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Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis

BACKGROUND: The World Health Organization (WHO) human immunodeficiency virus (HIV) diagnostic strategy requires 6 rapid diagnostic tests (RDTs). Point-of-care nucleic acid tests (POC NATs) are costlier, less sensitive, but more specific than RDTs. METHODS: We simulated a 1-time screening process in...

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Autores principales: Neilan, Anne M, Cohn, Jennifer, Sacks, Emma, Gandhi, Aditya R, Fassinou, Patricia, Walensky, Rochelle P, Kouadio, Marc N, Freedberg, Kenneth A, Ciaranello, Andrea L
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8231387/
https://www.ncbi.nlm.nih.gov/pubmed/34189169
http://dx.doi.org/10.1093/ofid/ofab225
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author Neilan, Anne M
Cohn, Jennifer
Sacks, Emma
Gandhi, Aditya R
Fassinou, Patricia
Walensky, Rochelle P
Kouadio, Marc N
Freedberg, Kenneth A
Ciaranello, Andrea L
author_facet Neilan, Anne M
Cohn, Jennifer
Sacks, Emma
Gandhi, Aditya R
Fassinou, Patricia
Walensky, Rochelle P
Kouadio, Marc N
Freedberg, Kenneth A
Ciaranello, Andrea L
author_sort Neilan, Anne M
collection PubMed
description BACKGROUND: The World Health Organization (WHO) human immunodeficiency virus (HIV) diagnostic strategy requires 6 rapid diagnostic tests (RDTs). Point-of-care nucleic acid tests (POC NATs) are costlier, less sensitive, but more specific than RDTs. METHODS: We simulated a 1-time screening process in Côte d’Ivoire (CI; undiagnosed prevalence: 1.8%), comparing WHO- and CI-recommended RDT-based strategies (RDT-WHO, RDT-CI) and an alternative: POC NAT to resolve RDT discordancy (NAT-Resolve). Costs included assays (RDT: $1.47; POC NAT: $27.92), antiretroviral therapy ($6–$22/month), and HIV care ($27–$38/month). We modeled 2 sensitivity/specificity scenarios: high-performing (RDT: 99.9%/99.1%; POC NAT: 95.0%/100.0%) and low-performing (RDT: 91.1%/82.9%; POC NAT: 93.3%/99.5%). Outcomes included true-positive (TP), false-positive (FP), true-negative (TN), or false-negative (FN) results; life expectancy; costs; and incremental cost-effectiveness ratios (ICERs: $/year of life saved [YLS]; threshold ≤$1720/YLS [per-capita gross domestic product]). RESULTS: Model-projected impacts of misdiagnoses were 4.4 years lost (FN vs TP; range, 3.0–13.0 years) and a $5800 lifetime cost increase (FP vs TN; range, $590–$14 680). In the high-performing scenario, misdiagnoses/10 000 000 tested were lowest for NAT-Resolve vs RDT-based strategies (FN: 409 vs 413–429; FP: 14 vs 21–28). Strategies had similar life expectancy (228 months) and lifetime costs ($220/person) among all tested; ICERs were $3450/YLS (RDT-CI vs RDT-WHO) and $120 910/YLS (NAT-Resolve vs RDT-CI). In the low-performing scenario, misdiagnoses were higher (FN: 22 845–30 357; FP: 83 724–112 702) and NAT-Resolve was cost-saving. CONCLUSIONS: We projected substantial clinical and economic impacts of misdiagnoses. Using POC NAT to resolve RDT discordancy generated the fewest misdiagnoses and was not cost-effective in high-performing scenarios, but may be an important adjunct to existing RDT-based strategies in low-performing scenarios.
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spelling pubmed-82313872021-06-28 Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis Neilan, Anne M Cohn, Jennifer Sacks, Emma Gandhi, Aditya R Fassinou, Patricia Walensky, Rochelle P Kouadio, Marc N Freedberg, Kenneth A Ciaranello, Andrea L Open Forum Infect Dis Major Articles BACKGROUND: The World Health Organization (WHO) human immunodeficiency virus (HIV) diagnostic strategy requires 6 rapid diagnostic tests (RDTs). Point-of-care nucleic acid tests (POC NATs) are costlier, less sensitive, but more specific than RDTs. METHODS: We simulated a 1-time screening process in Côte d’Ivoire (CI; undiagnosed prevalence: 1.8%), comparing WHO- and CI-recommended RDT-based strategies (RDT-WHO, RDT-CI) and an alternative: POC NAT to resolve RDT discordancy (NAT-Resolve). Costs included assays (RDT: $1.47; POC NAT: $27.92), antiretroviral therapy ($6–$22/month), and HIV care ($27–$38/month). We modeled 2 sensitivity/specificity scenarios: high-performing (RDT: 99.9%/99.1%; POC NAT: 95.0%/100.0%) and low-performing (RDT: 91.1%/82.9%; POC NAT: 93.3%/99.5%). Outcomes included true-positive (TP), false-positive (FP), true-negative (TN), or false-negative (FN) results; life expectancy; costs; and incremental cost-effectiveness ratios (ICERs: $/year of life saved [YLS]; threshold ≤$1720/YLS [per-capita gross domestic product]). RESULTS: Model-projected impacts of misdiagnoses were 4.4 years lost (FN vs TP; range, 3.0–13.0 years) and a $5800 lifetime cost increase (FP vs TN; range, $590–$14 680). In the high-performing scenario, misdiagnoses/10 000 000 tested were lowest for NAT-Resolve vs RDT-based strategies (FN: 409 vs 413–429; FP: 14 vs 21–28). Strategies had similar life expectancy (228 months) and lifetime costs ($220/person) among all tested; ICERs were $3450/YLS (RDT-CI vs RDT-WHO) and $120 910/YLS (NAT-Resolve vs RDT-CI). In the low-performing scenario, misdiagnoses were higher (FN: 22 845–30 357; FP: 83 724–112 702) and NAT-Resolve was cost-saving. CONCLUSIONS: We projected substantial clinical and economic impacts of misdiagnoses. Using POC NAT to resolve RDT discordancy generated the fewest misdiagnoses and was not cost-effective in high-performing scenarios, but may be an important adjunct to existing RDT-based strategies in low-performing scenarios. Oxford University Press 2021-05-13 /pmc/articles/PMC8231387/ /pubmed/34189169 http://dx.doi.org/10.1093/ofid/ofab225 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Major Articles
Neilan, Anne M
Cohn, Jennifer
Sacks, Emma
Gandhi, Aditya R
Fassinou, Patricia
Walensky, Rochelle P
Kouadio, Marc N
Freedberg, Kenneth A
Ciaranello, Andrea L
Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis
title Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis
title_full Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis
title_fullStr Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis
title_full_unstemmed Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis
title_short Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d’Ivoire Modeling Analysis
title_sort evaluating point-of-care nucleic acid tests in adult human immunodeficiency virus diagnostic strategies: a côte d’ivoire modeling analysis
topic Major Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8231387/
https://www.ncbi.nlm.nih.gov/pubmed/34189169
http://dx.doi.org/10.1093/ofid/ofab225
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