Summary: Clinical studies demonstrate the effectiveness of the Gazelle Hb Variant Test from Hemex Health for newborn and premarital screening, offering a faster, affordable alternative to traditional lab tests for sickle cell disease and beta thalassemia.
Takeaways:
- Premarital Screening Success in Turkiye: The Gazelle test proved to be a highly effective and affordable point-of-care tool for premarital screening of beta thalassemia and sickle cell disease, comparable to HPLC, helping to reduce affected births.
- Accurate Newborn Screening in Ghana: A study from Ghana showed Gazelle’s equivalent diagnostic accuracy to standard laboratory tests for newborn screening of sickle cell disease, making it a game-changer for rural and underserved areas.
- Broader Impact: The Gazelle Hb Variant Test is revolutionizing hemoglobinopathy screening with its portability, affordability, and digital capabilities, making screening accessible in regions with limited healthcare infrastructure.
The results of two clinical studies detailed at a conference hosted by the Academy for Sickle Cell and Thalassaemia (ASCAT) reported on the effectiveness of the Gazelle Hb Variant Test from Hemex Health as a clinical tool for newborn and premarital screening in environments disproportionately affected by Hb variant-associated illnesses.
Turkiye Study: Effective Premarital Screening for Beta Thalassemia
Prof. Duran Canatan, MD, pediatric hematologist and geneticist, Antalya Bilim University, Antalya, Turkiye presented the results of a comparison study of Gazelle versus HPLC to evaluate Gazelle as a premarital screening tool for beta thalassemia and sickle cell disease (SCD). These hemoglobinopathies are serious health problems in Turkiye, and previous research has shown that a significant reduction in affected births can be achieved through premarital screening.(1) Canatan and researchers at Antalya Bilim University sought to identify an affordable POC replacement for the central laboratory tests typically used for the screening.
“To ensure continued progress on our goal of lowering impacted births, ongoing education and screening must be prioritized among Turkish citizens, as well as newer immigrants and refugees, particularly in areas where centralized testing is not available,” says Prof. Canatan. “In our efforts to expand premarital screening for beta thalassemia, we found that Gazelle is a highly effective replacement for HPLC. Not only is the Gazelle test as effective in identifying and quantifying hemoglobin variants, but it also offers additional advantages, such as affordability, fast turnaround time, and digital capabilities. Importantly, Gazelle is the only test that can identify beta thalassemia at the point of care [based on detection of Hb variants].”
Ghana Study: Accurate Newborn Screening for Sickle Cell Disease
The second study, headed by Catherine I. Segbefia, MD, Department of Child Health, University of Ghana Medical School and Korle Bu Teaching Hospital, Accra, Ghana, was focused on newborn screening for sickle cell disease in Ghana.
Based on the results of this study of 379 newborns screened at Korle Bu Hospital in Accra, Ghana, the study concluded that Gazelle yielded equivalent diagnostic accuracy for all Hb variants compared to standard laboratory tests (HPLC).
“Gazelle is revolutionizing how we think about testing for sickle cell disease,” says Segbefia. “Its ability to quantify the Hb variants is what gives it the edge among all available SCD point-of-care tests on the market.”
Sickle cell is a significant health issue in Ghana, and at least 2% of all newborns are affected by the disease.(2) However, access to testing and care facilities are limited, especially for families in rural areas.
“Reflecting on the promising results from both Türkiye and Ghana presented at ASCAT, it’s clear that the Gazelle device is transforming the landscape of hemoglobinopathy screening,” says Patti White, CEO of Hemex Health. “These studies highlight Gazelle’s potential to provide convenient, affordable, and accurate screening for hemoglobin variants in diverse settings.
Sickle Cell Disease and Beta Thalassemia
Sickle cell disease and beta thalassemia are both inherited blood disorders that affect the production and shape of hemoglobin, which is the protein in red blood cells that carries oxygen throughout the body. In sickle cell disease, the hemoglobin forms into a sickle or crescent shape, leading to blockages in blood vessels, pain, and complications such as infections and organ damage.(3) Beta thalassemia reduces the production of hemoglobin, which can result in anemia, fatigue, and growth delays.(4) Both disorders often go undiagnosed.
Sickle cell disease affects millions globally, particularly in Africa, India, the Middle East, and the Mediterranean. Beta thalassemia, regionally prevalent in the Mediterranean, Middle East, and Southeast Asia, also affects millions. The true impact of sickle cell disease has been historically underrecognized due to its being an underlying and unreported cause of infection and of death from conditions like stroke, heart problems, kidney problems, and pregnancy complications. Policy recommendations include improving newborn screening, enhancing access to treatments, and addressing structural racism in healthcare. Prioritizing these measures can significantly improve the lives of those affected.(5)
About Gazelle
Gazelle is a compact, rugged, battery-operated in vitro diagnostic platform that uses artificial intelligence, innovative optics, and miniaturization to help a broader range of users to diagnose diseases in underserved areas. Gazelle is approved for identifying sickle cell disease and beta thalassemia over 35 countries.
Healthcare workers of all skill levels in areas with limited access, resources, or electricity are able to use the cost-effective technology, the company says. Patient information and results are captured digitally for storage, printing, or later transmission. Over-the-air software updates allow Hemex to add to its menu of tests, expanding its utility to new users. Gazelle is an accurate and rapid digital platform that can work in the most demanding environments in the world.
Featured image: Red blood cells of a patient with sickle cell anemia under the microscope. Image courtesy Dreamstime.
References:
- Canatan D. Thalassemias and hemoglobinopathies in Turkey. Hemoglobin. 2014;38(5):305-7. doi:10.3109/03630269.2014.938163. Epub 2014 Jul 17.
- Kyerewaa Edwin A, Edwin F, Etwire V. Controlling Sickle Cell Disease in Ghana–ethics and options. Pan Afr Med J. 2011;10:14. doi: 10.4314/pamj.v10i0.72223. Epub 2011 Oct 3. PMID: 22187596; PMCID: PMC3282939.
- National Heart, Lung, and Blood Institute. (2020). Sickle Cell Disease. https://www.nhlbi.nih.gov
- Thalassemia International Federation. (2023). Beta Thalassemia. https://www.thalassemia.org
- Institute for Health Metrics and Evaluation. (2023). Sickle cell disease 11 times more deadly than previously recorded. Retrieved from https://www.healthdata.org/news-events/newsroom/news-releases/sickle-cell-disease-11-times-more-deadly-previously-recorded
