Lara-Oya, AnaMendoza-Lopez, PabloRodriguez-Granger, JavierFernández-Sánchez, Ana MaríaBermúdez-Ruiz, María PilarToro-Peinado, InmaculadaPalop-Borrás, BegoñaNavarro-Marí, Jose MaríaMartínez-Lirola, Miguel José2016-01-142016-01-142013-01Lara-Oya A, Mendoza-Lopez P, Rodriguez-Granger J, Fernández-Sánchez AM, Bermúdez-Ruiz MP, Toro-Peinado I, et al. Evaluation of the speed-oligo direct Mycobacterium tuberculosis assay for molecular detection of mycobacteria in clinical respiratory specimens. J Clin Microbiol. 2013; 51(1):77-820095-1137http://hdl.handle.net/10668/2130Comparative Study; Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't;We present the first evaluation of a novel molecular assay, the Speed-oligo Direct Mycobacterium tuberculosis (SO-DMT) assay, which is based on PCR combined with a dipstick for the detection of mycobacteria and the specific identification of M. tuberculosis complex (MTC) in respiratory specimens. A blind evaluation was carried out in two stages: first, under experimental conditions on convenience samples comprising 20 negative specimens, 44 smear- and culture-positive respiratory specimens, and 11 sputa inoculated with various mycobacterium-related organisms; and second, in the routine workflow of 566 fresh respiratory specimens (4.9% acid-fast bacillus [AFB] smear positives, 7.6% MTC positives, and 1.8% nontuberculous mycobacteria [NTM] culture positives) from two Mycobacterium laboratories. SO-DMT assay showed no reactivity in any of the mycobacterium-free specimens or in those with mycobacterium-related organisms. Compared to culture, the sensitivity in the selected smear-positive specimens was 0.91 (0.92 for MTC and 0.90 for NTM), and there was no molecular detection of NTM in a tuberculosis case or vice versa. With respect to culture and clinical data, the sensitivity, specificity, and positive and negative predictive values for the SO-DMT system in routine specimens were 0.76 (0.93 in smear positives [1.0 for MTC and 0.5 for NTM] and 0.56 in smear negatives [0.68 for MTC and 0.16 for NTM]), 0.99, 0.85 (1.00 in smear positives and 0.68 in smear negatives), and 0.97, respectively. Molecular misidentification of NTM cases occurred when testing 2 gastric aspirates from two children with clinically but not microbiologically confirmed lung tuberculosis. The SO-DMT assay appears to be a fast and easy alternative for detecting mycobacteria and differentiating MTC from NTM in smear-positive respiratory specimens.enHumanosTécnicas de diagnóstico molecularMycobacterium tuberculosisOligonucleótidosSensibilidad y especificidadEsputoTuberculosis pulmonarTécnicas bacteriológicasMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Molecular Diagnostic TechniquesMedical Subject Headings::Organisms::Bacteria::Gram-Positive Bacteria::Actinobacteria::Actinomycetales::Mycobacteriaceae::Mycobacterium::Mycobacterium tuberculosisMedical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleotides::Polynucleotides::OligonucleotidesMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Sensitivity and SpecificityMedical Subject Headings::Anatomy::Fluids and Secretions::Bodily Secretions::SputumMedical Subject Headings::Phenomena and Processes::Physical Phenomena::Time::Time FactorsMedical Subject Headings::Diseases::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::Tuberculosis::Tuberculosis, PulmonaryMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Microbiological Techniques::Bacteriological Techniquesresearch article23100355open access10.1128/JCM.00533-121098-660XPMC3536200