DiaMetra Anti beta 2 Glycoprotein 1 Screen Elisa Kit

PRINCIPLE
Dia.Metra Anti beta 2 Glycoprotein 1 Screen test allowsto determine the unknown concentration of autoantibodies directed against theβ2-Glycoprotein 1complex through two different calibration curve (onespecific for IgG test, one specific for IgM test), twodifferent conjugates linked to horseradish peroxidase(one specific for IgG test, the other specific for IgMtest) and one microplate only. The principle of themethod and the procedure are the same in both thetests. Use reagents for IgG or reagents for IgMdepending on the isotype which is under investigation.

CLINICAL SIGNIFICANCE The antiphospholipid syndrome (APS) is a disorder that presents peculiar symptoms: arterial and venous thrombosis, thrombocytopenia, ulcers of the lower limbs, hemolytic anemia, loss of the fetus during pregnancy and is associated with the presence of antiphospholipid antibodies. Antiphospholipid antibodies represent a large and heterogeneous immunoglobulins group, including anticardiolipin antibodies and lupus anticoagulant. The former are diagnosed by on their reactivity with cardiolipin or other anionic phospholipids in ELISA test, while the latter is detected in phospholipid-dependent coagulation tests (aPTT, KCT, dRVVT).

PRECAUTIONS
Please adhere strictly to the sequence of pipettingsteps provided in this protocol. The performance datarepresented here were obtained using specific reagentslisted in this Instruction For Use.
All reagents should be stored refrigerated at 2-8°C intheir original container. Any exceptions are clearlyindicated. The reagents are stable until the expiry datewhen stored and handled as indicated.
Allow all kit components and specimens to reach roomtemperature (22-28°C) and mix well prior to use.
Do not interchange kit components from different lots.The expiry date printed on box and vials labels must beobserved. Do not use any kit component beyond theirexpiry date.

Preparation of the Sample
For determination of anti beta 2 Glycoprotein 1 Screen antibodies human serum or plasma are the preferred sample matrixes. All serum and plasma samples have to be pre-diluted with sample diluent 1:100; for example 10 μL of sample may be diluted with 990 μL of sample diluent. The patients need not to be fasting, and no special sample preparation is necessary. Collect blood by venipuncture into vacutainers and separate serum (after clot formation) or plasma from the cells by centrifugation. Samples may be stored refrigerated at 2-8°C for at least 5 days. For longer storage of up to six months samples should be stored frozen at -20°C. To avoid repeated thawing and freezing the samples should be aliquoted. Neither Bilirubin nor Hemolysis have significant effect on the procedure. The controls are ready for use.