title: Disposable platform provides visual and color-based point-of-care anemia self-testing.
abstract: BACKGROUND
  Anemia, or low blood hemoglobin (Hgb) levels, afflicts 2 billion people worldwide. Currently, Hgb levels are typically measured from blood samples using hematology analyzers, which are housed in hospitals, clinics, or commercial laboratories and require skilled technicians to operate. A reliable, inexpensive point-of-care (POC) Hgb test would enable cost-effective anemia screening and chronically anemic patients to self-monitor their disease. We present a rapid, stand-alone, and disposable POC anemia test that, via a single drop of blood, outputs color-based visual results that correlate with Hgb levels.
  
  
  METHODS
  We tested blood from 238 pediatric and adult patients with anemia of varying degrees and etiologies and compared hematology analyzer Hgb levels with POC Hgb levels, which were estimated via visual interpretation using a color scale and an optional smartphone app for automated analysis.
  
  
  RESULTS
  POC Hgb levels correlated with hematology analyzer Hgb levels (r = 0.864 and r = 0.856 for visual interpretation and smartphone app, respectively), and both POC test methods yielded comparable sensitivity and specificity for detecting any anemia (n = 178) (<11 g/dl) (sensitivity: 90.2% and 91.1%, specificity: 83.7% and 79.2%, respectively) and severe anemia (n = 10) (<7 g/dl) (sensitivity: 90.0% and 100%, specificity: 94.6% and 93.9%, respectively).
  
  
  CONCLUSIONS
  These results demonstrate the feasibility of this POC color-based diagnostic test for self-screening/self-monitoring of anemia.
  
  
  BACKGROUND
  Not applicable.
  
  
  BACKGROUND
  This work was funded by the FDA-funded Atlantic Pediatric Device Consortium, the Georgia Research Alliance, Children's Healthcare of Atlanta, the Georgia Center of Innovation for Manufacturing, and the InVenture Prize and Ideas to Serve competitions at the Georgia Institute of Technology.
authors.forename: Erika A
authors.initials: EA
authors.lastname: Tyburski
authors.forename: Scott E
authors.initials: SE
authors.lastname: Gillespie
authors.forename: William A
authors.initials: WA
authors.lastname: Stoy
authors.forename: Robert G
authors.initials: RG
authors.lastname: Mannino
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Weiss
authors.forename: Alexa F
authors.initials: AF
authors.lastname: Siu
authors.forename: Rayford H
authors.initials: RH
authors.lastname: Bulloch
authors.forename: Karthik
authors.initials: K
authors.lastname: Thota
authors.forename: Anyela
authors.initials: A
authors.lastname: Cardenas
authors.forename: Wilena
authors.initials: W
authors.lastname: Session
authors.forename: Hanna J
authors.initials: HJ
authors.lastname: Khoury
authors.forename: Siobhán
authors.initials: S
authors.lastname: O'Connor
authors.forename: Silvia T
authors.initials: ST
authors.lastname: Bunting
authors.forename: Jeanne
authors.initials: J
authors.lastname: Boudreaux
authors.forename: Craig R
authors.initials: CR
authors.lastname: Forest
authors.forename: Manila
authors.initials: M
authors.lastname: Gaddh
authors.forename: Traci
authors.initials: T
authors.lastname: Leong
authors.forename: L Andrew
authors.initials: LA
authors.lastname: Lyon
authors.forename: Wilbur A
authors.initials: WA
authors.lastname: Lam
mesh_terms: D000328:Adult; D000740:Anemia / Q000175:diagnosis*; D001331:Automation; D040421:Cell Phone; D002648:Child; D003116:Color; D003362:Cost-Benefit Analysis; D004209:Disposable Equipment; D005260:Female; D006454:Hemoglobins; D006801:Humans; D008297:Male; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D016353:Self-Examination / Q000295:instrumentation* / Q000379:methods*; D012680:Sensitivity and Specificity; D013053:Spectrophotometry
chemical_list: D006454:Hemoglobins