Abbott i-STAT 1 System Manual

CARDIAC TROPONIN I /
(cTnI)
Rev. Date: 23-May-12 Art: 715595-00R
Intended Use
The i-STAT cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitative measurement of
cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the
diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute
coronary syndromes with respect to their relative risk of mortality.
Method Explanation
The i-STAT cTnI test cartridge uses a two-site enzyme-linked immunosorbant assay (ELISA) method.
Antibodies specific for human cardiac troponin I (cTnI) 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 cTnI molecule. The whole blood or
plasma sample is brought into contact with the sensors allowing the enzyme conjugate to dissolve into
the sample. The cTnI 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, as well as excess enzyme conjugate, is washed off the sensors. 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 cTnI
within the sample.
Contents
Each i-STAT cTnI cartridge provides a sample inlet, sensors to detect the cTnI 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 Caprine IgG: Bovine Intestine
IgG Caprine IgG: Murine IgG
Sodium Aminophenyl Phosphate N/A
Heparin Porcine Intestine
IgM Murine IgM
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Abbott i-STAT 1 Specifications

General

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