Werfen secures CE mark for Aptiva APS IgG and APS IgM reagents

2024-02-20

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The Aptiva APS IgG and APS IgM reagents are immunoassays designed for semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma Aptiva leverages particle-based multi-analyte technology (PMAT). (Credit: PRNewswire/Werfen) Spanish diagnostics solutions provider Werfen has received the CE mark for its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents. Werfen secured the CE mark under the European Union’s (EU) in-vitro diagnostic medical devices regulation (IVDR). The Aptiva APS IgG and APS IgM reagents are immunoassays that leverage Aptiva particle-based multi-analyte technology (PMAT). They are intended for semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. When used together with other laboratory findings, the IgG and APS IgM reagents will help in the diagnosis of primary and secondary APS. Werfen research and development vice president Michael Mahler said: “Antiphospholipid syndrome is an autoimmune disease that manifests clinically as venous or arterial thrombosis and/or foetal loss and can be challenging to diagnose as its symptoms can mimic those of other conditions. “Early diagnosis is crucial in preventing complications as well as unnecessary procedures and increased healthcare costs. “Aptiva APS IgG and APS IgM deliver expanded information to clinicians to help with the diagnosis and management of patients with autoimmune diseases.” Werfen said that its new Aptiva APS reagents will complement its previous Aptiva Celiac Disease and Connective Tissue Diseases (CTD) Essential reagents. The APS reagents also expand the number of CE-marked analytes detected by Aptiva to 19. Aptiva is designed to target additional autoimmune disease states and has more than 60 analytes in various stages of advanced development. The analytes can potentially improve the accuracy of autoimmune disease diagnosis and support better patient management. The Aptiva system is a fully automated multi-analyte system that represents the next-generation high throughput analysers for the autoimmunity and immunology laboratory. Aptiva uses particle-based multi-analyte technology to deliver up to 120 APS results per hour and allows the laboratory to complete the workload faster with PMAT. Established in 1966, Werfen is a provider of specialised diagnostic instruments, related reagents, and data management solutions for use in hospitals and clinical laboratories. The company’s business focuses on autoimmunity, haemostasis, acute care diagnostics, transfusion, transplant, and original equipment manufacturing (OEM).

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机构

Instrumentation Laboratory SpA