Abbott i-STAT 1 System Manual

CREATINE KINASE MB/
(CK-MB)
Rev. Date: 03-Aug-12 Art: 716675-00L
Intended Use
The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase
MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the
diagnosis and treatment of myocardial infarction (MI).
Method Explanation
The i-STAT CK-MB test cartridge uses a two-site enzyme-linked immunosorbant assay (ELISA) method.
Antibodies specific for an epitope unique to the CK-MB subunit, that therefore do not bind CK-MM or
CK-BB, 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 an
epitope on the B subunit of creatine kinase. The specificity of the conjugate antibody to the B subunit
allows this conjugate to recognize CK-MB and CK-BB, but not CK-MM. The whole blood or plasma
sample is brought into contact with the sensors allowing the enzyme conjugate to dissolve into the
sample. The CK-MB within the sample becomes labeled with alkaline phosphatase and is captured onto
the surface of the electrochemical sensor during an incubation period of approximately three 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 CK-
MB within the sample.
Contents
Each i-STAT CK-MB cartridge provides a sample inlet, sensors to detect the CK-MB 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 Reactive Ingredient
Antibody/Alkaline Phosphate Conjugate Murine IgG: Bovine Intestine
IgG Caprine IgG: Murine IgG
Sodium Aminophenyl Phosphate N/A
Heparin Porcine Intestine
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Abbott i-STAT 1 Specifications

General

Brand	Abbott
Model	i-STAT 1
Category	Measuring Instruments
Language	English