Quality: Low risk of bias Exclusion and a smear prepared The results were Culture-based DST for ZN microscopy obtained using the Xpert was performed using Receiving anti-TB Patient selection ? MTB/RIF software either the BACTEC drugs within 60 days The remaining portion Index test MGIT 960 system or prior to specimen (≥ 3 mL) was Comparator the absolute collection decontaminated with Reference std ? concentration NALC-NaOH and Flow and timing method on L-J centrifuged for culture medium Applicability: C1, P2 and Xpert Lee et al. () Level III-2: N=35 culture-positive Inclusion Samples were The Xpert MTB/RIF The AFB smears Culture-based DST Xpert-positive decontaminated with assay was performed were examined was performed using Korea A comparison with Retrospective review bronchoscopy samples NaOH and centrifuged following the after AUR staining the proportion reference standard (not of all records for for AFB microscopy, manufacturer’s method on 3% blinded or blinding not Age and HIV status not patients with culture and Xpert instructions Ogawa medium suspected PTB, known) reported among whom the AFB Quality: Low risk of bias microscopy, culture Patient selection and Xpert assays Index test ? were performed using Comparator bronchial washings or Reference std ? BAL Flow and timing Exclusion Applicability: C1, P2 Patients diagnosed with sputum AFB +ve PTB before bronchoscopy or who had received anti-TB medication for ≥ 2 weeks within 90 days before bronchoscopy Lee, Chen & N=150 sputum Decontamination using LAMP assay for AFB staining Mycobacterial Level III-2: Inclusion Peng () specimens NALC-NaOH detection of 16S rRNA in (method not culture (method not A comparison with Suspected TB treatment, and clinical isolates of MTB specified) specified) Taiwan reference standard (not Age and HIV status not patients admitted to subsequent using an ELISA blinded or blinding not reported Kaohsiung Medical concentration by detection system known) University Hospital
Quality: Low risk of bias Patient selection ? Index test Comparator Reference std ? Flow and timing Applicability: C1, P2 Exclusion Receiving anti-TB drugs within 60 days prior to specimen collection and a smear prepared for ZN microscopy The remaining portion (≥ 3 mL) was decontaminated with NALC-NaOH and centrifuged for culture and Xpert The results were obtained using the Xpert MTB/RIF software Culture-based DST was performed using either the BACTEC MGIT 960 system or the absolute concentration method on L-J medium Lee et al. () Korea 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=35 culture-positive Xpert-positive bronchoscopy samples Age and HIV status not reported Inclusion Retrospective review of all records for patients with suspected PTB, among whom the AFB microscopy, culture and Xpert assays were performed using bronchial washings or BAL Exclusion Patients diagnosed with sputum AFB +ve PTB before bronchoscopy or who had received anti-TB medication for ≥ 2 weeks within 90 days before bronchoscopy Samples were decontaminated with NaOH and centrifuged for AFB microscopy, culture and Xpert The Xpert MTB/RIF assay was performed following the manufacturer’s instructions The AFB smears were examined after AUR staining Culture-based DST was performed using the proportion method on 3% Ogawa medium Lee, Chen & Peng () Taiwan Level III-2: A comparison with reference standard (not blinded or blinding not known) N=150 sputum specimens Age and HIV status not reported Inclusion Suspected TB patients admitted to Kaohsiung Medical University Hospital Decontamination using NALC-NaOH treatment, and subsequent concentration by LAMP assay for detection of 16S rRNA in clinical isolates of MTB using an ELISA detection system AFB staining (method not specified) Mycobacterial culture (method not specified)
1234_FinalAssessmentReport-accessible.docx