[EXTERNAL QUALITY ASSESSMENT OF ANTI-TUBERCULOSIS DRUG SUSCEPTIBILITY TESTING FOR DIAGNOSING EXTENSIVELY DRUG-RESISTANT MYCOBACTERIUM TUBERCULOSIS].

Abstract

[Objective] The infectious disease control law has been amended in May 2015, and the category definition of Mycobacterium tuberculosis as infectious pathogen has been changed, following the definition of extensively drug-resistant M.tuberculosis (XDR-TB) by World Health Organization. To assess the diagnostic capacity of XDR-TB, we conducted an external quality assessment (EQA) for the anti-tuberculosis drug susceptibility testing (DST). [Method] A total of 10 M.tuberculosis strains with known drug susceptibility were sent to each participating laboratory. The drugs assessed were isoniazid (INH), rifampicin (RFP), streptomycin (SM), ethambutol (EB), levofloxacin (LVFX), and kanamycin (KM). DST was performed using each routine method(s), and the results were compared with the judicial diagnoses. The sensitivity, specificity, overall agreement (effi- ciency) and kappa coefficient were calculated for each drug tested. In addition, the diagnostic accuracy of multidrug-resis- tant M. tuberculosis (MDR-TB) and XDR-TB was assessed. [Results] A total of 88 institutes including 67 hospitals, 16 commercial laboratories, and 5 public health laboratories par- ticipated in the EQA. With 2 laboratories submitting 2 sets of results, a total of 90 independent data sets were analyzed. As for INH, RFP and LVFX, the efficiency was over 95%, but we found two strains each for SM, EB and KM with the efficiency less than 95%. Especially, strain 1 and strain 2 showed efficiency of 72.2% and 71.1% to SM, respectively. This error was mainly found in a certain test kit. If we consider the passing score as showing ≥95 % sensitivity and specificity both to INH and RFP, the diagnostic accuracy of MDR-TB was 92.2% (83/90) in this study. With the same criteria to INH, RFP, LVFX and KM, that of XDR-TB was 79.7% (63/79). [Discussion] The diagnostic capacity of XDR-TB was not sufficient in the current study. Good case management and pathogen control requires higher accuracy. The government may need to conduct a constant EQA and relevant remedial actions.