The Development Of Chemiluminescent Immunoassay Quantitative Detection Kit For Cardiac Troponin I And Creatine Kinase MB

Acute myocardial infarction, with high motality, rapid onset, and long latency, has been one of the biggest killer for human health. Cardiac troponin I (cTnI) and creatinekinase MB (CK-MB) are two important blood markers for cardiac muscle and play a significant role in the diagnosis of AMI.In this study, two quantitative detection kits of cTnI and CK-MB were established based on chemiluminescent immunoassay. The main principle is based on a two-site immunoassay with chemiluminescence. The antibody (anti-cTnI/CK-MB) that coated on the paramagnetic particle is used for capturing, and the other antibody (anti-cTnI/CK-MB) which labled with alkaline phosphatase is used for detection. The two antibodies will react with the Antigen, if it exists in sample, and a "sandwich" complex will form. The chemiluminescent substrate will be then added and reacted with antibody-alkline phophatase conjugates. The light emission measeured by the device is direct proportional to the concentration of antigen in the sample.The analytical performance of the two established assays were further evaluated by a series of analysis, and the results showed a compatible performance with the recognized international brands (for cTnI:LoB<0.01ng/mL, Linear range=0.01-50ng/mL, Spiking recovery=(100±10)%, Total precision CV<5%; for CK-MB:LoB<0.1ng/mL, Linear range=0.1～300ng/mL, Spiking recovery=100±10%, Total precision CV<5%). And a good correlation (r>0.98) between the eatablished assays and the commercial assaywas also observed with clinical sample measurement. The assays established in this study can be potentially applied in diagnosis of AMI in China.