reference standard among reported origin alone or processing 8 weeks non-consecutive patients associated with cervical Quality: Low risk of bias lymphadenopathy, Patient selection ascites, bone marrow Index test transplant, as well as Comparator those with pyrexia Reference std accompanying renal failure or aplastic Flow and timing anaemia were Applicability: C1, P2 investigated for TB Exclusion None Sohn et al. () Level III-2: N=436 sputum samples Inclusion Not reported The Xpert MTB/RIF was AFB microscopy Liquid culture on performed at the TB with AUR staining three processed Canada A comparison with Median age of patients Consecutive patients clinic according to the samples was reference standard (not 44 years (IQR 31–61) aged > 17 years, standard protocol for followed by blinded or blinding not referred for evaluation 12/49 (24%) patients unprocessed samples, phenotypic known) of suspected active tested were HIV+ per the manufacturer DST at the pulmonary TB Quality: Some risk of bias provincial reference Exclusion Patient selection laboratory Not reported Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P1 N=138 sputum The clinical specimens PCR–ICA DNA Specimens were Specimens were Suzuki et al. () Level II: Inclusion specimens were treated with amplification with fixed and stained inoculated into MGIT Japan A comparison against Patients hospitalised Sputerzyme and then labelled primers with AUR, and 960 tubes independent, blinded Age and HIV status not in Minami–Yokohama decontaminated using targeting dnaJ and using their fluorescence reference standard among reported National Hospital, Growth of MTB was the NALC-NaOH was examined consecutive patients under suspicion of TB evaluated on the method using microscopy during a designed consumption of Quality: Low risk of bias detection of the amplified period The presence of oxygen in the Patient selection product by application on AFBs was medium, as Exclusion Index test ? a sample pad of the test
reference standard among non-consecutive patients Quality: Low risk of bias Patient selection Index test Comparator Reference std Flow and timing Applicability: C1, P2 reported origin alone or associated with cervical lymphadenopathy, ascites, bone marrow transplant, as well as those with pyrexia accompanying renal failure or aplastic anaemia were investigated for TB Exclusion None processing 8 weeks Sohn et al. () Canada Level III-2: A comparison with reference standard (not blinded or blinding not known) Quality: Some risk of bias Patient selection Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P1 N=436 sputum samples Median age of patients 44 years (IQR 31–61) 12/49 (24%) patients tested were HIV+ Inclusion Consecutive patients aged > 17 years, referred for evaluation of suspected active pulmonary TB Exclusion Not reported Not reported The Xpert MTB/RIF was performed at the TB clinic according to the standard protocol for unprocessed samples, per the manufacturer AFB microscopy with AUR staining Liquid culture on three processed samples was followed by phenotypic DST at the provincial reference laboratory Suzuki et al. () Japan Level II: A comparison against independent, blinded reference standard among consecutive patients Quality: Low risk of bias Patient selection Index test ? N=138 sputum specimens Age and HIV status not reported Inclusion Patients hospitalised in Minami–Yokohama National Hospital, under suspicion of TB during a designed period Exclusion The clinical specimens were treated with Sputerzyme and then decontaminated using the NALC-NaOH method PCR–ICA DNA amplification with labelled primers targeting dnaJ and using detection of the amplified product by application on a sample pad of the test Specimens were fixed and stained with AUR, and their fluorescence was examined using microscopy The presence of AFBs was Specimens were inoculated into MGIT 960 tubes Growth of MTB was evaluated on the consumption of oxygen in the medium, as
1234_FinalAssessmentReport-accessible.docx