Research On The Key Technologies And System Construction Of Automatic POCT Chemiluminescence Immune Analyzer

In order to solve the problem of overcrowding in large hospitals and insufficient utilization of resources in primary medical institutions,the state has established and continued to promote the "graded diagnosis and treatment" policy,which has promoted the increasing demand for POCT medical equipment in primary medical institutions.At the same time,the establishment of five major centers with the main purpose of rescuing critically ill patients not only brought development opportunities and market space for POCT products,but also put forward requirements for the detection process "fast" and test results " accurate " of POCT products.As an important Diagnostic method for in vitro diagnosis,chemiluminescence immunoassay method is widely used in POCT products because of its specificity,high sensitivity,quantitative detection,and high degree of automation.At present,the POCT chemiluminescence immunoassay analyzer generally has the problem of add samples manually,and the reagent uses a single-person,single-target reagent chip solution,which limits the test speed of the instrument and increases the test cost.Therefore,in this thesis,based on the in-depth research on the key technologies of the full-automatic POCT chemiluminescence immunoanalyzer,based on a single-person,multi-target reagent chip scheme,a suitable for deployment in basic-level hospitals and outpatient departments with limited space is designed Full automatic POCT chemiluminescence immunoassay analyzer.This thesis focuses on the following three aspects:1.This paper systematically studies the principle of chemiluminescence immunoassay,and analyzes the key factors that easily affect the detection results during the test.Compare the advantages and disadvantages of different chemiluminescence analysis methods,and finally choose enzymatic chemiluminescence as the analytical method of this instrument.Finally,by summarizing the working process of the analyzer,the main directions and contents of the subsequent system construction are pointed out,which provides a reference for the overall design.2.This topic studies the factors that affect the rapid aggregation of magnetic particles and the cleaning of free markers during the magnetic separation and cleaning process.In order to address the problems of the current traditional fixed magnetic separation methods,such as large magnets,incomplete cleaning of free markers,and unsuitable for small instruments,A magnetic separation cleaning structure combining a fixed magnetic field magnetic absorption method and an interleaved magnetic field was designed,and a corresponding time sequence control magnetic separation cleaning process was developed.It is verified by experiments that the cleaning effect of the free marker is only higher than the 200 RLU background,which indicates that the cleaning effect of this structure is obvious.3.This thesis builds a full automatic POCT chemiluminescence immunoassay analyzer,and systematically tests and evaluates key performance indicators such as temperature performance,sample addition performance,and optical detection performance of the instrument.All indicators meet the design requirements.Finally,using procalcitonin(PCT)as a sample,the in-batch precision test of a single item was performed on the instrument,and the results showed that the concentrations varied between(0.5 ± 0.1)ng / m L and(10 ± 1)ng / m L.The coefficient(CV)is less than 2%,which is far less than the 8% required by the line standard.