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. 2019 May 24;57(6):e01113-18. doi: 10.1128/JCM.01113-18

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
a

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.

b

These studies did not use culture to confirm TBM.