Table 1.
Study characteristics
| Study | Health system level | Microscopy type | TB culture type | MGIT contamination rate | Tests done on stored sputum | Xpert specimen type | Median Age (IQR) | Female | HIVa | Culture-positive TBb | Smear- negative TBc |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Evaluation Studies | |||||||||||
| Brazil | Reference Lab | Direct ZN ×2 | 2x MGIT, 2x LJ | 0% | Xpert Culture |
Frozen Processed | 48 (35–60) | 40% | 0.4% | 32% | 25% |
| Peru | Reference Lab | Direct ZN ×2 | 2x MGIT, 2x LJ | 1·3% | Xpert Culture |
Fresh Processed | 43 (28–56) | 50% | 1.0% | 22% | 42% |
| South Africa | Reference Lab | Direct ZN ×2 | 2x MGIT, 2x LJ | 3·1% | Xpert Culture |
Fresh Processed | 39 (29–47) | 34% | 35% | 26% | 51% |
| Vietnam | Reference Lab | Direct ZN ×2 | 2x MGIT, 2x LJ | 0% | Xpert Culture |
Frozen Processed | 39 (26–50) | 30% | 2% | 66% | 42% |
| Demonstration Study | |||||||||||
| India | Microscopy center | Direct ZN ×2 | MGIT, LJ | 6·5% | Culture | None | 40 (27–51) | 35% | 2% | 11% | 25% |
| Request for Application (RFA) Studies | |||||||||||
| India | University-affiliated DOTS clinic | Direct ZN × 1 | MGIT | 11·5% | Xpert Culture |
Frozen Processed | 43 (29–55) | 37% | 2% | 15% | 54%3 |
| Vietnam | Microscopy center | Direct ZN × 2 | MGIT | 0% | Xpert Culture |
Fresh Processed | 60 (52–70) | 42% | 0.5% | 8% | 59% |
| Malawi | Microscopy center | Direct FM × 1 | MGIT, LJ | 8·7% | Xpert Culture |
Fresh Direct | 35 (26–41) | 48% | 44% | 16% | 15%3 |
| Tanzania | District Hospital TB clinic | Direct FM × 2 | MGIT, LJ | 5·1% | Culture | Fresh Direct | 37 (28–46) | 45% | 6% | 29% | 28% |
| Uganda | District Hospital outpatient clinic | Direct FM ×2 | 2x MGIT, 2x LJ | 1·3% | Culture | Fresh Direct | 43 (30–54) | 43% | 48% | 31% | 45% |
| Ivory Coast | District Hospital outpatient clinic | Direct ZN ×2 | MGIT | 6·0% | Xpert Culture |
Fresh Processed | 38 (28–44) | 51% | 12% | 33% | 13% |
| Madagascar | University-affiliated DOTS clinic | Direct FM ×2 | 2x LJ | --- | Xpert Culture |
Fresh Direct | 42 (29–52) | 40% | --- | 37% | 27% |
| Sponsored Study | |||||||||||
| Haiti (Kaku, et al) | Urban Hospital outpatient clinic | Direct FM ×2 | 3x MGIT | 0% | Culture | None | --- | --- | --- | 34% | 23% |
--- information not available
Abbreviations: TB tuberculosis, MGIT Mycobacterial Growth Indicator Tube, ZN Ziehl-Neelsen, FM fluorescence microscopy, LJ Lowenstein-Jensen
aHIV unknown counted as negative. Reflects proportion of study population known to be HIV positive
bReference standard 3 used for all studies in this calculation
cSmear microscopy results based on analysis of 1 smear only