12 lymph node receiving anti-TB punctures therapy for more than 11 urine 6 days or who had 5 pus completed treatment 2 semen less than 12 months 6 stool before the date of enrolment Drouillon et al. N=179 pulmonary A minimum of 2 mL of qPCR was performed to Method not Culture was Level III-2: Inclusion () specimens (sputa and pulmonary specimen amplify and detect the specified performed using A comparison with Consecutive, gastric fluids) were was collected IS6110 sequence MGIT liquid media France reference standard (not patients with collected from 100 and Coletsos slants blinded or blinding not suspected TB Some was used patients known) between April and directly for the DNA Age and HIV status not October 2004 extraction Quality: Some risk of bias reported Exclusion The remainder was Patient selection decontaminated using None stated Index test ? NALC-NaOH solution Comparator ? Reference std ? Flow and timing Applicability: C1, P1 Ekrami et al. () Level III-1: N=152 sputum samples Inclusion Processed according PCR and nPCR ZN-stained AFB L-J solid medium to standard routine microscopy culture Iran A comparison against Age and HIV status not Patients who were Purified DNA was diagnostic procedures independent, blinded reported suspected of having amplified using primers using the NALC-NaOH reference standard among pulmonary TB specific to IS6110 and method two specific pairs of non-consecutive patients Exclusion external and internal Quality: Some risk of bias Not reported primers for this Patient selection bacterium Index test ? Comparator ? Reference std ? Flow and timing Applicability: C1, P2
12 lymph node punctures 11 urine 5 pus 2 semen 6 stool receiving anti-TB therapy for more than 6 days or who had completed treatment less than 12 months before the date of enrolment Drouillon et al. () France 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, P1 N=179 pulmonary specimens (sputa and gastric fluids) were collected from 100 patients Age and HIV status not reported Inclusion Consecutive, patients with suspected TB between April and October 2004 Exclusion None stated A minimum of 2 mL of pulmonary specimen was collected Some was used directly for the DNA extraction The remainder was decontaminated using NALC-NaOH solution qPCR was performed to amplify and detect the IS6110 sequence Method not specified Culture was performed using MGIT liquid media and Coletsos slants Ekrami et al. () Iran Level III-1: A comparison against independent, blinded reference standard among non-consecutive patients Quality: Some risk of bias Patient selection Index test ? Comparator ? Reference std ? Flow and timing Applicability: C1, P2 N=152 sputum samples Age and HIV status not reported Inclusion Patients who were suspected of having pulmonary TB Exclusion Not reported Processed according to standard routine diagnostic procedures using the NALC-NaOH method PCR and nPCR Purified DNA was amplified using primers specific to IS6110 and two specific pairs of external and internal primers for this bacterium ZN-stained AFB microscopy L-J solid medium culture
1234_FinalAssessmentReport-accessible.docx