El Khechine et Level III-2: N=134 patients each Inclusion Respiratory tract qPCR amplification and Direct ZN-stained Decontaminated with one sputum and specimens were microscopy of sputum was al. () detection of IS6110 A comparison with Sputum specimens one stool sample digested and sputum or filtered inoculated into a France reference standard (not and stool specimens decontaminated using stool BACTEC 9000 bottle blinded or blinding not Mean age 37 ± collected from the NALC-NaOH and incubated in an known) 15 years patients suspected of method automated BACTEC having pulmonary TB Quality: Low risk of bias HIV status not reported 9000 MB system for Stool specimens were Exclusion Patient selection 2 months filtered using a faecal Not reported Index test ? specimen filtration vial Stool culture: in L-J Comparator kit medium for 2 months Reference std ? Flow and timing Applicability: C1, P1 Ereqat et al. () Level III-2: N=95 sputum samples Inclusion The sputum samples DNA was extracted from ZN-stained AFB L-J medium culture from 84 patients were processed using ZN-stained material microscopy (37 °C, up to A comparison with Patients suspected of Palestine the NALC-NaOH scraped off from the 8 weeks) reference standard (not Mean age 46.4 ± having pulmonary TB method microscopic slides blinded or blinding not 2.5 years Exclusion PCR used primers known) HIV status not reported Not reported targeting a 123-bp Quality: Some risk of bias segment of IS6110 Patient selection Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P2 Fan et al. () Level III-1: N=200 AFB –ve Inclusion Not reported Simultaneous AFB microscopy MGIT culture was respiratory samples amplification and testing performed in the BD China A comparison against Patients suspected of for MTB (SAT-TB) assay BACTEC MGIT960 independent, blinded Mean age 43 ± pulmonary TB Mycobacteria reference standard among 18 years > 18 years of age with MTB 16S rRNA was Culture System non-consecutive patients abnormal CXR reverse transcribed to 120 sputum findings that had three generate a 170-bp DNA Quality: Low risk of bias 80 BAL consecutive negative fragment in a real-time Patient selection AFB microscopy PCR Index test
El Khechine et al. () France 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=134 patients each with one sputum and one stool sample Mean age 37 ± 15 years HIV status not reported Inclusion Sputum specimens and stool specimens collected from patients suspected of having pulmonary TB Exclusion Not reported Respiratory tract specimens were digested and decontaminated using the NALC-NaOH method Stool specimens were filtered using a faecal specimen filtration vial kit qPCR amplification and detection of IS6110 Direct ZN-stained microscopy of sputum or filtered stool Decontaminated sputum was inoculated into a BACTEC 9000 bottle and incubated in an automated BACTEC 9000 MB system for 2 months Stool culture: in L-J medium for 2 months Ereqat et al. () Palestine 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=95 sputum samples from 84 patients Mean age 46.4 ± 2.5 years HIV status not reported Inclusion Patients suspected of having pulmonary TB Exclusion Not reported The sputum samples were processed using the NALC-NaOH method DNA was extracted from ZN-stained material scraped off from the microscopic slides PCR used primers targeting a 123-bp segment of IS6110 ZN-stained AFB microscopy L-J medium culture (37 °C, up to 8 weeks) Fan et al. () China Level III-1: A comparison against independent, blinded reference standard among non-consecutive patients Quality: Low risk of bias Patient selection Index test N=200 AFB –ve respiratory samples Mean age 43 ± 18 years 120 sputum 80 BAL Inclusion Patients suspected of pulmonary TB > 18 years of age with abnormal CXR findings that had three consecutive negative AFB microscopy Not reported Simultaneous amplification and testing for MTB (SAT-TB) assay MTB 16S rRNA was reverse transcribed to generate a 170-bp DNA fragment in a real-time PCR AFB microscopy MGIT culture was performed in the BD BACTEC MGIT960 Mycobacteria Culture System
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