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First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

By LabMedica International staff writers
Posted on 08 Feb 2024
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Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's population, with 40,000 newborns diagnosed annually. Beta thalassemia patients often require lifelong transfusions for survival. Many individuals with the beta-thal trait are unaware of their condition and the risk of having a child with the disease if their partner also carries the trait. Consequently, early screening and timely diagnosis are critical for managing beta-thalassemia, both for genetic counseling to aid in family planning and for preventing and managing later clinical complications. Now, a beta thalassemia test offers an accurate and convenient solution, aiding couples in making informed reproductive decisions, ensuring proper maternal care, and facilitating early diagnosis in infants.

Hemex Health’s (Portland, OR, USA) Gazelle Hb Variant test is capable of identifying 19 hemoglobinopathy conditions, including both beta-thal disease and trait, and sickle cell disease and trait. The test runs on the Gazelle compact, rugged, battery-powered in vitro diagnostic device that is designed for cost-effective use by entry-level healthcare workers, even in areas with limited access, resources, or electricity. The device digitally captures patient information and results for storage, printing, or subsequent transmission. Approved for identifying sickle cell disease and beta-thalassemia in an increasing number of countries, Gazelle integrates miniaturized versions of trusted technologies, innovative optics, and artificial intelligence. Priced similarly to an iPhone, Gazelle offers low-cost individual tests. Its sensitive detection and precise quantification capabilities enable it to identify beta-thal disease or trait in infants as young as six months and sickle cell disease and trait in newborns as early as 37 weeks gestation.

A clinical study validating the Gazelle Hb Variant Test's diagnostic accuracy for beta thalassemia revealed that it correctly identified subjects with beta-thal major, beta-thal intermedia, and beta-thal trait with over 99% accuracy, compared to the laboratory gold standard of high-performance liquid chromatography (HPLC). The study concluded that Gazelle represents an affordable, rapid solution for beta-thal identification at the point of care. Its demonstrated ability to provide accurate, rapid results (available in 8 minutes) suggests Gazelle's suitability for widespread beta-thal testing at the point of care. The test's affordability and convenience could greatly facilitate informed reproductive decisions for millions of couples, ensure appropriate maternal care, and enable prompt diagnosis in infants.

“By combining accuracy and affordability with on-site accessibility, Gazelle can make a significant impact in areas of the world with a high prevalence of beta-thalassemia,” said Patti White, CEO of Hemex Health. “Before Gazelle, lab-based, high-volume batch testing, with its slow turn-around time, was the best option. With Gazelle, young adults can be conveniently tested at primary care centers or even at screening events at schools or other community centers.”

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