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

Kontsevaya 2013

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

  2. World Bank classification of country: Middle/low

  3. Type of lab: unknown

  4. Type of patients: confirmed MDR-TB cases

  5. Median age: 35

  6. All HIV-infected (n = 90)

  7. Previous TB: 38/90

  8. Male: 71/90

Index tests
  1. Manufacturer involvement: no

  2. Type of testing: direct

  3. Type of specimens: smear-positive

  4. Specimen treatment: unknown

  5. Specimen condition: unknown

  6. Duration of freezing: unknown

Target condition and reference standard(s)
  1. Culture (Liquid; MGIT960) used for FQ, SLID

  2. FQ drugs: ofloxacin (2 µg/mL) and moxifloxacin (0.25 µg/mL)

  3. SLIDs: kanamycin (5 µg/mL), amikacin (1 µg/mL) and capreomycin (2.5 µg/mL)

  4. Discrepant analysis: no

Flow and timing Uninterpretable results reported: no
Comparative
Notes Other findings: analysis of test performance stratified according to sputum smear positivity showed that the test readability for individual drugs and their drug groups ranged from 80.0% to 100.0%, with the lowest for specimens graded 1 (Table 5). Within this group of specimens, lower readability rates were observed for the AG/CP group of drugs (n 3; 20.0% of tests failed), with higher readability rates for FQ and ethambutol. Similar trends were observed in specimens graded 2 and 3 (Fig. 1).Total agreement between the molecular assay and phenotypic DST was the highest (84.1%) for FQs and lowest (23.5%) for the injectable drugs.
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? 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