Table 1 Description of included studies – commercial testsa
Country, year | Independent comparison | Cross-Sectional study design | Double or single blind | Consecutive or random sample | Prospective data collection | Type of testb (target sequence) | Reference standardc | Study qualityd | No. of pleural specimens or subjects with TB/No. without TB | Sensitivity (95% CI)e | Specificity (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|---|
AMPLICOR® Test |  |  |  |  |  |  |  |  |  |  |  |
USA,[28] 1996 | Yes | Yes | Unknown | Unknown | Unknown | Amplicor (16s rRNA) | Culture | Low | 3/89 | 0.67 (0.13, 0.98) | 1.00 (0.96, 1.00) |
Japan,[42] 2000 | Yes | Yes | No | Yes | No | Amplicor (16s rRNA) | Culture/biopsy | Medium | 33/42 | 0.27 (0.14, 0.46) | 0.98 (0.86, 1.00) |
Germany,[54] 1998 | Yes | Yes | Yes | Yes | Yes | Amplicor (16s rRNA) | Culture | High | 3/66 | 0.67 (0.13, 0.98) | 0.98 (0.91, 1.00) |
USA,[55] 1998 | Yes | Yes | Unknown | Yes | Yes | Amplicor (16s rRNA) | Culture | Medium | 8/367 | 0.50 (0.18, 0.82) | 1.00 (0.98, 1.00) |
LCx ® Test |  |  |  |  |  |  |  |  |  |  |  |
Argentina,[44] 2001 | Yes | Yes | Yes | Yes | Yes | LCx (38 kDa) | Culture/clinical | High | 16/186 | 0.69 (0.42, 0.88) | 0.96 (0.92, 0.98) |
Spain,[46] 1998 | Yes | Yes | Yes | Yes | Yes | LCx (38 kDa) | Culture/biopsy | High | 15/171 | 0.87(0.59, 0.98) | 0.98 (0.95, 1.00) |
Finland,[52] 2001 | Partly | Yes | Yes | Yes | No | LCx (38 kDa) | Culture | Medium | 5/142 | 0.40 (0.07, 0.83) | 0.99 (0. 95, 1.00) |
Spain,[37] 1999 | Yes | Yes | No | Yes | Yes | LCx (38 kDa) | Culture | Medium | 3/12 | 1.00 (0.29, 1.00) | 1.00 (0.74, 1.00) |
MTD ® Test |  |  |  |  |  |  |  |  |  |  |  |
Spain,[26] 2001 | Yes | Yes | No | Yes | Yes | MTD-2 (rRNA) | Culture/clinical | Medium | 5/96 | 0.20 (0.01, 0.70) | 0.98 (0.92, 1.00) |
Germany,[33] 1996 | Yes | Yes | Yes | No | Partly | MTD-1 (rRNA) | Culture/clinical | Medium | 3/32 | 1.00 (0.29, 1.00) | 1.00 (0.89, 1.00) |
Spain,[34] 1997 | Yes | Yes | Yes | No | Yes | MTD-1 (rRNA) | Culture | High | 13/36 | 1.00 (0.75, 1.00) | 1.00 (0.90, 1.00) |
Spain,[35] 1997 | Yes | Yes | Yes | No | Yes | MTD-1 (rRNA) | Culture | High | 13/28 | 1.00 (0.75, 1.00) | 1.00 (0.88, 1.00) |
Switzerland,[49] 1996 | Yes | Yes | Unknown | Unknown | Unknown | MTD-1 (rRNA) | Culture | Low | 4/61 | 0.50 (0.09, 0.91) | 0.95 (0.85, 0.99) |
Netherlands,[61] 1995 | Yes | Yes | Unknown | Yes | Unknown | MTD-1 (rRNA) | Culture | Medium | 5/56 | 0.20 (0.01, 0.70) | 0.96 (0.87, 0.99) |