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Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

By LabMedica International staff writers
Posted on 09 Apr 2024
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Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)
Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations ranges from mild cases with minimal symptoms to severe disorders like sickle cell disease and Hb Bart’s hydrops fetalis, which can cause extensive organ damage and necessitate lifelong blood transfusions. Capillary electrophoresis has been established as a reliable method for newborn screening of hemoglobin disorders, offering high-quality outcomes. Now, a next-generation instrument dedicated to newborn hemoglobin screening offers a smooth workflow and excellent analytical capabilities.

Sebia’s (Lisses, France) CAPILLARYS 3 DBS instrument is an automated, multitasking capillary electrophoresis instrument that uses 12 capillaries simultaneously for hands-free electrophoretic separation at high throughput. Designed to detect both standard (F and A) and abnormal hemoglobins (S, C, E, D, and Bart’s) in dried blood samples collected on filter paper from newborns, this instrument provides a qualitative analysis that enhances laboratory efficiency, ensures high throughput, and maintains complete traceability from the dried blood spot card to the final result, all within a cyber-secured environment.

The CAPILLARYS 3 DBS enables the analysis of samples from microplate wells and fully automates the electrophoresis separation process, from the dried blood spots on filter paper (Guthrie card) through to the final electrophoretic pattern: sample identification, sample dilution, sample incubation, capillary washing, sample injection into the capillaries, migration, detection, processing of the results, and data transmission to the Laboratory Information System (LIS). Offering an innovative alternative to traditional methods like IEF and HPLC, the CAPILLARYS for labs engaged in newborn hemoglobin screening, CAPILLARYS 3 DBS provides seamless sample traceability, exceptional results quality, and high throughput while with minimal hands-on time. Sebia has now received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.

“As a global leader for hemoglobinopathy testing, Sebia is expanding its portfolio in the United States with this innovative solution, which can be easily integrated into the laboratory workflow significantly reducing manual intervention while ensuring comprehensive traceability,” said Arnaud Collin, Sebia Group Vice President Global Regulatory Affairs & Quality. “This will help laboratories to make timely and accurate decisions for newborns.”

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