LIPID-DEPENDENT DIAGNOSTIC ASSAYS.

摘要

For use in a lipid-dependent diagnostic assay, a stable aqueous suspension of a phospholipid which normally has a hexagonal (HII) organization when dispersed in an aqueous medium without detergent, the suspension containing the phospholipid, a detergent, and an aqueous phase. In the stable suspension, the phospholipid remains in suspension at a temperature of 25 DEG C for at least one hour. The suspension is suitable for providing the phospholipid to an assay for lupus anticoagulants which includes the step of pre-incubating a test sample with the phospholipid. In a further aspect of the invention an assay is provided for use in determining whether a patient has a lupus anticoagulant, the assay including the steps of: a) obtaining first and second samples of the patient's plasma; b) incubating the first sample with the stable aqueous phospholipid suspension of the present invention; c) performing a lipid-dependent diagnostic assay on both the first and second samples, the assay producing a positive reading when used to assay a sample which contains lupus anticoagulants; and d) comparing the results of the assays performed on the first and second samples, the presence of a normal result for the first sample and a positive result for the second sample being indicative of the patient having a lupus anticoagulant.