FIG 2.

Limit of detection (LOD) of the Genedrive assay for detection of M. tuberculosis. LOD of Genedrive assay using (A) M. tuberculosis DNA. M. tuberculosis DNA at final concentration of 10 fg, 1pg, 10 pg, 100 pg, and 1 ng per PCR vial was loaded into Genedrive PCR cartridges and was processed according to the Genedrive protocol. (B) M. tuberculosis H37Rv mc²6030 quantified culture cells in water. M. tuberculosis mc²6030 quantified cells diluted in sterile water were tested by the Genedrive assay at final concentrations ranging from 10¹ to 10⁷ CFU/ml (n = 15); the percentage of M. tuberculosis positive results was plotted for each dilution. (C) M. tuberculosis H37Rv mc²6030 quantified culture cells in Sputum. M. tuberculosis mc²6030 cells were added to TB negative sputum to final concentrations of 10¹ to 10⁷ CFU/ml (n = 20) and were then processed according to the Genedrive assay protocol. The percentage of assays where M. tuberculosis was detected was then plotted for each concentration of cells.