I. ID
ID substudy (for study centres: a, b, c, etc)
First author
Corresponding author & email
Was author contacted?	1 – Yes 2 – No If yes, dates(s)
Title
Year (of publication)
Year (study start date)
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 ‐ Low and middle income 6 ‐ Low, middle, and high 7 – Other combination, describe
Purpose of testing as described in the study	1 ‐ Diagnosis 2 ‐ Screening in HIV‐positive people 9 ‐ Could not tell Study states:
Objective of study	1 ‐ Detection of PTB only 2 ‐ Detection of rifampicin resistance only 3 ‐ Both, detection of PTB and rifampicin resistance
Study design	1 – Randomized controlled trial 2 – Cross‐sectional 3 – Cohort 4 – Other, specify 9 – Could not tell If other, describe:
IIa. Questions about pre‐selection during enrolment
Were patients pre‐selected based upon microscopy results?	1 ‐ Yes 2 ‐ No 9 ‐ Unknown/NR
If yes, what was the basis for pre‐selection?	1‐ Primarily or exclusively smear positive 2 ‐ Primarily or exclusively smear negative 8 ‐ Not applicable
Did study include exclusively retreatment patients upon enrolment? (for example, patients who previously received first‐line drugs and those with nonconverting pulmonary tuberculosis who were receiving therapy)	1 ‐ Yes 2 ‐ No 9 ‐ Unknown/NR
Participant selection	1 – Consecutive 2 – Random 3 – Convenience 7 – Other 9 – Unknown/NR
Direction of study data collection	1 – Prospective 2 – Retrospective 9 – Unknown/NR
Number included after recruitment by inclusion and exclusion criteria	_____ 9 – Unknown/NR
Number included in analysis (# recruited ‐ # withdrawals)	_____ 9 – Unknown/NR
Unit of analysis	1 – Patient (with a single Xpert per patient) 2 – Specimen (there are more specimens than patients) 9 – Unknown/NR Describe as in paper, if unclear:
Comments about study design
III. Patient characteristics and setting
Presenting signs and symptoms
Did the study avoid inappropriate exclusions? Please list exclusions noted in study, if any (for example, study includes predominantly or exclusively smear‐positive or "difficult‐to‐diagnose" patients)	1 ‐ Yes 2 ‐ No 9 ‐ Unknonwn/NR Describe exclusions as stated in study:
Type of specimen (may include expectorated, induced, bronchial alveolar lavage (BAL), tracheal aspirates)(check all that apply). Assume expectorated sputum if not specifically stated.	1 – Expectorated sputum 2 – Induced sputum 3 – Bronchial alveolar lavage or bronchial aspirates 4 – Tracheal aspirates 6 – Other 9 – Unknown/NR If other, describe types and record numbers:
Clinical setting; describe as written in the paper	1 – Outpatient 2 ‐ Inpatient 3 – Both out‐ and in‐patient 4 – Other, specify 5 – Laboratory based 9 – Unknown/NR Describe as in paper:
Was Xpert testing performed at point of care? (POCT is diagnostic testing that will result in a clear and actionable management decision (e.g. start of treatment, referral, initiation of confirmatory test) within the same clinical encounter (e.g. same day). POCT should be mentioned in the study as it is unlikely if testing takes place in a central level laboratory.	1 ‐ Yes 2 ‐ No 9 ‐ Could not tell
Level of the laboratory system where Xpert tests were performed (Tests generally available at different laboratory levels, though tests may overlap) Central: Intermediate laboratory tests and culture on liquid media and DST (1st and 2nd line anti‐tuberculosis drugs) on solid or in liquid media and LPA on positive cultures and rapid speciation tests Intermediate: Peripheral laboratory tests and culture on solid media and line probe assay (LPA) from smear positive sputum Peripheral: AFB (Ziehl‐Neelsen, Auramine‐rhodamine, Auramine‐O staining) and Xpert MTB/RIF	1‐ Central 2 ‐ Intermediate 3 ‐ Peripheral 4‐ Other, specify Describe as in paper:
IV. Other demographics
Age (range, mean (SD), median (IQR))	9 ‐ Unknown/NR
##/total and % female	9 ‐ Unknown/NR
HIV status of participants	0 ‐ HIV ‐ 1 ‐ HIV + 2 ‐ Both HIV+/‐ 9 ‐ Unknown/NR
If HIV‐positive participants included, what is the percentage?	% (specify numerator/denominator)
Prior tuberculosis history: Did the study include patients with prior tuberculosis history?	1 ‐ Yes 2 ‐ No 9 ‐ Unknown/NR
If so, what is the percentage?	% (specify numerator/denominator) 9 ‐ Unknown/NR (for data entry write "NR")
Prior treatment: Did the study include patients with prior tuberculosis treatment?	1 ‐ Yes 2 ‐ No 9 ‐ Unknown/NR
