known) reported indications for TB GeneXpert instrument bacterial colonies were investigated Quality: Low risk of bias Exclusion with the GenoType Patient selection None MTBDRplus assay Index test ? and confirmed by Comparator DST using the Reference std ? proportion method on L-J culture Flow and timing medium and/or Applicability: C1, P1 MGIT for RIF Jiang et al. () Level III-2: N=235 mixed Inclusion Respiratory specimens qRT-PCR using MTB AFB smears with Liquid MGIT 960 and specimens: were decontaminated 16S rRNA-specific ZN stain solid L-J cultures China A comparison with Clinical specimens with NALC-NaOH primers reference standard (not sputum (88.1%), were obtained from Extrapulmonary blinded or blinding not pleural fluid (3.0%), patients with specimens from closed known) lymph node (3.0%), suspected TB and normally sterile CSF (2.1%), Quality: Low risk of bias Exclusion sites were used urine (1.7%), Patient selection None directly without abscess and exudate Index test ? decontamination after (1.7%) and Comparator a single centrifugation faeces (0.4%) Reference std ? Age and HIV status not Flow and timing reported Applicability: C1, P2 Keys et al. () Level III-2: N=6 pleural biopsied Inclusion Not reported PCR, details not AFB microscopy Culture from children provided A comparison with Children with clinical Australia reference standard (not Age and HIV status not suspicion of TB with blinded or blinding not reported both respiratory and known) constitutional symptoms Quality: Some risk of bias Exclusion Patient selection ? None stated Index test ? Comparator ? Reference std ? Flow and timing ?
known) Quality: Low risk of bias Patient selection Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P1 reported indications for TB Exclusion None GeneXpert instrument bacterial colonies were investigated with the GenoType MTBDRplus assay and confirmed by DST using the proportion method on L-J culture medium and/or MGIT for RIF Jiang et al. () China 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=235 mixed specimens: sputum (88.1%), pleural fluid (3.0%), lymph node (3.0%), CSF (2.1%), urine (1.7%), abscess and exudate (1.7%) and faeces (0.4%) Age and HIV status not reported Inclusion Clinical specimens were obtained from patients with suspected TB Exclusion None Respiratory specimens were decontaminated with NALC-NaOH Extrapulmonary specimens from closed and normally sterile sites were used directly without decontamination after a single centrifugation qRT-PCR using MTB 16S rRNA-specific primers AFB smears with ZN stain Liquid MGIT 960 and solid L-J cultures Keys et al. () Australia 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 ? N=6 pleural biopsied from children Age and HIV status not reported Inclusion Children with clinical suspicion of TB with both respiratory and constitutional symptoms Exclusion None stated Not reported PCR, details not provided AFB microscopy Culture
1234_FinalAssessmentReport-accessible.docx