Applicability: C1, P2 Maurya et al. Level III-1: N=328 extrapulmonary Inclusion Specimens were PCR was performed Smear BACTEC vials were () specimens from new divided into two parts using IS6110 primer examination was incubated and A comparison against Non-repeated cases suspected of TB and kept at °C sequences by ZN staining interpreted as per −20 independent, blinded specimens from India the Becton Dickinson until processing reference standard among Mean patient age 39.8 suspected cases of (method not instruction manual non-consecutive patients ± 16.1 years extrapulmonary TB described) Quality: Low risk of bias HIV status not reported Exclusion Patient selection Lymph node aspirates, None stated cold abscesses, pleural Index test fluid, CSF, synovial Comparator fluid, ascetic fluid, Reference std urine, gastric aspirate, Flow and timing pus, bone marrow, Applicability: C1, P2 wound and pus swabs, and biopsy tissues Michelon et al. Level III-2: N=476 sputum Inclusion All samples were PCR amplification Method not Method not reported treated with reactions were () specimens reported A comparison with Samples of suspected performed with Brazil reference standard (not Age and HIV status not TB patients biotinylated primers blinded or blinding not reported Mycobacterial culture Exclusion derived from IS6110 known) and AFB microscopy 301 induced sputum Not reported were carried out for all This was followed by a Quality: Low risk of bias specimens clinical samples and microwell hybridisation Patient selection 175 spontaneous the association of assay to detect the sputum specimens: Index test these results was amplified product 47 patients with a Comparator chosen as the gold single collection that Reference std ? standard were processed in Flow and timing duplicate Applicability: C1, P2 128 patients with two collections on different days that were processed at a single time
Applicability: C1, P2 Maurya et al. () India 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=328 extrapulmonary specimens from new cases suspected of TB Mean patient age 39.8 ± 16.1 years HIV status not reported Lymph node aspirates, cold abscesses, pleural fluid, CSF, synovial fluid, ascetic fluid, urine, gastric aspirate, pus, bone marrow, wound and pus swabs, and biopsy tissues Inclusion Non-repeated specimens from suspected cases of extrapulmonary TB Exclusion None stated Specimens were divided into two parts and kept at −20 °C until processing (method not described) PCR was performed using IS6110 primer sequences Smear examination was by ZN staining BACTEC vials were incubated and interpreted as per the Becton Dickinson instruction manual Michelon et al. () Brazil 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=476 sputum specimens Age and HIV status not reported 301 induced sputum specimens 175 spontaneous sputum specimens: 47 patients with a single collection that were processed in duplicate 128 patients with two collections on different days that were processed at a single time Inclusion Samples of suspected TB patients Exclusion Not reported All samples were treated with Mycobacterial culture and AFB microscopy were carried out for all clinical samples and the association of these results was chosen as the gold standard PCR amplification reactions were performed with biotinylated primers derived from IS6110 This was followed by a microwell hybridisation assay to detect the amplified product Method not reported Method not reported
1234_FinalAssessmentReport-accessible.docx