ELISA Kit for Diagnosing Fibromyalgia

An enzyme-linked immunosorbent assay (ELISA) for antipolymer antibodies (APAs) is designed to aid the diagnosis of patients presenting with the symptoms of fibromyalgia.

Fibromyalgia syndrome (FMS) is a chronic disorder afflicting primarily women and appears to have multiple causes. Signs and symptoms include widespread pain, specific painful "tender points,” fatigue, stiffness, sleep disturbance, headache, depression, anxiety, cognitive problems, and other symptoms. The American College of Rheumatology (ACR) criteria for fibromyalgia require that a patient manifest localized pain in at least 11 of 18 tender points and have a history of chronic widespread pain of greater than three month's duration. Because all of the current diagnostic criteria are subjective, some doctors and others believe that FMS is a psychologic disorder rather than a physical disorder. The majority of patients are APA-positive.

"The APA assay is the first specific clinical laboratory test for objectively identifying fibromyalgia patients,” said Russell B. Wilson, Ph.D., president and chief science officer of Autoimmune Technologies.

The serum-based assay was developed under an agreement between Corgenix Medical Corp. (Westminster, CO, USA) and Autoimmune Technologies, LLC (New Orleans, LA, USA). The product employs patented technology developed by Autoimmune, but Corgenix has the exclusive rights to manufacture the kit. Both companies will distribute the test.

"Although other laboratory markers exist, this is the only serum-based lab test that specifically picks up fibromyalgia patients. Research findings to date strongly suggest that fibromyalgia in APA-positive patients is associated with an abnormal immune system response,” said Doug Simpson, president of Corgenix. The companies expect to launch the test in Europe in the fall of 2004.




Related Links:
Corgenix
Autoimmune Tech.