A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志

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.

HBV DNA load detected by two domestic fluorescent quantitative PCR reagents: a comparative analysis / 中国输血杂志

【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.

Analysis of Class II Common Problems in the Registration of / 中国医疗器械杂志

From the perspective of technical review, this paper made statistics on the supplement contents of

Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials / 中国医疗器械杂志

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.

Cases Study on Ethical Issues in Clinical Trials of In Vitro Diagnostic Reagent / 中国医学伦理学

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.