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Diagnostic accuracy of oral mucosal transudate tests compared to blood-based rapid tests for HIV among children ages 18 months to 18 years in Kenya and Zimbabwe

Chikwari, Chido Dziva1,2,*; Njuguna, Irene N.3,4,*; Neary, Jillian7; Rainer, Crissi5; Chihota, Belinda6; Slyker, Jennifer A.3,7; Katz, David A.8; Wamalwa, Dalton C.9; Oyiengo, Laura10; Bandason, Tsitsi2; McHugh, Grace2; Dauya, Ethel2; Mujuru, Hilda11; Stewart, Kearsley A5; John-Stewart, Grace C.3,7,12; Ferrand, Rashida A.1,2; Wagner, Anjuli D.7

JAIDS Journal of Acquired Immune Deficiency Syndromes: August 16, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/QAI.0000000000002146
Clinical Science: PDF Only

Background: Gaps persist in HIV testing for children who were not tested in prevention of mother-to-child HIV transmission programs. Oral mucosal transudate rapid HIV tests (OMT) have been shown to be highly sensitive in adults but their performance has not been established in children.

Methods: ART-naïve children aged 18 months to 18 years in Kenya and Zimbabwe were tested for HIV using rapid OraQuick ADVANCE Rapid HIV-1/2 Antibody test on oral fluids (OMT) and blood-based rapid diagnostic testing (BBT). BBT followed Kenyan and Zimbabwean national algorithms. Sensitivity and specificity were calculated using the national algorithms as the reference standard.

Results: A total of 1,776 children were enrolled; median age was 7.3 years (IQR: 4.7, 11.6). Among 71 children positive by BBT, 71 were positive by OMT (sensitivity: 100% [97.5%CI: 94.9-100%]). Among the 1,705 children negative by BBT, 1,703 were negative by OMT (specificity: 99.9% [95%CI: 99.6-100.0%]). Due to discrepant BBT and OMT results, 2 children who initially tested BBT negative and OMT positive were subsequently confirmed positive within 1 week by further tests. Excluding these 2 children, the sensitivity and specificity of OMT compared to BBT were each 100% (97.5%CI: 94.9-100% and 99.8-100%, respectively).

Conclusions: Compared to national algorithms, OMT did not miss any HIV-positive children. These data suggest that OMTs are valid in this age range. Future research should explore the acceptability and uptake of OMT by caregivers and health workers to increase pediatric HIV testing coverage.

1London School of Hygiene and Tropical Medicine, London, United Kingdom

2Biomedical Research and Training Institute, Harare, Zimbabwe

3Department of Epidemiology, University of Washington, Seattle, WA, USA

4Research and Programs, Kenyatta National Hospital, Nairobi, Kenya

5Duke Global Health Institute, Duke University, Durham, NC, USA

6Centre for Infectious Disease Research in Zambia, Lusaka, Zambia

7Department of Global Health, University of Washington, Seattle, WA, USA

8Allergy and Infectious Disease, School of Medicine, University of Washington, Seattle, WA, USA

9Department of Paediatric and Child Health, University of Nairobi, Nairobi, Kenya

10National AIDS & STI Control Programme, Ministry of Health, Nairobi, Kenya

11University of Zimbabwe College of Health Sciences, Harare, Zimbabwe

12Departments of Medicine and Pediatrics, University of Washington, Nairobi, Kenya

Corresponding Author: Chido Dziva Chikwari Biomedical Research and Training Institute 10 Seagrave Road, Avondale Harare, Zimbabwe Tel: +263772773879/+2634745583 Email:

The authors report no conflicts of interest related to this work.

* Joint first authors

Funding: The study in Zimbabwe was jointly funded by the Duke Global Health Institute, the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID concordat agreement and is also part of the EDCTP2 programme supported by the European Union (MR/P011268/1).

The Saliva Testing and Video Information to Expand Uptake of Pediatric HIV Testing (STEP-UP) study was funded by the National Institutes of Health (NIH; P30 AI027757 [CFAR New Investigator Award; PI: Wagner]) and the Thrasher Research Foundation (A119882). INN, DAK, JN, ADW were supported by P30 AI027757. ADW was also supported by A119882. INN was supported by Fogarty International Centre (FIC) D43TW009783. This publication was supported by the University of Washington Global Center for the Integrated Health of Women, Adolescents, and Children (Global WACh). This publication was funded in part by the University of Washington / Fred Hutch Center for AIDS Research, and NIH funded program under award number AI027757, which is supported by the following NIH Institutes and Centers: NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA, NIGMS, NIDDK.

The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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