Sysmex launches fully automated HISCL HIT IgG Assay Kit to enhance heparin-induced thrombocytopenia (HIT) diagnosis accuracy and speed across EMEA
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Sysmex launches fully automated HISCL HIT IgG Assay Kit to enhance heparin-induced thrombocytopenia (HIT) diagnosis accuracy and speed across EMEA
Hamburg, Germany, 27.07.2026 – Sysmex Europe SE announced the launch of the HISCL™ HIT IgG Assay Kit (“the assay kit”) for measuring IgG antibodies against the platelet factor 4 and heparin complexes. The new assay became available under the IVDR across the entire EMEA market on 03 July 2026.*
Sysmex is set to expand its leadership in integrated haematology and haemostasis diagnostics with the forthcoming launch of the assay kit, an advanced reagent test designed to support the rapid and reliable diagnosis of heparin-induced thrombocytopenia (HIT). HIT is a rare yet potentially life-threatening immune reaction that can occur during heparin therapy, making a timely and precise diagnostic approach essential for effective clinical intervention.
The new assay kit is compatible with the Sysmex CN-3500/CN-6500 automated coagulation analysers, which uses the HISCL-Series chemiluminescent enzyme immunoassay (CLEIA) technology. It delivers a 17-minute reaction time that speeds up laboratory workflows and supports faster clinical decision-making.
“With the HISCL HIT IgG Assay Kit, we provide laboratories with a fully automated, precise and ready-to-use solution that supports clinicians in making faster and more accurate decisions when HIT is suspected.” — Alain Baverel, CEO Sysmex Europe SE.
Building on Sysmex’s strategic focus on disease-oriented diagnostics, the HISCL HIT IgG Assay Kit contributes to the development of integrated pathways. This aligns with Sysmex’s other additional innovations, including the BloodScience Workcell, which combines blood cell count and coagulation parameters for a more comprehensive assessment of complex conditions and the Extended IPU middleware, which automates and intelligently coordinates laboratory processes, enhancing the detection and management of rare and critical disorders such as thrombocytopenia, platelet function abnormalities and sepsis.
Optimising HIT workflow with Sysmex solutions
Our CN-6500/CN-3500 analysers simultaneously measure blood coagulation and serological testing parameters, allowing not only diagnostic support but also treatment management in the case of HIT diagnosis. This improved and extended testing workflow streamlines patient management in a cost-effective and beneficial manner for both patient and the clinic. This supports the enhancement of patients’ quality of life and drastically improves the operational efficiency of medical institutions. With this launch, Sysmex continues to expand its portfolio of high-clinical-value testing solutions, reinforcing its commitment to improving diagnostic accuracy, workflow efficiency and patient outcomes across medical institutions.
About Sysmex Europe SE
Sysmex supports healthcare professionals and patients around the world with a broad range of medical diagnostics products and solutions in a variety of fields. With over 50 years’ experience in in-vitro diagnostics, we are continuously developing our product and service portfolio to cover the entire patient pathway of care. Our multi-functional solutions work together with high-quality reagents and reliable service and support to create a better healthcare journey for all.
Sysmex Europe SE, located in Hamburg, Germany, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Hamburg offices, we serve our affiliates, distributors and customers throughout Europe, the Middle East, and Africa (EMEA). For more Information, visit www.sysmex-europe.com.
* For information about product availability in your country, please contact your local Sysmex representative.
Contact:
Sysmex Europe SE - Corporate Communications
Deelböge 19 D, 22297 Hamburg, Germany Email: PR@sysmex-europe.com
