Quality: Some risk of bias Exclusion centrifugation Patient selection Not reported Index test ? Comparator Reference std ? Flow and timing ? Applicability: C1, P2 Ligthelm et al. N=48 lymph node The Xpert MTB/RIF AFB smears with MGIT 960 for growth Level III-2: Inclusion Sample used directly. () FNAs assay was performed both ZN staining detection A comparison with All patients referred following the and fluorescence South Africa reference standard (not Mean age of patients for FNA biopsy with manufacturer’s microscopy blinded or blinding not 27.9 ± 15.1 years possible TB instructions known) lymphadenitis 36/48 had unknown Quality: Low risk of bias HIV status Exclusion Patient selection 9/12 (75%) patients Inadequate sample for tested were HIV+ testing Index test ? Comparator Reference std ? Flow and timing Applicability: C1, P2 Makeshkumar, Level III-2: N=178 extrapulmonary Inclusion Sterile body fluid PCR using primers AFB microscopy Specimens were Madhavan & specimens samples (ascitic fluid, targeting IS6110 with ZN stain inoculated onto solid A comparison with All clinically suspected Narayanan () pleural fluid, CSF, L-J medium and reference standard (not Age and HIV status not extrapulmonary TB synovial fluid, examined every India blinded or blinding not reported patients who were pericardial fluid and second day during known) visiting SRM Medical 59 ascetic fluid pancreatic cyst fluid) the first week and College Hospital Quality: Low risk of bias 54 pleural fluid were centrifuged weekly for up to during the period May 25 CSF Patient selection 8 weeks Pus specimens were 2008 – May 2009 12 FNA Index test ? decontaminated using 8 urine Exclusion Comparator Petroff’s method 7 pus None Reference std ? 6 synovial fluid Biopsy and skin tissue Flow and timing 7 other samples were ground and then centrifuged Applicability: C1, P2
Quality: Some risk of bias Patient selection Index test ? Comparator Reference std ? Flow and timing ? Applicability: C1, P2 Exclusion Not reported centrifugation Ligthelm et al. () South Africa 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=48 lymph node FNAs Mean age of patients 27.9 ± 15.1 years 36/48 had unknown HIV status 9/12 (75%) patients tested were HIV+ Inclusion All patients referred for FNA biopsy with possible TB lymphadenitis Exclusion Inadequate sample for testing Sample used directly. The Xpert MTB/RIF assay was performed following the manufacturer’s instructions AFB smears with both ZN staining and fluorescence microscopy MGIT 960 for growth detection Makeshkumar, Madhavan & Narayanan () India 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=178 extrapulmonary specimens Age and HIV status not reported 59 ascetic fluid 54 pleural fluid 25 CSF 12 FNA 8 urine 7 pus 6 synovial fluid 7 other Inclusion All clinically suspected extrapulmonary TB patients who were visiting SRM Medical College Hospital during the period May 2008 – May 2009 Exclusion None Sterile body fluid samples (ascitic fluid, pleural fluid, CSF, synovial fluid, pericardial fluid and pancreatic cyst fluid) were centrifuged Pus specimens were decontaminated using Petroff’s method Biopsy and skin tissue samples were ground and then centrifuged PCR using primers targeting IS6110 AFB microscopy with ZN stain Specimens were inoculated onto solid L-J medium and examined every second day during the first week and weekly for up to 8 weeks
1234_FinalAssessmentReport-accessible.docx