title: Diagnostic accuracy of the genotype MTBDRsl assay for rapid diagnosis of extensively drug-resistant tuberculosis in HIV-coinfected patients.
abstract: The Russian Federation is a high-tuberculosis (TB)-burden country with high rates of Mycobacterium tuberculosis multidrug resistance (MDR) and extensive drug resistance (XDR), especially in HIV-coinfected patients. Rapid and reliable diagnosis for detection of resistance to second-line drugs is vital for adequate patient management. We evaluated the performance of the GenoType MTBDRsl (Hain Lifescience GmbH, Nehren, Germany) assay on smear-positive sputum specimens obtained from 90 HIV-infected MDR TB patients from Russia. Test interpretability was over 98%. Specificity was over 86% for all drugs, while sensitivity varied, being the highest (71.4%) for capreomycin and lowest (9.4%) for kanamycin, probably due to the presence of mutations in the eis gene. The sensitivity of detection of XDR TB was 13.6%, increasing to 42.9% if kanamycin (not commonly used in Western Europe) was excluded. The assay is a highly specific screening tool for XDR detection in direct specimens from HIV-coinfected TB patients but cannot be used to rule out XDR TB.
authors.affiliation: Samara Oblast Tuberculosis Dispensary, Samara, Russia.
authors.forename: Irina
authors.initials: I
authors.lastname: Kontsevaya
authors.forename: Olga
authors.initials: O
authors.lastname: Ignatyeva
authors.forename: Vladyslav
authors.initials: V
authors.lastname: Nikolayevskyy
authors.forename: Yanina
authors.initials: Y
authors.lastname: Balabanova
authors.forename: Alexander
authors.initials: A
authors.lastname: Kovalyov
authors.forename: Andrey
authors.initials: A
authors.lastname: Kritsky
authors.forename: Olesya
authors.initials: O
authors.lastname: Matskevich
authors.forename: Francis
authors.initials: F
authors.lastname: Drobniewski
mesh_terms: D000328:Adult; D001431:Bacteriological Techniques / Q000379:methods*; D024901:Drug Resistance, Multiple, Bacterial; D054908:Extensively Drug-Resistant Tuberculosis / Q000175:diagnosis* / Q000382:microbiology; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D012680:Sensitivity and Specificity