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. 2014 Oct 29;(10):4–123. doi: 10.1002/14651858.CD010705.pub2

Brossier 2010

Study characteristics
Patient sampling Case-control design with unknown mechanism of enrolment of participants, prospective data collection
Patient characteristics and setting
  1. Country of origin: France

  2. World Bank classification of country: high

  3. Type of lab: reference

  4. Type of patients: confirmed MDR-TB cases, confirmed XDR-TB cases, confirmed DS-TB patients

Index tests
  1. Manufacturer involvement: no

  2. Type of testing: indirect

Target condition and reference standard(s)
  1. Culture (Solid; agar proportion method on LJ) and sequencing used for FQ, SLID

  2. FQ drugs: ofloxacin (2 µg/mL)

  3. SLIDs: amikacin (20 µg/mL), kanamycin (20 µg/mL), capreomycin (20 µg/mL)

  4. Genes sequenced for FQ: gyrA and gyrB

  5. Genes sequenced for SLIDs: rrs

  6. 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? No
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
Unclear
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