Sun 2019.
Study characteristics | |||
Patient Sampling | Cohort, consecutive, prospective | ||
Patient characteristics and setting | Presenting signs and symptoms: patients with symptoms such as pain, swelling in the joints, tenderness, effusion, restriction of movements, and systematic symptoms such as fever, loss of weight/appetite, elevated erythrocyte sedimentation rate, and cough, breathlessness, and history of TB Age: osteoarticular TB: median 51 years (range 16 to 86) Sex, female: osteoarticular TB: 55% Children: no HIV infection: 0% Clinical setting: national level TB referral centre Past history of TB: not reported Participants on anti‐TB treatment: not reported Number of specimens evaluated: 166 Laboratory level: central Country: China 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 and Xpert Ultra WHO SOP or manufacturer's protocol followed: yes |
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Target condition and reference standard(s) | Bone or joint TB, fluid MGIT Composite reference standard: clinical, laboratory, histopathological, radiological and ≥ 6 months’ follow‐up Rifampicin resistance LJ‐DST Speciation: yes Decontamination: Yes |
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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) | |||
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 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Unclear | ||
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? | Unclear | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear 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 |