Patient selection antibiotic treatment for diagnostic tests pneumonia Index test ? Exclusion Comparator Pregnant women and Reference std ? patients with oxygen Flow and timing saturation < 90% Applicability: C1, P2 under 6 L/minute Kim et al. () Level III-2: N=2,973 patients Inclusion Sputum, bronchial nPCR using primers AUR-stain positive Specimens were aspirate, urine and pus targeting IS6110 specimens were inoculated onto 3% Korea A comparison with Age and HIV status not Patients who visited were incubated with confirmed with ZN Ogawa media and reference standard (not reported Kyung Hee Medical NaOH and then microscopy then incubated for at blinded or blinding not Center between July n=1,134 pulmonary centrifuged least 8 weeks at known) 2003 and July 2006 specimens: 37 °C for TB diagnosis Tissues were minced Quality: Low risk of bias 863 sputum with scissors and Exclusion Patient selection 271 bronchial treated with proteinase aspirate None Index test ? K and then centrifuged n=1,839 Comparator Cerebrospinal and extrapulmonary Reference std ? other body fluids were specimens: Flow and timing centrifuged without 834 pleural fluid any pre-treatment Applicability: C1, P2 313 CSF 248 urine 147 tissue 109 pus 59 peritoneal fluid 34 blood 12 gastric aspirate 9 pericardial fluid 7 bone marrow 67 other Kurbatova et Level III-2: N=238 sputum Inclusion Sputum samples were The Xpert MTB/RIF Direct and AUR Sample was al. () specimens from 201 homogenised and split assay was performed fluorescence inoculated onto L-J A comparison with Adults (> 17 years of patients into two portions. From according to the microscopy solid medium and Russia reference standard (not age) with presumptive one portion, 1.0 mL manufacturer’s BACTEC MGIT 960 blinded or blinding not Age and HIV status not or recently diagnosed was tested by Xpert instructions liquid medium known) reported pulmonary TB
Patient selection Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P2 antibiotic treatment for pneumonia Exclusion Pregnant women and patients with oxygen saturation < 90% under 6 L/minute diagnostic tests Kim 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=2,973 patients Age and HIV status not reported n=1,134 pulmonary specimens: 863 sputum 271 bronchial aspirate n=1,839 extrapulmonary specimens: 834 pleural fluid 313 CSF 248 urine 147 tissue 109 pus 59 peritoneal fluid 34 blood 12 gastric aspirate 9 pericardial fluid 7 bone marrow 67 other Inclusion Patients who visited Kyung Hee Medical Center between July 2003 and July 2006 for TB diagnosis Exclusion None Sputum, bronchial aspirate, urine and pus were incubated with NaOH and then centrifuged Tissues were minced with scissors and treated with proteinase K and then centrifuged Cerebrospinal and other body fluids were centrifuged without any pre-treatment nPCR using primers targeting IS6110 AUR-stain positive specimens were confirmed with ZN microscopy Specimens were inoculated onto 3% Ogawa media and then incubated for at least 8 weeks at 37 °C Kurbatova et al. () Russia Level III-2: A comparison with reference standard (not blinded or blinding not known) N=238 sputum specimens from 201 patients Age and HIV status not reported Inclusion Adults (> 17 years of age) with presumptive or recently diagnosed pulmonary TB Sputum samples were homogenised and split into two portions. From one portion, 1.0 mL was tested by Xpert The Xpert MTB/RIF assay was performed according to the manufacturer’s instructions Direct and AUR fluorescence microscopy Sample was inoculated onto L-J solid medium and BACTEC MGIT 960 liquid medium
1234_FinalAssessmentReport-accessible.docx