Autoimmune Tests for Diagnosing Antiphospholipid Syndrome

The tests have been cleared by the US Food and Drug Administration (FDA).

The clinical hallmark of APS is recurrent arterial or venous thromboembolism. Clinical manifestations include spontaneous abortions, thrombocytopenia, and various neurologic symptoms. The appearance of anticardiolipin antibodies is particularly associated with APS. Studies suggest that antibodies to beta-2-glycoprotein ([beta]-2-GPI) cause the development of APS. For patients suspected of having APS, antibodies to both cardiolipin and (beta)-2-GPI are used to diagnose the condition.

The tests, developed by Hycor Boiomedical, Inc. (Garden Grove, CA, USA), can be performed manually or on the company's Hy-Tec 288 Plus automated immunoassay system. "Hycor's autoimmune disease test menu is one of the broadest available in the US,” said J. David Tholen, president and CEO. Autoimmune diseases, long considered rare, have in recent years been moved to the top of the women's research agenda by the US National Institutes of Health.




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