Dataset Information

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.

Trial registration

Not applicable.

Funding

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.

SUBMITTER: Tyburski EA

PROVIDER: S-EPMC4191020 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Tyburski Erika A EA Gillespie Scott E SE Stoy William A WA Mannino Robert G RG Weiss Alexander J AJ Siu Alexa F AF Bulloch Rayford H RH Thota Karthik K Cardenas Anyela A Session Wilena W Khoury Hanna J HJ O'Connor Siobhán S Bunting Silvia T ST Boudreaux Jeanne J Forest Craig R CR Gaddh Manila M Leong Traci T Lyon L Andrew LA Lam Wilbur A WA

The Journal of clinical investigation 20140826 10

<h4>Background</h4>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, a ...[more]

PMID: 25157824

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Funding

Publications

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

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