Rev. Date: 23-May-12 Art: 716969-00J
B-TYPE NATRIURETIC PEPTIDE /
(BNP)
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Intended Use
The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-type natriuretic
peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can
be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
Method Explanation
The i-STAT BNP test cartridge uses a two-site enzyme-linked immunosorbant assay (ELISA) method.
Antibodies specific for BNP are located on an electrochemical sensor fabricated on a silicon chip. Also
deposited in another location on the sensor silicon chip is an antibody/alkaline phosphatase enzyme
conjugate specific to a separate portion of the BNP molecule. The whole blood or plasma sample is
brought into contact with the sensors allowing the enzyme conjugate to dissolve into the sample. The
BNP within the sample becomes labeled with alkaline phosphatase and is captured onto the surface of the
electrochemical sensor during an incubation period of approximately seven minutes. The sample is washed
off the sensors, as well as excess enzyme conjugate. Within the wash fluid is a substrate for the alkaline
phosphatase enzyme. The enzyme bound to the antibody/antigen/antibody sandwich cleaves the substrate
releasing an electrochemically detectable product. The electrochemical (amperometric) sensor measures
this enzyme product which is proportional to the concentration of BNP within the sample.
Contents
Each i-STAT BNP cartridge provides a sample inlet, sensors to detect the BNP as described above, and all
the necessary reagents needed to perform the test. The cartridge contains a buffer and preservatives. A list
of reactive ingredients is indicated below:
Reactive Ingredient Biological Source
Antibody/Alkaline Phosphatase Conjugate Murine IgG: Bovine Intestine
IgG Caprine IgG: Murine IgG
Sodium Aminophenyl Phosphate N/A
Heparin Porcine Intestine
IgM Murine IgM