Quality: Low risk of bias Received > two doses GeneXpert System for inoculated into liquid of TB treatment, analysis medium Patient selection failure to provide a DST was performed Index test second sputum using the L-J Comparator sample proportional method Reference std Flow and timing Applicability: C1, P2 Chakravorty et N=506 sputum samples Universal sample PCR assay amplified a USP AFB Culture was on L-J Level III-2: Inclusion: al. () from 506 patients processing method, 308-bp region of the microscopy with slopes A comparison with Patients visiting TB which involves devR gene ZN staining India reference standard (not Age and HIV status not centres for the Cultures were homogenisation and blinded or blinding not reported diagnosis of An additional PCR assay confirmed to be MTB decontamination of known) pulmonary TB targeting the repetitive by the niacin test or specimens by IS6110 sequence was by devR PCR Quality: Low risk of bias Exclusion treatment with also carried out Patient selection Patients already Universal Sample receiving Index test ? Processing solution tubercular treatment Comparator The sample was Reference std ? centrifuged, the sediment was Flow and timing resuspended and then Applicability: C1, P2 used Chakravorty et Level III-2: N=571 sputum samples Inclusion: Universal sample The isolated DNAs were USP AFB Each sputum sample al. () from 571 patients processing method used for IS6110-specific microscopy with was decontaminated A comparison with Patients with fever, (homogenisation and PCRs ZN staining and inoculated onto India reference standard (not Age and HIV status not cough, expectoration decontamination of L-J medium blinded or blinding not of sputum, reported specimens by known) haemoptysis, pain, treatment with dyspnoea, weight Quality: Some risk of bias Universal Sample loss, night sweats, Patient selection Processing solution) general weakness, Index test ? positive CXR, A subset of 325 Comparator mantoux status and samples was also Reference std ? any past history of TB processed by the NALC-NaOH method, Flow and timing ? Exclusion centrifuged and the Applicability: C1, P2 Receiving
Quality: Low risk of bias Patient selection Index test Comparator Reference std Flow and timing Applicability: C1, P2 Received > two doses of TB treatment, failure to provide a second sputum sample GeneXpert System for analysis inoculated into liquid medium DST was performed using the L-J proportional method Chakravorty et al. () India 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=506 sputum samples from 506 patients Age and HIV status not reported Inclusion: Patients visiting TB centres for the diagnosis of pulmonary TB Exclusion Patients already receiving treatment Universal sample processing method, which involves homogenisation and decontamination of specimens by treatment with Universal Sample Processing solution The sample was centrifuged, the sediment was resuspended and then used PCR assay amplified a 308-bp region of the devR gene An additional PCR assay targeting the repetitive IS6110 sequence was also carried out USP AFB microscopy with ZN staining Culture was on L-J slopes Cultures were confirmed to be MTB by the niacin test or by devR PCR Chakravorty et al. () India 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=571 sputum samples from 571 patients Age and HIV status not reported Inclusion: Patients with fever, cough, expectoration of sputum, haemoptysis, pain, dyspnoea, weight loss, night sweats, general weakness, positive CXR, mantoux status and any past history of TB Exclusion Receiving Universal sample processing method (homogenisation and decontamination of specimens by treatment with Universal Sample Processing solution) A subset of 325 samples was also processed by the NALC-NaOH method, centrifuged and the The isolated DNAs were used for IS6110-specific PCRs USP AFB microscopy with ZN staining Each sputum sample was decontaminated and inoculated onto L-J medium tubercular