Rachow et al. Level II: N=292 patients with Inclusion Sputum samples were Frozen sputa were AFB microscopy L-J solid and MGIT sputum samples (each split into two aliquots, thawed and processed () with ZN staining liquid culture A comparison against Patients with provided three one of which was according to the Xpert Tanzania independent, blinded symptoms suggestive samples, results were stored at –80 ºC; the MTB/RIF assay test reference standard among of pulmonary TB recorded from other was processed procedure consecutive patients Exclusion morning sample) for standard AFB Quality: Low risk of bias Not able to produce microscopy and Mean age 39.2 ± Patient selection sputum at recruitment, culture 13.8 years lost to follow-up Index test Sputa were 58.9% were HIV+ during recruitment Comparator decontaminated using procedures Reference std the NALC-NaOH method Flow and timing Applicability: C1, P2 Santos et al. () Level III-2: N=218 sputum samples Inclusion 48 samples had to be PCR targeting IS6110 AFB microscopy L-J medium culture transported in using direct and (using NaOH as A comparison with 60 non-Indigenous Non-Indigenous and Brazil cetylpyridinium concentrated decontaminant) reference standard (not 158 Indigenous Indigenous patients chloride solution and techniques blinded or blinding not presenting with Age and HIV status not were then respiratory symptoms 48 samples were known) reported homogenised and suspected of stained with Quality: Some risk of bias pulmonary TB, bromothymol blue Patient selection providing sputum Index test ? sample Comparator Exclusion Reference std ? Not reported Flow and timing Applicability: C1, P2 Sharma et al. Level III-2: N=80 osteoarticular TB Inclusion The specimens were M-PCR with primers AFB microscopy Culture was on L-J () (OATB) specimens concentrated by targeting IS6110 and with ZN staining medium A comparison with Specimens received centrifugation MPB64 India reference standard (not 67 synovial fluid for AFB staining and blinded or blinding not 13 pus culture for diagnosis known) of OATB Age and HIV status not Quality: Some risk of bias reported Exclusion Patient selection None stated Index test ?
Rachow et al. () Tanzania Level II: A comparison against independent, blinded reference standard among consecutive patients Quality: Low risk of bias Patient selection Index test Comparator Reference std Flow and timing Applicability: C1, P2 N=292 patients with sputum samples (each provided three samples, results were recorded from morning sample) Mean age 39.2 ± 13.8 years 58.9% were HIV+ Inclusion Patients with symptoms suggestive of pulmonary TB Exclusion Not able to produce sputum at recruitment, lost to follow-up during recruitment procedures Sputum samples were split into two aliquots, one of which was stored at –80 ºC; the other was processed for standard AFB microscopy and culture Sputa were decontaminated using the NALC-NaOH method Frozen sputa were thawed and processed according to the Xpert MTB/RIF assay test procedure AFB microscopy with ZN staining L-J solid and MGIT liquid culture Santos et al. () Brazil 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=218 sputum samples 60 non-Indigenous 158 Indigenous Age and HIV status not reported Inclusion Non-Indigenous and Indigenous patients presenting with respiratory symptoms and suspected of pulmonary TB, providing sputum sample Exclusion Not reported 48 samples had to be transported in cetylpyridinium chloride solution and were then homogenised PCR targeting IS6110 AFB microscopy using direct and concentrated techniques 48 samples were stained with bromothymol blue L-J medium culture (using NaOH as decontaminant) Sharma 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 ? N=80 osteoarticular TB (OATB) specimens 67 synovial fluid 13 pus Age and HIV status not reported Inclusion Specimens received for AFB staining and culture for diagnosis of OATB Exclusion None stated The specimens were concentrated by centrifugation M-PCR with primers targeting IS6110 and MPB64 AFB microscopy with ZN staining Culture was on L-J medium
1234_FinalAssessmentReport-accessible.docx