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The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and may be used to assess the immune status of pregnant women. This product is not FDA cleared/approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens or infants.

The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative detection of Toxoplasma gondii-specific IgG antibody in adult human serum using the Access Immunoassay Systems. The Access Toxo IgG assay consists of the reagent pack, calibrators, and quality controls (OCs), packaged separately. Other items needed to run the assay include substrate and wash buffer.

The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection in males and pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay. Note: This assay has not been cleared/approved by the FDA for the screening of blood or plasma donors in the United States.

The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM II assay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay callorators, Access QCs, along with the UniCel DxI Wash Buffer II are designed for use with the DxI 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems. The detection of TPOAb is an aid in the diagnosis of thyroid autoimmune disorders.

The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPO Ab) levels in human serum and plasma using the Access Immunoassay Systems. The Access TPO Antibody Calibrators are intended to calibrate the Access TPO Antibody assay for the quantitative determination of TPO Antibody levels in human serum and plasma using the Access Immunoassay Systems. The Access TPO Antibody assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with thyroperoxidase protein. The serum or plasma TPO Ab binds to the thyroperoxidase. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD). This assay may also be used in conunction with an Access Ferritin measurement to provide a calculated sTR log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.

Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coated with streptavidin:biotinylated soluble transferrin receptor monoclonal antibody, proteins (mouse, goat, bovine), bovine serum albumin (BSA), 0.1% sodium azide, and 0.17% ProClin 300; and (R1b) Monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase (bovine) conjugate, BSA, 0.1% sodium azide and 0.17% ProClin 300. Two assay packs containing 50 tests per pack are provided for a total of 100 assay determinations. The Access sTfR assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-sTfR antibody. During incubation, the sTfR antigen in the sample binds to the immobilized anti-sTfR antibody on the solid phase. Alkaline phosphatase conjugated anti-sTfR antibody is then added and reacts with a different antigenic site on the sTfR molecule. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thyroqlobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease. The Access Thyroglobulin Antibody II assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with the thyroglobulin protein. The TgAb in the sample binds to the thyroglobulin coated on the particles. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The thyroglobulin-alkaline phosphatase conjugate is added and binds to the TgAb. After second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.

The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.

The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems. The Access EPO assay is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with the paramagnetic particles coated with mouse monoclonal anti-EPO, blocking reagent and the alkaline phosphatase conjugate. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the automated DxI Access Immunoassay Analyzers to aid in the following: 1. diagnosis of patients suspected of having acute heart failure in the Emergency Department 2. assessment of heart failure severity 3. risk stratification of patients with heart failure 4. risk stratification of patients with acute coronary syndrome

The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the automated Dxl 9000 Access Immunoassay Analyzers to aid in the following: 1) diagnosis of patients suspected of acute heart failure in the Emergency Department, 2) assessment of heart failure severity, 3) risk stratification of patients with heart failure, 4) risk stratification of patients with acute coronary syndrome. The Access NT-proBNP is a two-site immunoenzymatic (sandwich) assay. Paramagnetic particles coated with monoclonal anti-NT-proBNP antibody and monoclonal anti-NTproBNP antibody conjugated to alkaline phosphatase are added to a reaction vessel along with a surfactant-containing buffer and serum or plasma sample. The human NTproBNP binds to the anti-NT-proBNP antibody on the solid phase, while the anti-NTproBNP antibody-alkaline phosphatase conjugate reacts with a different antigenic site on the NT-proBNP molecule. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration. Other items required to use the assay include calibrators, Lumi-Phos PRO, and wash buffer. The Access NT-proBNP reagent packs. Access NT-proBNP calibrators, along with the Access wash buffer, and Lumi-Phos PRO are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.

The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Access Intact PTH assay is a sandwich immunoenzymatic assay. The Access Intact PTH assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The Access intact PTH assay reagent pack, Access intact PTH assay calibrators, along with the Access wash buffer and substrate are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.

The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access SHBG assay is indicated for use in the assessment of androgen disorders.

The Access SHBG assay is a sequential two-site immunoenzymatic ("sandwich") assay. The Access SHBG assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access SHBG assay reagent pack, Access SHBG assay calibrators, Access SHBG QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.