Background
Methods
Search strategy
Study selection
Data extraction and quality assessment
Statistical analysis
Results
Study search
Author Year | Study design | Country | Number of participants | Number of samples sent for culture | Culture+/− | Type of test (target sequence) | Acid-fast stain | Culture | Respiratory specimen | Non-respiratory specimen | R/NR | TP | FP | FN | TN |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aggarwal 2012 [20] | Cross-sectional | India | 80 | 80 | 18/62 | 16 s rRNA | ? | MGIT | – | csf | 0/80 | 12 | 14 | 6 | 48 |
Albuquerque 2014 [21] | Cross-sectional | Brazil | 140 | 140 | 47/93 | IS6110 | ZN | 7H9,LJ | sp | – | 140/0 | 41 | 1 | 6 | 92 |
Barletta 2014 [10] | Cross-sectional | Peru | 112 | 112 | 84/28 | IS6110 | ZN | LJ | sp | – | 109/0 | 79 | 1 | 5 | 25 |
Chaidir 2013 [22] | Case-control | Indonesia | 230 | 230 | 102/105 | IS6110 | ZN | Liquid and solid | – | csf | 0/207 | 94 | 46 | 8 | 59 |
Darban-Sarokhalil 2012 [23] | Case-control | Iran | 247 | 247 | 112/135 | cyp141 | ZN | LJ | sp | – | 247/0 | 101 | 3 | 11 | 132 |
Gallo 2016 [24] | Cross-sectional | Brazil | ? | 1451 | 1351/100 | mpt64 | ? | Liquid and solid | sp | – | 1451/0 | 1347 | 4 | 4 | 96 |
Inoue 2011 [25] | Cross-sectional | Singapore | 414 | 414 | 55/128 | IS6110 | ? | MGIT | sp | csf,pf,ti | 104/66 | 43 | 3 | 8 | 116 |
Lee 2011 [26] | Case-control | Korea | 370 | 129 | 53/76 | senX3-regX3 | ZN | 3% Ogawa | ti | ti | 53/76 | 47 | 1 | 16 | 65 |
Lira, LA 2012 [27] | Case-control | Brazil | 165 | 165 | 66/99 | IS6110 | ZN | LJ | sp | – | 165/0 | 58 | 2 | 8 | 97 |
Lyra 2014 [28] | Cross-sectional | Brazil | 181 | 194 | 11/91 | IS6110 | ZN | LJ | sp | – | 102/0 | 11 | 3 | 0 | 88 |
Miller 2011 [29] | Cross-sectional | America | 90 | 112 | 89/23 | IS6110 | ? | MGIT, LJ,7H11 | sp,ba,bal.,ti | In,ab,pf,ti | 89/23 | 30 | 4 | 7 | 71 |
Rao 2016 [30] | Cross-sectional | India | 100 | 200 | 44/56 | 16sRNA | ? | MGIT | sp | – | 100/0 | 44 | 2 | 0 | 54 |
Rozales 2014 [31] | Cross-sectional | Brazil | 447 | 447 | 42/405 | IS6110 | ZN | 7H9,MGIT | sp,bal | – | 124/0 | 41 | 7 | 1 | 75 |
Sanjuan-Jimenez 2015 [32] | Case-control | Spain | 153 | 145 | 76/69 | senX3-regX3 | ZN | LJ,MGIT | sp,ba,bal | pf,In,ur,csf,ar | 125/20 | 65 | 0 | 11 | 69 |
Sanjuan-Jimenez 2015 [32] | Case-control | Spain | 153 | 145 | 76/69 | IS6110 | ZN | LJ,MGIT | sp,ba,bal | pf,In,ur,csf,ar | 125/20 | 72 | 9 | 4 | 60 |
Quality evaluation
Diagnostic accuracy of hRT-PCR assay
Accuracy Measure | Pooled summary measurea (95% CI) | P value for heterogeneityb |
---|---|---|
Sensitivity | 0.96 (0.95–0.96) | < 0.001 |
Specificity | 0.92 (0.90–0.93) | < 0.001 |
Positive Likelihood Ratio (LR+) | 16.90 (7.22–39.56) | < 0.001 |
Negative Likelihood Ratio (LR-) | 0.11 (0.06–0.18) | < 0.001 |
Diagnostic Odds Ratio (DOR) | 192.96 (68.46–543.90) | < 0.001 |
Exploration of heterogeneity
Subgroup (Number of studies) | Summary diagnostic odds ratio (95% CI)a | Chi2 square test of heterogeneity | P value for heterogeneityb |
---|---|---|---|
Study design | |||
Cross-sectional (10) | 403.18 (120.05–1354.05) | 36.66 | < 0.001 |
Case-control (8) | 73.86 (20.40–267.48) | 34.01 | < 0.001 |
Target sequence | |||
IS6110 (11) | 144.74 (51.24–408.86) | 39.39 | < 0.001 |
Other target (7) | 297.17 (30.22–2921.73) | 66.27 | < 0.001 |
Specimen type | |||
Respiratory (11) | 598.12 (269.12–1329.32) | 19.09 | 0.039 |
Non-respiratory (5) | 12.39 (6.67–22.73) | 3.57 | 0.468 |
Both (2) | 202.47 (64.68–633.83) | 0.00 | 0.944 |
Region of study | |||
TB high-burden country (8) | 281.86 (37.69–2107.75) | 90.46 | < 0.001 |
Other country (10) | 160.73 (72.80–354.83) | 15.17 | 0.086 |
Quality of study | |||
High-quality (7) | 926.97 (303.59–2830.38) | 12.83 | 0.046 |
Medium-quality (8) | 76.77 (22.98–256.50) | 26.65 | < 0.001 |
Low-quality (3) | 72.35 (4.47–1170.04) | 19.07 | < 0.001 |
Intercept | Coefficient | P value | Relative diagnostic odds ratio (RDOR) | 95% confidence interval |
---|---|---|---|---|
Intercept | 5.347 | 0.0000 | – | – |
Threshold (S) | 0.169 | 0.5382 | – | – |
TB high-burden country vs. other country | 0.756 | 0.3056 | 2.13 | (0.46;9.96) |
IS6110 vs. other target sequences | −0.812 | 0.2266 | 0.44 | (0.11;1.77) |
Cross-sectional design vs. case-control design | −0.759 | 0.5102 | 0.47 | (0.04;5.45) |
High-quality level vs moderate/low-quality level | 1.175 | 0.0272 | 3.24 | (1.17;9.00) |
Respiratory specimens vs non-respiratory specimens /both | 2.262 | 0.0025 | 9.60 | (2.54;36.25) |