Security Design And Application On ELISA Analysis System

ELISA analysis system is a kind of IVD, which is commonly used in the diagnosis ofHIV, HBV, HCV. The user may contact with a infectious biological samples during thediagnosis, which has a great chance of being infected with the virus. Incorrect testing resultscan cause blood transfusion problem, even blood disaster could happen. Therefore, theresearch on ELISA analysis system safety design and application has important engineeringvalue and social significance. The main research of this topic includes the following aspects:(1) Use the combination of Borda sequence value method and risk matrix method to rankthe risk facts of ELISA analysis system, and get a conclusion that color interpretation errorand abnormal washing effect are the two highest risks of it.(2) Study the influence element of Color interpretation performance. Aim at the problemthat the light source and voltage fluctuations have a large influence on the stability ofmeasurement, this design increases the optical reference channel to improve it. Theperformance tests show that the stability of enzyme label analyzer measuring absorbancevalues are within 0.003, measuring channel differences are within 0.02, absorbancerepeatability are within 0.4%, which is explained the colorimetric interpretation performanceis obviously improved.(3) The article expounds the working principle and basic structure of enzyme washingmachine, and study the influence element of washing performance. In order to prevent crosscontamination effectively, it uses the independent design of separating fluid needle andaspirating fluid needle, which improved the washing effect. The performance tests show thateach hole suction fluid residues are less than 2u L, veneer average liquid injection rate testresults are within ±5%, which is explained the washing performance is obviously improved.(4) Use the optimized ELISA analysis system to test the blood specimen, and makecomparison with the detection results before optimization. In terms of ELISA detection, it canget a conclusion that the ELISA analysis system the paper designed is improved onrepeatability, specificity and sensitivity. The results indicate that, optimizing the performanceof ELISA analysis system can improve detection accuracy of blood transfusion, reduce therisk of the spread of the virus during blood transfusion, increase the safety of bloodtransfusion.