TABLE 3.
Comparative studies of available CDATs for detection of MTB in clinical samplesa
Study (reference) | Method | No. of specimens/ specimen type | No. of MTB cultures/smear- positive specimens | Gold standard used for assay's evaluation | Sensitivity (%) | Specificity (%) | PPV (%) | NPV (%) | Sensitivity (%) for:
|
|
---|---|---|---|---|---|---|---|---|---|---|
Smear-positive specimens | Smear-negative specimens | |||||||||
Piersimoni et al. (48) | LCx | 273/R | 61/36 | Culture, clinical correlation | 75.7 | 98.8 | 96.4 | 90.5 | 91.6 | 58.8 |
184/E | 24/11 | Culture, clinical correlation | 53.6 | 99.3 | 93.7 | 92.1 | 81.8 | 35.3 | ||
AMTD2 | 273/R | 61/36 | Culture, clinical correlation | 92.8b | 99.4 | 98.5 | 97 | 100 | 85.3b | |
184/E | 24/11 | Culture, clinical correlation | 78.6b | 99.3 | 95.6 | 96.2 | 100 | 64.7b | ||
Wang and Tay (64) | LCx | 230/R | 72/66 | Culture, clinical correlation | 100 | 99.3 | 98.7 | 100 | 100 | 100 |
PCR | 230/R | 72/66 | Culture, clinical correlation | 96.1 | 100 | 100 | 98.1 | 96.9 | 91.7 | |
AMTD | 230/R | 72/66 | Culture, clinical correlation | 98.6 | 99.4 | 98.6 | 99.4 | 100 | 85.7 | |
Brown et al. (12) | LCx | 42/R | NA | Culture, clinical correlation | 79.2 | 100 | 100 | 77.2 | 84.2 | 55.6 |
21/E | NA | Culture, clinical correlation | 60 | 100 | 100 | 76.5 | ||||
PCRc | 42/R | NA | Culture, clinical correlation | 75.0 | 100 | 100 | 77.5 | 84.2 | 33.3 | |
21/E | NA | Culture, clinical correlation | 50 | 100 | 100 | 74 | ||||
Tortoli et al. (62) | LCx | 697/R+E | 110/84 | Culture, clinical correlation | 85.7d | 99.4 | NA | NA | 93 | 70.2d |
PCRc | 697/R+E | 110/84 | Culture, clinical correlation | 75.5 | 99.8 | NA | NA | 94 | 36.1 | |
Scarparo et al. (57) | AMTD2 | 296/R | 114/97 | Culture, clinical correlation | 85.7 | 100 | 100 | 90.4 | 91.7 | 65.5 |
190/E | 33/25 | Culture, clinical correlation | 82.9 | 100 | 100 | 95.5 | 88 | 75 | ||
PCR | 296/R | 114/97 | Culture, clinical correlation | 94.2 | 100 | 100 | 96 | 98.9 | 75 | |
190/E | 33/25 | Culture, clinical correlation | 85 | 100 | 100 | 96.1 | 95.8 | 68.7 | ||
Della-Latta and Whittier (20) | AMTD2 | 1385/R | 62/NA | Culture, clinical correlation | 97.1 | 99.5 | NA | NA | 100 | 92.9 |
PCRc | 1380/R | 62/NA | Culture, clinical correlation | 96.7 | 100 | NA | NA | 97.4 | 95.9 | |
Piersimoni et al. (49) | AMTD2 | 331/R | 91/76 | Culture, clinical correlation | 88 | 99.2 | 110e | 0.11e | 93.4 | 62.5 |
184/E | 30/22 | Culture, clinical correlation | 74.3 | 100 | 235e | 0.05e | 95.4 | 47 | ||
DTB | 331/R | 91/76 | Culture, clinical correlation | 94.5 | 99.6 | 740e | 0.26e | 98.7 | 75 | |
184/E | 30/22 | Culture, clinical correlation | 92.3f | 100 | 920e | 0.07e | 100 | 82.3 |
Abbreviations: R, respiratory specimens; E, extrapulmonary specimens; NA, not available.
Statistically significant with both respiratory (P = 0.005) and extrapulmonary (P = 0.048) specimens.
Manual version not including IAC.
Statistically significant with either all specimens (P = 0.026) or smear-negative (P = 0.020) specimens.
Positive and negative likelihood ratios.
Statistically significant with extrapulmonary (P = 0.03) specimens.