Product News: Next-generation instrument screens for hemoglobin disorders in newborns

Sebia’s CAPILLARYS 3 DBS instrument is an automated, multitasking capillary electrophoresis instrument

18 Apr 2024

The CAPILLARYS 3 DBS devices have received US FDA 510(k) clearance

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. Capillary electrophoresis has been established as a reliable method for newborn screening of hemoglobin disorders, offering high-quality outcomes. The CAPILLARYS 3 DBS from Sebia is an automated high-throughput solution for newborn hemoglobin disorders screening that offers a smooth workflow and excellent analytical capabilities. 

The CAPILLARYS 3 DBS instrument 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, 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 3 DBS provides seamless sample traceability, exceptional results quality, and high throughput with minimal hands-on time. 

Sebia has received 510(k) clearance from the US Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices. Arnaud Collin, Sebia Group Vice President Global Regulatory Affairs & Quality, commented, “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”.

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