Ignatyeva 2012

Study characteristics
Patient sampling	Case control design with consecutive enrolment of participants, prospective data collection
Patient characteristics and setting	Country of origin: Estonia World Bank classification of country: middle/low Type of lab: reference Type of patients: confirmed MDR-TB cases, confirmed XDR-TB cases and confirmed DS-TB cases
Index tests	Manufacturer involvement: no Type of testing: indirect
Target condition and reference standard(s)	Culture (liquid; MGIT 960) used for FQ, SLID FQ drugs: ofloxacin (2 µg/mL) SLIDs: amikacin (1 µg/mL), kanamycin (5 µg/mL) and capreomycin (2.5 µg/mL)
Flow and timing	Uninterpretable results reported: yes
Comparative
Notes	Other findings: the interpretability of the Genotype® MTBDRsl assay was high, varying between 98.0% and 100% for the first reading and between 95.5% and 100% for the second reading (Table 3).
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?	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?	Yes
Were all patients included in the analysis?	Yes