Fig 1.
Developed kits: (A) ‘TB detect’ kit; (B) ‘TB concentration & transport’ kit; and (C) ‘TB DNA extraction’ kit.
Fig 2.
(A) Sample processing and staining of BioFM-Filter by using ‘TB detect’ kit; (B) sample processing by using ‘TB concentration & transport’ kit; (C) DNA extraction from Trans-Filter by using ‘TB DNA extraction’ kit.
Fig 3.
Study design.
Fig 4.
Workflow of the ‘TB detect’ kit evaluation study.
Fig 5.
Workflow of the ‘TB concentration & transport’ kit and ‘TB DNA extraction’ kit evaluation study.
Fig 6.
(A) Limit of Detection of BioFM-Filter microscopy (40x magnification); (B) PCR amplification of DNA isolated from Trans-Filter. 10, 5, 1 indicate the amount of DNA (in μl) added in PCR and I indicates inhibitor check reaction. Numbers in panels (A) and (B) indicate the number of M. tuberculosis bacteria spiked in 1 ml of sputum; (C) Assessment of stability of DNA on Trans-Filter. Well 0 represents amplification of freshly isolated DNA (day 0) and wells 1 to 4 represent amplification of DNA isolated from Trans-Filters stored at 50ºC at weekly intervals upto 4 weeks. Data for a scanty smear grade sputum sample is shown.
Fig 7.
Comparison of smear grade status by ‘BioFM-Filter’ vs. Direct smear microscopy (LED-FM and ZN).
(A) At site 1, NITRD (n = 550); (B) At site 2, TB hospital, Ambala (n = 640); (C) combined performance at both the sites (n = 1190). Left panel: smear grade status; right panel: smear results.
Table 1.
Performance of ‘BioFM-filter’, LED-FM and ZN microscopy.
Fig 8.
Participant enrolment and testing in ‘TB concentration & transport’ kit and ‘TB DNA extraction’ kit evaluation study.
Table 2.
Performance of Mol-DST vs. phenotypic DST#.