Mobile Digital Fluorescence Microscopy for Diagnosis of Tuberculosis

摘要: Access to sputum smear microscopy in high-tuberculosis (TB)-burden regions is limited by a scarcity of microscopes and experienced technicians. We evaluated the accuracy CellScope, novel digital fluorescence microscope that may expand access microscopy. The study utilized slides prepared from specimens submitted consecutive adults with ≥ 2 weeks cough who were admitted Mulago Hospital (Kampala, Uganda). Conventional light-emitting diode (LED) (FM) mycobacterial culture performed Two U.S.-based postgraduate researchers without prior experience restained, imaged, interpreted using CellScope. assessed whether sensitivity specificity CellScope-based LED FM was noninferior conventional preselected margin inferiority 15%. Of 525 patients included, 72% HIV seropositive 39% had culture-confirmed TB. proportions positive results similar CellScope (34% versus 32%, respectively; P = 0.32), agreement substantial. within noninferiority for both (63% 70%; difference, -7%; 95% confidence interval [CI], -13% -1%) (85% 92%; CI, -12% -3%). A subanalysis 43 each reader found substantial interreader reliability (custom-weighted kappa, 0.65) variable intrareader 0.11 0.48). offers promise expanding services. Future studies should evaluate device when operated health workers low-resource settings, feasibility image transmission analysis microscopists, automated algorithms.