management, especially for a subset of rifampin-resistant MTBC. The Comprehensive Resistance Prediction for Tuberculosis International Consortium (CRyPTIC) is conducting research to correlate MIC values to genetic mutations acquired from whole genome sequencing data. Further collaboration with clinical and laboratory partners to correlate MIC values of MTBC isolates to clinical outcome and treatment response is necessary to expand interpretative breakpoints. Limited clinical data for correlation and the inherent challenges Above: Inoculating a Sensititre MycoTB plate for MIC testing. Photo: Florida Bureau of Public Health Laboratories Left: Reading the Sensititre MycoTB Plate to determine the MIC(s) of patient isolates of Mycobacterium tuberculosis. Photo: Florida Bureau of Public Health Laboratories of MTBC susceptibility testing with discrepancies between testing methods (including genotypic screens), make obtaining FDA approval for MTBC microbroth dilution out of reach. Due to the lack of interpretative guidelines for MTBC MIC testing, consultation with clinicians and TB Control Programs for interpretation of results and appropriate patient management are vital. Susceptibility testing of MTBC remains challenging regardless of the method. Even with the limitations of interpretative guidelines, MIC data provide detailed information for susceptibility profiles of clinical isolates that are not obtainable from other methods—valuable data that can alert physicians to potential issues due to low-level resistance, can guide dosing in patients with complicated cases of infection or mitigate harmful side effects. The author thanks Dr. Marie-Claire Rowlinson (Florida), Dr. Kimberlee Musser (New York), Dr. Anne Gaynor (APHL) and the APHL TB Subcommittee for their input. • DIGITAL EXTRA: Find more tuberculosis testing resources here. 24 LAB MATTERS Summer 2020 PublicHealthLabs @APHL APHL.org