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FDA clears Abbott¡¯s Alinity H-series lab instruments, enabling advanced testing of patients¡¯ complete blood counts

2023/8/8 17:42:04¡¡Views£º619

Original from: Abbott


Abbott has received U.S. Food and Drug Administration clearance for its advanced Alinity® h-series hematology system, paving the way for laboratories throughout the country to run complete blood counts (CBC) as a part of Abbott¡¯s Alinity family of diagnostic products.


Complete blood counts are one of the most ordered tests in the healthcare system and are common in routine checkups because they can help screen for a variety of disorders including infections, anemia, diseases of the immune system, and blood cancers.


The Alinity h-series includes Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer. A key differentiator for Alinity hq is that it leverages the advanced MAPSSTM technology, which uses light scattering to distinguish cellular features and better identify various blood cells.


With the Alinity h-series, Abbott now offers one of the broadest laboratory diagnostic systems, providing a wide array of tests doctors can use to quickly and effectively care for their patients. Laboratories and hospitals across the U.S. will be able to seamlessly integrate the Alinity h-series hematology system into their existing core lab operations, allowing lab staff to easily adopt with minimal effort and training. This is especially important in labs where time, resources and staff are stretched thin.


¡°U.S. healthcare systems have experienced significant resource constraints and rapidly shifting dynamics post-pandemic,¡± said Louis Morrone, executive vice president for Abbott¡¯s core diagnostics business. ¡°The Alinity h-series system, as with the entire suite of Alinity products, was developed to transform the way laboratories run tests so they can focus on their most important mission: the delivery of patient care.¡±


The Alinity family of systems in the U.S. now includes the Alinity h-series (hematology), Alinity ci (clinical chemistry and immunoassay), Alinity m, (molecular), Alinity s (transfusion) and the point-of-care i-STAT Alinity.


The Alinity h-series system offers several advantages for laboratories:


¡¤    Processes up to 119 CBC results per hour, among the fastest on the market

¡¤    Requires less floor space, which is critical for labs to maximize resources and operations

¡¤    Loads samples from the front and from a laboratory automation system

¡¤    Ensures urgent samples receive priority without compromising capacity or workflow

¡¤    Offers hands-off maintenance so labs can schedule automated daily and weekly cleanings

¡¤    Integrates the slide maker with the analyzer to reduce manual intervention

¡¤    Provides customizable reports and rules for systems

¡¤    Centralizes results and control functions at a single point


Source: FDA clears Abbott¡¯s Alinity H-series lab instruments, enabling advanced testing of patients¡¯ complete blood counts