Miotto 2012

Study characteristics
Patient sampling	Isolates: case-controlled design with consecutive enrolment of participants, prospective data collection Specimens: cross-sectional design with consecutive enrolment of participants, prospective data collection
Patient characteristics and setting	Country of origin: Italy World Bank classification of country: high Type of lab: hospital Type of patients: confirmed MDR-TB cases, confirmed XDR-TB cases, confirmed MDR-TBs with some known 2nd line resistance
Index tests	Manufacturer involvement: yes, donation of test 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 (solid; 7H11) and sequencing used for FQ, SLID FQ drugs: ofloxacin (2 µg/mL) SLIDs: kanamycin (5 µg/mL) and capreomycin (10 µg/mL) Discrepant analysis: no Genes for FQ: gyrA Genes for SLIDs: rrs
Flow and timing	Uninterpretable results reported: yes
Comparative
Notes	Other findings: NPV for SLID is higher in Beijing strains
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