Cost for sickle cell disease screening using isoelectric focusing with dried blood spot samples and estimation of price thresholds for a point-of-care test in Uganda

Abstract

Mercy Mvundura,1 Charles Kiyaga,2 Mutsumi Metzler,1 Carol Kamya,3 Jeanette M Lim,1 Catherine Maiteki-Sebuguzi,4 Patricia S Coffey1 1Devices and Tools Global Program, PATH, Seattle, WA, USA; 2Uganda Central Public Health Laboratory, Ministry of Health, Kampala, Uganda; 3Evaluation Projects, Infectious Diseases Research Collaboration, Kampala, Uganda; 4Independent Consultant, Kampala, Uganda Background: 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. Methods: 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. Results: 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. Conclusion: 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. Keywords: point-of-care, sickle cell disease, costing, Uganda, diagnostics, screening

Keywords

• Point-of-care
• sickle cell disease
• costing
• Uganda
• diagnostics
• screening