blinded or blinding not 71 respiratory including confirm or rule out TB NALC-NaOH and manufacturer’s were confirmed by growth detection known) sputum, BAL in newly identified centrifuged for instructions for ZN staining DST was performed 8 non-respiratory suspect cases sedimentation of respiratory specimens Quality: Low risk of bias using the BACTEC including ascetic fluid, mycobacteria Non-respiratory Exclusion MGIT 960 system Patient selection pleural fluid, biopsy specimens were tested None stated Index test tissue similarly Comparator ? Reference std ? Flow and timing Applicability: C1, P1 Derese et al. N=134 FNA samples Specimens were PCR was performed AFB microscopy Four L-J medium Level III-2: Inclusion () from lymph nodes decontaminated using using IS1081 primers with ZN staining (two with glycerol A comparison with Retrospective study NALC-NaOH method and two with Ethiopia reference standard (not Mean age 28.6 ± on previously and centrifuged for pyruvate) slopes blinded or blinding not collected FNA 12.7 years sedimentation of were incubated and known) specimens stored at HIV status not reported mycobacteria examined weekly for –80 °C to diagnose Quality: Some risk of bias 8 consecutive weeks lymphadenitis TB Patient selection ? Exclusion Index test ? None stated Comparator Reference std ? Flow and timing Applicability: C1, P2 Desai et al. () Level III-2: N=30 CSF samples Inclusion Sample split in two PCR targeting IS6110 ZN-stained smears L-J solid medium The first 1-mL portion was performed India A comparison with Age and HIV status not In-house patients with was centrifuged and reference standard (not reported a provisional used for AFB blinded or blinding not diagnosis of microscopy and known) tuberculous meningitis culture, and the and had 2 mL of CSF Quality: second 1-mL portion available for study Patient selection was stored at °C −20 Index test and used for DNA Comparator extraction and PCR Reference std ?
blinded or blinding not known) Quality: Low risk of bias Patient selection Index test Comparator ? Reference std ? Flow and timing Applicability: C1, P1 71 respiratory including sputum, BAL 8 non-respiratory including ascetic fluid, pleural fluid, biopsy tissue confirm or rule out TB in newly identified suspect cases Exclusion None stated NALC-NaOH and centrifuged for sedimentation of mycobacteria manufacturer’s instructions for respiratory specimens Non-respiratory specimens were tested similarly were confirmed by ZN staining growth detection DST was performed using the BACTEC MGIT 960 system Derese et al. () Ethiopia 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, P2 N=134 FNA samples from lymph nodes Mean age 28.6 ± 12.7 years HIV status not reported Inclusion Retrospective study on previously collected FNA specimens stored at –80 °C to diagnose lymphadenitis TB Exclusion None stated Specimens were decontaminated using NALC-NaOH method and centrifuged for sedimentation of mycobacteria PCR was performed using IS1081 primers AFB microscopy with ZN staining Four L-J medium (two with glycerol and two with pyruvate) slopes were incubated and examined weekly for 8 consecutive weeks Desai et al. () India Level III-2: A comparison with reference standard (not blinded or blinding not known) Quality: Patient selection Index test Comparator Reference std ? N=30 CSF samples Age and HIV status not reported Inclusion In-house patients with a provisional diagnosis of tuberculous meningitis and had 2 mL of CSF available for study Sample split in two The first 1-mL portion was centrifuged and used for AFB microscopy and culture, and the second 1-mL portion was stored at −20 °C and used for DNA extraction and PCR PCR targeting IS6110 was performed ZN-stained smears L-J solid medium
1234_FinalAssessmentReport-accessible.docx