Research And Development Of Full-Automatic Chemiluminescent Immunoassay

Chemiluminescent immunoassay is an important clinical medical test method in clinical immunological test.According to the process requirements on immunity test by using chemiluminescent immunoassay kit,a full-automatic chemiluminescent immunoassay was developed in the paper with functions of full-automatic sample addition,incubation at constant temperature,automatic washing and separation,adding substrate,photon detection and data analysis and processing,which realized automation of the overall process of chemiluminescent immunity test.The paper was based on Research and Development,Application and Promotion of Full-Automatic High-Precision Chemiluminescentb(Immunity)Analyzer,an innovation fund project for middle and small-sized enterprises by Ministry of Science and Technology of the People's Republic of China.According to the process requirements on chemiluminescent immunoassay,the following overall design scheme was made in this paper:large-scale three-dimensional motion mechanism was adopted to realize operation on instrument platform;three-dimensional motion mechanism inside detecting unit was tested for microplate incubation and photon number test hole by hole.The complete machine can be divided into five modules including large-scale three-dimensional motion control unit,micro sample addition unit,constant temperature incubation unit,washing and separation unit and single photon counting unit.According to the control requirements to motion on platform,professional integrated circuit board was adopted to control the triaxial motor driver so as to realize large-scale three-dimensional motion control.In this way,host computer was free from abundant motion control calculation so that host computer can have better control and communication with several slave computers,as well as better control,coordination and management over the complete machine.For micro sample addition module,mechanical structure of screw rod motor with precise linear guideway was designed to guarantee the air impermeability of precise micro sample addition injection pump,so as to reach key index of high-precision sample addition of the instrument.Constant temperature incubation unit was structurally implanted into the photon detecting unit to simplify motion mechanism;metal heating film of uniform heating and several temperature sensors were embodied in the bin with PID algorithm adopted for software,to realize balanced microplate incubation.For washing and separation unit,the washing hydraulic route that injecting washing liquor under positive pressure and sucking waste liquid under negative pressure was designed.Additionally,single-hole multi-point imbibition algorithm was applied in software,to reach preset washing cleanliness index of washing plate.Ingenious mechanical structure was designed for single photon counting unit,with microplate firmly immobilized on the tray,to detect the three-dimensional motion in the detecting unit so as to test photon number hole by hole.Silicon photomultiplier was adopted for core sensor along with a series of corresponding electric circuits,which improved the detection sensitivity substantially on low-end photon number.Extensive testing results of the developed instrument indicated that,full-automatic chemiluminescent immunoassay developed in the paper was characterized by high degree of automation,stable and reliable operation,whose key indexes including test flux,precision of sample addition,temperature accuracy of constant temperature incubation,cleanliness of washing and separation,photon testing precision met design requirements.