More than 72 hours of TB treatment, could not be followed up, no informed consent, or if an induced sputum specimen could not be obtained Inclusion Pahwa et al. N=100 FNAs from 100 FNAs from the PCR was performed on AFB using ZN and L-J medium culture Level III-2: () patients Patients with clinically involved lymph node all specimens, targeting fluorescent FNAs were liquefied A comparison with and cytologically were divided into the gene encoding the staining and digested using India reference standard (not 55 had PCR results suspected TB parts; five were MPB64 protein N-acetyl L-cysteine, blinded or blinding not Age range 2.5 months lymphadenitis used for AFB stains, decontaminated by known) – 60 years one for PCR and one standard procedure The clinical symptoms Quality: Some risk of bias HIV status not reported for L-J medium using Petroff’s suggestive of TB were Patient selection culture method, inoculated fever, anorexia or Index test on to L-J slants and weight loss, and Comparator incubated at 37 ºC lymphadenopathy for 6–8 weeks Reference std ? Flow and timing Applicability: C1, P2 Park et al. () Level III-1: N=320 respiratory Inclusion The respiratory The specimen sample Specimens were Specimens were specimens from 311 specimens were was transferred to the examined blindly examined by Korea A comparison against Samples were adult patients processed with Xpert MTB/RIF cartridge by fluorescence cultures with both independent, blinded prospectively followed by and the test was run in staining solid and liquid reference standard among Age and HIV status not collected from centrifugation the GeneXpert media patients with non-consecutive patients reported instrument suspected pulmonary For the Xpert assay, Quality: Low risk of bias 254 sputum TB between 26 May 1 mL of a respiratory 66 BAL Patient selection 2011 and 2 December specimen without Index test 2011 at a tertiary care decontamination or Comparator hospital concentration was Reference std used Exclusion Flow and timing None stated Applicability: C1, P2
More than 72 hours of TB treatment, could not be followed up, no informed consent, or if an induced sputum specimen could not be obtained Pahwa 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=100 FNAs from 100 patients 55 had PCR results Age range 2.5 months – 60 years HIV status not reported Inclusion Patients with clinically and cytologically suspected TB lymphadenitis The clinical symptoms suggestive of TB were fever, anorexia or weight loss, and lymphadenopathy FNAs from the involved lymph node were divided into parts; five were used for AFB stains, one for PCR and one for L-J medium culture PCR was performed on all specimens, targeting the gene encoding the MPB64 protein AFB using ZN and fluorescent staining L-J medium culture FNAs were liquefied and digested using N-acetyl L-cysteine, decontaminated by standard procedure using Petroff’s method, inoculated on to L-J slants and incubated at 37 ºC for 6–8 weeks Park et al. () Korea 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=320 respiratory specimens from 311 adult patients Age and HIV status not reported 254 sputum 66 BAL Inclusion Samples were prospectively collected from patients with suspected pulmonary TB between 26 May 2011 and 2 December 2011 at a tertiary care hospital Exclusion None stated The respiratory specimens were processed with followed by centrifugation For the Xpert assay, 1 mL of a respiratory specimen without decontamination or concentration was used The specimen sample was transferred to the Xpert MTB/RIF cartridge and the test was run in the GeneXpert instrument Specimens were examined blindly by fluorescence staining Specimens were examined by cultures with both solid and liquid media