Written by: Mediware Consulting and Analytics on Monday, January 4, 2016 Posted in: Blood Management

New At-Home Point of Care Test (POCT) for Anemia Will Likely Impact Clinical Laboratories

Image Credit: atlanticpediatricdeviceconsortium.org

Image Credit: atlanticpediatricdeviceconsortium.org

Anemia affects nearly 2 billion people worldwide each year. Currently, anemia is screened using a hematology analyzer found only in clinics and hospitals. The machines require a few tablespoons of blood and trained personnel to perform. The first of its kind, the AnemoCheck is an inexpensive, disposable, self-contained, easy to use, point-of-care, patient-operated, diagnostic test for anemia. It may shift testing out of the clinical laboratories and into the hands of patients and only requires a single drop of blood. AnemoCheck was developed by researchers at Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology, is currently awaiting clearance by the FDA. The device is expected to be available in 2016.

AnemoCheck’s technology involves a simple prick of the finger and could potentially help reduce iatrogenic anemia. The blood is drawn into a capillary tube and the hemoglobin present acts as a catalyst for a reduction-oxidation reaction. In less than 1 minute, a color change occurs that ranges from green-blue to red. Results can even be sent to a Smartphone application. A clinical trial of the AnemoCheck POCT on 238 patients with anemia was published in the Journal of Clinical Investigations in 2014. Results showed a sensitivity and specificity of 90% and 79% respectively. The device could even detect the mildest form of anemia among many different etiologies.

Due to its convenience, simplicity and no requirement for infrastructure, AnemoCheck can be used in remote places. Additionally, since the device isn’t cost-prohibitive, it may be useful in resource-poor countries, where severe anemia is the leading cause of morbidity and mortality among children. Additionally, the device would be beneficial for chronic anemia populations in the US for home-testing. Although it is not meant to replace clinical testing, it can be used for self-screening or self-monitoring hemoglobin levels in disease-specific crises, for example sickle cell anemia. Other potential uses include behind the counter pharmacy sales to populations at high risk for anemia including pregnant women and children.

 

Cheaper and faster, but is it better?

Excitement surrounding this device, like other POCT has the benefit of convenience, cost savings, privacy and empowerment of consumers to take responsibility in their own healthcare and it may even bring more patients into the healthcare system.   However, there are a number of valid concerns that healthcare professionals should be aware of including appropriate interpretation and follow-up of results.

Additionally, a common question surrounds POCT’s clinical benefit and whether or not convenience trumps accuracy. According to the WHO and the Disease Control Priorities Project, the relevant criterion for a “better” test isn’t which test is cheapest, but rather the cost of the test needed to provide the desired clinical benefit. In other words, if our goal is to improve public health, the cost and speed of a laboratory test do not exist in a vacuum: they must be balanced against what real clinical benefits can be derived. In the US, POCT such as the iSTAT, Biosite Triage and others have dramatically improved public health at price points of tens or even hundreds of dollars per test. At just three dollars per test, AnemoCheck, and its technology, will be beneficial for a range of indications and likely improve health worldwide.

 

References:

  1. Tyburski EA. Et al. Disposable platform provides visual and color-based point-of-care anemia self-testing. J Clin Invest. 2014;124(10):4387-4394.
  2. McGann PT. et al. An Accurate and Rapid Color-Based Point-of-Care Assay for the Detection of Severe Anemia in Low Resource Settings. Oral Abstract. December 8, 2014. American Society of Hematology.
  3. De Benoist B. Et al. Worldwide Prevalence of Anemia. World Health Organization, 2008.
  4. Chin CD. Et al. Commercialization of microfluidic point-of-care diagnostic devices. The Royal Society of Chemistry. 2012. DOI: 10.1039/c21c21204h.

 

Author: Sarah Daccarett, MD, FCAP

 

 

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