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

Anne M Neilan; Jennifer Cohn; Emma Sacks; Aditya R Gandhi; Patricia Fassinou; Rochelle P Walensky; Marc N Kouadio; Kenneth A Freedberg; Andrea L Ciaranello

doi:10.1093/ofid/ofab225

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

Open Forum Infect Dis. 2021 May 13;8(6):ofab225. doi: 10.1093/ofid/ofab225. eCollection 2021 Jun.

Authors

Anne M Neilan^{1

2

3

4}, Jennifer Cohn⁵, Emma Sacks^{5

6}, Aditya R Gandhi², Patricia Fassinou⁷, Rochelle P Walensky^{2

3

4}, Marc N Kouadio⁷, Kenneth A Freedberg^{2

3

4

8}, Andrea L Ciaranello^{2

3

4}

Affiliations

¹ Division of General Academic Pediatrics, Department of Pediatrics, Massachusetts General Hospital for Children, Boston, Massachusetts, USA.
² Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
³ Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA.
⁴ Harvard Medical School, Boston, Massachusetts, USA.
⁵ Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.
⁶ Johns Hopkins School of Public Health, Baltimore, Maryland, USA.
⁷ Elizabeth Glaser Pediatric AIDS Foundation, Abidjan, Côte d'Ivoire.
⁸ Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

Abstract

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.

Keywords: LMIC; cost-effectiveness; diagnostics; modeling; point-of-care.

Abstract

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