LF‐LAM‐ Lateral flow urine lipoarabinomannan assay for diagnosing active tuberculosis in people living with HIV Data form
I. STUDY IDENTIFICATION
1	First author
2	Corresponding author and email
3	Title of study
4	Year of publication
5	Year of study start
6	Language if other than English
II. STUDY DETAILS
7	Population	1.Adults (15 years of age) 2.Children and adolescents 3.Both adults, children and adolescents 4.Other If other, describe
8	In which country or countries was the study conducted?	List all countries:
9	Country World Bank Classification (income) (World Bank 2018)	1.Low income 2.Lower‐middle income 3.Upper‐middle‐income 4.High income 7. Other combination 9.Unknown/Not reported If other, describe:
10	Country WHO classification for high TB burden country (WHO Global Tuberculosis Report 2018)	1.Yes, part of the High TB/HIV burden list 2.No, not part of the High TB/HIV burden list
11	Study design	1.Randomized controlled trial 2.Cross‐sectional 3.Cohort 7.Other, specify 9.Could not tell If other, describe:
12	Was a case‐control design avoided?	1.Yes 2.No 9.Unclear
III. PATIENT SELECTION
13	What was the manner of participant selection into the study?	1.Consecutive 2.Random 3.Convenience 7.Other, specify 9.Unknown/Not Reported/Unclear If other, describe:
14	Direction of study data collection	1.Prospective 2.Retrospective 9.Unknown/Not reported
15	Please select the statement that best describes the selection of participants into the study.	1.HIV‐positive participants with signs or symptoms suggestive of active tuberculosis were tested using LF‐LAM. Please provide study definition of ‘signs and symptoms’: 2.A preAlered target population of HIV‐positive individuals, irrespective of signs and symptoms of tuberculosis, were tested using LF‐LAM. Please specify target population: 3.Both 1 and 2 4.Neither 1 nor 2. This is what was done:
16	Sample size	1._____ 9.Unknown/Not reported
17	Did the study avoid inappropriate exclusions?	1.Yes 2.No 9.Unknown/Not reported/Unclear
17a	Could the selection of patients have introduced bias?	1.High risk 2.Low risk 9.Unclear risk
18	NOTES ON PATIENT SELECTION
IV. PATIENT CHARACTERISTICS AND SETTING
19	Presenting signs and symptoms	List
20	Age (years)	__________ If age is reported in median indicate IQR If age is reported in mean indicate SD
21	Age of all study participants, Range	Upper Lower
22	HIV infection (%)
23	Participants included of female sex (%)
24	CD4	_________ If CD4 is reported in median indicate IQR If CD4 is reported in mean indicate SD
25	Number (percent) of tuberculosis cases in the study (%):
26	What was the target condition?	1.Pulmonary tuberculosis 2.Extra pulmonary tuberculosis 3.Mycobacteraemia 4.Both 1 and 2 5.Any of 1,2,3 7.Other, specify
27	Did the study include patients with prior tuberculosis history?	1.Yes 2.No 9.Unknown/Not reported If yes, what is the % _____ Specify the numerator/denominator _____/_____
28	What was the clinical setting of the study?	1.Outpatient 2.Inpatient 3.Both out‐patient and in‐patient 7.Other, describe: 9.Unknown/Not reported
29	How would you describe the health facility where the study took place?	1.Primary care clinic, stand alone 2.Primary care clinic, connected to a referral hospital 3.Referral hospital 7.Other, describe: 9.Unknown/Not reported
30	Are there concerns that the included patients and setting do not match the review question?	1.High concern 2.Low concern 9.Unclear concern
31	NOTES ON CHARACTERISTICS
V. INDEX TEST
32	Was a LF‐LAM threshold used to define positivity that was pre‐specified in the primary analysis?	1.Yes, Grade 1/5 2.Yes, Grade 2/5 3.Yes, Grade 1/4 4.Yes, Grade 2/4 5.No 7.Other, specify:
33	What LF‐LAM threshold was used to define positivity for data extraction?	1.Grade 2/5 2.Grade 1/4 7. Other, specify
