Table 3 Primary analysis. Diagnostic test values using aggregated culture results as the reference standard. Comparison between the per-protocol and the intention-to-treat cohort.
Per-protocol analysis; Microbiological gold-standard (n = 166) | Intention to treat analysis; Microbiological gold standard (n = 216) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sensitivity (95%CI*) | Specificity (95%CI) | PPV§ (95%CI) | NPV# (95%CI) | Sensitivity (95%CI) | Specificity (95%CI) | PPV (95%CI) | NPV (95%CI) | |||||||||
Overall | ||||||||||||||||
Smear microscopy | 0.54 (0.33;0.73) | 0.99 (0.96;1.00) | 0.93 (0.68;1.00) | 0.92 (0.87;0.96) | 0.52 (0.32;0.71) | 0.99 (0.97;1.00) | 0.93 (0.68;1.00) | 0.95 (0.86;0.97) | ||||||||
Xpert MTB/ RIF | 0.73 (0.52;0.88) | 0.96 (0.92;0.99) | 0.79 (0.58;0.93) | 0.95 (0.90.0.98) | 0.70 (0.50;0.86) | 0.97 (0.94;0.99) | 0.79 (0.58;0.93) | 0.96 (0.92; 0.98) | ||||||||
RT-MTB | 0.92 (0.75;0.99) | 0.80 (0.72;0.86) | 0.46 (0.32; 0.61) | 0.98 (0.94;1.00) | 0.89 (0.71;0.98) | 0.80 (0.74;0.86) | 0.39 (0.27;0.53) | 0.98 (0.94;1.00) | ||||||||
p value = 0.06 | p alue < 0.001 | p value = 0.06 | p value < 0.001 | |||||||||||||
Smear negative | ||||||||||||||||
Xpert MTB/ RIF | 0.42 (0.15;0.72) | 0.97 (0.93;0.99) | 0.56 (0.21;0.86) | 0.95 (0.90;0.98) | 0.38 (0.14;0.68) | 0.98 (0.95;0.99) | 0.56 (0.21;0.86) | 0.96 (0.92;0.98) | ||||||||
RT-MTB | 0.83 (0.51;0.98) | 0.81 (0.73;0.87) | 0.27 (0.14;0.44) | 0.98(0.94;1.00) | 0.77 (0.46;0.95) | 0.81 (0.74;0.86) | 0.22 (0.11; 0.36) | 0.98 (0.94;1.00) | ||||||||
p value = 0.06 | p value < 0.001 | p value = 0.06 | p value < 0.001 | |||||||||||||
Smear positive | ||||||||||||||||
Xpert MTB/ RIF | 1.00 (0.77;1.00) | – | 0.93 (0.68;1.00) | – | 1.00 (0.77; 1.00) | – | 0.93 (0.68;1.00) | – | ||||||||
RT-MTB | 1.00 (0.77;1.00) | – | 0.93 (0.68;1.00) | – | 1.00 (0.77; 1.00) | – | 0.93 (0.68;1.00) | – | ||||||||
