Miniature objective lens for array digital pathology: design improvement based on clinical evaluation

A miniature objective designed for digital detection of Mycobacterium tuberculosis (MTB) was evaluated for diagnostic accuracy. The objective was designed for array microscopy, but fabricated and evaluated at this stage of development as a single objective. The counts and diagnoses of patient samples were directly compared for digital detection and standard microscopy. The results were found to be correlated and highly concordant. The evaluation of this lens by direct comparison to standard fluorescence sputum smear microscopy presented unique challenges and led to some new insights in the role played by the system parameters of the microscope. The design parameters and how they were developed are reviewed in light of these results. New system parameters are proposed with the goal of easing the challenges of evaluating the miniature objective and maintaining the optical performance that produced the agreeable results presented without over-optimizing. A new design is presented that meets and exceeds these criteria.