A Novel Assay for Improved Diagnosis of Antiphospholipid Syndrome

NU 2015-169

 

Inventors

Ke Ke Songwang

Hou Ming Zhao*

 

Short Description

A standardized assay to detect anti-phosphatidylethanolamine antibodies for the purpose of improving the clinical diagnosis of Antiphospholipid Syndrome (APS).

 

Abstract

Northwestern researchers have developed an assay that improves the reliability of diagnosing Antiphospholipid Syndrome (APS), a disorder that is commonly present in patients with Systemic Lupus Erythematosus or other autoimmune disorders. Phospholipids, specifically a subset of phospholipids called phosphatidyl-ethanolamine (PE) are thought to play a critical role in this syndrome. Complications of APS include life-threatening vascular blood clots and recurrent pregnancy loss. The current clinical tests for APS include a lupus anticoagulant test and an Enzyme-Linked Immunosorbent Assay (ELISA) for membrane phospholipids, including anti-cardiolipin and associated plasma protein anti-beta 2 glycoprotein. However, these tests do not take into account the role of antibodies against PE. Currently, there is no standard test for detecting PE, though the most common method uses an ELISA based on phospholipids collected directly from eggs. Variance in PE composition in the eggs used for this test creates inconsistencies from test to test. To improve precision in detection of PE antibodies, Northwestern researchers have developed a method to create a defined population of synthetic PE antigens that can be used instead of egg-derived PE for ELISA. The use of these synthetic antigens improve the overall accuracy and reliability of anti-PE tests and also take into account cofactor dependent and independent conditions. Through this standardization, anti-PE antibody testing can be used to complement existing tests to diagnose APS.

 

Applications

  • Clinical diagnostic tool for APS
  • Research tool for studying PE antibodies and compositions

 

Advantages

  • Specific for antibodies against PE
  • Reliable and consistent results
  • Complements APS diagnostic tests

 

Publications

Ke K, Strango Z, Harper P, Zhao M (2016) Influence of Phosphatidylethanolamine Concentration and Composition on the Detection of Antiphosphatidylethanolamine Antibodies by ELISA. Journal of Clinical Laboratory Analysis. 30: 689-96.

 

IP Status

US application filed.

 

Patent Information: