Table 1.
List of tests and reference standard definitionsτ.
Fig 1.
ATT, anti-TB therapy; CRS, composite reference standard; eMRS, extended microbiological reference standard; MRS, microbiological reference standard. Unclassifiable is neither reference standard positive nor reference standard negative. Reasons for non-eligibility of the 1797 persons screened but not enrolled were: being HIV negative, not interested to participate in the study, already on anti-TB treatment, on isoniazid preventive therapy, not willing to come back for follow-up visit, too weak or confused, refused to give blood.
Table 2.
Demographic and clinical characteristics of study participants.
Table 3.
Sensitivity and specificity of Day 1 FujiLAM against the eMRS.
Fig 2.
Out of the total of 1637 participants, nine did not have a valid FujiLAM result on Day 1 and were not included in the FujiLAM Day 1 diagnostic accuracy analysis. FN, false negative; FP, false positive; N, number; TN, true negative; TP true positive.
Fig 3.
Exploratory comparison of FujiLAM positivity rates in 111 eMRS negative, FujiLAM positive Day 1 samples from the study.
eMRS, extended microbiological reference standard; NTM, nontuberculous mycobacteria; CRS, composite reference standard; Red cells indicate positive result and light blue cells indicate negative result on FujiLAM or AlereLAM. For AlereLAM positive results, the numbers further indicate line grade intensity (1–3). LAM concentration measured with EclLAM is illustrated on the purple scale from darkest to lightest: >200 pg/mL, 51–200 pg/mL, 11–50 pg/mL; diagonal stipe pattern indicates <limit of detection (11 pg/mL); Dark yellow–Full NTM speciation not done; green—slow growing mycobacteria; dark blue- fast growing mycobacteria; A- M. simiae; B- M. intracellulare; C- M. avium, D- M. scrofulaceum; D- M. gordonae; F- M. fortuitum; Dark grey- CRS positive, mid grey-CRF neg, light grey- unclassifiable. Very dark green: CD4 counts of ≤100 cells/μl; dark green: CD4 counts of 101–200 cells/μl; mid green: CD4 counts of 201–500 cells/μl; light green: CD4 counts of ≥500 cells/μl; white: no CD4 data available.