known) reported Jos, Nigeria mycobacteria 10 sputum Quality: Low risk of bias Exclusion 11 gastric wash Patient selection None stated 5 CSF Index test ? 5 ascitic fluid Comparator 9 pleural effusions Reference std ? Flow and timing Applicability: C1, P2 Balcells et al. Level III-2: N=160 HIV+ patients Inclusion When two sputum Xpert MTB/RIF was Uncontaminated Culture on solid L-J () samples were performed according to sputum samples and MGIT liquid A comparison with Mean age 37.4 years Adults (aged collected, a mixture of manufacturer’s and mouthwash medium Chile reference standard (not (range 19–65) > 18 years) with both was subjected to instructions were subjected to blinded or blinding not confirmed HIV Cultures were 81 had two sputum testing microscopy with infection and Repeated Xpert performed for all the known) samples ZN staining suspicion of The sputum samples MTB/RIF assays were samples, irrespective Quality: Low risk of bias 53 had one sputum pulmonary TB were processed with performed for patients of rapid test results Patient selection sample NALC-NaOH, followed who had discordant They had to have 26 provided mouth Index test by centrifugation results (AFB-negative cough (> 10 days), wash sample Comparator with Xpert bloody sputum, Reference std ? MTB/RIF or vice versa) pneumonia Flow and timing unresponsive to previous antibiotics, Applicability: C1, P2 fever (> 10 days), abnormal CXR or weight loss Exclusion Empiric anti-TB treatment initiated > 7 days before enrolment Bates et al. () Level III-2: N=930 specimens from Inclusion After AFB microscopy The concentrated Fluorescent AFB 1 MGIT tube was children aged 15 years sample was taken, sample was added to the microscopy (AUR) inoculated with Zambia A comparison with Any new child or younger samples were Xpert MTB/RIF sample was done directly 0.5 mL concentrated reference standard (not inpatient with a homogenised and reagent in a 1:3 ratio and on all samples sample and blinded or blinding not Median age 24 months primary or secondary
known) Quality: Low risk of bias Patient selection Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P2 reported 10 sputum 11 gastric wash 5 CSF 5 ascitic fluid 9 pleural effusions Jos, Nigeria Exclusion None stated mycobacteria Balcells et al. () Chile 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, P2 N=160 HIV+ patients Mean age 37.4 years (range 19–65) 81 had two sputum samples 53 had one sputum sample 26 provided mouth wash sample Inclusion Adults (aged > 18 years) with confirmed HIV infection and suspicion of pulmonary TB They had to have cough (> 10 days), bloody sputum, pneumonia unresponsive to previous antibiotics, fever (> 10 days), abnormal CXR or weight loss Exclusion Empiric anti-TB treatment initiated > 7 days before enrolment When two sputum samples were collected, a mixture of both was subjected to testing The sputum samples were processed with NALC-NaOH, followed by centrifugation Xpert MTB/RIF was performed according to manufacturer’s instructions Repeated Xpert MTB/RIF assays were performed for patients who had discordant results (AFB-negative with Xpert MTB/RIF or vice versa) Uncontaminated sputum samples and mouthwash were subjected to microscopy with ZN staining Culture on solid L-J and MGIT liquid medium Cultures were performed for all the samples, irrespective of rapid test results Bates et al. () Zambia Level III-2: A comparison with reference standard (not blinded or blinding not N=930 specimens from children aged 15 years or younger Median age 24 months Inclusion Any new child inpatient with a primary or secondary After AFB microscopy sample was taken, samples were homogenised and The concentrated sample was added to the Xpert MTB/RIF sample reagent in a 1:3 ratio and Fluorescent AFB microscopy (AUR) was done directly on all samples 1 MGIT tube was inoculated with 0.5 mL concentrated sample and