ELISA KIT SPECIFIC FOR THE ANTI-PHOSPHOLIPID SYNDROME

IN SOME PATIENTS, PHOSPHOLIPID-BINDING ANTIBODIES HAVE BEEN ASSOCIATED WITH RECURRENT VENOUS AND/OR ARTERIAL THROMBOSIS AS WELL AS WITH RECURRENT FETAL LOSS (THE ANTIPHOSPHOLIPID SYNDROME, OR APS). THESE ANTIBODIES ARE INDUCED IN A VARIETY OF CLINICAL CIRCUMSTANCES, AND IT IS LIKELY THAT THE ABOVE CLINICAL ASSOCIATIONS ARE LIMITED ONLYTO PATIENTS WITH PARTICULAR SUBGROUPS OF ANTIPHOSPHOLIPID (APL) ANTIBODIES. ANTIBODY SUBGROUPS MAY DIFFER IN THEIR AFFINITIES FOR PARTICULAR PHOSPHOLIPIDS OR IN THEIR SPECIFICITIES FOR PARTICULAR PHOSPHOLIPID CONFORMATIONS, SUCH CONFORMATIONS BEING DETERMINED BY PHOSPHOLIPID-LIPID MIXTURES. IT IS POSSIBLE THAT MANIPULATION OF PHOSPHOLIPID ANTIGEN CONCENTRATION OR OF PHOSPHOLIPID-LIPID MIXTURES IN AN ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) SYSTEM MAY ENABLE MORE SPECIFIC IDENTIFICATION OF PATIENTS WITH APS. WITH A VIEW TO PREPARING A MARKETABLE ELISA KIT SPECIFICALLYDESIGNED TO IDENTIFY PATIENTS WITH APS, THIS STUDY WILL COMPARE ELISA SYSTEMS WITH VARYING CONCENTRATIONS OF NEGATIVELY CHARGED PHOSPHOLIPIDS AND PHOSPHOLIPID-LIPID MIXTURES TO DETERMINE THE SYSTEM THAT IS MOST SENSITIVE AND SPECIFIC FOR IDENTIFYING APS PATIENTS. MATERIALS USED IN THE ASSAY SYSTEMS WILL BE EVALUATED FOR THEIR STABILITY OVERTIME TO DETERMINE THEIR UTILITY IN AN ELISA KIT.