TABLE 2.
Method by HIV status | Number of test results with valid results by reference standard |
Number positive for test: % sensitivity (95% CIb) | Pc | Number negative for test: % specificity (95% CIb) | Pc | ||
---|---|---|---|---|---|---|---|
M. tuberculosis detected | M. tuberculosis not detected | Contaminated | |||||
HIV-infected stratum | |||||||
Reference standard (MGIT)d | 146 | 527 | 40 | ||||
Comparison of direct AFB to SMFe | |||||||
Direct AFB EM + spotf for SMF comparison | 135 + 134 | 479 + 488 | 30 + 35 | 183: 68.0 (60.6 to 74.6) | 0.81 | 959: 99.2 (97.9 to 99.7) | 0.79 |
SMF EM + spotf | 136 + 134 | 479 + 481 | 29 + 35 | 18: 67.4 (59.9 to 74.1) | 956: 99.3 (98.2 to 99.7) | ||
Comparison of direct AFB or SMF to Xpert MTB/RIFe | |||||||
Xpert MTB/RIF | 134 | 479g | 34 | 122: 91.0 (85.0 to 94.8) | 464: 96.9 (94.9 to 98.1) | ||
Direct AFB spot for Xpert comparison | 135 | 491 | 35 | 93: 68.9 (60.6 to 76.1) | <0.001 | 488: 99.4 (98.2 to 99.8) | 0.003 |
SMF for Xpert comparison | 134 | 482 | 29 + 35 | 90: 67.2 (58.8 to 74.5) | <0.001 | 478: 99.2 (97.9 to 99.7) | 0.011 |
HIV-uninfected stratum | |||||||
Reference standard (MGIT)d | 85 | 212 | 6 | ||||
Comparison of direct AFB to SMFe | |||||||
Direct AFB EM + spotf for SMF comparison | 76 + 76 | 197 + 200 | 6 + 6 | 122: 80.3 (70.8 to 87.2) | 0.067 | 390: 98.2 (95.6 to 99.3) | 0.56 |
SMF EM + spotf | 74 + 75 | 196 + 200 | 6 + 6 | 108: 72.5 (62.1 to 80.9) | 388: 98.0 (95.4 to 99.1) | ||
Comparison of direct AFB or SMF to Xpert MTB/RIFe | |||||||
Xpert MTB/RIF | 77 | 197 † | 6 | 72: 93.5 (85.7 to 97.2) | 190: 96.4 (92.8 to 98.3) | ||
Direct AFB spot for Xpert comparison | 79 | 199 | 6 | 64: 81.0 (71.0 to 88.1) | 0.001 | 196: 98.5 (95.7 to 99.5) | 0.044 |
SMF for Xpert comparison | 75 | 200 | 6 | 54: 72.0 (61.0 to 80.9) | <0.001 | 196: 98.0 (95.0 to 99.2) | 0.24 |
AFB, acid-fast bacilli.
CI, confidence interval.
Since all comparisons used multiple results per person, P values were calculated using the generalized estimating equations score test.
Reference standard was based on manual MGIT liquid culture (three samples), with the final MGIT culture result determined as a composite of three values; any positive culture determined a positive composite result.
Comparisons of direct AFB versus SMF use an early morning (EM) sample plus a spot sample randomized for SMF testing. Comparisons of direct AFB versus Xpert MTB/RIF use one sample randomized for Xpert MTB/RIF testing. Comparisons of SMF versus Xpert MTB/RIF use one sample randomized to Xpert MTB/RIF.
EM, early morning. When two samples from a participant are used for analysis, the number of EM and spot samples was delineated (EM + spot).
One Xpert MTB/RIF result was contaminated and excluded.