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Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity

The long delay in returning test results during early infant diagnosis of HIV (EID) often causes loss-to-follow-up prior to antiretroviral treatment (ART) initiation in resource-limited settings. A point-of-care (POC) test may help overcome these challenges. We evaluated the performance of the LYNX...

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Autores principales: Meggi, Bindiya, Bollinger, Timothy, Mabunda, Nédio, Vubil, Adolfo, Tobaiwa, Ocean, Quevedo, Jorge I., Loquiha, Osvaldo, Vojnov, Lara, Peter, Trevor F., Jani, Ilesh V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5218410/
https://www.ncbi.nlm.nih.gov/pubmed/28060886
http://dx.doi.org/10.1371/journal.pone.0169497
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author Meggi, Bindiya
Bollinger, Timothy
Mabunda, Nédio
Vubil, Adolfo
Tobaiwa, Ocean
Quevedo, Jorge I.
Loquiha, Osvaldo
Vojnov, Lara
Peter, Trevor F.
Jani, Ilesh V.
author_facet Meggi, Bindiya
Bollinger, Timothy
Mabunda, Nédio
Vubil, Adolfo
Tobaiwa, Ocean
Quevedo, Jorge I.
Loquiha, Osvaldo
Vojnov, Lara
Peter, Trevor F.
Jani, Ilesh V.
author_sort Meggi, Bindiya
collection PubMed
description The long delay in returning test results during early infant diagnosis of HIV (EID) often causes loss-to-follow-up prior to antiretroviral treatment (ART) initiation in resource-limited settings. A point-of-care (POC) test may help overcome these challenges. We evaluated the performance of the LYNX p24 Antigen POC test in Mozambique. 879 HIV-exposed infants under 18 months of age were enrolled consecutively at three primary healthcare clinics (PHC). Lancet heel-drawn blood was tested on-site by nurses using a prototype POC test for HIV Gag p24 antigen detection. Results of POC testing were compared to laboratory-based nucleic acid testing on dried blood spots. A comparison of the effect of sensitivity and timely test results return on successful diagnosis by POC and laboratory-based platforms was also calculated. The sensitivity and specificity of the LYNX p24 Ag test were 71.9%; (95% confidence interval [CI]: 58.5–83.0%) and 99.6% (95% CI: 98.9–99.9%), respectively. The predictive value of positive and negative tests were 93.2% (95% CI: 81.3–98.6%) and 97.9% (95% CI: 96.8–98.8%), respectively. Overall agreement was high (Cohen Kappa = 0.80; 95% CI: 0.71–0.89). Despite its lower sensitivity, the POC test had the potential to provide test results to up to 81% more patients compared to the laboratory-based test. This prototype POC p24 assay was feasible for use in PHCs but demonstrated low sensitivity for HIV detection. POC EID technologies that perform below standard recommendations may still be valuable diagnostic tools in settings with inefficient EID networks.
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spelling pubmed-52184102017-01-19 Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity Meggi, Bindiya Bollinger, Timothy Mabunda, Nédio Vubil, Adolfo Tobaiwa, Ocean Quevedo, Jorge I. Loquiha, Osvaldo Vojnov, Lara Peter, Trevor F. Jani, Ilesh V. PLoS One Research Article The long delay in returning test results during early infant diagnosis of HIV (EID) often causes loss-to-follow-up prior to antiretroviral treatment (ART) initiation in resource-limited settings. A point-of-care (POC) test may help overcome these challenges. We evaluated the performance of the LYNX p24 Antigen POC test in Mozambique. 879 HIV-exposed infants under 18 months of age were enrolled consecutively at three primary healthcare clinics (PHC). Lancet heel-drawn blood was tested on-site by nurses using a prototype POC test for HIV Gag p24 antigen detection. Results of POC testing were compared to laboratory-based nucleic acid testing on dried blood spots. A comparison of the effect of sensitivity and timely test results return on successful diagnosis by POC and laboratory-based platforms was also calculated. The sensitivity and specificity of the LYNX p24 Ag test were 71.9%; (95% confidence interval [CI]: 58.5–83.0%) and 99.6% (95% CI: 98.9–99.9%), respectively. The predictive value of positive and negative tests were 93.2% (95% CI: 81.3–98.6%) and 97.9% (95% CI: 96.8–98.8%), respectively. Overall agreement was high (Cohen Kappa = 0.80; 95% CI: 0.71–0.89). Despite its lower sensitivity, the POC test had the potential to provide test results to up to 81% more patients compared to the laboratory-based test. This prototype POC p24 assay was feasible for use in PHCs but demonstrated low sensitivity for HIV detection. POC EID technologies that perform below standard recommendations may still be valuable diagnostic tools in settings with inefficient EID networks. Public Library of Science 2017-01-06 /pmc/articles/PMC5218410/ /pubmed/28060886 http://dx.doi.org/10.1371/journal.pone.0169497 Text en © 2017 Meggi et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Meggi, Bindiya
Bollinger, Timothy
Mabunda, Nédio
Vubil, Adolfo
Tobaiwa, Ocean
Quevedo, Jorge I.
Loquiha, Osvaldo
Vojnov, Lara
Peter, Trevor F.
Jani, Ilesh V.
Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity
title Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity
title_full Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity
title_fullStr Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity
title_full_unstemmed Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity
title_short Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity
title_sort point-of-care p24 infant testing for hiv may increase patient identification despite low sensitivity
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5218410/
https://www.ncbi.nlm.nih.gov/pubmed/28060886
http://dx.doi.org/10.1371/journal.pone.0169497
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