TABLE 1.
Characterization of included studiesa
| First author (reference) | Country | Yr published | NAA test | Diagnostic method | Gene target(s) | Reference standard | No. of confirmed TBM cases | No. of non-TBM (control) cases | Study design | Consecutive sampling | Data collection | Blinding |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dil-Afrozeb (37) | India | 2008 | In-house | Conventional PCR | MPB64 | CRS | 27 | 10 | CC | NM | R | Yes |
| Baveja (38) | India | 2009 | In-house | Conventional PCR | IS6110 | CRS | 22 | 78 | CS | Yes | P | NM |
| Berwal (39) | India | 2017 | In-house | Conventional PCR | IS6110 | CRS | 26 | 48 | CS | NM | P | NM |
| Bhigjee (40) | South Africa | 2007 | In-house | Conventional PCR | IS6110 | Culture | 20 | 24 | CS | NM | P | Yes |
| South Africa | 2007 | In-house | Conventional PCR | MPB64 | Culture | 20 | 24 | CS | NM | P | Yes | |
| South Africa | 2007 | In-house | Conventional PCR | Pt8/Pt9 | Culture | 20 | 24 | CS | NM | P | Yes | |
| South Africa | 2007 | In-house | Real-time PCR | IS6110 | Culture | 20 | 24 | CS | NM | P | Yes | |
| Brienze (41) | Brazil | 2001 | In-house | Nested PCR | MPB64 | CRS | 15 | 50 | CS | NM | P | NM |
| Caws (42) | United Kingdom | 2000 | In-house | Conventional PCR | IS6110 | Culture | 4 | 105 | CS | Yes | P | NM |
| Chaidir (43) | Indonesia | 2012 | In-house | Real-time PCR | IS6110 | Culture | 102 | 105 | CS | Yes | P | Yes |
| Desai (44) | India | 2006 | In-house | Conventional PCR (QIAamp protocol) | IS6110 | CRS | 8 | 27 | CS | Yes | P | NM |
| India | 2006 | In-house | Conventional PCR (CTAB protocol) | IS6110 | CRS | 8 | 27 | CS | Yes | P | NM | |
| Deshpande (15) | India | 2007 | In-house | Conventional PCR | IS6110 | CRS | 35 | 29 | CC | NM | P | NM |
| Haldar (45) | India | 2009 | In-house | Conventional PCR (filtrate protocol) | IS6110 | Culture | 10 | 86 | CS | NM | NM | Yes |
| India | 2009 | In-house | Conventional PCR (sediment protocol) | IS6110 | Culture | 10 | 86 | CS | NM | NM | Yes | |
| India | 2009 | In-house | Conventional PCR (filtrate protocol) | devR | Culture | 10 | 86 | CS | NM | NM | Yes | |
| India | 2009 | In-house | Conventional PCR (sediment protocol) | devR | Culture | 10 | 86 | CS | NM | NM | Yes | |
| India | 2009 | In-house | Real-time PCR (filtrate protocol) | devR | Culture | 10 | 86 | CS | NM | NM | Yes | |
| India | 2009 | In-house | Real-time PCR (sediment protocol) | devR | Culture | 10 | 86 | CS | NM | NM | Yes | |
| Haldar (87) | India | 2012 | In-house | Conventional PCR | devR | Culture | 29 | 338 | CS | NM | P | Yes |
| San Juan (46) | Spain | 2006 | In-house | Conventional PCR | IS6110 | CRS | 12 | 59 | CS | Yes | P | NM |
| Kulkarnib (18) | India | 2005 | In-house | Conventional PCR (ETBR protocol) | Protein b | CRS | 30 | 30 | CS | NM | NM | Yes |
| India | 2005 | In-house | Conventional PCR (Southern protocol) | Protein b | CRS | 30 | 30 | CS | NM | NM | Yes | |
| Lekhakb (47) | Nepal | 2016 | In-house | Conventional PCR | IS6110 | CRS | 37 | 75 | CS | NM | NM | NM |
| Nepal | 2016 | In-house | Conventional PCR | MPB64 | CRS | 37 | 75 | CS | NM | NM | NM | |
| Michael (48) | India | 2002 | In-house | Conventional PCR | IS6110 | Culture | 17 | 68 | CS | NM | R | Yes |
| Miörner (49) | India | 1995 | In-house | Conventional PCR | IS6110 | Culture | 6 | 34 | CC | NM | NM | NM |
| Modi (50) | India | 2016 | In-house | Conventional PCR | IS6110 | Culture | 50 | 100 | CS | NM | NM | NM |
| India | 2016 | In-house | LAMP PCR | IS6110 | Culture | 50 | 100 | CS | NM | NM | NM | |
| India | 2016 | In-house | LAMP PCR | MPB64 | Culture | 50 | 100 | CS | NM | NM | NM | |
