Device Description : INTENDED USEAnti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for (View more) INTENDED USEAnti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG classautoantibodies against double-stranded DNA in human serum or plasma. The assay is intended as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAutoimmune diseases are characterized by the occurence of antibodies against one’s own antigenic structures, also known as autoantibodies. Presence of autoantibodies to native desoxyribonucleic acids (n-DNA, dsDNA, double-stranded DNA) is typical for the clinical picture of SLE. Antibodies against dsDNA belong to the group of Anti Nuclear Antibodies (ANA), which are directed against various structures of the nucleus of the cell. They appear in a variety of rheumatoid diseases. Antibodies to dsDNA are found during the active phases of SLE. Diagnostic sensitivity of the anti-dsDNA determination in cases of SLE is approximately 91 % combined with a diagnostic specificity of nearly 96 percent. SLE like diseases are caused by some drugs. For differential diagnosis of drug-induced SLE the determination of anti-dsDNA is a valuable diagnostic tool. PRINCIPLE OF THE TESTHuman recombinant double-stranded DNA (dsDNA) is bound to microwells. Antibodies to this antigen bind to the respective antigen. Washing of the microwells removes unspecific serum/plasma components. Horseradish peroxidase (HRP) conjugated anti-human IgG immunologically detects the bound patient antibodies forming a conjugate/antibody/antigen complex. Washing of the microwells removes unbound conjugate. An enzyme substrate in the presence of bound conjugate hydrolyzes to form a blue color. The addition of an acid stops the reaction forming a yellow color in the test well which is measured photometrically at 450 nm. The amount of color is directly proportional to the concentration of IgG antibodies present in the original sample. Refer to Product Package Insert. (View less)

Device Description : INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aP (View more) INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Antiphospholipid antibodies are a heterogeneous group of immunoglobulins (IgG, IgM, IgA) that bind to several anionic phospholipids (e.g., cardiolipin, phosphatidylserine), to phospholipid-protein complexes, and to certain proteins in the absence of anionic phospholipids. The REAADS aPT ELISA test kit uses purified human prothrombin as antigen to detect IgG anti-prothrombin antibodies in human serum or citrated plasma in the absence of other exogenous cofactors or phospholipids. High serum or plasma levels of aPT antibodies may add valuable information in the laboratory assessment of antiphospholipid antibodies.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrators and controls are incubated in microwells coated with purified human prothrombin. After the removal of unbound proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the prothrombin bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells. Results are obtained by reading the O.D. of each test well in a spectrophotometer. Calibrator sera are provided with the IgG anti-prothrombin antibody concentration. The user will run a single point calibration, dividing the concentration value of the calibrator sera by the O.D. value of the calibrator providing a conversion factor. The O.D. values of the other samples are multiplied by the conversion factor to obtain IgG anti-prothrombin antibody concentrations in G units. Refer to Product Package Insert. (View less)

Device Description : INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibo (View more) INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed byoxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.SUMMARY AND EXPLANATION OF THE ASSAYThe antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such asSLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TESTThis test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, 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 IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. (View less)

Device Description : REAADS Coagulation Control 1 (CC-1) is an assayed control plasma in coagulation (View more) REAADS Coagulation Control 1 (CC-1) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use.PRINCIPLE OF THE PROCEDURECoagulation Control 1 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert. (View less)

Device Description : REAADS Coagulation Control 2 (CC-2) ) is an assayed control plasma in coagulatio (View more) REAADS Coagulation Control 2 (CC-2) ) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use.PRINCIPLE OF THE PROCEDURECoagulation Control 2 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert. (View less)

Device Description : INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative d (View more) INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Activity (VWF:Act) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY OF THE TEST Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also known as the anti-hemophilic factor. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes von Willebrand disease. Von Willebrand Disease is characterized by a deficiency or defect of VWF. Greater than 70% of Von Willebrand disease patients have a type 1 deficiency while approximately 20% have a type II deficiency. The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative (functional) determinations to differentiate the two predominant subtypes of the disease, type I and type II. The classification of Von Willebrand disease into subtypes is important in determining the course of clinical treatment. PRINCIPLE OF THE TEST The REAADS VWF:Act assay is a sandwich ELISA. A monoclonal capture antibody specific for the portion of VWF which binds platelets is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells. The plates are washed to remove unbound proteins and other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in O.D. units with a spectrophotometer at 450 nm. Patient VWF:Act in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. Refer to Product Package Insert. (View less)

Device Description : INTENDED USE The 11dhTxB2 Test Kit is an enzyme-linked immunoassay (ELISA) to de (View more) INTENDED USE The 11dhTxB2 Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine which aids in the qualitative detection of acetylsalicylic acid (ASA) effect in apparently healthy individuals post ingestion. For In Vitro Diagnostic Use.SUMMARY OF THE ASSAY Activated platelets produce Thromboxane A2 (TxA2), a potent vasoconstrictor and inducer of platelet aggregation. TxA2 is generated by Thromboxane synthase from molecules derived from arachidonic acid by cyclooxygenase-1 (COX-1). TxA2 has a short half-life in plasma and is rapidly hydrolyzed to Thromboxane B2 (TxB2). TxB2, in turn, is metabolized to 11-Dehydro Thromboxane B2 (11dhTxB2).The measurement of stable metabolites of TxA2, such as urinary11dhTxB2, is a means of quantitating TxA2 production in vivo and thus a direct way to analyze ASA’s effect post ingestion. PRINCIPLE OF THE TEST The 11dhTxB2 Test Kit measures urinary 11dhTxB2 and is performed as a competitive ELISA. Diluted samples (Reference Solution, controls, and patient urine), purified 11dhTxB2 conjugated to alkaline phosphatase (AP), and purified mouse monoclonal antibody directed to 11dhTxB2 are combined and incubated in microwells coated with a polyclonal anti-mouse antibody. The monoclonal antibody then binds to the polyclonal anti-mouse antibody coated on the microtiter plate. After the removal of unbound complexes by washing, the bound AP-11dhTxB2 conjugate is assayed by the addition of para-nitrophenylphosphate (pNPP) chromogenic substrate. Color develops in the wells at an intensity inversely proportional to the sample urine concentration of 11dhTxB2, and is read at 405nm. Results (pg/mL) are calculated against a reference curve prepared from the Reference Solution provided in the kit. Final results are reported as pg 11dhTxB2 per mg creatinine to normalize results for urine concentration. Refer to product package insert. (View less)