Table 2.
Country, year | Independent comparison | Cross-sectional study design | Double or single blind | Consecutive or random sample | Prospective data collection | Type of testb sequence) | (target Reference standardc | Study qualityd | No. of pleural specimens or Subjects with TB/No. without TB | Sensitivity (95% CI)e | Specificity (95% CI) |
Brazil,[24] 2000 | Yes | No | Yes | Yes | Partly | PCR (16S rRNA) | Culture/clinical | Medium | 28/17 | 0.89 (0.71, 0.97) | 1.00 (0.80, 1.00) |
Spain,[25] 2000 | Yes | No | Yes | Yes | Yes | PCR (IS6110) | Culture/clinical | Medium | 9/16 | 0.89 (0.51, 0.99) | 1.00 (0.79, 1.00) |
China,[27] 1996 | Yes | Yes | Unknown | Yes | Unknown | PCR (IS6110/38 kDa) | Culture | Medium | 25/76 | 0.44 (0.25, 0.65) | 0.99 (0.92, 1.00) |
India,[29] 1998 | Yes | No | Yes | Unknown | Yes | PCR (MPB64) | Culture/clinical | Medium | 28/16 | 0.61 (0.41, 0.78) | 0.94 (0.68, 1.00) |
France,[30] 1992 | Yes | No | No | No | Partly | PCR (IS6110) | Culture/biopsy | Low | 15/10 | 0.60 (0.33, 0.82) | 1.00 (0.69, 1.00) |
France,[30] 1992 | Yes | No | No | No | Partly | PCR (65 kDa) | Culture/biopsy | Low | 15/10 | 0.20 (0.05, 0.48) | 1.00 (0.69, 1.00) |
S. Africa,[31] 1992 Yes | Yes | Yes | Yes | Yes | Yes | PCR (336 bp repetitive sequence) | Culture/biopsy | High | 50/31 | 0.82 (0.68, 0.91) | 0.77 (0.59, 0.90) |
S. Africa,[32] 1990 Yes | Yes | Yes | Unknown | Unknown | Unknown | PCR (336 bp repetitive sequence) | Culture | Medium | 11/5 | 1.00 (0.72, 1.00) | 1.00 (0.48, 1.00) |
India,[36] 2001 | Yes | Yes | Yes | No | Yes | PCR (IS6110) | Culture | Medium | 4/26 | 0.25 (0.01, 0.78) | 0.96 (0.79, 1.00) |
Chile,[38] 1993 | Yes | No | Yes | Unknown | Unknown | PCR (65 kDa) | Culture/microscopy | Medium | 15/11 | 0.93 (0.66, 1.00) | 1.00 (0.72, 1.00) |
Mexico et al,[39] 2001 | Yes | Yes | Yes | Yes | Yes | PCR (465 bp sequence) | Culture | High | 3/12 | 0.33 (0.02, 0.87) | 0.83 (0. 51, 0.97) |
France,[40] 1996 | Yes | No | No | Yes | Yes | PCR (IS6110) | Culture/biopsy | Medium | 17/25 | 0.76 (0.50, 0.92) | 1.00 (0.86, 1.00) |
Brazil,[41] 2000 | Yes | Yes | Yes | Yes | Partly | PCR (MPB64) | Culture/biopsy | High | 19/11 | 0.68 (0.44, 0.86) | 0.91 (0.57, 0.99) |
Japan,[43] 1993 | Yes | Yes | Unknown | Unknown | Unknown | PCR (38 kDa) | Culture | Low | 5/105 | 0.80 (0.30, 0.99) | 0.93 (0.86, 0.97) |
India,[45] 2001 | Yes | Yes | Yes | Unknown | No | PCR (150 bp sequence) | Microscopy/biopsy | High | 20/40 | 0.70 (0.46, 0.87) | 1.00 (0.91, 1.00) |
Taiwan,[47] 1990 | Yes | Yes | Unknown | Unknown | Unknown | PCR (65 kDa) | Culture | Medium | 11/37 | 1.00 (0.72, 1.00) | 0.78 (0.61, 0.90) |
India,[48] 2000 | Yes | Yes | Unknown | Unknown | Unknown | PCR (IS6110/TRC4) | Culture/microscopy | Medium | 30/20 | 1.00 (0.88, 1.00) | 0.70 (0.46, 0.87) |
Mexico,[50] 2000 | Yes | No | Yes | Yes | Yes | PCR (IS6110) | Culture/biopsy | High | 17/56 | 0.94 (0.69, 1.00) | 1.00 (0.94, 1.00) |
Spain,[51] 1995 | Yes | No | Yes | Yes | Yes | PCR (IS6110) | Culture/biopsy | High | 21/86 | 0.81 (0.58, 0.94) | 0.98 (0.91, 1.00) |
Thailand,[53] 2000 | Yes | Yes | Unknown | Yes | Yes | PCR (16S rRNA) | Culture/biopsy | High | 36/62 | 0.72 (0.55, 0.85) | 0.53 (0.40, 0.66) |
Singapore,[57] 1995 | Yes | No | Unknown | Unknown | Unknown | PCR (IS6110) | Culture/biopsy | Low | 10/13 | 0.70 (0.36, 0.92) | 1.00 (0.75, 1.00) |
Singapore,[57] 1995 | Yes | No | Unknown | Unknown | Unknown | PCR (MPB64) | Culture/biopsy | Low | 10/13 | 0.70 (0.36, 0.92) | 1.00 (0.75, 1.00) |
Singapore,[56] 1997 | Yes | Yes | Yes | Yes | Yes | PCR (IS6110) | Culture/clinical | High | 16/49 | 1.00 (0.79, 1.00) | 0.88 (0.75, 0.95) |
India,[58] 1995 | Yes | No | Yes | No | Yes | PCR (150 bp sequence) | Clinical/biopsy | Medium | 38/29 | 0.63 (0.46, 0.78) | 0.93 (0.76, 0.99) |
Colombia,[59] 2000 | Yes | Yes | Yes | Yes | No | PCR (IS6110) | Culture/biopsy | High | 42/70 | 0.74 (0.58, 0.86) | 0.90 (0.80, 0.96) |
Spain,[60] 1998 | Yes | Yes | Yes | No | Yes | PCR (IS6110) | Culture/biopsy | High | 33/98 | 0.42 (0.26, 0.61) | 0.99 (0.94, 1.00) |
aIncorporates additional information provided by authors of the primary studies bType of test: PCR: polymerase chain reaction cReference standard: culture refers to culture of pleural fluid/sputum/biopsy; biopsy refers to pleural biopsy; clinical refers to data such as signs and symptoms, response to therapy, and pleural fluid analysis dSee text for description of quality assessment eCI: Confidence Interval