| Nagdev (51) | India | 2010 | In-house | Nested PCR | IS6110 | Culture | 1 | 13 | CC | NM | NM | NM |
| Nagdev (52) | India | 2010 | In-house | Conventional PCR | IS6110 | Culture | 13 | 139 | CC | NM | P | NM |
| Nagdevb (19) | India | 2011 | In-house | Nested PCR | IS6110 | CRS | 17 | 10 | CC | NM | R | NM |
| India | 2011 | In-house | LAMP PCR | IS6110 | CRS | 17 | 10 | CC | NM | R | NM | |
| Nagdev (53) | India | 2015 | In-house | Multiplex PCR | 16S rRNA | Culture | 8 | 85 | CS | NM | P | NM |
| India | 2015 | In-house | Multiplex PCR | IS6110 | Culture | 8 | 85 | CS | NM | P | NM | |
| Narayanan (54) | India | 2001 | In-house | Conventional PCR | IS6110 | Culture | 20 | 8 | CS | NM | NM | NM |
| India | 2001 | In-house | Conventional PCR | TRC4 | Culture | 20 | 8 | CS | NM | NM | NM | |
| Nguyen (55) | Vietnam | 1996 | In-house | Conventional PCR | IS6110 | Culture | 17 | 32 | CS | Yes | R | Yes |
| Palomob (56) | Brazil | 2017 | In-house | Conventional PCR | IS6110 | CRS | 35 | 65 | CS | NM | NM | NM |
| Brazil | 2017 | In-house | Conventional PCR | MBP64 | CRS | 35 | 65 | CS | NM | NM | NM | |
| Brazil | 2017 | In-house | Conventional PCR | hsp65 | CRS | 35 | 65 | CS | NM | NM | NM | |
| Portillo-Gomez (57) | Mexico | 2000 | In-house | Conventional PCR | IS6110 | Culture | 13 | 113 | CS | NM | NM | NM |
| Quan (16) | China | 2006 | In-house | Conventional PCR | IS6110 | Culture | 3 | 49 | CC | NM | NM | NM |
| Rafi (14) | India | 2007 | In-house | Conventional PCR | IS6110 | Culture | 45 | 75 | CS | NM | R | Yes |
| India | 2007 | In-house | Nested PCR | MPB64 | Culture | 45 | 75 | CS | NM | R | Yes | |
| India | 2007 | In-house | Nested PCR | 65-kDa antigen | Culture | 45 | 75 | CS | NM | R | Yes | |
| Rafi (58) | India | 2007 | In-house | Conventional PCR | IS6110 | Culture | 136 | 268 | CS | NM | P | Yes |
| Rana (59) | India | 2010 | In-house | Conventional PCR | IS6110 | Culture | 5 | 37 | CS | NM | P | NM |
| Rios-Sarabiab (60) | Mexico | 2016 | In-house | Multiplex PCR | Protein b | CRS | 50 | 50 | CC | Yes | P | Yes |
| Mexico | 2016 | In-house | Multiplex PCR | IS6110 | CRS | 50 | 50 | CC | Yes | P | Yes | |
| Mexico | 2016 | In-house | Multiplex PCR | MPB40 | CRS | 50 | 50 | CC | Yes | P | Yes | |
| Mexico | 2016 | In-house | Nested PCR | MPB40 | CRS | 50 | 50 | CC | Yes | P | Yes | |
| Sastry (61) | India | 2013 | In-house | Nested PCR | IS6110 | Culture | 2 | 33 | CC | Yes | P | NM |
| Shankar (62) | India | 1991 | In-house | Conventional PCR | MPB64 | Culture | 4 | 51 | CS | NM | NM | NM |
| Sharma (63) | India | 2010 | In-house | Conventional PCR | Protein b | Culture | 10 | 40 | CS | NM | NM | NM |
| Kusum (64) | India | 2011 | In-house | Multiplex PCR | IS6110 | Culture | 18 | 100 | CS | Yes | NM | Yes |
| India | 2011 | In-house | Multiplex PCR | MPB64 | Culture | 18 | 100 | CS | Yes | NM | Yes | |
| India | 2011 | In-house | Multiplex PCR | Protein b | Culture | 18 | 100 | CS | Yes | NM | Yes | |
| Kusum (65) | India | 2012 | In-house | Conventional PCR | MPB64 | Culture | 9 | 40 | CS | NM | P | NM |
| Sharma (66) | India | 2015 | In-house | Real-time PCR | IS6110 | Culture | 12 | 120 | CS | NM | NM | NM |
| India | 2015 | In-house | Real-time PCR | MPB64 | Culture | 12 | 120 | CS | NM | NM | NM | |
| India | 2015 | In-house | Real-time PCR | rpoB | Culture | 12 | 120 | CS | NM | NM | NM | |
| Sumi (67) | India | 2002 | In-house | Conventional PCR | IS6110 | Culture | 8 | 45 | CC | NM | NM | Yes |
| Bahr (10) | Uganda | 2015 | Commercial | GeneXpert | rpoB | Culture | 18 | 89 | CS | NM | NM | NM |
