Study of First Affordable and Rapid Test for Beta Thalassemia Performs at 99% Accuracy in Diagnosing the Blood Disorder

An Accurate, Convenient, Beta Thalassemia Test Could Help Couples Make Informed Reproductive Choices, Ensure Appropriate Maternal Care, and Facilitate Diagnosis in Infants

PORTLAND, Ore. and MUMBAI, India, Feb. 05, 2024 (GLOBE NEWSWIRE) -- A clinical study to validate the beta thalassemia (beta-thal) diagnostic capability of the Gazelle™ Hb Variant Test from Hemex Health, published in the journal Biosensors, showed that Gazelle correctly identified participating subjects with beta-thal major, beta-thal intermedia, and beta-thal trait with a combined accuracy of over 99% compared with the laboratory gold standard--high performance liquid chromatography (HPLC). This study concluded that Gazelle provides, for the first time, an affordable and rapid solution for identifying beta-thal at point of care.

The ability to test accurately and rapidly (results are available in 8 minutes) as demonstrated in this study suggests that Gazelle is suitable for large-scale testing of beta-thal at point of care. The affordability and convenience of a point-of-care test would make it easier for millions of couples to make informed reproductive choices, ensure appropriate maternal care, and facilitate diagnosis in infants.

Beta thalassemia is an inherited blood disorder. Patients with the most severe form of the disease, beta-thal major, may require life-long transfusions for survival. Most people with beta-thal trait do not know they have it or do not realize that they may have a child with disease if their partner also has trait. A study published in the European Journal of Hematology has shown, however, that incidence rates decrease in areas with screening and education programs.

“Beta thalassemia can be a very serious disease that often goes undetected before it is too late in India and many other parts of the world,” said Tulika Seth, MD, Founding Trustee and Professor of Hematology at All India Institute of Medical Sciences, New Delhi. “Young adults especially need to understand their status before marriage since they may carry the trait.”

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The Gazelle Hb Variant Test

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