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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, 23–28]

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, 23–28]

  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.