blinded or blinding not 91 AFB –ve) western USA for and concentrate cartridge and the test prepared, stained by a broth known) routine mycobacterial respiratory specimens was run in the and read method Age and HIV status not testing were included GeneXpert instrument Quality: Some risk of bias reported Method not stated in the study Patient selection Exclusion Index test ? None stated Comparator Reference std ? Flow and timing Applicability: C1, P1 Mashta et al. Level III-1: Sputum samples used PCR, targeting IS6110 AFB smear: L-J medium culture N=463 sputum samples Inclusion () A comparison against directly for AFB and devR staining by free Samples were Age and HIV status not Samples from patients independent, blinded microscopy and carbol fuchsin, liquefied by 4% India reported suspected of TB reference standard among culture at NDTB centre decolourising by NaOH solution for Exclusion 25% sulphuric acid 20 minutes, non-consecutive patients Transferred cool to NII, Not reported and counterstained centrifuged at Quality: Low risk of bias where samples were by 0.1% methylene 3,000 g, and pellet sputum liquefaction Patient selection blue was washed twice and decontamination Index test with distilled water occurred Comparator Reference std Flow and timing Applicability: C1, P2 Maurya et al. Level III-1: N=102 pleural effusions Inclusion Specimens were PCR was performed Smear BACTEC vials were () from 102 patients divided into two parts using IS6110 primer examination was incubated and A comparison against Clinically suspected and kept at °C sequences by ZN staining interpreted as per −20 India independent, blinded Mean age 30.4 ± cases of pleural TB until processing the Becton Dickinson reference standard among 13.2 years Exclusion (method not instruction manual non-consecutive patients 2/102 (2%) were HIV+ Patients with described) Quality: Low risk of bias undetermined Patient selection aetiology Index test Comparator Reference std Flow and timing
blinded or blinding not known) Quality: Some risk of bias Patient selection Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P1 91 AFB –ve) Age and HIV status not reported western USA for routine mycobacterial testing were included in the study Exclusion None stated and concentrate respiratory specimens cartridge and the test was run in the GeneXpert instrument prepared, stained and read Method not stated by a broth method Mashta 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=463 sputum samples Age and HIV status not reported Inclusion Samples from patients suspected of TB Exclusion Not reported Sputum samples used directly for AFB microscopy and culture at NDTB centre Transferred cool to NII, where samples were sputum liquefaction and decontamination occurred PCR, targeting IS6110 and devR AFB smear: staining by free carbol fuchsin, decolourising by 25% sulphuric acid and counterstained by 0.1% methylene blue L-J medium culture Samples were liquefied by 4% NaOH solution for 20 minutes, centrifuged at 3,000 g, and pellet was washed twice with distilled water 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 N=102 pleural effusions from 102 patients Mean age 30.4 ± 13.2 years 2/102 (2%) were HIV+ Inclusion Clinically suspected cases of pleural TB Exclusion Patients with undetermined aetiology 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