Mvundura Mercy, Kiyaga Charles, Metzler Mutsumi, Kamya Carol, Lim Jeanette M, Maiteki-Sebuguzi Catherine, Coffey Patricia S
Devices and Tools Global Program, PATH, Seattle, WA, USA,
Uganda Central Public Health Laboratory, Ministry of Health, Kampala, Uganda.
J Blood Med. 2019 Feb 5;10:59-67. doi: 10.2147/JBM.S186528. eCollection 2019.
Early identification through newborn screening is the first step in active management of sickle cell disease (SCD). Uganda currently screens newborns and infants under 2 years for SCD in high HIV-burden districts using isoelectric focusing with dried blood spot samples. Our analysis sought to estimate the costs per child screened for SCD using this method in Uganda and then to use those data to estimate the price threshold for screening with a point-of-care (POC) test.
We estimated the financial and economic costs per child screened for SCD using data from health facilities and the Central Public Health Laboratory. These costs included sample collection, transportation, and laboratory processing. Price thresholds for a POC test were estimated using two scenarios.
The price threshold of an SCD POC test used for diagnosis would be $3.77 when taking into account only financial costs and $5.14 when taking into account economic costs. Thresholds for a POC test used for screening would be $3.07-$3.51 and $4.38-$5.09, respectively, depending on test specificity.
The price threshold of a POC test for SCD will depend on the assumptions on how it will be used - either as a screening or diagnostic test. If used for screening, test specificity will have significant impact. Results from this type of costing study can allow developers to incorporate quantitatively estimated price thresholds for innovative products into target product profiles early in the product development cycle.
通过新生儿筛查进行早期识别是镰状细胞病(SCD)积极管理的第一步。乌干达目前在高负担艾滋病毒地区,使用干血斑样本的等电聚焦法,对新生儿和2岁以下婴儿进行SCD筛查。我们的分析旨在估算在乌干达使用该方法筛查每名SCD患儿的成本,然后利用这些数据估算即时检验(POC)筛查的价格阈值。
我们利用来自医疗机构和中央公共卫生实验室的数据,估算了每名SCD筛查患儿的财务和经济成本。这些成本包括样本采集、运输和实验室处理。使用两种情景估算了POC检测的价格阈值。
仅考虑财务成本时,用于诊断的SCD POC检测价格阈值为3.77美元;考虑经济成本时为5.14美元。用于筛查的POC检测阈值分别为3.07 - 3.51美元和4.38 - 5.09美元,具体取决于检测特异性。
SCD的POC检测价格阈值将取决于其使用方式的假设——用作筛查还是诊断检测。如果用于筛查,检测特异性将产生重大影响。这类成本研究的结果可使开发者在产品开发周期早期,将创新产品的定量估算价格阈值纳入目标产品概况。