Hillemann 2009

Study characteristics
Patient sampling	Case-control design with the random enrolment of participants, prospective data collection for clinical specimens, retrospective for culture isolates
Patient characteristics and setting	Country of origin: Germany World Bank classification of country: high Type of lab: reference Type of patients: confirmed XDR-TB cases, confirmed DS-TB cases The specimens tested were smear positive and smear negative
Index tests	Manufacturer involvement: yes, donation of tests Type of testing: direct and indirect Type of specimens: smear-positive Specimen treatment: NALC-NaOH Specimen condition: frozen Duration of freezing: = 1 year
Target condition and reference standard(s)	Culture (liquid and solid; MGIT 960 and LJ) and sequencing used for FQ, SLID FQ drugs: ofloxacin (2 µg/mL for liquid) SLIDs: amikacin (1 µg/mL for liquid) and capreomycin (2.5 µg/mL for liquid) Genes sequenced for FQ: gyrA Genes sequenced for SLIDs: rrs Discrepant analysis: no
Flow and timing	Uninterpretable results reported: yes
Comparative
Notes
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
Was a case-control design avoided?	No
Did the study avoid inappropriate exclusions?	Yes
			High
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard?	Unclear
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?	Unclear
			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?	Yes
Were all patients included in the analysis?	Yes