Madhavan & Low risk of IS6110 PCR 2 2 0 4 Narayanan () bias India AFB (ZN) 4 0 6 190 Khosravi et al. () Level III-2 L-J culture N=200 urine samples None reported IS6110 nPCR 10 0 0 190 Iran Some risk of bias Ghaleb, Afifi & Level III-2 BACTEC N=100 urine samples AFB (ZN) 1 0 0 99 None reported El-Gohary () 12B and/or IS6110 PCR 3 3 0 94 Some risk of L-J culture - AFB + NAAT 3 3 0 94 Egypt bias n=99 AFB –ve IS6110 PCR 2 3 0 94 Khan, Cheema Level III-2 L-J culture N=50 urine samples AFB (ZN) 11 2 8 29 None reported & Khan () 16 2 3 29 Some risk of PCR Egypt bias AFB = acid-fast bacilli; L-J = Lowenstein-Jensen; MGIT = Mycobacterium Growth Indicator Tubes; NAAT = nucleic acid amplification test; nPCR = nested PCR; PCR = polymerase chain reaction; ZN = Ziehl-Neelsen Table 88 Diagnostic accuracy of in-house NAAT compared with AFB microscopy and culture in tissue biopsies Study Evidence Reference Population Tests Inconclusive results level and risk standard Country Samples of bias results results results results Bhanu et al. () Level III-1 L-J culture N=14 endometrial AFB (ZN) 1 0 0 13 3 negative PCR biopsies mpt64 PCR 1 7 0 6 included in analysis India Low risk of were found to be bias inhibitory Deshmukh et MGIT N=164 tissue AFB (ZN) 37 7 23 97 Level III-2 None reported al. 2013 and/or L-J specimens IS6110 PCR 57 3 3 84 Low risk of culture AFB + NAAT 57 3 3 84 India bias N=50 endoscopic Sharma et al. () Level III-2 L-J culture AFB (ZN) 1 1 0 47 None reported ileocaecal biopsies M-PCR 2 0 29 19 India Low risk of bias
Madhavan & Narayanan () India Low risk of bias IS6110 PCR 2 2 0 4 Khosravi et al. () Iran Level III-2 Some risk of bias L-J culture N=200 urine samples AFB (ZN) IS6110 nPCR 4 10 0 0 6 0 190 190 None reported Ghaleb, Afifi & El-Gohary () Egypt Level III-2 Some risk of bias BACTEC 12B and/or L-J culture N=100 urine samples - n=99 AFB (ZN) IS6110 PCR AFB + NAAT AFB –ve IS6110 PCR 1 3 3 2 0 3 3 3 0 0 0 0 99 94 94 94 None reported Khan, Cheema & Khan () Egypt Level III-2 Some risk of bias L-J culture N=50 urine samples AFB (ZN) PCR 11 16 2 2 8 3 29 29 None reported AFB = acid-fast bacilli; L-J = Lowenstein-Jensen; MGIT = Mycobacterium Growth Indicator Tubes; NAAT = nucleic acid amplification test; nPCR = nested PCR; PCR = polymerase chain reaction; ZN = Ziehl-Neelsen Table 88 Diagnostic accuracy of in-house NAAT compared with AFB microscopy and culture in tissue biopsies Study Country Evidence level and risk of bias Reference standard Population Samples Tests results results results results Inconclusive results Bhanu et al. () India Level III-1 Low risk of bias L-J culture N=14 endometrial biopsies AFB (ZN) mpt64 PCR 1 1 0 7 0 0 13 6 3 negative PCR included in analysis were found to be inhibitory Deshmukh et al. 2013 India Level III-2 Low risk of bias MGIT and/or L-J culture N=164 tissue specimens AFB (ZN) IS6110 PCR AFB + NAAT 37 57 57 7 3 3 23 3 3 97 84 84 None reported Sharma et al. () India Level III-2 Low risk of bias L-J culture N=50 endoscopic ileocaecal biopsies AFB (ZN) M-PCR 1 2 1 0 0 29 47 19 None reported
1234_FinalAssessmentReport-accessible.docx