Beckman Coulter, Inc. has expanded the anemia menu on its Access family of immunoassay systems with the release of a test for intrinsic factor antibodies (Ab). The new test aids in the diagnosis of pernicious anemia.

The Intrinsic Factor Ab assay gives mid- to large-volume hospitals and reference laboratories the ability to produce rapid, accurate results for the differential diagnosis of pernicious anemia, which is characterized by megaloblastic anemia, neuropathy and gastritis with intrinsic factor autoantibodies. This disease can affect the general population, but is more prevalent in elderly people.

The new test can be performed on serum or heparinized plasma and requires a sample volume of 55 µL. The liquid, ready-to-use reagent features total imprecision of less than 8 percent of the coefficient of variation (CV) across the assay range. Time to first result is less than 35 minutes. The assay provides 14-day calibration stability and 56-day open-pack stability.

Intrinsic factor is a natural substance present in the stomach and is essential to the digestion of vitamin B₁₂. Lack of intrinsic factor leads to pernicious anemia and vitamin B₁₂ deficiency. 

Pernicious anemia and the presence of intrinsic factor antibodies are associated with a number of autoimmune disease states, such as Hashimoto’s thyroiditis, insulin-dependent diabetes mellitus, Grave’s disease, rheumatoid arthritis, myasthenia gravis, hypoparathyroidism and Lambert-Eaton syndrome.

Beckman Coulter’s Access family of instruments includes the Access, Access 2 and UniCel® DxI 800 Access immunoassay system, which can perform up to 400 tests per hour.

Besides Intrinsic Factor Ab, Beckman Coulter’s anemia menu on immunoassay systems includes vitamin B₁₂, ferritin, folate and RBC folate. The company’s menu also includes cancer, cardiac, infectious disease, reproductive and other endocrine tests. The menu includes approximately 40 tests worldwide.

Beckman Coulter, Inc. is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes.  Spanning the biomedical testing continuum – from systems biology and clinical research to laboratory diagnostics and point-of-care testing – Beckman Coulter’s 200,000 installed systems provide essential biomedical information to enhance health care around the world.  The company, based in Fullerton, Calif., reported 2003 annual sales of $2.2 billion with 64 percent of this amount generated by recurring revenue from supplies, test kits and services.