Next-generation instrument screens for hemoglobin disorders in newborns

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

17 Apr 2024
Jessica Calvey
Product and Reviews Admin Assistant

Product news

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”.

Want the latest clinical science news straight to your inbox? Become a SelectScience member for free today>>

Links

Tags

HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ElectrophoresisElectrophoresis equipment is used to separate mixtures of protein, DNA or RNA, based on their electric charge, size and other physical characteristics, by passing them through a medium such as a polyacrylamide gel, an agarose gel or a capillary tube. Electrophoresis equipment includes horizontal and vertical gel electrophoresis chambers, isoelectric focusing systems, 2D electrophoresis and capillary electrophoresis instruments. Precast gels with a gradient can be used or gels can be hand cast. Samples are run alongside ladders or markers to identify the approximate size of a molecule. Separated proteins and nucleic acids in the gel can be stained or probed with fluorescent markers and then imaged and detected using gel documentation instruments, transilluminators, densitometers and scanners. Find the best electrophoresis equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical AutomationClinical laboratory automation refers to the use of automated systems in clinical laboratories to increase efficiency, reduce human error, and improve patient care. From sample analysis to total laboratory automation, this plays a critical role in modern diagnostics and laboratory workflows. Explore clinical automation solutions in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.
Next-generation instrument screens for hemoglobin disorders in newborns