| Bahr (23) | Uganda | 2018 | Commercial | GeneXpert Ultra | rpoB, IS6110, IS1081 | Culture | 22 | 107 | CS | NM | P | NM |
| Baker (68) | United States | 2002 | Commercial | Gen-Probe MTD | 16S RNA | Culture | 5 | 24 | CS | NM | NM | Yes |
| Bonington (17) | South Africa | 2000 | Commercial | Cobas Amplicor MTB | 16S RNA | Culture | 8 | 29 | CS | NM | P | NM |
| Brienze (41) | Brazil | 2001 | Commercial | Cobas Amplicor MTB | 16S RNA | CRS | 11 | 17 | CS | NM | P | NM |
| Causse (69) | Spain | 2011 | Commercial | GeneXpert | rpoB | Culture | 6 | 299 | CS | Yes | NM | NM |
| Spain | 2011 | Commercial | Cobas Amplicor MTB | 16S RNA | Culture | 6 | 299 | CS | Yes | NM | NM | |
| Chedore (70) | Canada | 2002 | Commercial | Gen-Probe MTD | 16S RNA | Culture | 16 | 295 | CS | NM | NM | NM |
| Chua (71) | Singapore | 2005 | Commercial | Abbott LCx ligase chain reaction | Protein b | Culture | 6 | 36 | CC | NM | P | NM |
| Cox (20) | Uganda | 2015 | Commercial | GeneXpert | rpoB | CRS | 8 | 69 | CS | NM | NM | NM |
| Johansen (72) | Denmark | 2004 | Commercial | ProbeTec | IS6110 | Culture | 13 | 88 | CS | NM | NM | NM |
| Jönsson (73) | Sweden | 2003 | Commercial | Cobas Amplicor MTB | 16S RNA | Culture | 9 | 145 | CS | Yes | R | NM |
| Khan (74) | Pakistan | 2018 | Commercial | GeneXpert | rpoB | Culture | 12 | 47 | CS | NM | NM | NM |
| Lang (88) | Dominican Republic | 1998 | Commercial | Gen-Probe MTD | 16S RNA | Culture | 5 | 60 | CS | Yes | P | NM |
| Li (75) | China | 2017 | Commercial | GeneXpert | rpoB | Culture | 4 | 70 | CS | Yes | NM | NM |
| Malbruny (76) | France | 2011 | Commercial | GeneXpert | rpoB | Culture | 1 | 14 | CS | Yes | P | NM |
| Moure (77) | Spain | 2012 | Commercial | GeneXpert | rpoB | Culture | 2 | 12 | CS | NM | NM | NM |
| Nhu (13) | Vietnam | 2014 | Commercial | GeneXpert | rpoB | Culture | 151 | 197 | CS | Yes | P | Yes |
| Patel (78) | South Africa | 2014 | Commercial | GeneXpert | rpoB | Culture | 31 | 53 | CS | Yes | P | Yes |
| South Africa | 2014 | Commercial | Cobas Amplicor MTB | 16S RNA | Culture | 31 | 53 | CS | Yes | P | Yes | |
| Pink (79) | United Kingdom | 2016 | Commercial | GeneXpert | rpoB | Culture | 37 | 703 | CS | NM | NM | NM |
| Rakotoarivelo (80) | Madagascar | 2018 | Commercial | GeneXpert | rpoB | Culture | 13 | 31 | CS | NM | NM | NM |
| Rufai (81) | India | 2017 | Commercial | GeneXpert | rpoB | Culture | 49 | 212 | CS | NM | NM | NM |
| Solomons (82) | South Africa | 2015 | Commercial | GenoType MTBDRplus | INH, RIF | Culture | 13 | 46 | CS | Yes | P | NM |
| South Africa | 2015 | Commercial | GeneXpert | rpoB | Culture | 13 | 46 | CS | Yes | P | NM | |
| Thwaites (11) | Vietnam | 2004 | Commercial | Gen-Probe MTD | 16S RNA | Culture | 42 | 79 | CS | Yes | P | Yes |
| Tortoli (83) | Italy | 2012 | Commercial | GeneXpert | rpoB | Culture | 13 | 120 | CS | NM | R | Yes |
| Vadwai (84) | India | 2011 | Commercial | GeneXpert | rpoB | CRS | 7 | 15 | CS | NM | NM | Yes |
| India | 2011 | Commercial | GeneXpert | rpoB | Culture | 3 | 19 | CS | NM | NM | Yes | |
| Wang (85) | China | 2016 | Commercial | GeneXpert | rpoB | Culture | 13 | 188 | CS | NM | P | Yes |
| Zmak (86) | Croatia | 2013 | Commercial | GeneXpert | rpoB | Culture | 1 | 45 | CS | NM | NM | NM |
CRS, combined reference standard; P, prospective; R, retrospective; CS, cross-sectional; CC, case-control; NM, not mentioned; CTAB, cetyltrimethylammonium bromide; ETBR, ethidium bromide; LAMP, loop-mediated isothermal amplification; INH, isoniazid resistance gene; RIF, rifampin resistance gene.
These studies did not use culture to confirm TBM.