Flow and timing Applicability: C1, P2 Walusimbi et Level III-1: N=430 AFB –ve, HIV+ Inclusion The samples were For the Xpert MTB/RIF Fluorescent Culture using MGIT digested and assay, a sample reagent microscopy al. () sputum samples and L-J medium A comparison against HIV+ patients with decontaminated using was added to the (unprocessed) Uganda independent, blinded Median age 34 years symptoms of TB, the NALC-NaOH processed sample in a using standard reference standard among giving consent, (IQR 29–40) method, and then 3:1 ratio AUR reagent non-consecutive patients providing spot and 369 had valid culture concentrated by early-morning sputum The mixture was Quality: Low risk of bias and Xpert results centrifugation sample introduced into a Patient selection cartridge, which was Exclusion Index test then loaded into the Patients on TB Comparator: GeneXpert instrument, treatment or unable to Reference std where the test was produce sputum performed automatically Flow and timing When sufficient residual Applicability: C1, P2 was available, repeat testing was carried out when an ‘invalid’ or ‘error’ result was obtained Zar et al. () Level III-2: N=384 children with Inclusion Samples were The treated specimen Fluorescent AFB MGIT culture was induced sputum decontaminated using sample was transferred microscopy using done using 0.5 mL of South Africa A comparison with Consecutive children samples standard NALC-NaOH to the Xpert MTB/RIF AUR resuspended pellet reference standard (not < 15 years of age procedure and cartridge and test was on sputum blinded or blinding not Median age presenting from concentrated by run in the GeneXpert specimens and known) 38.3 months (IQR 1 August 2010 to centrifugation instrument incubated for up to 21.2–56.5) 30 July 2012 with Quality: Low risk of bias 6 weeks suspected pulmonary 31/384 (8%) were HIV+ Patient selection TB Index test Exclusion Comparator None reported Reference std ? Flow and timing Applicability: C1, P1
Flow and timing Applicability: C1, P2 Walusimbi et al. () Uganda Level III-1: A comparison against independent, blinded reference standard among non-consecutive patients Quality: Low risk of bias Patient selection Index test Comparator: Reference std Flow and timing Applicability: C1, P2 N=430 AFB –ve, HIV+ sputum samples Median age 34 years (IQR 29–40) 369 had valid culture and Xpert results Inclusion HIV+ patients with symptoms of TB, giving consent, providing spot and early-morning sputum sample Exclusion Patients on TB treatment or unable to produce sputum The samples were digested and decontaminated using the NALC-NaOH method, and then concentrated by centrifugation For the Xpert MTB/RIF assay, a sample reagent was added to the processed sample in a 3:1 ratio The mixture was introduced into a cartridge, which was then loaded into the GeneXpert instrument, where the test was performed automatically When sufficient residual was available, repeat testing was carried out when an ‘invalid’ or ‘error’ result was obtained Fluorescent microscopy (unprocessed) using standard AUR reagent Culture using MGIT and L-J medium Zar et al. () South Africa Level III-2: A comparison with reference standard (not blinded or blinding not known) Quality: Low risk of bias Patient selection Index test Comparator Reference std ? Flow and timing Applicability: C1, P1 N=384 children with induced sputum samples Median age 38.3 months (IQR 21.2–56.5) 31/384 (8%) were HIV+ Inclusion Consecutive children < 15 years of age presenting from 1 August 2010 to 30 July 2012 with suspected pulmonary TB Exclusion None reported Samples were decontaminated using standard NALC-NaOH procedure and concentrated by centrifugation The treated specimen sample was transferred to the Xpert MTB/RIF cartridge and test was run in the GeneXpert instrument Fluorescent AFB microscopy using AUR MGIT culture was done using 0.5 mL of resuspended pellet on sputum specimens and incubated for up to 6 weeks
1234_FinalAssessmentReport-accessible.docx