About this item:

572 Views | 639 Downloads

Author Notes:

Address correspondence to: Wilbur A. Lam, 2015 Uppergate Drive, Emory Children’s Center - Room 448, Atlanta, Georgia 30332, USA. Phone: 404.727.7473; E-mail: wilbur.lam@emory.edu.

We thank the physicians and nurse practitioners of the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta and the physicians and nurse practitioners of the Winship Cancer Institute at Emory University who assisted with the collection of clinical samples.

We also thank the Global Center for Medical Innovation (GCMI) for all prototype iteration and production. We thank M. Byrd, N. Hotaling, M. McKinnon, and M. Platt for initial discussions, advice, and help with initial experiments.

The authors have declared that no conflict of interest exists.

Subjects:

Research Funding:

The study was designed, conducted, analyzed, and reported entirely by the authors. The Georgia Research Alliance and FDA-funded Atlantic Pediatric Device Consortium provided funding support through phase I funding programs.

Children’s Healthcare of Atlanta, the Georgia Center of Innovation for Manufacturing, and the Georgia Tech InVenture Prize and Ideas to Serve competitions provided funding for test supplies and other clinical assessment resources

We thank the following funding sources: the FDA-funded Atlantic Pediatric Device Consortium (P50FD004193), the Georgia Research Alliance for phase 1 venture funding, the Children’s Healthcare of Atlanta–sponsored summer internship program, the Georgia Center of Innovation for Manufacturing, and the InVenture Prize and the Ideas to Serve competitions at the Georgia Institute of Technology.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Medicine, Research & Experimental
  • Research & Experimental Medicine
  • IRON-DEFICIENCY ANEMIA
  • HEMOGLOBIN
  • SCALE
  • PREVALENCE
  • TETRAMETHYLBENZIDINE
  • SCHISTOSOMIASIS
  • ACCURACY
  • CRITIQUE
  • CHILDREN

Disposable platform provides visual and color-based point-of-care anemia self-testing

Show all authors Show less authors

Tools:

Journal Title:

Journal of Clinical Investigation

Volume:

Volume 124, Number 10

Publisher:

, Pages 4387-4394

Type of Work:

Article | Final Publisher PDF

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, standalone, 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. TRIAL REGISTRATION. Not applicable.

Copyright information:

© 2014, American Society for Clinical Investigation

Export to EndNote