Summary of findings 2. LF‐LAM for unselected participants.

Review question: what is the diagnostic accuracy of LF‐LAM for the diagnosis of active tuberculosis in HIV‐positive adults irrespective of signs and symptoms of tuberculosis? Studies: cross‐sectional studies and randomized controlled trials Participants: HIV‐positive unselected adults not assessed for signs and symptoms of tuberculosis i.e. irrespective of symptoms Setting: all settings (inpatient and outpatient) Index test: LF‐LAM Threshold for index tests: manufacturer's recommended threshold for positivity i.e. grade 1 of 4 (revised reference card) or the corresponding grade 2 of 5 (prior reference card) Reference standard: microbiological (mycobacterial culture and/or nucleic acid amplification test) Role: an add on to clinical judgement and with other tests to assist in tuberculosis diagnosis Pooled sensitivity (95% CrI): 35% (22% to 50%); pooled specificity (95% CrI): (89% to 98%)
Test result	Number of results per 1000 participants tested (95% CrI)			Number of participants (studies)	Certainty of the evidence (GRADE)
	Prevalence 1% Typically seen in asymptomatic persons in outpatient settings	Prevalence 10% Typically seen in symptomatic persons in all settings	Prevalence 30% Typically seen in seriously ill persons in inpatient settings
True positives	3 (2 to 5)	35 (22 to 50)	105 (66 to 150)	432 (7)	⊕⊕⊕⊝ MODERATEa,b,c
False negatives	7 (5 to 8)	65 (50 to 78)	195 (150 to 234)
True negatives	941 (881 to 970)	855 (801 to 882)	665 (623 to 686)	2933 (7)	⊕⊕⊝⊝ LOWd,e,f
False positives	49 (20 to 109)	45 (18 to 99)	35 (14 to 77)
Abbreviations: Crl: Credible interval. Explanations aAs assessed by QUADAS‐2, in the patient selection domain, we judged four studies (57%) at high risk of bias because they did not avoid inappropriate exclusions. We downgraded one level for risk of bias. bFor individual studies, sensitivity ranged from 0% to 67%. We thought that the percentage of patients with tuberculosis symptoms or differences in CD4 count could explain in part the heterogeneity. One study, LaCourse 2016, with sensitivity of 0% differed from the other studies by including a) a population of exclusively pregnant women attending an antenatal care setting, b) a low proportion of symptomatic participants (19%), c) a low tuberculosis prevalence (1%), and d) a high median CD4 cell count (437 cells per µL). One study, Thit 2017, with sensitivity 67% differed from the other studies by being conducted in Myanmar, and was the only study included in this review that evaluated LF‐LAM in a setting outside sub‐Saharan Africa. We did not downgrade for inconsistency. cWe thought the 95% CrI around true positives and false negatives would likely not lead to different decisions depending on which credible limits are assumed. We did not downgrade for imprecision. dAs assessed by QUADAS‐2, in the reference standard domain, we judged five studies (71%) at high risk of bias because we thought the reference standard used was unlikely to correctly classify the target condition. We downgraded one level for risk of bias. eFor individual studies, specificity ranged from 67% to 99%. Eighty‐six per cent (6/7) of the included studies had specificity of 94% or higher. One study, Thit 2017, with specificity 67% differed from the other studies by being conducted in Myanmar, and is the only study included in this review that evaluated LF‐LAM in a setting outside sub‐Saharan Africa. We did not downgrade for inconsistency. fWe thought the wide 95% Crls around true negatives and false positives would lead to different decisions depending on which credible limits are assumed. We downgraded one level for imprecision. GRADE certainty of evidence (GRADEpro 2015; Balshem 2011) High: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. The table displays normalized frequencies within a hypothetical cohort of 1000 patients at three different prevalences of tuberculosis (pre‐test probabilities): 1%, 10% and 30%. Credible limits (Crls) were estimated based on those around the point estimates for pooled sensitivity and specificity. Note: the results on this table should not be interpreted in isolation from the results of the individual included studies contributing to each summary test accuracy measure. These are reported in the main body of the text of the review.