Abbott Laboratories announced expanded test menus in the United States for its AxSYM Automated Immunoassay Instrument System. Two thyroid tests, thyroid peroxidase autoantibodies (Anti-TPO) and thyroglobulin autoantibodies (Anti-Tg), enhance AxSYM's thyroid test offering. With the addition of Cortisol, the endocrinology test menu is complete.
The Anti-TPO and Anti-Tg tests measure the antibodies that are characteristic of autoimmune thyroid disease. Cortisol, a hormone, is used in diagnosing adrenal gland disorders including Addison's disease and Cushing's syndrome. All three tests received 510(k) clearance from the Food and Drug Administration (FDA).
"Our popular AxSYM system continues to support the busy needs of medium-sized laboratories. These three assays add value to this system and demonstrate our commitment to further expanding AxSYM's diagnostic menu in the US," said Michael J Collins, vice president, US Diagnostic Commercial Operations, Abbott Laboratories.
"Endocrine disorders often go undiagnosed. Patients and their doctors may attribute symptoms such as fatigue or weight fluctuation to lifestyle or aging factors. This is particularly the case with thyroid disorders, which are estimated to affect 27 million Americans. Among those with an over- or under-active thyroid, more than half still remain undiagnosed," said Paul W Ladenson, professor of Medicine and director of Endocrinology and Metabolism at Johns Hopkins.
"With our AxSYM system, a laboratory can process a variety of immunodiagnostic tests simultaneously," said William Brown, vice president, Diagnostic Assays and Systems Development, Abbott Laboratories. "Within the endocrinology menu, the Anti-TPO and Anti-Tg assays are sensitive, precise and results are ready within 19 minutes. Our Cortisol assay is also sensitive, features good precision across the range, and provides results within 12 minutes," he added.
The AxSYM immunoassay system can process up to 80 to 120 tests per hour. Besides endocrinology, other test menus include assays for abused drugs, cancer, cardiac, fertility, hepatitis, infectious disease, metabolic/renal, therapeutic drug monitoring and toxicology.