Fig 1.
Study flow diagram representing steps from inclusion of adults and children to arrival of the stool samples at EPHI and their allocation to the different experiments.
* Site of action is depicted with blue background boxes; and stool samples are in yellow boxes. Abbreviations used: ASTTIE; Alternatives to Sputum Testing for Tuberculosis in Indonesia and Ethiopia, PODTEC: Painless Optimized Diagnosis of TB in Ethiopian Children, NTRL: National TB Reference Laboratory, NGA: Naso-Gastric Aspiration, MTB: M.tuberculosis, GX; GeneXpert, Exp.: Experiment.
Fig 2.
Arrows indicate what experiments are done with the different stool specimens. Note that for adult participants, in principle all experiments will be done on all three stool samples, provided that enough stool is collected per bowel movement. Abbreviations used: MTB, M. tuberculosis; N, North; S, South; E/W, East or West; Exp, experiment; RT, room temperature; H, hours; SR, sample reagent; g, gram.
Fig 3.
Overview of assigning stool to the experiments outlined in Fig 2.
Note that for adults, in principle, all experiments will be conducted if there is enough stool available per sample. Abbreviations used: ASTTIE; Alternatives to Sputum Testing for Tuberculosis in Indonesia and Ethiopia, MTB: M. tuberculosis, GX; GeneXpert, Exp.: Experiment; g, gram: ml, milliliter. Explanation of experiment numbers: Experiment 1: Stool sampling strategy; Experiment 2: Stool sample storage conditions; Experiment 3a: incubation time and shaking method; Experiment 3b: time and temperature for keeping the processed stool-sample reagent mixture; Experiment 3c: stool volume.
Fig 4.
Required sample size as estimated using McNemar’s two-sample paired proportions test using Stata SE v.
17.0, assuming discordance in pairs of stool aliquots.