Study On The Impact Of ALP Kit Performance Under Abnormal Transportation Temperature And Duration

Alkaline phosphatase is a phosphomonoester hydrolase,a group of specific phosphatase.There are four structural genotypes of alkaline phosphatase in serum:liver-bone-kidney type,Intestinal,placental,and germ cell variants.It is distributed in osteoblasts,hepatocytes,granulocytes,kidney,spleen,placenta,prostate and small intestine.Among them,the liver-bone-kidney type is particularly important.Elevated alkaline phosphatase can be seen in various forms of cholestasis,especially obstructive jaundice.Disorders of the skeletal system,such as Paget’s disease,hyperparathyroidism,rickets,osteomalacia,as well as fractures and malignancies can also lead to elevated alkaline phosphatase.Significant elevations in alkaline phosphatase are also seen in children and adolescents.The reason is that the bones grow rapidly and the activity of osteoblasts increases significantly.This assay was first proposed by King and Armstrong,modified by Ohmori,Bessey,Lowry and Brock,and later by Hausamen et al.In 1983,the International Federation of Clinical Chemistry（IFCC）recommended a standardized method for the determination of alkaline phosphatase by optimizing substrate concentrations and using 2-amino-2-methyl-1-propanol with the addition of magnesium and zinc ions Buffer assay for alkaline phosphatase.This assay is based on this recommendation,but has been optimized for performance and stability.This method has been standardized according to the IFCC reference method described above.p-nitrophenyl phosphate+H₂O?^A??^LP?phosphate+p-nitrophenolDetection principle:colorimetric method consistent with the standardization method.In the presence of magnesium and zinc ions,p-nitrophenyl phosphate is enzymatically hydrolyzed into phosphoric acid and p-nitrophenol by phosphatase.The released p-nitrophenol is proportional to the catalytic activity of alkaline phosphatase.It can be detected by measuring the increased absorbance.The research group will use its detection principle to manually intervene the kit,and perform low-temperature and high-temperature treatments on the kit at different temperatures to study the performance of the kit under different temperatures and different conditions.The effect on its own performance under constant conditions will provide reliable data support for the search for the maximum tolerance against uncertain transport temperature conditions.This simulated transport temperature anomaly study is to carry out a comprehensive challenge test on the tolerance of the kit at different temperatures and different times.After the kit has been subjected to simulated temperature,its performance is tested on the machine.The instrument used is Roche.The provided cobas 8000 series c701 can judge the actual tolerance of the kit through performance data indicators.To this end,we will get a full range of indicator parameters of the kit,so as to provide strong data support for the actual use of this brand of kit in the market.The research content of this paper is divided into the following three parts:The first part,the interpretation of the components of the alkaline phosphatase kit,comprehensively summarizes the quality research on the preparation,production,packaging,quality control,release,and follow-up stability of the alkaline phosphatase kit in the factory.A comprehensive analysis of the performance stability of the alkaline phosphatase kit to find the maximum tolerance against uncertain transport temperature conditions will provide reliable data for research.The second part,the experimental design,in order to prove the performance stability of the samples after the abnormal temperature inspection,the parameter performance of the kits at each temperature and each time was verified,and the performance parameters were selected with reference to the YY/T related performance indicators.Research to see if it can still meet the performance index requirements.The third part is the analysis and summary of experimental data results.The data analysis is carried out on the temperature axis and the performance axis respectively,and the maximum tolerance time of the kit at this temperature is obtained through the acceptance criteria of the experimental data.Through the experimental data,the temperature and time tolerance of the kit under a specific acceptance standard is obtained.The fourth part further analyzes the content determination test of p-nitrophenyl phosphate,another possible influence of the temperature anomaly study,it is suspected that the main reaction substance 4-nitrophenyl phosphate after the manager temperature anomaly study,the chemical changes in the reaction substance,there may be a change in the content,resulting in the chemical reaction can not be normal or reduced to proceed,this study uses 45℃48h after the failure of the kit as In this study,we used the kit that failed after 45℃for 48h as a sample to test the content of 4-nitrophenyl phosphate in the kit reaction system.If the content is not within a certain range,it means that the 4-nitrophenyl phosphate in the reaction system is damaged by temperature and causes chemical changes that lead to changes in the content.