title: First evaluation after implementation of a quality control system for the second line drug susceptibility testing of Mycobacterium tuberculosis joint efforts in low and high incidence countries.
abstract: Three networks/projects involving 27 European countries were established to investigate the quality of second-line drug (SLD) susceptibility testing with conventional and molecular methods. 1. The "Baltic-Nordic TB-Laboratory Network" comprised 11 reference laboratories in the Baltic-Nordic States. They performed SLD testing in the first phase with a panel of 20 Mycobacterium tuberculosis strains. After several laboratories made technical changes a second panel of 10 strains with a higher proportion of resistant strains were tested. Although the concordance for Ofloxacin, Kanamycin, and Capreomycin was consistently high, the largest improvements in performance were achieved for the analysis of Ofloxacin resistant (from 88.9 to 95.0%), and Capreomycin resistant (from 71.0 to 88.9%) strains. 2. Within the FP7 TB PAN-NET project (EU Grant agreement 223681) a quality control panel to standardize the EQA (External Quality Assurance) for first-line drugs (FLD) and SLD testing for phenotypic and molecular methods was established. The strains were characterized by their robustness, unambiguous results when tested, and low proportion of secondary drug resistances. 3. The (European Reference Laboratory Network-TB) ERLN-TB network analyzed four different panels for drug resistance testing using phenotypic and molecular methods; in two rounds in 2010 the 31 participating laboratories began with 5 strains, followed by 10 strains and 6 additional crude DNA extracts in 2011 and 2012 were examined by conventional DST and molecular methods. Overall, we demonstrated the importance of developing inter-laboratory networks to establish quality assurance and improvement of SLD testing of M. tuberculosis.
authors.affiliation: National Reference Laboratory for Mycobacteria, Forschungszentrum Borstel, Borstel, Germany.
authors.forename: Doris
authors.initials: D
authors.lastname: Hillemann
authors.forename: Sven
authors.initials: S
authors.lastname: Hoffner
authors.forename: Daniela
authors.initials: D
authors.lastname: Cirillo
authors.forename: Francis
authors.initials: F
authors.lastname: Drobniewski
authors.forename: Elvira
authors.initials: E
authors.lastname: Richter
authors.forename: Sabine
authors.initials: S
authors.lastname: Rüsch-Gerdes
mesh_terms: D000995:Antitubercular Agents / Q000494:pharmacology* / Q000627:therapeutic use*; D005060:Europe / Q000453:epidemiology; D006284:Health Plan Implementation; D006801:Humans; D015994:Incidence; D008826:Microbial Sensitivity Tests / Q000379:methods* / Q000592:standards*; D009169:Mycobacterium tuberculosis / Q000187:drug effects*; D011785:Quality Assurance, Health Care; D011786:Quality Control; D014376:Tuberculosis / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D000995:Antitubercular Agents