Lacoma 2012

Study characteristics
Patient sampling	Cross-sectional design with convenience-based enrolment of participants, prospective data collection
Patient characteristics and setting	Country of origin: Spain World Bank classification of country: high Type of lab: hospital Type of patients: confirmed MDR-TB cases Smear-positive patients whose specimens were tested directed: 49/54
Index tests	Manufacturer involvement: no Type of testing: direct and indirect Type of specimens: smear-positive and smear negative Specimen treatment: NALC-NaOH Specimen condition: frozen Duration of freezing: = 1 year
Target condition and reference standard(s)	Culture (liquid; BACTEC460TB) used for FQ, SLID FQ drugs: moxifloxacin (0.5 µg/mL) SLIDs: kanamycin (5 µg/mL) and capreomycin (1.25 µg/mL) Discrepant analysis: yes (for indirect testing only)
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?	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?	No
			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