STUDY OUTCOME MEASURES AND ANALYSIS Sample Clauses

STUDY OUTCOME MEASURES AND ANALYSIS. The main outcomes of interest are sensitivity and specificity of the point of care TransDot test during phase 3 of this study. Sensitivity will be calculated as the proportion of true positives (as determined by the composite gold standard of TB case definitions), who test positive on the TransDot test. Specificity will be calculated as the proportion of true negatives who test negative on the TransDot test. For the primary analysis, the true positives as determined by the composite gold standard of TB case definitions, will consist of the Definite and Probable TB classes. The Possible TB class will be excluded as their diagnosis may involve a significant amount of uncertainty. This group will be included in a secondary analysis to show the TransDot test’s performance in this uncertain group of participants. Secondary outcomes of interest are positive and negative predictive values of the TransDot test, which will be calculated as the proportion of participants with positive or negative tests who are positive or negative according to case definitions, respectively. Sensitivity, specificity, positive and negative predictive values will be reported with 95% confidence intervals. Reproducibility of the test will be determined between laboratory based tests and point of care tests, as well as between the point of care tests conducted in the different countries, using the Kappa statistic for agreement.
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