Moussa 2016.
Study characteristics | |||
Patient Sampling | Cohort, manner of selection not reported, prospective | ||
Patient characteristics and setting | Presenting signs and symptoms: children older than 1 year and younger than 15 years with clinical signs of PTB Age, months: not reported Sex, female: 39% HIV infection: 0% Sample size included for analysis: 115 Clinical setting: not reported Laboratory level where index test was performed: intermediate Country: Egypt World Bank income classification: middle income High TB burden country: no High TB/HIV burden country: no High MDR‐TB burden country: no Prevalence of tuberculosis cases in the study: 31% | ||
Index tests | Xpert MTB/RIF | ||
Target condition and reference standard(s) | Pulmonary tuberculosis Solid culture (LJ); composite reference standard; clinical reference standard |
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Flow and timing | Index and reference tests were collected within pre‐specified time period | ||
Comparative | |||
Notes | No method for stool processing before Xpert has been established; this study used centrifugation | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Unclear risk | ||
Are there concerns that the included patients and setting do not match the review question? | Unclear | ||
DOMAIN 2: Index Test (Xpert MTB/RIF) | |||
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 | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Unclear | ||
DOMAIN 2: Index Test (Xpert Ultra) | |||
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? | Yes | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Low risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
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 | ||
Could the patient flow have introduced bias? | Low risk |