Hong Geng, Liu Dongxin, Zhao Yuanyuan, Zhai Yalin, Zhao Fengzekuan, Wang Yanhai, Jiang Mengnan, Wei Qiang
National Pathogen Resource Center, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
China Center for Food and Drug International Exchange, Beijing 100082, China.
Biosaf Health. 2024 Jun 7;6(4):199-205. doi: 10.1016/j.bsheal.2024.05.001. eCollection 2024 Aug.
In recent years, as the infectious diseases caused by pathogens such as novel coronavirus and mpox (formerly called monkeypox) spread globally, the significance of identification, preservation, and sharing of pathogenic resources become prominent. Along with the rapid development of biorepositories, it is imperative to evaluate their operation in a scientific manner. By using the literature review and modified Delphi method, this study develops a benchmarking tool for the comprehensive evaluation of the operation of biorepositories for pathogenic resources. The effective response rates of both rounds of expert surveys were 100 %. The authority coefficients (Cr) were 0.82 and 0.85, respectively, manifesting the reliability of consultation results. In the second-round survey, the Kendall's coefficient of concordance (Kendall's W) of all indicators ranged from 0.09 to 0.31 ( < 0.001), the comprehensive score ranged from 4.02 to 4.94, the standard deviation ranged from 0.21 to 0.77, and the coefficient of variation (CV) ranged from 0.04 to 0.22, indicating that the expert opinions reached consensus. The final benchmarking tool was composed of 4 primary indicators, 12 secondary indicators, and 65 tertiary indicators. The weights of the four primary indicators allocated through the rank-sum ratio method, namely organizational structure, management requirements, biobanking capacity, and sharing capacity, were 30.50 %, 30.08 %, 25.45 %, and 13.97 %, respectively. The benchmarking tool established in this study provides references for the comprehensive evaluation of the operation and puts forward advice for the sustainable development of biorepositories for pathogenic resources.
近年来,随着新型冠状病毒和猴痘(原称猴天花)等病原体引发的传染病在全球蔓延,病原资源的鉴定、保藏和共享的重要性日益凸显。随着生物样本库的迅速发展,以科学的方式评估其运行情况势在必行。本研究通过文献回顾和改进的德尔菲法,开发了一种用于全面评估病原资源生物样本库运行情况的基准工具。两轮专家调查的有效回复率均为100%。权威系数(Cr)分别为0.82和0.85,表明咨询结果的可靠性。在第二轮调查中,所有指标的肯德尔和谐系数(Kendall's W)在0.09至0.31之间(<0.001),综合得分在4.02至4.94之间,标准差在0.21至0.77之间,变异系数(CV)在0.04至0.22之间,表明专家意见达成了共识。最终的基准工具由4个一级指标、12个二级指标和65个三级指标组成。通过秩和比法分配的四个一级指标,即组织结构、管理要求、生物样本保藏能力和共享能力的权重分别为30.50%、30.08%、25.45%和13.97%。本研究建立的基准工具为运行情况的全面评估提供了参考,并为病原资源生物样本库的可持续发展提出了建议。