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

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.