Diagnostic accuracy of Xpert in the diagnosis of child tuberculosis: data extraction form
I. ID
Study ID	First Name/Publication Year
First author	Name
Corresponding author	Name
Corresponding author email	Email
Was author contacted?	1 – Yes 2 – No If yes, dates(s)
If yes, author response?
Study data	1 ‐ Published 2 ‐ In press 3 ‐ Ongoing
Title
Year (of publication)	YYYY or 9 – Not reported
Year study start date	YYYY or 9 – Not reported
Language	1 – English 2 – Other If other, specify:
II. Study details
Country where study was conducted
Country World Bank classification	1 ‐ Low income 2 ‐ Middle income 3 ‐ High income 4 ‐ Low and high income 5 ‐ Other combination, describe
Country tuberculosis burden (WHO 2015)	1 ‐ WHO tuberculosis high burden 2 ‐ WHO tuberculosis/HIV high burden 3 ‐ WHO MDR tuberculosis high burden 4 ‐ WHO tuberculosis + MDR tuberculosis high burden 5 ‐ WHO tuberculosis + HIV/tuberculosis high burden 6 ‐ WHO tuberculosis + HIV/tuberculosis + MDR tuberculosis high burden 7 ‐ Not a WHO high‐burden country 8 ‐ Both non‐high‐burden and high‐burden countries included 9 ‐ Other
Study design	1 – Randomized controlled trial 2 – Cross‐sectional 3 – Cohort 4 – Other, specify 9 – Could not tell If other, describe:
Participant selection	1 – Consecutive 2 – Random 3 – Convenience 7 – Other 9 – Unknown/Not reported
Direction of study data collection	1 – Prospective 2 – Retrospective 9 – Unknown/Not reported
Inclusion criteria	1 – Broad 2 – Rigorous 9 – Unknown/Not reported
Inclusion criteria for presumptive tuberculosis	1 – Tuberculosis contact 2 – Cough 3 – Loss of weight 4 – Suggestive chest X‐ray 5 – Immunological evidence of tuberculosis infection (TST/IGRA) 6 ‐ Malnutrition 7 – HIV 8 ‐ Other, describe 9 – Unknown/Not reported
Describe inclusion criteria as in study
Number included after recruitment by inclusion and exclusion criteria	Enter number or 9 – Unknown/Not reported
Total number of children included in systematic review analysis	Enter number or 9 – Unknown/Not reported
Total number of specimens included in analysis with collection method	Enter number or 9 – Unknown/Not reported
Unit of analysis (Xpert)	1 – One specimen per patient 2 – Multiple specimens per patient 3 ‐ Unknown number of specimens per patient 9 – Unknown/Not reported Describe as written in study, if unclear:
Did the study include patients with previous tuberculosis history?	1 – Yes 0 – No 9 – Unknown/Not reported
If so, what is the percentage?	Enter % and specify numerator/denominator
Target condition? Pulmonary tuberculosis?	1 ‐ Yes 0 ‐ No
Target condition? Rifampicin resistance?	1 ‐ Yes 0 ‐ No
Target condition? Lymph node tuberculosis?	1 ‐ Yes 0 ‐ No
Target condition? Tuberculous meningitis?	1 ‐ Yes 0 ‐ No
Comments about study design
III. Patient characteristics and setting
Description of study population (age, HIV info, etc.)	1 – All enrolled 2 – All analysed 9 – Unknown/Not reported
Age: median, mean, range by months	Enter number or 9 – Unknown/Not reported
Gender	##/total and % female
HIV status of participants	0 – HIV‐ 1 – HIV+ 2 – Both HIV+/‐ 9 – Unknown/Not reported
If HIV‐positive participants included, what is the percentage?	% and specify numerator/denominator
Type of respiratory specimen included	1 – All expectorated 2 – All induced 3 – All bronchoalveolar lavage 4 – All gastric lavage 5 – Nasopharyngeal aspirate 6 ‐ Stool 7 – Multiple types 8 – Other 9 – Unknown/Not reported If 7 or 8, describe types and record numbers:
Type of non‐respiratory specimen	1 – Fine needle aspirate 2 – Lymph node biopsy 3 – Cerebrospinal fluid 4 – Multiple types 5 ‐ Other 9 ‐ Unknown/Not reported If 4 or 5, describe types and record numbers:
Were Xpert sample and culture obtained from same specimen?	1 – Yes 0 – No 9 – Unknown/Not reported
Number of cultures used to exclude tuberculosis	Describe
Information on smear microscopy: was it used?	1 – Yes 0 – No 9 – Unknown/Not reported
Type of microscopy used	1 – Ziehl‐Neelsen 2 – Fluoresence microscopy 3 ‐ Light emitting diode‐based fluorescence microscopy 4 ‐ Multiple, describe: 9 – Unknown/Not reported
Smear type	1 – Direct 2 – Concentrated (processed) 3 ‐ Both direct and concentrated 9 – Unknown/Not reported
Data on culture performance provided?	# of contaminated culture/Total # cultures performed or 9 ‐ Unknown/Not reported
Were patient‐important outcomes evaluated? (time to diagnosis, time to treatment, others)	1 – Yes 2 – No 9 – Unknown/Not reported
