title: A Paper-Based Test for Screening Newborns for Sickle Cell Disease.
abstract: The high cost, complexity and reliance on electricity, specialized equipment and supplies associated with conventional diagnostic methods limit the scope and sustainability of newborn screening for sickle cell disease (SCD) in sub-Saharan Africa and other resource-limited areas worldwide. Here we describe the development of a simple, low-cost, rapid, equipment- and electricity-free paper-based test capable of detecting sickle hemoglobin (HbS) in newborn blood samples with a limit of detection of 2% HbS. We validated this newborn paper-based test in a cohort of 159 newborns at an obstetric hospital in Cabinda, Angola. Newborn screening results using the paper-based test were compared to conventional isoelectric focusing (IEF). The test detected the presence of HbS with 81.8% sensitivity and 83.3% specificity, and identified SCD newborns with 100.0% sensitivity and 70.7% specificity. The use of the paper-based test in a two-stage newborn screening process could have excluded about 70% of all newborns from expensive confirmatory testing by IEF, without missing any of the SCD newborns in the studied cohort. This study demonstrates the potential utility of the newborn paper-based test for reducing the overall cost of screening newborns for SCD and thus increasing the practicality of universal newborn SCD screening programs in resource-limited settings.
authors.affiliation: Department of Biomedical Engineering, University of Houston, Houston, Texas, USA.
authors.forename: Nathaniel Z
authors.initials: NZ
authors.lastname: Piety
authors.affiliation: Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Alex
authors.initials: A
authors.lastname: George
authors.affiliation: Sickle Cell Newborn Screening Laboratory, Angola Sickle Cell Initiative, Cabinda City, Angola.
authors.forename: Sonia
authors.initials: S
authors.lastname: Serrano
authors.affiliation: Sickle Cell Newborn Screening Laboratory, Angola Sickle Cell Initiative, Cabinda City, Angola.
authors.forename: Maria R
authors.initials: MR
authors.lastname: Lanzi
authors.affiliation: Global Health Corps, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Palka R
authors.initials: PR
authors.lastname: Patel
authors.affiliation: Global Health Corps, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Maria P
authors.initials: MP
authors.lastname: Noli
authors.affiliation: Global Health Corps, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Silvina
authors.initials: S
authors.lastname: Kahan
authors.affiliation: Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine, Houston, Texas, USA.|Global Health Corps, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Damian
authors.initials: D
authors.lastname: Nirenberg
authors.affiliation: Universidade Onze de Novembro Medical School, Cabinda City, Angola.
authors.forename: João F
authors.initials: JF
authors.lastname: Camanda
authors.affiliation: Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Gladstone
authors.initials: G
authors.lastname: Airewele
authors.affiliation: Department of Biomedical Engineering, University of Houston, Houston, Texas, USA.|Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Sergey S
authors.initials: SS
authors.lastname: Shevkoplyas
mesh_terms: D000755:Anemia, Sickle Cell / Q000097:blood / Q000175:diagnosis*; D006451:Hemoglobin, Sickle / Q000032:analysis*; D006801:Humans; D007231:Infant, Newborn; D007525:Isoelectric Focusing; D057230:Limit of Detection; D015997:Neonatal Screening / Q000379:methods*; D010209:Paper; D012503:Saponins / Q000737:chemistry; D012995:Solubility; D013447:Sulfites / Q000737:chemistry
chemical_list: D006451:Hemoglobin, Sickle; D012503:Saponins; D013447:Sulfites; C569244:sodium hydrogen sulfite