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

Said 2012

Study characteristics
Patient sampling Cross-sectional design with consecutive-based enrolment of participants, prospective data collection
Patient characteristics and setting
  1. Country of origin: South Africa

  2. World Bank classification of country: middle/low

  3. Type of lab: research

  4. Type of patients: confirmed MDR-TB cases

Index tests
  1. Manufacturer involvement: yes, financial support.

  2. Type of testing: indirect

Target condition and reference standard(s)
  1. Culture (solid; 7H11)

  2. FQ drugs: ofloxacin (2 µg/mL)

  3. SLIDs: kanamycin (5 µg/mL) and capreomycin (10 µg/mL). Not the WHO critical concentrations for SLIDs.

  4. Discrepant analysis: no

Flow and timing Uninterpretable results reported: yes
Comparative
Notes Other findings: turnaround times for DST ranged from 6 to 21 days (median 11) for the agar proportion method and from 2 to 3 days (median 2) for the MTBDRsl assay. DST results of the MTBDRsl assay as compared to the agar proportion method are shown in Table 2.
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? 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? No
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