Diagnostic accuracy of WHO screening criteria to guide lateral-flow lipoarabinomannan testing among HIV-positive inpatients: A systematic review and individual participant data meta-analysis

Ashar Dhana, Yohhei Hamada, Andre P. Kengne, Andrew D. Kerkhoff, Tobias Broger, Claudia M. Denkinger, Molebogeng X. Rangaka, Ankur Gupta-Wright, Katherine Fielding, Robin Wood, Helena Huerga, Sekai Chenai Mathabire Rücker, Stephanie Bjerrum, Isik S. Johansen, Swe Swe Thit, Mar Mar Kyi, Josh Hanson, David A. Barr, Graeme Meintjes, Gary Maartens*

*Kontaktforfatter

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

Background: WHO recommends urine lateral-flow lipoarabinomannan (LF-LAM) testing with AlereLAM in HIV-positive inpatients only if screening criteria are met. We assessed the performance of WHO screening criteria and alternative screening tests/strategies to guide LF-LAM testing and compared diagnostic accuracy of the WHO AlereLAM algorithm (WHO screening criteria followed by AlereLAM if screen positive) with AlereLAM and FujiLAM (a novel LF-LAM test) testing in all HIV-positive inpatients. Methods: We searched MEDLINE, Embase, and Cochrane Library from Jan 1, 2011 to March 1, 2020 for studies among adult/adolescent HIV-positive inpatients regardless of tuberculosis signs and symptoms. The reference standards were (1) AlereLAM or FujiLAM for screening tests/strategies and (2) culture or Xpert for AlereLAM/FujiLAM. We determined proportion of inpatients eligible for AlereLAM using WHO screening criteria; assessed accuracy of WHO criteria and alternative screening tests/strategies to guide LF-LAM testing; compared accuracy of WHO AlereLAM algorithm with AlereLAM/FujiLAM testing in all; and determined diagnostic yield of AlereLAM, FujiLAM, and Xpert MTB/RIF (Xpert). We estimated pooled proportions with a random-effects model, assessed diagnostic accuracy using random-effects bivariate models, and assessed diagnostic yield descriptively. Findings: We obtained data from all 5 identified studies (n = 3,504). The pooled proportion of inpatients eligible for AlereLAM using WHO criteria was 93% (95%CI 91, 95). Among screening tests/strategies to guide LF-LAM testing, WHO criteria, C-reactive protein (≥5 mg/L), and CD4 count (<200 cells/μL) had high sensitivities but low specificities; cough (≥2 weeks), hemoglobin (<8 g/dL), body mass index (<18.5 kg/m2), lymphadenopathy, and WHO-defined danger signs had higher specificities but suboptimal sensitivities. AlereLAM in all had the same sensitivity (62%) and specificity (88%) as WHO AlereLAM algorithm. Sensitivity of FujiLAM and AlereLAM was 69% and 48%, while specificity was 88% and 96%, respectively. In 2 studies that collected sputum and non-sputum samples for Xpert and/or culture, diagnostic yield of sputum Xpert was 40–41%, AlereLAM was 39–76%, and urine Xpert was 35–62%. In one study, FujiLAM diagnosed 80% of tuberculosis cases (vs 39% for AlereLAM), and sputum Xpert combined with AlereLAM, urine Xpert, or FujiLAM diagnosed 61%, 81%, and 92% of all cases, respectively. Interpretation: WHO criteria and alternative screening tests/strategies have limited utility in guiding LF-LAM testing, suggesting that AlereLAM testing in all HIV-positive medical inpatients be implemented. Routine FujiLAM may improve tuberculosis diagnosis. Funding: None.

OriginalsprogEngelsk
TidsskriftJournal of Infection
Vol/bind85
Udgave nummer1
Sider (fra-til)40-48
ISSN0163-4453
DOI
StatusUdgivet - jul. 2022

Bibliografisk note

Funding Information:
AD received training in research that was supported by the Fogarty International Center of the National Institutes of Health under Award Number D43 TW010559 and National Research Foundation. GrM and GaM were supported by core funding from the Wellcome centre for Infectious Diseases Research in Africa (203135/Z/16/Z). GrM was supported by the Wellcome Trust (214321/Z/18/Z), and the South African Research Chairs Initiative of the Department of Science and Technology and National Research Foundation of South Africa (Grant No 64787). We thank Mrs Joy Oliver (Cochrane South Africa and South African Medical Research Council) for assisting to conduct searches for the review. We would also like to thank FIND, the global alliance for diagnostics, for agreeing to share FujiLAM data. This research was funded, in part, by the Wellcome Trust. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. None.

Funding Information:
AD received training in research that was supported by the Fogarty International Center of the National Institutes of Health under Award Number D43 TW010559 and National Research Foundation. GrM and GaM were supported by core funding from the Wellcome centre for Infectious Diseases Research in Africa (203135/Z/16/Z). GrM was supported by the Wellcome Trust (214321/Z/18/Z), and the South African Research Chairs Initiative of the Department of Science and Technology and National Research Foundation of South Africa (Grant No 64787). We thank Mrs Joy Oliver (Cochrane South Africa and South African Medical Research Council) for assisting to conduct searches for the review. We would also like to thank FIND, the global alliance for diagnostics, for agreeing to share FujiLAM data. This research was funded, in part, by the Wellcome Trust. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.

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