Study | First author [ref.] | Year | Country | Setting | Blinding# | Patient selection method | Prospective enrolment | HIV % | Children % | Culture reference standard | CRS | Total samples n | Specimen type (samples n) |
1 | Al-Ateah [14] | 2012 | Saudi Arabia | Tertiary care centre | Yes | Consecutive | Yes | 0 | 2.9 | MGIT/LJ | None | 67 | Pleural fluid (13) Lymph node (8) CSF (14) |
2 | Armand [15] | 2011 | France | Tertiary care centre | Yes | Convenience | No | 2 | 2 | MGIT/LJ | None | 56 | Pleural fluid (8) Lymph node (20) CSF (5) |
3 | Causse [16] | 2011 | Spain | Reference laboratory | Yes | Consecutive | Yes | 0 | 15 | MGIT/LJ | None | 340 | Pleural fluid (34) Lymph node (80) CSF (50) |
4 | Christopher [17] | 2013 | India | Tertiary care centre | Yes | Consecutive | Yes | 0 | 0 | MGIT | Histopathology/smear+culture on pleural biopsy/biochemical analysis of fluid | 96 | Pleural fluid (96) |
5 | Friedrich [18] | 2011 | South Africa | Tertiary care centre | Yes | Consecutive | Yes | 28 | 0 | MGIT | Histopathology/improvement on ATT/positive culture from any other site | 24 | Pleural fluid (24) |
6 | Hanif [19] | 2011 | Kuwait | Reference laboratory | No | Consecutive | Yes | 0 | 0 | MGIT/Bactec 460/LJ | None | 29 | Pleural fluid (11) Lymph node (9) CSF (5) |
7 | Hillemann [20] | 2011 | Germany | Reference laboratory | Yes | Consecutive | Yes | Unknown | 5 | MGIT/LJ | None | 495 | Pleural fluid (111) Lymph node (65) CSF (19) |
8 | Ligthelm [21] | 2011 | South Africa | Tertiary care centre | Yes | Consecutive | Yes | 18.8 | 4.2 | MGIT | Histopathology | 48 | Lymph node (48) |
9 | Malbruny [22] | 2011 | France | Tertiary care centre | No | Convenience | Yes | Unknown | 6.8 | MGIT | None | 124 | Pleural fluid (12) Lymph node (23) CSF (15) |
10 | Moure [23] | 2012 | Spain | Tertiary care centre | Yes | Convenience | No | 11.2 | 0 | MGIT/LJ | None | 149 | Pleural fluid (34) Lymph node (38) CSF (14) |
11 | Nhu [24] | 2013 | Vietnam | Tertiary care centre | No | Consecutive | Yes | 34.8 | 0 | MGIT | Clinical symptoms | 386 | CSF (386) |
12 | Patel [25] | 2013 | South Africa | Tertiary care centre | Yes | Consecutive | Yes | 87 | 1.5 | MGIT | NAAT | 151 | CSF (151) |
13 | Porcel [26] | 2013 | Spain | Tertiary care centre | No | Consecutive | Yes | 0 | 0 | LJ (confirmed Mycobacterium tuberculosis) | Histopathology/improvement on ATT/smear/biochemical profile/positive sputum | 67 | Pleural fluid (67) |
14 | Safianowska [27] | 2012 | Poland | Tertiary care centre | No | Consecutive | Yes | 0 | 0 | LJ (confirmed M. tuberculosis) | None | 68 | Pleural fluid (32) Lymph node (2) |
15 | Tortoli [28] | 2012 | Italy | Tertiary care centre | Yes | Convenience | No | 10 | 33.5 | MGIT/LJ | Histopathology/improvement on ATT | 1491 | Pleural fluid (330) Lymph node (118) CSF (138) |
16 | Vadwai [29] | 2011 | India | Tertiary care centre | Yes | Consecutive | Yes | 3 | 2.8 | MGIT/LJ | Histopathology/improvement on ATT/radiology | 342 | Pleural fluid (29) Lymph node (188) |
17 | Van Rie [30] | 2013 | South Africa | Tertiary care centre | Yes | Consecutive | Yes | 100 | 0 | MGIT | Histopathology/smear with species identification | 353 | Lymph node (344) |
18 | Zeka [31] | 2011 | Turkey | Tertiary care centre | Yes | Consecutive | No | 1.4 | 13.3 | Bactec 460/LJ | Histopathology/radiology | 175 | Pleural fluid (56) Lymph node (26) CSF (31) |
Xpert MTB/RIF is manufactured by Cepheid (Sunnyvale, CA, USA), and the Mycobacteria Growth Indicator Tube (MGIT) and Bactec 460 are manufactured by BD (East Rutherford, NJ, USA). LJ: Löwenstein–Jensen culture; CRS: composite reference standard; ATT: antituberculous therapy; NAAT: nucleic acid amplification test; CSF: cerebrospinal fluid. #: this item refers to whether the reference standard results were interpreted without knowledge of the index test results; the Xpert result, being automated, was considered blinded to the reference standard result in all studies.