Van Rie 2013.
Study characteristics | |||
Patient Sampling | Cross‐sectional, consecutive, prospective | ||
Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected patients with suspicion of LNTB Age: mean 36 years, range 18 to 73 years Sex, female: 49% Children: no HIV infection: 100% Clinical setting: tertiary care centre (inpatient and outpatient) Past history of TB: not reported Patients on anti‐TB treatment: no Number of specimens evaluated: 344 Laboratory level: central Country: South Africa World Bank Income Classification: middle income High TB burden: yes High TB/HIV burden: yes High MDR‐TB burden: yes |
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Index tests | Xpert MTB/RIF WHO SOP or manufacturer's protocol followed: yes Manufacturer's involvement: no |
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Target condition and reference standard(s) | Target condition: lymph node TB
Reference standard TB detection: MGIT Reference standard rifampicin resistance detection: MGIT‐DST Speciation: yes Decontamination: no |
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Flow and timing | |||
Comparative | |||
Notes | |||
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 | ||
Could the selection of patients have introduced bias? | Low 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? | Low concern | ||
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 | ||
For rifampicin resistance testing, were the reference standard results interpreted without knowledge of the results of the index test? | 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 |