Use of a dual monoclonal solid phase and a polyclonal detector to create an immunoassay for the detection of human cardiac troponin I.
OBJECTIVE
We report the development of a fully automated, random access, chemiluminescent immunoassay, for the detection of human cardiac Troponin I (cTnI) in serum and plasma for use on the ACS:180(R) System.


METHODS
This assay format uses a combination of two monoclonal antibodies covalently coupled to paramagnetic (PMP) particles as a solid phase and an affinity purified polyclonal antibody, specific to the N-terminal domain of cTnI (peptide-3 region) labeled with a chemiluminescent compound as the detector antibody. The assay offers excellent low-end sensitivity and precision.


RESULTS
No interferences are observed from by blood components such as HAMA and drugs used in cardiac therapy. Patient samples tested on the ACS:180 cTnI assay showed good correlation with the Stratus cTnI assay (ACS: cTnI = 1. 02*Stratus + 0.05 g/L, r = 0.96, n = 1170).


CONCLUSIONS
Paired with the other ACS:180 cardiac assays, myoglobin and CKMBII, the ACS:180 system now offers an excellent panel of cardiac assay for use in rapid and accurate diagnosis of a myocardial event.
Oh
S K
SK
Bayer Corporation, Diagnostics Division E, Walpole, MA 02032, USA.
Foster
K
K
Datta
P
P
Orswell
M
M
Tasaico
K
K
Mai
X
X
Connolly
P
P
Reamer
R
R
Walsh
R
R
Yang
G
G
Barlow
E
E
Bluestein
B
B
Parsons
G
G
D000911:Antibodies, Monoclonal; D000918:Antibody Specificity; D015415:Biomarkers / Q000097:blood; D019963:Clinical Chemistry Tests; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008163:Luminescent Measurements; D008297:Male; D009203:Myocardial Infarction / Q000175:diagnosis; D009206:Myocardium / Q000737:chemistry*; D012044:Regression Analysis; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000097:blood* / Q000276:immunology
D000911:Antibodies, Monoclonal; D015415:Biomarkers; D019210:Troponin I