If so, what is the percentage?	% (specify numerator/denominator) 9 ‐ Unknown/NR (for data entry write "NR")
Current treatment: Were patients on treatment (defined as tuberculosis drugs for greater than 7 days) for the current tuberculosis episode? (note: may impact culture results)	1 ‐ Yes 2 ‐ No 9 ‐ Unknown/NR
If so, what is the percentage?	% (specify numerator/denominator) 9 ‐ Unknown/NR (for data entry write "NR")
V. Index test
Xpert version(s) evaluated	1 ‐ Xpert MTB/RIF only 2 ‐ Xpert Ultra only 3 ‐ Any combination Xpert MTB/RIF and Xpert Ultra
Xpert platform: Was Omni used? Unless Omni explicitely 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
Was the index test result interpreted without knowledge of the result of the reference standard result?	1‐Yes (Since Xpert is automated, we will answer ‘Yes” for all studies)
VI. Reference standard
For tuberculosis detection, what reference standard(s) was used?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 9 – Unknown/NR 1a ‐ Solid culture LJ 7H10 7H11 Other 9‐ Unknown/NR 2a – Liquid culture MGIT 960 Other (specify): 9‐ Unknown/NR
For MGIT only, if more than one specimen was inoculated for culture, were these specimens obtained on different days?	1 – Yes 2 – No 8 – Not applicable 9 – Unknown/NR
For rifampicin resistance detection, what reference standard(s) was used?	1 – Solid culture (specify 1a) 2 – Liquid culture (specify 2a) 3 – Both solid and liquid culture (specify 1a and 2a) 4 ‐ MTBDRplus 5 ‐ Other, specify 9 – Unknown/NR 1a ‐ Solid culture LJ 7H10 7H11 Other Specify method, e.g., proportion 2a – Liquid culture MGIT 960 Other (specify)
Tuberculosis detection: Was the reference standard result interpreted without knowledge of the index test result? Answer yes for MGIT and LJ with species confirmation	1 – Yes 2 – No 9 – Unknown/NR
Rifampicin resistance detection: Was the reference standard result interpreted without knowledge of the index test result? Answer yes for MGIT	1 – Yes 2 – No 9 – Unknown/NR
VII. Specimen flow
Were Xpert sample and culture obtained from same specimen?	1 – Yes 2 – No 9 – Unknown/NR
What specimen processing procedure was used before testing with Xpert?	1 – None 2 – NALC‐NaOH 3 – NaOH (Petroff) 4 – Other 9 – Unknown/NR
Was microscopy used?	1 – Yes 2 – No 9 – Unknown/NR
Type of microscopy used	1 – Ziehl‐Neelsen 2 – Fluorescence microscopy 3 ‐ Both Ziehl‐Neelsen and fluorescence microscopy 9 – Unknown/NR
Smear type (if study used both direct and concentrated, select concentrated)	1 – Direct 2 – Concentrated (processed) 9 – Unknown/NR
For Xpert specimen, what was the condition of the specimen when tested?	1 – Fresh 2 – Frozen 3 ‐ Both fresh and frozen 9 – Unknown/NR
VIII. Results
Did the study report % contaminated cultures? (Enter percentage contaminated cultures, if provided): # of contaminated cultures/Total # cultures performed = %	1 – Yes ‐> % contaminated cultures: 2 – No
Did the study report the number of uninterpretable results for Xpert for tuberculosis detection? (invalid, error, no result) The uninterpretable rate for detection of PTB is the number of tests classified as “invalid,” “error,” or “no result” divided by the total number of Xpert tests performed.	1 – Yes ‐> # Uninterpretable results: Denominator is total number of Xpert tests performed (Add total from Table 1 plus # of uninterpretable results): 2 – No
Did the study report the number of indeterminate results for Xpert for rifampicin resistance detection? The indeterminate rate for detection of rifampicin resistance was the number of tests classified as “MTB detected; Rif resistance INDETERMINATE” divided by the total number of Xpert‐MTB positive results	1 – Yes ‐># Indeterminate results: (Enter 0 indeterminate results if the total number in Table 6 = the number of TPs in Table1) Denominator is total number of Xpert tests performed (Total Xpert positive results from Table 1 first row): 2 – No
Did the study report any Xpert rifampicin resistant positive results in culture negative specimens?	1 – Yes ‐> Number reported: 2 – No
Did the study report nontuberculous mycobacteria (NTM)? Record number NTM over the number of cultures performed	1 – Yes ‐> Number reported: 2 – No
If NTMs were identified, record number of Xpert positive results among NTMs	#Xpert positive tests among total number NTMs: 9 – Unknown/NR