Table 1.

Repositories From Existing Studies Evaluating Tuberculosis Biomarkers

Reference Sample Biorepository	UCT Pediatric TB	Kenya Pediatric TB	Pneumonia Etiology Research for Child Health TB	Grand Challenges in Global Health GC6-74 Biomarkers for TB	Aeras TB	European Union Action for Diseases of Poverty, Diagnostics Consortium–TB	Foundation for Innovative New Diagnostics–TBa	Consortium for Tuberculosis Biomarkers–TB
Enrollment type(s)	P	P	P	A, P	A, P	A, P	A	A
HIV status, Positive or negative	Both	Both	Both	Both	Both	Both	Both	Both
Clinical categories	Suspected TB cases (n = 1800)	Children <5 y of age with (1) Suspected TB (n = 300), further categorized as definite, probable, possible, unlikely, no TB; (2) asymptomatic children (n = 100)	(1) Children with severe and very severe pneumonia and (2) healthy community controls	(1) Newly diagnosed adult pulmonary TB cases, (2) HHCs: adults with TB disease and healthy controls, (3) adolescents (non-HHC) including progressors with TB disease	Vaccine trial cohorts	(1) Suspected TB cases and (2) TB contacts further categorized as TB disease (culture positive, probable or possible TB), non-TB diseases, or healthy LTBI	Suspected pulmonary TB further categorized as (1) TB disease including (i) Smear and culture positive; (ii) smear negative, culture positive; (2) clinical diagnosis only, with response to treatment (chest radiograph), (3) not TB	Newly diagnosed pulmonary TB. Culture-confirmed TB disease specimens from clinical trials: TB Alliance, CDC TB Trials Consortium, and AIDS Clinical Trials Group
Countries included	South Africa	Kenya	South Africa, Zambia, Kenya, The Gambia, Mali, Thailand, Bangladesh	South Africa, The Gambia, Malawi, Uganda, Ethiopia	Sub-Saharan Africa	South Africa, Kenya, Malawi	Bangladesh, Brazil, Moldova Peru, South Africa, Vietnam, Zimbabwe. TDR/WHO TB Specimen Bank samples: Bangladesh, Brazil, Canada, Colombia, Kenya, Peru, South Africa, Spain, The Gambia, Uganda, Vietnam	To date: South Africa, Kenya, Uganda
Subject follow-up duration	6 mo if TB treatment given, 2 mo if TB treatment not given	6 mo or until TB treatment completion. Evaluations at 0, 0.5, 2, 6 mo)	Up to 30 d after hospital discharge	24 mo (HHC evaluations at 0, 6, 18 mo, index case evaluations at 0, 12 mo).	Up to 24 mo	6 mo	2–3 mo	Samples collection at treatment initiation, weeks 2, 4, and 8, months 4, 6, and 12. Also at time of relapse or withdrawal from study
Type of samples	Whole-blood (EDTA tube), whole blood (PAXgene tube), serum, induced sputum, NP swab, urine, stool, selected extrapulmonary specimens	Whole blood (PAXgene tube), plasma, serum, QFT supernatant, nasopharyngeal and oropharyngeal (NP/OP) swabs, gastric aspirate, urine, stool	Whole blood, nasopharyngeal and oropharyngeal (NP/OP) swabs, induced sputum or gastric aspirate (if no sputum; cases only), pleural fluid (cases only), lung aspirates (cases only), urine, postmortem lung needle biopsy	Serum, plasma, PBMC, RNA, DNA. Most samples stored at field sites, selected samples at UCT central repository	PBMC, whole blood, plasma, serum, urine	Whole blood (PAXgene tubes), plasma, throat swabs	Plasma (EDTA), plasma (P800), serum, sputum, saliva, urine	Whole blood (PAXgene tube),whole blood (EDTA), whole blood in QFT tubes (nil, mitogen, TB antigen), sputum, spot urine
Diagnostic gold standard	MGIT culture of 2× induced sputum or Xpert of respiratory specimen.	MGIT culture and Xpert MTB/RIF (suspected TB cohort, per participant): NP aspirate (2), induced sputum (2), gastric aspirate (2), string test (2), urine (2), stool (2); MGIT culture on blood (1)	TB culture	TB culture (solid and liquid), concentrated Ziehl-Neelsen microscopy post-NALC-NaOH.	TB culture	TB culture	TB culture (solid or liquid), concentrated Ziehl-Neelsen microscopy post-NALC-NaOH	TB culture (solid or liquid)
PI and contact	PI's Heather Zar and Mark Nicol (Mark.Nicol@uct.ac.za) (heather.zar@uct.ac.za)	PI Rinn Song (Rinn.Song@childrens.harvard.edu); Ellie Click (eoc9@cdc.gov); Kevin Cain (bvz1@cdc.gov)	PI Katherine O'Brien (kobrien2@jhu.edu) Contact: David Murdoch (David.murdoch@otago.ac.nz)	PI Stefan H. E. Kaufmann Contacts: Gerhard Walzl (gwalzl@sun.ac.za), Thomas Scriba (thomas.scriba@uct.ac.za), Katrina Downing (Katrina.Downing@uct.ac.za)	Contact: Lew Barker (LBarker@aeras.org) & Heather Siefers/Aeras; for SATVI Thomas Scriba (thomas.scriba@uct.ac.za)	Contact: Mike Levin (m.levin@imperial.ac.uk).	Contact: Eloise Valli (eloise.valli@finddiagnostics.org)	Contact: Derek Ambrosino (derek.ambrosino@tballiance.org)
Website	TBD	TBD	http://www.jhsph.edu/research/centers-and-institutes/ivac/projects/perch/	http://www.biomarkers-for-tb.net/consortium/the-consortium	http://www.aeras.org/	TBD	http://www.finddiagnostics.org/programs/tb/find_activities/tb_specimen_bank.html	www.tbbiorepository.org

Blank fields indicate no data available.

Abbreviations: A, adult; HHC, household contact; EDTA, ethylenediaminetetraacetic acid; HIV, human immunodeficiency virus; LTBI, latent tuberculosis; MGIT, mycobacteria growth indicator tube; NALC, N-acetyl-L-cysteine; NaOH, sodium hydroxide; NP, nasopharyngeal; OP, oropharyngeal; P, pediatric; PBMC, peripheral blood mononuclear cell; PI, principal investigator; QFT, Quantiferon-TB; SATVI, South African Tuberculosis Vaccine Initiative; TBD, to be determined; TDR/WHO, World Health Organization Special Programme for Research and Training in Tropical Diseases; UCT, University of Cape Town.

^a Also includes the TDR/WHO specimen samples. The WHO Tuberculosis Strain Bank has been transferred to the Institute of Tropical Medicine, Antwerp, Belgium.