Study characteristics |
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Patient sampling |
Cross-sectional design with random enrolment of participants, prospective data collection |
Patient characteristics and setting |
Country of origin: Colombia
World Bank classification of country: middle/low
Type of lab: reference
Type of patients: confirmed DS-TB, MDR-TB, MDR-TB with some known second-line resistance and XDR-TB patients
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Index tests |
Manufacturer involvement: yes
Type of testing: indirect
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Target condition and reference standard(s) |
Culture based DST (solid, 7h10)
FQ drugs: moxifloxacin 2 µg/mL
SLIDS: amikacin 5 µg/mL, kanamycin 5 µg/mL
No XDR information reported
There was no discrepant analysis
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Flow and timing |
Uninterpretable results reported: yes |
Comparative |
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Notes |
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Methodological quality |
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Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
DOMAIN 1: Patient Selection |
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Was a consecutive or random sample of patients enrolled? |
Yes |
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Was a case-control design avoided? |
Yes |
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Did the study avoid inappropriate exclusions? |
Unclear |
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Low |
DOMAIN 2: Index Test All tests |
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Were the index test results interpreted without knowledge of the results of the reference standard? |
Unclear |
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If a threshold was used, was it pre-specified? |
Yes |
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Low |
DOMAIN 3: Reference Standard |
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Is the reference standards likely to correctly classify the target condition? |
Yes |
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Were the reference standard results interpreted without knowledge of the results of the index tests? |
Unclear |
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Low |
DOMAIN 4: Flow and Timing |
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Was there an appropriate interval between index test and reference standard? |
Yes |
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Did all patients receive the same reference standard? |
Yes |
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Were all patients included in the analysis? |
Unclear |
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