Werfen, announced that it has received the CE ( Conformité EuropéenneAptiva Immunoglobulin G ( IgG ) and Immunoglobulin M ( IgM ) Reagents for Antiphospholipid Syndrome ( APS ). under the European Union ( EUVitro Diagnostic Medical Devices Regulation ( IVDR ) .
Aptiva APS IgG and APS IgM reagents are immunoassays utilizing Aptiva’s particle-based multianalyte technology (PMAT) for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies. in human serum and citrated plasma. They are used to aid in the diagnosis of primary and secondary APS, when used in conjunction with other laboratory findings.
“Antiphospholipid syndrome is an autoimmune disease that manifests clinically as venous or arterial thrombosis and/or fetal loss and can be difficult to diagnose because its symptoms can mimic those of other diseases,” said Michael Mahler , PhD, vice president of Research and Werfen development.
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“Early diagnosis is crucial to prevent complications, as well as unnecessary procedures and increased healthcare costs. Aptiva APS IgG and APS IgM offer expanded information to physicians to assist with the diagnosis and treatment of patients with autoimmune diseases.”
The new Aptiva APS reagents complement Werfen’s previously registered Aptiva essential reagents for celiac disease and connective tissue diseases (CTD) and expand the number of CE-marked analytes detected by Aptiva to 19.
In addition to APS, CTD and celiac disease trials, Aptiva will focus on additional autoimmune disease states and has more than 60 analytes in various stages of advanced development. These analytes have the potential to 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 of high-throughput analyzers for the autoimmunity and immunology laboratory.
Aptiva uses particle-based multi-analyte technology to deliver results up to 120 APS per hour. With PMAT, Aptiva enables the laboratory to complete its workload faster and with minimal hands-on time.
SOURCE : PRNewswire