A stool based qPCR for the diagnosis of TB in children and people living with HIV in Uganda, Eswatini and Mozambique (Stool4TB): a protocol for a multicenter diagnostic evaluation

Table 2 Definitions for the pediatric cohort

TB case	“Confirmed tuberculosis”	M. tb to be laboratory-confirmed (culture or NAAT-based assay) from at least 1 specimen or positive urine LAM
TB case	“Unconfirmed tuberculosis”	Bacteriological confirmation not obtained and at least 2 of the following: 1. symptoms/signs suggestive of tuberculosis, 2. chest radiograph consistent with tuberculosis, 3. close tuberculosis exposure or immunologic evidence of M. tuberculosis infection 4. positive response to tuberculosis treatment (requires documented positive clinical response on tuberculosis treatment—no time duration specified)
Not TB case	“Unlikely tuberculosis”	bacteriological confirmation not obtained and criteria for “unconfirmed tuberculosis” not met

For the adult cohort participants will be classified as “bacteriologically confirmed TB” or “clinically diagnosed TB”. “TB case” definition will be equivalent to decision to start treatment irrespective of bacteriological confirmation so it will include both “bacteriologically confirmed TB” and “clinically diagnosed TB”

ISSN: 1471-2334