Barnard 2012

Study characteristics
Patient sampling	Cross-sectional design with convenience-based enrolment of participants, prospective data collection
Patient characteristics and setting	Country of origin: South Africa World Bank classification of country: middle/low Type of lab: reference Type of patients: confirmed MDR-TB cases, confirmed RIF monoR, confirmed INH monoR Patients were smear-positive (n = 516; excluding EPTB)
Index tests	Manufacturer involvement: yes, reduced price Type of testing: direct Type of specimens: smear-positive Specimen treatment: NALC-NaOH Specimen condition: fresh Tested after storage at room temperature or refrigerated within 48 hours of collection
Target condition and reference standard(s)	Culture (solid; AP method on 7H11) used for FQ, SLID FQ drugs: ofloxacin (2 µg/mL) SLIDs: amikacin (4 µg/mL) Discrepant analysis: yes, with sequencing
Flow and timing	Uninterpretable results reported: yes
Comparative
Notes	Reported performance on EPTB specimens Reported on the utility of the index test on specimens that were culture-contaminated (and hence could not receive a phenotypic DST) Reported on time-to-result
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	No
Was a case-control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Yes
			Low
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
If a threshold was used, was it pre-specified?	Yes
			Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Yes
			Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	No
Were all patients included in the analysis?	Yes