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

Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d'Ivoire Modeling Analysis.
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DOI:
10.1093/ofid/ofab225
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发表时间:
2021-06
影响因子:
4.2
通讯作者:
Ciaranello AL
Ciaranello AL
中科院分区:
医学3区
文献类型:
--
作者:
Neilan AM;Cohn J;Sacks E;Gandhi AR;Fassinou P;Walensky RP;Kouadio MN;Freedberg KA;Ciaranello AL

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世界卫生组织 (WHO) 人类免疫缺陷病毒 (HIV) 诊断策略需要 6 项快速诊断测试 (RDT)。护理点核酸检测 (POC NAT) 比 RDT 更昂贵、灵敏度更低,但特异性更高。我们模拟了科特迪瓦的一次筛查过程(CI;未确诊患病率:1.8%),比较了 WHO 和 CI 推荐的基于 RDT 的策略(RDT-WHO、RDT-CI)和替代方案:POC NAT 来解决 RDT 不一致问题(NAT-Resolve)。费用包括化验(RDT:1.47 美元;POC NAT:27.92 美元)、抗逆转录病毒治疗(6-22 美元/月)和艾滋病毒护理(27-38 美元/月)。我们模拟了 2 种敏感性/特异性场景:高性能(RDT:99.9%/99.1%;POC NAT:95.0%/100.0%)和低性能(RDT:91.1%/82.9%;POC NAT:93.3%/99.5%)。结果包括真阳性(TP)、假阳性(FP)、真阴性(TN)或假阴性(FN)结果;预期寿命;成本;增量成本效益比(ICER:每挽救生命一年 [YLS] 美元;阈值 ≤ 1720 美元/YLS [人均国内生产总值])。模型预测误诊的影响为损失 4.4 年(FN 与 TP;范围,3.0-13.0 年),终身成本增加 5800 美元(FP 与 TN;范围,590-14 680 美元)。在高性能场景中,NAT-Resolve 与基于 RDT 的策略相比,每 10 000 000 次测试的误诊率最低(FN:409 vs 413-429;FP:14 vs 21-28)。所有测试的策略具有相似的预期寿命(228 个月)和终生成本(220 美元/人); ICER 为 3450 美元/YLS(RDT-CI 与 RDT-WHO)和 120 910 美元/YLS(NAT-Resolve 与 RDT-CI)。在表现不佳的情况下,误诊率较高(FN:22 845–30 357;FP:83 724–112 702),并且 NAT-Resolve 可以节省成本。我们预计误诊会产生重大的临床和经济影响。使用 POC NAT 解决 RDT 不一致问题产生的误诊最少,并且在高性能场景中并不具有成本效益,但在低性能场景中可能是现有基于 RDT 策略的重要辅助手段。
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. 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]). 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. 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.
DOI: 10.1002/jia2.25095
发表时间: 2018-04
影响因子: 6
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