ABSTRACT
On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.
Subject(s)
Medical Device Legislation , Reagent Kits, Diagnostic/standardsABSTRACT
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.
Subject(s)
Indicators and Reagents , Marketing , Reference StandardsABSTRACT
Microfluidics is the science and technology to manipulate small amounts of fluids in micro/nano-scale space. Multiple modules could be integrated into microfluidic device, and due to its advantages of microminiaturization and controllability, microfluidics has drawn extensive attention since its birth. In this paper, the literature data related to microfluidics research from January 1, 2006 to December 31, 2021 were obtained from Web of Science Core Collection database. CiteSpace 5.8.R3 software was used for bibliometrics analysis, so as to explore the research progress and development trends of microfluidics research at home and abroad. Based on the analysis of 50 129 articles, it could be seen that microfluidics was a hot topic of global concern, and the United States had a certain degree of authority in this field. Massachusetts Institute of Technology and Harvard University not only had a high number of publications, but also had strong influence and extensive cooperation network. Combined with ultrasonic, surface modification and sensor technology, researchers constructed paper-based microfluidic, droplet microfluidic and digital microfluidic platforms, which were applied in the field of immediate diagnosis, nucleic acid and circulating tumor cell analysis of in vitro diagnosis and organ-on-a-chip. China was one of the countries with a high level of research in the field of microfluidics, while the industrialization of high-end products needed to be improved. As people's demand for disease risk prediction and health management increased, promoting microfluidic technological innovation and achievement transformation is of great significance to safeguard people's life and health.
Subject(s)
Humans , China , Microfluidic Analytical Techniques , Microfluidics , Oligonucleotide Array Sequence AnalysisABSTRACT
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
Subject(s)
Humans , Indicators and Reagents , Reference ValuesABSTRACT
Reference interval study and clinical evaluation are crucial supportive researches to demonstrate the intended use of quantitative
Subject(s)
Indicators and Reagents , Reference ValuesABSTRACT
Referring to relevant normative documents, we summarized the commonly used statistical methods in clinical evaluation of
Subject(s)
Humans , Indicators and Reagents , ROC Curve , Research Design , Sensitivity and SpecificityABSTRACT
【Objective】 To compare the quantitative detection results of two domestic quantitative real-time PCR reagents in HBV-DNA detection. 【Methods】 A total of 306 serum samples form hepatitis B patients were selected for quantitative parallel detection of high-sensitiveity HBV-DNA using domestic reagent A and B, and the difference and consistency of the results were analyzed. 【Results】 1) The yielding rate of reagent A and B was 86.92% and 84.64%, respectively. The regression linear equation was Y=0.984 9x+ 0.154 9, R2=0.945 7, the correlation coefficient r=0.972 5, indicating the results by the two reagents had good correlation. 2) When the concentration was in the range of(20~1 000) IU/mL, the yielding rates of reagent A and B were 39.9% and 37.6%, respectively. 【Conclusion】 Reagent A is more suitable for post-treatment monitoring in patients with OBI and HBeAg(-), but also can be used to detect HBV pathogens in patients before operations or blood transfusions.
ABSTRACT
By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.
Subject(s)
European Union , Industry , Reagent Kits, DiagnosticABSTRACT
There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on
Subject(s)
European Union , Marketing , Reagent Kits, DiagnosticABSTRACT
From the perspective of technical review, this paper made statistics on the supplement contents of
Subject(s)
Chemistry, Clinical/standards , China , Indicators and Reagents , Reagent Kits, Diagnostic/standardsABSTRACT
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.
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Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.
Subject(s)
Clinical Trials as Topic , Indicators and Reagents/administration & dosage , Reagent Kits, DiagnosticABSTRACT
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.
Subject(s)
Indicators and Reagents , Neural Networks, Computer , Risk AssessmentABSTRACT
OBJECTIVE@#To improve the monitoring mode of diagnostic medical devices adverse events.@*METHODS@#By discussing the objective laws of the characteristics, performances and causes of diagnostic medical devices adverse events, the key points of monitoring work were clarified.@*RESULTS@#The whole-process cloud monitoring mode for adverse events of diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated.@*CONCLUSIONS@#The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.
Subject(s)
China , Equipment and Supplies , Reagent Kits, Diagnostic , Risk ManagementABSTRACT
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.
Subject(s)
Government Regulation , Indicators and Reagents , RiskABSTRACT
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.
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Objective To explore the common methods for determining the expiration rate of the in vitro diagnostic medical device and the significance for signing the expiration date.Methods The methods for determining the expiration date were analyzed based on the features of the in vitro diagnostic medical device and Regulations for Medical Devices Registration and Management.Results The methods estimated the expiration date effectively,while the expiration date had to be monitored and calibrated in time according to risk management principle.Conclusion The safety and efficiency of the in vitro diagnostic medical device are enhanced by signing the expiration date in the technical manual and label.
ABSTRACT
Norovirus is a leading cause of epidemic and sporadic acute gastroenteritis worldwide. Rapid and accurate detection of norovirus is essential for the prevention and control of norovirus outbreaks. The purpose of this study was to propose and develop a process for establishing appropriate standardized guidelines for the approval and evaluation of in vitro diagnostic medical devices (IVDD) for norovirus detection in Korea based on the related laws, regulations, and guidelines of USA, Europe, and Korea. We expect that this study could be used for diagnostic test standardization and the approval and evaluation of domestic norovirus diagnostic devices. We also expect the results will contribute to industrial expansion and public health promotion.
Subject(s)
Diagnostic Tests, Routine , Disease Outbreaks , Europe , Gastroenteritis , Jurisprudence , Korea , Norovirus , Public Health , Reagent Kits, Diagnostic , Social Control, FormalABSTRACT
From the interest of subjects in clinical trials,this paper analyzed the ethical issues of the following cases.It included that the standard operating procedures of the clinical trial were contrary to the programs;the clinical trials failed because of statistical problems;unnecessary duplication blood increased the damage to subjects.It is recommend that relative researchers of the clinical trials of in vitro diagnostic reagent should grasp the scientificity and ethicality,improve the quality of clinical trials and effectively protect the rights and interests of subjects.
ABSTRACT
Objective To explore the common methods for determining the expiration rate of the in vitro diagnostic medical device and the significance for signing the expiration date.Methods The methods for determining the expiration date were analyzed based on the features of the in vitro diagnostic medical device and Regulations for Medical Devices Registration and Management.Results The methods estimated the expiration date effectively,while the expiration date had to be monitored and calibrated in time according to risk management principle.Conclusion The safety and efficiency of the in vitro diagnostic medical device are enhanced by signing the expiration date in the technical manual and label.