Study characteristics |
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Patient sampling |
Cross-sectional design with convenience-based enrolment of participants, prospective data collection |
Patient characteristics and setting |
Country of origin: South Africa
World Bank classification of country: middle/low
Type of lab: reference
Type of patients: confirmed MDR-TB cases, confirmed RIF monoR, confirmed INH monoR
Patients were smear-positive (n = 516; excluding EPTB)
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Index tests |
Manufacturer involvement: yes, reduced price
Type of testing: direct
Type of specimens: smear-positive
Specimen treatment: NALC-NaOH
Specimen condition: fresh
Tested after storage at room temperature or refrigerated within 48 hours of collection
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Target condition and reference standard(s) |
Culture (solid; AP method on 7H11) used for FQ, SLID
FQ drugs: ofloxacin (2 µg/mL)
SLIDs: amikacin (4 µg/mL)
Discrepant analysis: yes, with sequencing
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Flow and timing |
Uninterpretable results reported: yes |
Comparative |
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Notes |
Reported performance on EPTB specimens
Reported on the utility of the index test on specimens that were culture-contaminated (and hence could not receive a phenotypic DST)
Reported on time-to-result
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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? |
No |
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Was a case-control design avoided? |
Yes |
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Did the study avoid inappropriate exclusions? |
Yes |
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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? |
Yes |
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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? |
Yes |
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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? |
No |
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Were all patients included in the analysis? |
Yes |
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