Reporting checklist for diagnostic test accuracy studies.

Reporting checklist for diagnostic test accuracy studies.</p

Summary of diagnostic accuracy for qXR version 4 using the culture (primary) and Xpert (secondary) reference standards in the triage and screening cohorts.

Summary of diagnostic accuracy for qXR version 4 using the culture (primary) and Xpert (secondary) reference standards in the triage and screening cohorts.</p

Summary of diagnostic accuracy for qXR version 3 compared to the culture (primary) and Xpert (secondary) reference standards.

Summary of diagnostic accuracy for qXR version 3 compared to the culture (primary) and Xpert (secondary) reference standards.</p

Sensitivity of qXR version 4 for culture-confirmed pulmonary tuberculosis, overall and in pre-specified stratified groups.

Sensitivity of qXR version 4 for culture-confirmed pulmonary tuberculosis, overall and in pre-specified stratified groups.</p

Optimized, automated TruTip extraction protocol for liquefied, raw sputum.

<p>Optimized, automated TruTip extraction protocol for liquefied, raw sputum.</p

<i>M</i>. <i>tuberculosis</i> DNA detection efficacy relative to primary sample characteristics.

<p><i>M</i>. <i>tuberculosis</i> DNA detection efficacy relative to primary sample characteristics.</p

Study flow diagram.

Tuberculosis (TB) transmission in healthcare facilities is common in high-incidence countries. Yet, the optimal approach for identifying inpatients who may have TB is unclear. We evaluated the diagnostic accuracy of qXR (Qure.ai, India) computer-aided detection (CAD) software versions 3.0 and 4.0 (v3 and v4) as a triage and screening tool within the FAST (Find cases Actively, Separate safely, and Treat effectively) transmission control strategy. We prospectively enrolled two cohorts of patients admitted to a tertiary hospital in Lima, Peru: one group had cough or TB risk factors (triage) and the other did not report cough or TB risk factors (screening). We evaluated the sensitivity and specificity of qXR for the diagnosis of pulmonary TB using culture and Xpert as primary and secondary reference standards, including stratified analyses based on risk factors. In the triage cohort (n = 387), qXR v4 sensitivity was 0.91 (59/65, 95% CI 0.81–0.97) and specificity was 0.32 (103/322, 95% CI 0.27–0.37) using culture as reference standard. There was no difference in the area under the receiver-operating-characteristic curve (AUC) between qXR v3 and qXR v4 with either a culture or Xpert reference standard. In the screening cohort (n = 191), only one patient had a positive Xpert result, but specificity in this cohort was high (>90%). A high prevalence of radiographic lung abnormalities, most notably opacities (81%), consolidation (62%), or nodules (58%), was detected by qXR on digital CXR images from the triage cohort. qXR had high sensitivity but low specificity as a triage in hospitalized patients with cough or TB risk factors. Screening patients without cough or risk factors in this setting had a low diagnostic yield. These findings further support the need for population and setting-specific thresholds for CAD programs.</div

Dilution of sputum extracts to investigate inhibition.

<p>Average C_t value of serially diluted sputum extracts for selected samples with variable quality characteristics (n = 3 for each C_t value; R² > 0.997 for each sample).</p

Relative impact of MagVor homogenization and lysis on <i>M</i>. <i>tuberculosis</i> DNA recovery from non-liquefied, raw sputum.

<p>Relative impact of MagVor homogenization and lysis on <i>M</i>. <i>tuberculosis</i> DNA recovery from non-liquefied, raw sputum.</p

Specificity of qXR version 4 for culture-confirmed pulmonary tuberculosis, overall and in pre-specified stratified groups.

Specificity of qXR version 4 for culture-confirmed pulmonary tuberculosis, overall and in pre-specified stratified groups.</p