Department of Biomedical Engineering, University of Houston, Houston, Texas, USA; Department of Biomedical Sciences, University of Houston, Houston, TX, USA; Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH, USA; Corresponding author.
Yuning Huang
Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH, USA
Anne Rocheleau
HemexHealth, Inc, Portland, OR, USA
Alireza Avanaki
HemexHealth, Inc, Portland, OR, USA
Priyaleela Thota
HemexHealth, Inc, Portland, OR, USA
Qiaochu Zhang
Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH, USA
Yuncheng Man
Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH, USA
Zoe Sekyonda
Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA
Catherine I. Segbefia
Department of Child Health, University of Ghana Medical School, Accra, Ghana; Korle Bu Teaching Hospital, Accra, Ghana
Yvonne Dei-Adomakoh
Korle Bu Teaching Hospital, Accra, Ghana; Department of Hematology, University of Ghana Medical School, Accra, Ghana
Enoch Mensah
Department of Hematology, University of Ghana Medical School, Accra, Ghana
Kwaku Ohene-Frempong
Sickle Cell Foundation of Ghana, Kumasi, Ghana
Isaac Odame
Division of Hematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada; Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada
Amma Owusu-Ansah
Department of Pediatrics, Division of Hematology and Oncology, University Hospitals Rainbow Babies and Children’s Hospital, Case Western Reserve University, Cleveland, OH, USA
Umut A. Gurkan
Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH, USA; Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA; Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA; Corresponding author.
Hemoglobin (Hb) disorders affect nearly 7% of the world’s population. Globally, around 400,000 babies are born annually with sickle cell disease (SCD), primarily in sub-Saharan Africa where morbidity and mortality rates are high. Screening, early diagnosis, and monitoring are not widely accessible due to technical challenges and cost. We hypothesized that multispectral imaging will allow sensitive hemoglobin variant identification in existing affordable paper-based Hb electrophoresis. To test this hypothesis, we developed the first integrated point-of-care multispectral Hb variant test: Gazelle-Multispectral. Here, we evaluated the accuracy of Gazelle-Multispectral for Hb variant newborn screening in 265 newborns with known hemoglobin variants including hemoglobin A (Hb A), hemoglobin F (Hb F), hemoglobin S (Hb S) and hemoglobin C (Hb C). Gazelle-Multispectral detected levels of Hb A, Hb F, Hb S, and Hb C/E/A2, demonstrated high correlations with the results reported by laboratory gold standard high performance liquid chromatography (HPLC) at Pearson Correlation Coefficient = 0.97, 0.97, 0.93, and 0.95. Gazelle-Multispectral demonstrated accuracy of 96.8% in subjects of 0–3 days, and 96.9% in newborns. The ability to obtain accurate results on newborn samples suggest that Gazelle-Multispectral can be suitable for large-scale newborn screening and for diagnosis of SCD in low resource settings.
