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Table 1 Commercially available NAAT assays for TB detection in clinical specimens*

From: Rapid diagnostics of tuberculosis and drug resistance in the industrialized world: clinical and public health benefits and barriers to implementation

Assay Manufacturer Method Material Sensitivity,% (95% CI) Specificity,% (95% CI) PLR NLR References
Amplified MTD Gen-Probe Inc., San Diego, CA, USA Transcription-mediated amplification DNA from decontaminated sputum 86.0 (74.2 to 93.7) 99.3 (96.3 to 100.0) 57.6 (25.5 to 129.9) 0.1 (0.07 to 0.22) [11, 16]
COBAS® TaqMan® MTB Test Roche Molecular Diagnostics, Pleasanton, CA, USA RT-PCR DNA from decontaminated sputum 91.5 (86.9 to 96.1) 98.7 (98.0 to 99.4) - - [17, 18]
79.1 98.2
artus® M. tuberculosis PCR Qiagen, Hilden, Germany RT-PCR DNA from decontaminated sputum 97.8 (93.6 to 95.5) 85.1 (75.8 to 91.8) 6.54 (4.0 to 10.8) 0.03 (0.01 to 0.08) [19]
Loopamp® Tuberculosis Complex Detection Reagent Kit EIKEN Chemical, Tokyo, Japan LAMP Untreated sputum 88.2 (81.4 to 92.7) - - - [20]
Amplicor MTB Roche Molecular Diagnostics, Pleasanton, CA, USA PCR amplification of 16S RNA DNA from decontaminated sputum - - 26.04 (17.04 to 39.80) 0.15 (0.11 to 0.22) [11]
Cobas Amplicor Roche Molecular Diagnostics, Pleasanton, CA, USA PCR amplification of 16S RNA DNA from decontaminated sputum - - 58.59 (37.77 to 90.86) 0.17 (0.13 to 0.22) [11]
LCx Abbott Laboratories, USA, Abbott Park, IL, USA Ligase chain reaction DNA from decontaminated sputum 88.9 (82.5 to 96.3) 96.8 (95.1 to 98.5) 26.91 (17.21 to 42.09) 0.16 (0.12 to 0.20) [11, 21]
BD Probe Tec Direct Becton Dickinson, Sparks, MD, USA Strand Displacement amplification DNA from decontaminated sputum 77.5 (72.0 to 83.0) 98.0 (97.1 to 98.9) 20.11 (10.42 to 38.82) 0.06 (0.04 to 0.10) [11, 22]
Xpert® MTB/RIF Cepheid Inc, Sunnyvale, CA, USA RT- PCR Smear-positive sputum 98.0 (98.0 to 99.0) 99.0 (99.0 to 99.0)    [13, 14, 2328]
Xpert® MTB/RIF Cepheid Inc, Sunnyvale, CA, USA RT-PCR Smear-negative sputum 75.0 (72.0 to 78.0) 99.0 (99.0 to 99.0)    [13, 14, 2328]
  1. *Sales of many of these commercial assays have now been discontinued.
  2. NAAT, Nucleic acid amplification techniques; NLR, Negative likelihood ratio; PLR, Positive likelihood ratio.