Method and kit for in vitro diagnosis of anti-phospholipid syndrome
Antiphospholipid antibodies are a group of autoantibodies which, in association with thrombosis (arterial and / or venous) and spontaneous abortions, characterize the Antiphospholipid Antibody Syndrome (APS). Anti-β2-Glycoprotein I (β2GPI) antibodies are the main autoantibodies used for the diagnosis of APS. The object of the invention is the carbamylation of the β2GPI protein and the method relating to the dosage of carbamylated anti-β2GPI antibodies using an immunoenzymatic method (ELISA).
To obtain a quick and easy-to-use test, the Kit includes the carbamylated β2GPI immobilized on a solid support (96-well polystyrene plate or preferably 8 strips of 12 wells each). Alternatively, the test can be developed in chemiluminescence. The kits also contain any additional components that allow the assay to be performed, for example, buffers, capture reagents, development reagents, markers, reaction surfaces, control samples, and instructions for use. The proposed test involves substantial improvements compared to routine diagnostic tests, because it involves the use of a completely new antigen (β2GPI carbamylated), that allows to detect the presence of new antibody specificities in a larger portion of patients than current diagnostic assays, which technically can detect antibodies directed only to the native (unmodified) form of β2GPI. The results of using the prototype of the invention were positive, especially for patients negative to conventional tests, TRL 5.
- Immunological diagnostics of the Antiphospholipid Antibody Syndrome;
- In the diagnosis of seronegative patients with thromboembolic problems related to APS.
- Use of a completely new antigen (carbamylated β2GPI);
- Ability to detect the presence of new antibody specificities in a larger portion of patients than current diagnostic assays.