Evaluation of a Urine-Based Rapid Molecular Diagnostic Test with Potential to Be Used at Point-of-Care for Pulmonary Tuberculosis Krutarth Patel, Matilde.

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Evaluation of a Urine-Based Rapid Molecular Diagnostic Test with Potential to Be Used at Point-of-Care for Pulmonary Tuberculosis Krutarth Patel, Matilde Nagel, Maria Wesolowski, Stefan Dees, Eric Rivera-Milla, Christof Geldmacher, Keertan Dheda, Michael Hoelscher, Ines Labugger The Journal of Molecular Diagnostics Volume 20, Issue 2, Pages 215-224 (March 2018) DOI: 10.1016/j.jmoldx.2017.11.005 Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 1 Laboratory tuberculosis (TB) test results for Mycobacterium growth indicator tube (MGIT) and Xpert MTB/RIF tests. Smear microscopy tests were performed in case of sputum availability. The Journal of Molecular Diagnostics 2018 20, 215-224DOI: (10.1016/j.jmoldx.2017.11.005) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 2 H37Rv genomic DNA (gDNA) PCR (dotted line) and capture calibration (dashed line) curves for the amplified direct repeat (DR) region. The amplification efficiencies for PCR and capture calibration curves were 108% and 104%, respectively. Serially diluted H37Rv gDNA were tested in triplicates, and the mean threshold cycle (CT) value is plotted against the log copy (log 0 to log 4). The square and triangular point on the calibration line represent CT values for corresponding log copy measured. The Journal of Molecular Diagnostics 2018 20, 215-224DOI: (10.1016/j.jmoldx.2017.11.005) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions

Figure 3 Flow diagram showing tuberculosis (TB) diagnosis based on the urine transrenal (Tr)–DNA assay using an automated analyzer. The performance characteristics of the Tr-DNA assay were compared against the liquid culture in HIV-positive and HIV-negative patients. In total, 428 patients were included in the study, and for 413 of them a liquid culture test result was available. Asterisk indicates HIV status not available in 1 patient. MGIT, Mycobacterium growth indicator tube. The Journal of Molecular Diagnostics 2018 20, 215-224DOI: (10.1016/j.jmoldx.2017.11.005) Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology Terms and Conditions