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The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:

• as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure
• for the risk stratification of patients with acute coronary syndromes
• for the risk stratification of patients with heart failure

The Access BNP II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of B-type natriuretic peptide (BNP) levels in human EDTA plasma using the Access Immunoassay Systems.

The Access BNP Calibrators are intended to calibrate the Access BNP and Access BNP II tests for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

The Access BNP II test is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse Omniclonal anti-human BNP antibody. BNP in human plasma binds to the immobilized anti-BNP on the solid phase, while the mouse anti-BNP conjugate reacts specifically with bound BNP.

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 inversely proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

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