Developed by researchers at Emory University, Children’s Healthcare of Atlanta, and the Georgia Institute of Technology, the anemia test device is awaiting clearance by the FDA
New diagnostic technology may shift some hemoglobin testing for anemia out of clinical laboratories and into near-patient settings. It may also be possible to use this new diagnostic device for patient self-testing.
The developers describe this as a new, easy, inexpensive point-of-care test (POCT) that detects anemia. The device may be available as early as 2016. It is possible for the test to be used in situations where resources are low and illiteracy is high.
The new medical laboratory test is called AnemoCheck and was developed by scientists and students at Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology in Atlanta.
Advantages of AnemoCheck over Hemoglobin Testing Done in Clinical Laboratories
Sanguina, the Atlanta, Georgia, company that was created to market this new diagnostic test, says AnemoCheck has many advantages over the conventional hematological tests done in clinics, hospital laboratories, and free-standing medical laboratories operating expensive lab analyzers. The benefits are:
• Price—AnemoCheck is inexpensive. Developers expect that the per-unit cost will be about $3, according to Erika Tyburski, a biomedical engineer who helped create AnemoCheck.
• No Infrastructure Requirements—Unlike expensive analyzers in hospitals and clinics, AnemoCheck requires no power source.
• Speed—The diagnostic test takes just one minute to complete and deliver a result.
• Simplicity—No expensive machinery or maintenance is necessary, and AnemoCheck “requires less than a drop of blood to deliver an estimated hemoglobin level quickly and accurately,” wrote Tyburski in a September 2014 article on Harvard Business School’s Open Forum website.
• Ease of Use—Samples can easily be obtained by the user or a caregiver. No nurses or clinical laboratory scientists needed.
• Easily Understood Results—The results are based on a color chart. That makes AnemoCheck ideal for use in developing countries, or situations where the medical staff is less educated, and places or incidences where patients have low literacy rates.
• Convenience—AnemoCheck eliminates the need for repeated trips to clinical laboratories for the chronically ill or for patients who must travel great distances to reach medical facilities.
How AnemoCheck Works
AnemoCheck’s technology involves using a drop of blood, which the user obtains by pricking his/her finger, much like diabetics do to check their blood sugar levels. The blood is drawn into a capillary tube, which is then inserted into a larger tube that contains a chemical solution. The hemoglobin present in the blood acts as a catalyst for a reduction-oxidation reaction. Within approximately 45 seconds, a color change occurs.
The user compares the solution in the tube to the color-scale card that comes with the kit. The color ranges from green-blue to red depending on the severity of anemia. Readings can be sent to a Smartphone application (app) for interpretation, storage, and sharing.
Who Will Use AnemoCheck?
Anemia affects 2 billion people annually, 83 million in the United States alone, and many in far remote areas that lack resources for storing or transporting blood specimens at temperature. Therefore, Tyburski notes, the need for such a device is great.
Causes of anemia include:
• bone marrow diseases, and,
Most of these are chronic diseases. People at greatest risk for anemia are women, pregnant women, the elderly, and infants. Left untreated in infants, anemia can progress and lead to permanent cognitive and neurologic damage. Obviously, patients could benefit from being able to test regularly without requiring frequent visits to a medical laboratory. However, this could likely impact the volume of anemia tests referred to clinical laboratories.
The Results of Clinical Trials of the AnemoCheck POC Test
Researchers published their findings in The Journal of Clinical Investigations (JCI) in August 2014. The blood from 238 pediatric and adult patients with anemia were tested with the AnemoCheck POCT. The resulting hemoglobin levels from the POCT were compared with the readings from a hematology analyzer. The levels of hemoglobin were estimated via visual interpretation using a color scale and a Smartphone app for automated analysis. The hemoglobin levels measured by the POCT correlated with the hematology analyzer.
“Results indicate that AnemoCheck can detect even the mildest form of anemia across many different etiologies with sensitivity and specificity of 90%+ and 79%+, respectively,” Tyburski wrote in Open Forum. “We are currently planning beta testing for home-validation in a sickle cell disease user group that will gauge the ease of use and likelihood of adoption within this group. We do not intend to replace clinical testing, but supplement it to offer piece of mind, and potentially screen for changes in hemoglobin prior to disease-specific crises.”
As of late 2014, Sanguina researchers also were conducting two pilot studies in India and South Africa to test AnemoCheck’s accuracy and how easily consumers in those nations can use it. The study allows for feedback from the patients’ providers who will comment on ease of use and how likely these providers might be to use AnemoCheck once it is available.
Sanguina expects U.S. Food and Drug Admininistration (FDA) approval of AnemoCheck sometime this year. The company would like to see AnemoCheck on the market by 2016, and plans to first generate revenue with sales in the United States, then use part of this money to make the test affordable in developing countries.