34	Are their concerns about index test conduct or interpretation differing from review question?	1.High concern 2.Low concern 9.Unclear concern
35	Was LF‐LAM performed on fresh or stored urine?	1.Fresh 2.Stored, specify type of storage (e.g. frozen) 3.Both fresh and stored 9.Unknown/Not reported
36	Was LF‐LAM result interpreted without knowledge of the result of the reference standard result?	1.Yes 2.No 9.Unknown/Not reported/Unclear
37	Were there any LF‐LAM results that were invalid (no bar in control window)?	1.Yes a.Specify number of invalid tests: _____ b.Were invalid tests repeated (yes/no): _____ 2.No 9. Unknown/Not reported
38	Could the conduct or interpretation of the index test have introduced bias?	1.High risk 2.Low risk 9.Unclear risk
39	NOTES ON INDEX TEST
VI. REFERENCE STANDARD
40	For the diagnosis of pulmonary tuberculosis, what reference standard was used to identify tuberculosis and not tuberculosis?	1.Sputum: solid culture 2.Sputum: liquid culture 3.Sputum: both solid and liquid culture 4.Nucleic acid amplification test, specify 5.Any of culture or nucleic amplification test, specify 7.Other, specify
41	Was sputum induction performed for individuals unable to produce expectorated sputum?	1.Yes Specify N/% requiring sputum induction ____ 2.No
42	Were patients without sputum specimens (for example, no expectorated, no induced sputum) included in this study?	1.Yes Specify N/% included without sputum ____ 2.No Specify N/% excluded due to lack of sputum____
43	Were non‐pulmonary specimens evaluated to allow diagnosis of extrapulmonary tuberculosis?	1.All participants received testing of non‐pulmonary specimens, please specify sites/fluids: 2.Some participants received testing of non‐pulmonary specimens, please specify which patients were tested, and sites/fluids: 3.Extrapulmonary tuberculosis was not evaluated 7.Other, please specify:
44	For the diagnosis of extrapulmonary tuberculosis, what tests were used to identify tuberculosis and not tuberculosis (circle all that apply)?	1.Solid culture 2.Liquid culture 3.Both solid and liquid culture 4.Nucleic acid amplification test, specify 7.Other, specify: __________________________ 8.Not applicable, extrapulmonary tuberculosis was not evaluated
45	Did the study speciate mycobacteria isolated in culture?	1.Yes 2.No 9.Unknown/Not reported
46	Was the reference standard likely to correctly classify the target condition	1.Yes 2.No 9. Unclear
47	Was the reference standard result interpreted without knowledge of the result of LF‐LAM?	1.Yes 2.No 9.Unclear
48	How many sputum specimens were obtained in order to detect pulmonary tuberculosis?	1. Single 2. Multiple 8.Not applicable
49	How many specimens from fluid (sites) other than sputum were obtained to detect extrapulmonary tuberculosis?	1. Single 2. Multiple 8.Not applicable
50	Could the reference standard, its conduct, or its interpretation have introduced bias?	1.High risk 2.Low risk 9.Unclear risk
51	Are there concerns that the target condition as defined by the reference standard does not match the question?	1.High concern 2.Low concern 9.Unclear concern
52	NOTES ON REFERENCE STANDARD
VII. FLOW AND TIMING
53	Was there appropriate interval between index test and reference standard	1.Yes, specimens collected at the same time. 2.No, specimens collected greater than 7 days apart 9.Unclear
54	Did all patients receive a reference standard?	1.Yes 2.No 9.Unclear
55	Did all patients receive the same reference standard?	1.Yes 2.No (answer no if clinicians chose sample types, or other differences in reference standards between patients) 9.Unclear
56	Were all participants included in the analysis?	1.Yes 2.No 9.Unclear
57	Could the patient flow have introduced bias?	1.High risk 2.Low risk 9.Unclear risk
58	NOTES ON FLOW AND TIMING