Performance assessment of two commercial amplification assays for direct detection of Mycobacterium tuberculosis complex from respiratory and extrapulmonary specimens

被引:69
作者
Piersimoni, C
Scarparo, C
Piccoli, P
Rigon, A
Ruggiero, G
Nista, D
Bornigia, S
机构
[1] Gen Hosp Umberto I Torrette, Dept Clin Microbiol, I-60020 Ancona, Italy
[2] San Bortolo Hosp, Reg Mycobacteria Reference Ctr, Vicenza, Italy
关键词
D O I
10.1128/JCM.40.11.4138-4142.2002
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
The new BDProbeTec ET Mycobacterium tuberculosis Complex Direct Detection Assay (DTB) was compared with the enhanced M. tuberculosis Amplified Direct Test (AMTDII). The system is an automated walkaway system characterized by simultaneous DNA amplification (strand displacement amplification) and real-time fluorometric detection. It also contains an internal amplification control (IAC) designed to identify inhibition from the processed samples. The AMTDII assay amplifies rRNA by transcription-mediated amplification; it uses hybridization with a chemoluminescent probe as a detection system and is entirely manual. A total of 5 15 N-acetyl-L-cysteine-sodium hydroxide-decontaminated respiratory (n = 331) and extrapulmonary (n = 184) sediments (from 402 patients) were tested in parallel by both assays. The results were compared with those of acid-fast staining and culture (solid plus liquid media), setting the combination of culture and clinical diagnosis as the "gold standard." Culture results from the tested specimens were as follows: 121 Mycobacterium tuberculosis complex (MTB) (98 smear-positive), 46 nontuberculous mycobacteria (38 smear-positive), and 338 culture-negative results. After resolution of the discrepant results, the percent sensitivity., percent specificity, and positive and negative likelihood ratios for AMTDII were 88%, 99.2%, 110, and 0.11 for respiratory specimens and 74.3%, 100%, 740, and 0.26 for extrapulmonary specimens, respectively. The corresponding values for DTB were 94.5%, 99.6%, 235, and 0.05 for respiratory specimens and 92.3%, 100%, 920, and 0.07 for extrapulmonary specimens, respectively. The cumulative difference for all tuberculosis-positive extrapulmonary specimens was significant (P = 0.03). The overall inhibition rate for DTB was 5% (26 specimens). We conclude that both amplification assays proved to be rapid and specific for the detection of MTB in clinical samples and particularly feasible for a routine laboratory work flow. DTB combines a labor-intensive specimen preparation procedure, with a completely automated amplification and detection. Finally, differences between AMTDII and DTB sensitivities were associated with the presence of inhibitory samples that the former assay, lacking IAC, could not detect.
引用
收藏
页码:4138 / 4142
页数:5
相关论文
共 17 条
  • [1] Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli
    Behr, MA
    Warren, SA
    Salamon, H
    Hopewell, PC
    de Leon, AP
    Daley, CL
    Small, PM
    [J]. LANCET, 1999, 353 (9151) : 444 - 449
  • [2] Clinical evaluation of the BDProbeTec ET system for rapid detection of Mycobacterium tuberculosis
    Bergmann, JS
    Keating, WE
    Woods, GL
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2000, 38 (02) : 863 - 865
  • [3] Removal of PCR inhibitors by silica membranes:: Evaluating the amplicor Mycobacterium tuberculosis kit
    Böddinghaus, B
    Wichelhaus, TA
    Brade, V
    Bittner, T
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2001, 39 (10) : 3750 - 3752
  • [4] Standardization and quality control of PCR analyses
    Burkardt, HJ
    [J]. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2000, 38 (02) : 87 - 91
  • [5] Mycolic acid analysis by high-performance liquid chromatography for identification of Mycobacterium species
    Butler, WR
    Guthertz, LS
    [J]. CLINICAL MICROBIOLOGY REVIEWS, 2001, 14 (04) : 704 - 726
  • [6] DIAGNOSIS OF TUBERCULOSIS BY AMPLICOR MYCOBACTERIUM-TUBERCULOSIS TEST - A MULTICENTER STUDY
    CARPENTIER, E
    DROUILLARD, B
    DAILLOUX, M
    MOINARD, D
    VALLEE, E
    DUTILH, B
    MAUGEIN, J
    BERGOGNEBEREZIN, E
    CARBONNELLE, B
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 1995, 33 (12) : 3106 - 3110
  • [7] The role of clinical suspicion in evaluating a new diagnostic test for active tuberculosis - Results of a multicenter prospective trial
    Catanzaro, A
    Perry, S
    Clarridge, JE
    Dunbar, S
    Goodnight-White, S
    LoBue, PA
    Peter, C
    Pfyffer, GE
    Sierra, MF
    Weber, R
    Woods, G
    Mathews, G
    Jonas, V
    Smith, K
    Della-Latta, P
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2000, 283 (05): : 639 - 645
  • [8] The mycobacteriology milestones - Journeying to the new millennium
    Della-Latta, P
    [J]. LABORATORY MEDICINE, 1999, 30 (06) : 408 - 417
  • [9] Comparative evaluation of initial and new versions of the Gen-Probe amplified Mycobacterium Tuberculosis Direct Test for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens
    Gamboa, F
    Fernandez, G
    Padilla, E
    Manterola, JM
    Lonca, J
    Cardona, PJ
    Matas, L
    Ausina, V
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 1998, 36 (03) : 684 - 689
  • [10] Evidence-based clinical microbiology
    Giocoli, G
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2000, 38 (09) : 3520 - 3521