title: Diagnostic value of the strand displacement amplification method compared to those of Roche Amplicor PCR and culture for detecting mycobacteria in sputum samples.
abstract: We compared the ability of the semiautomated BDProbeTec-SDA system, which uses the strand displacement amplification (SDA) method, with that of the Roche Amplicor-PCR system and the Septi-Chek AFB culture system to directly detect Mycobacterium tuberculosis complex (MTB) and other mycobacteria in sputum samples. A total of 530 sputum samples from 299 patients were examined in this study. Of the 530 samples, 129 were culture positive for acid-fast bacilli with the Septi-Chek AFB system; 95 for MTB, 29 for M. avium-M. intracellulare complex (MAC), and 5 for other mycobacteria. The BDProbeTec-SDA system detected 90 of the 95 samples culture positive for MTB (sensitivity, 94.7%), and the Amplicor-PCR system detected 85 of the 95 samples culture positive for MTB (sensitivity, 89.5%). The specificity of each system, based on the clinical diagnosis, was 99.8% for SDA and 100% for PCR, respectively. Among the 29 samples culture positive for MAC, the BDProbeTec-SDA system detected MAC in 24 samples (sensitivity, 82.8%), whereas the Amplicor-PCR system detected MAC in 23 samples (sensitivity, 79.3%). The specificities of the systems were 98.3 and 100%, respectively. The high degrees of sensitivity and specificity of the BDProbeTec-SDA system suggest that it should be very useful in clinical laboratories for the rapid detection of mycobacteria in sputum samples.
authors.affiliation: Department of Clinical Laboratory Medicine, Nagoya University Hospital, Nagoya University School of Medicine, Japan. sichiyam@tsuru.med.nagoya-u.ac.jp
authors.forename: S
authors.initials: S
authors.lastname: Ichiyama
authors.forename: Y
authors.initials: Y
authors.lastname: Ito
authors.forename: F
authors.initials: F
authors.lastname: Sugiura
authors.forename: Y
authors.initials: Y
authors.lastname: Iinuma
authors.forename: S
authors.initials: S
authors.lastname: Yamori
authors.forename: M
authors.initials: M
authors.lastname: Shimojima
authors.forename: Y
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: K
authors.initials: K
authors.lastname: Shimokata
authors.forename: N
authors.initials: N
authors.lastname: Nakashima
mesh_terms: D001431:Bacteriological Techniques / Q000706:statistics & numerical data; D004269:DNA, Bacterial / Q000235:genetics / Q000302:isolation & purification; D005069:Evaluation Studies as Topic; D006801:Humans; D009161:Mycobacterium / Q000235:genetics* / Q000302:isolation & purification*; D009164:Mycobacterium Infections / Q000175:diagnosis / Q000382:microbiology; D015269:Mycobacterium avium Complex / Q000235:genetics / Q000302:isolation & purification; D015270:Mycobacterium avium-intracellulare Infection / Q000175:diagnosis / Q000276:immunology; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification; D021141:Nucleic Acid Amplification Techniques; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis / Q000382:microbiology
chemical_list: D004269:DNA, Bacterial