Use of a dual monoclonal solid phase and a polyclonal detector to create an immunoassay for the detection of human cardiac Troponin I

Objectives: 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. Design and methods: This assay format uses a combination of two monoclonal antibodies covalently coupled to paramagnetic (PMP) particles as a solid ph ase and an affinity purified polyclonal antibody, specific to the N-termina l domain of cTnI (peptide-3 region) labeled with a chemiluminescent compoun d as the detector antibody. The assay offers excellent low-end sensitivity and precision. Results: No interferences are observed from by blood components such as HAM A 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). Conclusion: Paired with the other ACS:180 cardiac assays, myoglobin and CKM BII, the ACS:180 system now offers an excellent panel of cardiac assay for use in rapid and accurate diagnosis of a myocardial event. Copyright (C) 20 00 The Canadian Society of Clinical Chemists.