The Patented Anti-Squalene Antibody Assay, or ASA Assay

The patented Anti-Squalene Antibody Assay, or ASA Assay, is a test that detects antibodies to squalene in human blood. Peer-reviewed research data that was obtained by using this test has linked squalene-contaminated lots of the vaccine used in the DoD's post-1997 Anthrax Vaccine Immunization Program (AVIP) to the development of anti-squalene antibodies. These antibodies were previously linked to the multi-symptom rheumatic illness known as Gulf War Syndrome. For more information about this data and its implications, see the Gulf War Syndrome Research Page.

U.S. Army researchers duplicated this test, and in November 2000 the Army researchers published their research confirming the discovery of anti-squalene antibodies. A patent on the ASA Assay was awarded in April 2001, and Autoimmune Technologies holds the rights to that patent. The patent covers various methods for detecting anti-squalene antibodies, including the testing method that was used by the Army researchers. To enable the DoD to sponsor a large confirmatory study of the link between squalene contamination in vaccines and GWS, Autoimmune has offered the patented ASA Assay technology to the Department of Defense and has strongly urged the DoD to sponsor such a study.

In addition to helping identify patients with GWS, the discovery of anti-squalene antibodies might also provide a key to more effectively treating GWS patients. The presence of the antibodies in GWS patients indicates that the immune system is involved in the development of GWS. Effective drugs which modulate the human immune system are already in wide use, but they have not been previously considered to be appropriate for GWS patients. The published data now suggests that the use of immune modulators in GWS patients should be studied.

Autoimmune Technologies is not currently offering the ASA Assay for investigation into individual GWS cases, but when the benefits of the test become clear to all of the groups involved in assessing GWS, Autoimmune will immediately make the ASA Assay available to interested physicians for investigational use.

GWS patients or physicians who would like to receive notification when the Assay does become available for investigational use may send their name, mailing address, and their physician's name if they are a patient, to GWS@autoimmune.com via e-mail or to the postal address given in the How to Contact Us page. IMPORTANT NOTE CONCERNING E-MAIL: Because of the recent proliferation of "spam" messages, the GWS@autoimmune.com mailbox is now being filtered by subject line. Please begin the subject line of your e-mail message with the word Test in order to pass through the filter.


For more information, go to the Gulf War Syndrome Research Page