Abstract The sensitivity of chemiluminescence immunoassay method mainly depends on the quality of chemiluminescence analyzer. This paper reports a chemiluminescence immunoassay apparatus that was developed independently. In this research, we employed the optical fiber conduction as the detecting system and fiber-optic probe which was more close to the analyte as the movement system to improve the detection performance. And then a clenbuterol chemiluminescent immunoassay kit (CLEN-kit) was also developed to evaluate the analyzer quality. A set of quality evaluation tests were designed to evaluate the comprehensive quality of the kit. Results showed that the linear detection range of CLEN-kit was 0.313~40.000 ng/mL, the sensitivity was 0.397 7 ng/mL, and the detection limit was 0.023~0.041 ng/mL. Besides, its cross-reactivity with its structural analogues, terbutaline, tulobuterol and adrenaline was not appeared. It was validated that CLEN-kit has a good ability to detect trace clenbuterol and the self-developed chemiluminescence immunoassay analyzer has a good performance when applied in CLEN-kit's development.
