一次性使用病毒采样管质量分析与讨论  

Quality Analysis and Discussion of Disposable Virus Sampling Tube

作　　者：高小凤 王书晗 刘尧 彭俊 彭思睿 赖宇堃 张彩梅 Gao Xiaofeng;Wang Shuhan;Liu Yao;Peng Jun;Peng Sirui;Lai Yukun;Zhang Caimei(Shenzhen Institute for Drug Control(Shenzhen Testing Center of Medical Devices),Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院(深圳市医疗器械检测中心),广东深圳518057

出　　处：《广东化工》2023年第24期133-135,共3页Guangdong Chemical Industry

基　　金：高风险医疗器械可沥滤物研究及标准化科技创新团队(2021TDB29);手术机器人临床前动物实验评价科技创新团队(2022TDB51);血液接触类医疗器械/材料涂层牢固度评价方法研究科技创新团队(2022TDB52)。

摘　　要：文章旨在探究一次性使用病毒采样管的质量情况,并对其结果进行分析,为病毒采样管的质量与风险控制提供参考。本文对T/SAMD 001-2021《一次性使用病毒采样管》和T/GDMDMA 0005-2022《样本保存管(含保存液)》两个团标进行比较,并结合本中心于2021~2022年病毒采样管的外观、装量、密封性、酸碱度和微生物指标评价抽验结果进行讨论和分析,发现病毒采样管在酸碱度和微生物指标方面的风险较高,需要加强质量监管。一方面为各大监管部门及生产企业提供参考,另一方面为相关部门制定更加全面的国行标提供一定的数据支撑。The article aims to investigate the quality of single-use virus sampling tubes and analyze the results to provide a reference for the quality and risk control of virus sampling tubes.This paper compares two regimental standards,T/SAMD 001-2021“single-use virus sampling tubes”and T/GDMDMA 0005-2022“sample preservation tubes(including preservation fluid)”,and discusses and analyzes the results of sampling tests on the evaluation of appearance,capacity,sealing property,acidity and microbiological indicators of virus sampling tubes in our center from 2021 to 2022,and finds that virus sampling tubes are at higher risk in terms of acidity and microbiological indicators,and need to strengthen quality control.As for the result,it can provides useful guideline for the major regulatory departments and production enterprises.In addition,it provides certain data support for the relevant departments in formulating more comprehensive national or trade standards.

关 键 词：病毒采样管 样本保存管 质量分析 核酸保存液 标准比对 

分 类 号：TQ[化学工程]