For in vitro quantitative determination of lupus anticoagulant substances in human plasma.
LA is a group of antibodies against coagulation lipids or phospholipids and protein (such as β-2-glycoprotein and coagulation factors) complexes, which can interfere with phospholipid-dependent hemostasis and in vitro coagulation tests (such as APTT, SCT, RVVT, etc.). Plasma LA is positive, which can be seen in autoimmune diseases, such as systemic lupus erythematosus (SLE), viral infection, myeloproliferative disease, recurrent miscarriage, etc. About 24% to 36% of patients can develop thrombosis.
LAS and LAC respectively determine the negative value quality control product, repeat the determination 10 times, the coefficient of variation (CV%) of the determination value should be ≤6%, LAS and LAC respectively determine the positive quality control product, repeat the determination 10 times, its measured value The coefficient of variation (CV%) should be ≤8%.
The inter-batch difference between LAS, LAC and quality control products should be ≤10%.