title: Evaluation of two commercial diagnostic kits for Mycobacterium tuberculosis completely based on bacterial DNA and rRNA amplification for direct detection of tubercle bacilli in sputum specimens.
abstract: The Roche Amplicor Mycobacterium Tuberculosis Kit (Amplicor PCR) and Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test (MTD) were compared for efficiency in the direct detection of tubercle bacilli in sputum specimens. In total, 72 sputum specimens obtained from patients with active tuberculosis were examined with the Amplicor PCR and MTD kits. Of the 72 test specimens, 45 and 41 samples were positive by the Amplicor PCR and MTD methods, respectively. These values were larger than those obtained by the culture method (Septi-Chek) and acid-fast bacilli-smear test, yielding 37 and 20 positive results, respectively, and the sensitivities were as follows: smear, 39.2%; culture, 72.5%; Amplicor PCR, 88.2%; MTD, 80.4%. Amplicor PCR was similarly or somewhat more sensitive in direct detection of M. tuberculosis in sputum samples from patients with clinically active tuberculosis than was MTD.
authors.affiliation: Department of Microbiology and Immunology, Shimane Medical University, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Sato
authors.forename: H
authors.initials: H
authors.lastname: Tomioka
authors.forename: S
authors.initials: S
authors.lastname: Kawahara
authors.forename: S
authors.initials: S
authors.lastname: Shishido
mesh_terms: D004269:DNA, Bacterial / Q000032:analysis*; D005069:Evaluation Studies as Topic; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques; D012329:RNA, Bacterial / Q000032:analysis*; D012335:RNA, Ribosomal / Q000032:analysis*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis / Q000382:microbiology
chemical_list: D004269:DNA, Bacterial; D012329:RNA, Bacterial; D012335:RNA, Ribosomal; D011933:Reagent Kits, Diagnostic