INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG or IgM labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of aCL antibodies. Results are obtained by reading the O.D. of each test well with a spectrophotometer. Calibrator sera are provided, with the IgG and IgM aCL concentrations expressed in GPL or MPL units, respectively. The O.D. values of all the other samples are multiplied by the conversion factors to obtain IgG and IgM aCL antibody concentrations in standard units. Control and patient results are determined from the calibration curve. Refer to Product Product Insert.

HemosIL Factor V Leiden (APC Resistance V)

HemosIL Factor V Reagent Plasma (for APC R V)

Coatest APC Resistance

Coatest APCR Control Plasma Level 1

Coatest APCR Control Plasma Level 2

Coatest APC Resistance V

Coatest APC Resistance V-S

Plasma based functional assay for the determination of resistance to activated protein C caused by the Factor V Leiden mutation (FV:Q506).

APTT reagent 5 x 5 ml

APTT reagent 5 x 10 ml with 5 Calcium Chloride

Screening test for LA 250 DET

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time

Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect