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 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). CONCLUSION: 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.

Evaluation of a centrifuge with rapid turnaround time for the preparation of plasma samples for measurement of common STAT markers on the ACS: 180 system.

Reported is the evaluation of a new centrifugation method, Statspin, that addresses both time and sample separation integrity. The method can successfully separate the plasma fraction from the cellular material in 2 minutes as compared to 20 minutes for the conventional centrifuge method. The Statspin, combined with the ACS:180 system, can generate test results in less than 30 minutes, exclusive of transport to the laboratory. This study demonstrated that the combined technologies offer timing-saving improvements for clinical laboratories offering STAT immunoassays for cardiac markers, endocrine molecules, and therapeutic drugs.