Multispectral imaging for MicroChip electrophoresis enables point-of-care newborn hemoglobin variant screening

Ran An; Yuning Huang; Anne Rocheleau; Alireza Avanaki; Priyaleela Thota; Qiaochu Zhang; Yuncheng Man; Zoe Sekyonda; Catherine I Segbefia; Yvonne Dei-Adomakoh; Enoch Mensah; Kwaku Ohene-Frempong; Isaac Odame; Amma Owusu-Ansah; Umut A Gurkan

doi:10.1016/j.heliyon.2022.e11778

Multispectral imaging for MicroChip electrophoresis enables point-of-care newborn hemoglobin variant screening

Heliyon. 2022 Nov 28;8(12):e11778. doi: 10.1016/j.heliyon.2022.e11778. eCollection 2022 Dec.

Authors

Ran An^{1

2

3}, Yuning Huang³, Anne Rocheleau⁴, Alireza Avanaki⁴, Priyaleela Thota⁴, Qiaochu Zhang³, Yuncheng Man³, Zoe Sekyonda⁵, Catherine I Segbefia^{6

7}, Yvonne Dei-Adomakoh^{7

8}, Enoch Mensah⁸, Kwaku Ohene-Frempong⁹, Isaac Odame^{10

11}, Amma Owusu-Ansah¹², Umut A Gurkan^{3

5

13}

Affiliations

¹ Department of Biomedical Engineering, University of Houston, Houston, Texas, USA.
² Department of Biomedical Sciences, University of Houston, Houston, TX, USA.
³ Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH, USA.
⁴ HemexHealth, Inc, Portland, OR, USA.
⁵ Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA.
⁶ Department of Child Health, University of Ghana Medical School, Accra, Ghana.
⁷ Korle Bu Teaching Hospital, Accra, Ghana.
⁸ Department of Hematology, University of Ghana Medical School, Accra, Ghana.
⁹ Sickle Cell Foundation of Ghana, Kumasi, Ghana.
¹⁰ Division of Hematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.
¹¹ Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
¹² Department of Pediatrics, Division of Hematology and Oncology, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH, USA.
¹³ Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.

Abstract

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.

Keywords: Genetic hemoglobin disorders; Multispectral imaging; Newborn screening; Point-of-care diagnostics; Sickle cell disease.