Test for the detection of anti-heparin antibodies

A method of detecting, in a sample obtained from a human, the presence of anti-heparin antibodies which inhibit the formation of a heparin accelerated antithrombin III-thrombin complex, comprising the steps of:

• providing a test measurement by
• a) reacting the sample with known amounts of heparin and antithrombin III to form a first complex comprising said heparin and said antithrombin III and, if anti-heparin antibodies which inhibit formation of the heparin accelerated antithrombin III-thrombin complex are present in the sample, a complex between the anti-heparin antibodies and said heparin;
• b) reacting the first complex with a known amount of thrombin to form the heparin accelerated antithrombin III-thrombin complex;
• c) contacting the heparin accelerated antithrombin III-thrombin complex with a capture antibody immobilized on a solid surface, wherein the capture antibody binds to the heparin accelerated antithrombin III-thrombin complex or to a member thereof;
• d) measuring the amount of complex bound to the solid surface;
• providing a reference measurement by performing steps a)-d) in the absence of the sample and comparing the test measurement with the reference measurement, wherein the presence of the anti-heparin antibodies which inhibit formation of the heparin accelerated antithrombin III-thrombin complex in the sample is detected when the test measurement is lower than the reference measurement.

A method of screening for Systemic Lupus Erythematosus in a human, comprising;

• a) obtaining a test sample from the human;
• b) measuring in the test sample the quantity of anti-heparin antibodies which inhibit formation of a heparin accelerated antithrombin III-thrombin complex;
• c) measuring in a reference sample obtained from a human without Systemic Lupus Erythenatosus the quantity of said anti-heparin antibodies which inhibit the formation of the heparin accelerated antithrombin III-thrombin complex present;
• and
• d) comparing the quantity of said anti-heparin antibodies which inhibit the formation of the heparin accelerated antithrombin III-thrombin complex present in the test sample and in the reference sample, wherein a greater quantity of antiheparin antibodies which inhibit the formation of the heparin accelerated antithrombin III-thrombin complex in the test sample than in the reference sample indicates a positive screen for Systemic Lupus Erythematosus.

A method of screening for Antiphospholipid Antibody Syndrome in a human, comprising:

• a) obtaining a test sample from the human;
• b) measuring in the test sample the quantity of anti-heparin antibodies which bind heparin pentasacaharide;
• c) measuring in a reference sample obtained from a human without Antiphospholipid Antibody Syndrome the quantity of said anti heparin antibodies which bind the heparin pentasaccharide;
• and
• d) comparing the quantity of said antiheparin antibodies which bind the heparin pentasaccharide present in the test sample and in the reference sample, wherein a greater quantity of said antiheparin antibodies which bind the heparin pentasaccharide in the test sample than in the reference sample indicates a positive screen for Antiphospholipid Antibody Syndrome.