Analysis on the Quality Status of in Vitro Diagnostic Reagents for National Medical Device Supervision and Inspection in 2020 / 中国医疗器械杂志

OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.

Analysis of Cut Off Value or Reference Interval of / 中国医疗器械杂志

The cut off value or reference interval is significant in clinical testing and diagnosis. If there is no scientific and reasonable cut off value or reference interval for

Relationship between Reference Interval Establishment and Clinical Evaluation in Quantitative / 中国医疗器械杂志

Reference interval study and clinical evaluation are crucial supportive researches to demonstrate the intended use of quantitative

Summary of Statistical Methods Commonly Used in Clinical Evaluation of / 中国医疗器械杂志

Referring to relevant normative documents, we summarized the commonly used statistical methods in clinical evaluation of

Analysis of the Development Status of Clinical Pharmacogenomics Based on External Quality Assessment from 2014 to 2019 in China / 中国药房

OBJECTIVE：To provide reference for promoting individualized medication in clinic. METHODS ：Information on external quality assessment （EQA）projects and approved kits for the guidance of chemical drug use were collected from the websites of National Center for Clinical Laboratories （NCCL） and National Medical Products Administration （NMPA） as of December 31，2019. The number of laboratories participating in each evaluation project was count. Taking EQA projects of clopidogrel and warfarin drug metabolism gene polymorphism detection as examples ，who was with the highest participation rate ， the methods and reagent kits of each laboratory were analyzed so as to analyze the current status of the clinical pharmacogenomics （PGx）in China. RESULTS ：The number of PGx genetic test EQA projects conducted by NCCL increased from 3（2014）to 9 （2019）. The total number of participating laboratories was 926 in 2018，and 1 249 in 2019. The number of laboratories of warfarin and clopidogrel drug metabolism gene polymorphism detection increased from 57 to 300.5 for warfarin and from 124 to 374.5 for clopidogrel. The more widely used methods were fluorescent PCR and PCR-chip hybridization. The number of reagent kits currently approved by NMPA was 7 for warfarin and 15 for clopidogrel ，respectively. But some of the laboratories participating in EQA used self-prepared reagents yet. CONCLUSIONS ：The clinical PGx is in its infancy ，and the awareness of laboratories about EQA is improving；the main method was fluorescence PCR ，but the use of self-made reagents in laboratories is still common ，regulations concerning the approval ，use and supervision still need to be further improved.

Study on Risk Assessment Model of in Diagnostic Reagent Adverse Events Based on BP Neural Network / 中国医疗器械杂志

OBJECTIVE@#To modify the monitoring process and means of adverse events diagnostic reagents,improve the quantity and quality of adverse events reported ,and reduce the workload of regulatory authorities,eventually ensure the safety and effectiveness of diagnostic reagents.@*METHODS@#The pre-filtering risk assessment system based on BP neural network was used to evaluate the adverse events of diagnostic reagents.According to the evaluation results,the administrative supervision departments took corresponding countermeasures.@*RESULTS@#The BP neural network learned the historical data,and the risk evaluation results of the adverse events were basically consistent with the expert group.@*CONCLUSIONS@#BP neural network can be used to evaluate the risk of adverse events and achieve risk signal aggregation of adverse events.

Discussion on Regulatory Risk of in Vitro Diagnostic Reagents in Use / 中国医疗器械杂志

According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.

The management and application of cold-chain for in vitro diagnostic reagent / 中国医学装备

Objective: To carry out effective management for the cold-chain temperature of in vitro diagnostic reagent so as to provide safe and credible inspection basis for clinical diagnosis and treatment. Methods: The remote control and alarm platform of cold storage and refrigerator were applied to achieve acceptance for temperature control of in vitro diagnostic reagent, and achieve acceptance for temperature and achieve differentiation management for unqualified product. These methods could ensure controllability of temperature for the reagent with requirements of cold-chain. Results: Through the management of cold-chain of in vitro diagnostic reagents, hospital has achieved effective supervising for them, and hospital has concrete record for these reagents in the entire medical process, and all of them were traceability. Therefore, it provide effective guarantee for clinical safety. Conclusion: The support of informatization technique and implementation of management system of hospital can ensure the cold-chain management of entire process is not out of control, and enhance the stability and accuracy of clinical test results and effective guarantee the safety of diagnosis and treatment for hospital.