Time to diagnosis?	Xpert: Culture: 9 – Unknown/Not reported Specify whether time from sample collection to diagnosis in lab or just turnaround time in lab
Time to treatment initiation	Xpert: Culture: 9 – Unknown/Not reported
Clinical setting, describe as written in the paper	1 – Outpatient 2 – Inpatient 3 – Both outpatient and inpatient 4 – Other, specify 5 – Laboratory based 9 – Unknown/Not reported Describe as in paper:
Laboratory services level	1 ‐ Central (reference) 2 ‐ Intermediate (regional) 3 ‐ Peripheral (microscopy centre, provincial hospital) 4 – Research laboratory 5 ‐ Other, specify
Where were Xpert tests performed? (tests generally available at different laboratory levels, although tests may overlap) Peripheral: acid‐fast bacilli (Ziehl‐Neelsen, Auramine‐rhodamine, Auramine‐O staining) and Xpert MTB/RIF Intermediate: peripheral laboratory tests and culture on solid media and line probe assay (LPA) from smear‐positive sputum Central: intermediate laboratory tests and culture on liquid media and DST (1st‐line and 2nd‐line anti‐tuberculosis drugs) on solid or in liquid media and LPA on positive cultures and rapid speciation tests	1 ‐ Central (reference) 2 ‐ Intermediate (regional) 3 ‐ Peripheral (microscopy centre, provincial hospital) 4 ‐ Other, specify
Was Xpert run outside of a laboratory?	1 ‐ Yes 0 ‐ No
Current treatment: were patients on treatment (defined as tuberculosis drugs for longer than 7 days) for the current tuberculosis episode? (note: may impact culture results)	1 – Yes 2 – No 9 – Unknown/Not reported
If so, what is the percentage?	% Specify numerator/denominator
IV. Index test
Xpert cartridge(s) evaluated	1 ‐ Xpert only 2 ‐ Ultra only 3 ‐ Any combination Xpert and Ultra
Xpert platform: was Omni used? Unless Omni was explicitly described, assume standard platform	1 – Yes, only Omni used for Xpert tests 2 – Yes, both Omni and standard platform used for Xpert tests 3 ‐ No
Pretreatment processing procedure for GeneXpert	1 – None 2 – NALC‐NaOH 3 – NaOH (Petroff) 4 – Other 9 – Unknown/Not reported
For Xpert specimen, what was the condition of the specimen when tested?	1 – Fresh 2 – Frozen 9 – Unknown/Not reported
Were uninterpretable (invalid error or no result) results reported for Xpert for tuberculosis detection?	1 – Yes 9 – Unknown/Not reported If yes, describe numbers:
Were indeterminate results reported for Xpert for rifampicin resistance?	1 – Yes 9 – Unknown/Not reported If yes, describe numbers:
V. Reference standard
For tuberculosis detection, what reference standard(s) was used? Respiratory samples?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 9 – Unknown/Not reported 1a ‐ Solid culture LJ 7H10 7H11 Other 2a – Liquid culture MGIT 960 Other (specify):
For tuberculosis detection, what reference standard(s) was used? Lymph node?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 9 – Unknown/Not reported 1a ‐ Solid culture LJ 7H10 7H11 Other 2a – Liquid culture MGIT 960 Other (specify):
For tuberculosis detection, what reference standard(s) was used? Cerebrospinal fluid?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 9 – Unknown/Not reported 1a ‐ Solid culture LJ 7H10 7H11 Other (specify): 2a – Liquid culture MGIT 960 Other (specify):
Reference standard pulmonary tuberculosis: clinical	1 ‐ Yes 0 – No Multiple answers, list:
If clinical, describe as in paper
For rifampicin resistance detection, what reference standard(s) was used? Respiratory samples?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 4 – M tuberculosis DRplus 9 – Unknown/NR 1a ‐ Solid culture LJ 7H10 7H11 Other: Specify method (e.g. proportion): 2a – Liquid culture MGIT 960 Other (specify):
For rifampicin resistance detection, what reference standard(s) was used? Lymph node?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 4 – M tuberculosis DRplus 9 – Unknown/Not reported 1a ‐ Solid culture LJ 7H10 7H11 Other: Specify method (e.g. proportion): 2a – Liquid culture MGIT 960 Other (specify):
For rifampicin resistance detection, what reference standard(s) was used? Cerebrospinal fluid?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 4 – M tuberculosis DRplus 9 – Unknown/Not reported 1a ‐ Solid culture LJ 7H10 7H11 Other: Specify method (e.g. proportion): 2a – Liquid culture MGIT 960 Other (specify):
If information is available
Is information on quality assurance of DST available in the study?	1 – Yes 2 ‐ No 9 – Unknown/Not reported If yes, describe potential sources of bias