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目的对血站NAT检测实验室的清洁消毒过程实施控制,采取监控措施对消毒效果进行评估,以满足核酸检测环境的需求。方法采用空气下落法和物体表面擦拭法,每月采集NAT实验室工作前消毒后1 h的环境和物体表面18个监控点的无菌生理盐水标本47份,以HBV DNA为参照物进行核酸检测并分析检测结果;结合实验室质控结果及NAT单阳性结果,分析检测实验列表有效率、假阳性率与监控结果的相关性。结果 2010年11月至2011年10月,11次清洁消毒监控结果中有2次监控合格率分别为95.5%、97.9%,均发生于NAT检测工作站出风口的监控点,其余均为100%,t=223.83,P<0.05,有统计学意义;跟进消毒措施后,对阳性监控点跟踪监控结果均为阴性。分析检测实验列表有效率和假阳性率与监控结果合格率的相关性,χ2=0.234,P>0.05,无统计学意义。结论 NAT检测工作站出风口监控点的反应性结果不会造成实验结果假阳性率的增高,设备维护保养中的清洁消毒工作可有效清除污染。NAT实验室现行清洁消毒方法有效,且符合生物安全实验室要求。
Objective To control the cleaning and disinfection of NAT laboratories in blood stations and monitor the disinfection effects with monitoring measures to meet the needs of nucleic acid detection environment. Methods The air drop method and object surface wipe method were used to collect 47 samples of sterile saline solution at the environment of 1 h after disinfection and NAT at the 18 monitoring points on the surface of the object every month. HBV DNA was used as reference And analyze the test results; Combined laboratory quality control results and NAT single positive results, the analysis of test list efficiency, false positive rate and the monitoring results. Results From November 2010 to October 2011, there were 2 monitoring and control pass rates of 95% and 97.9% of the 11 cleaning and disinfection monitoring results respectively, which occurred at the monitoring points of the outlet of the NAT detection workstation with the remaining 100% t = 223.83, P <0.05, with statistical significance; follow-up disinfection measures, the positive monitoring point tracking and monitoring results were negative. Analyze the correlation between the efficiency of the test list and the false positive rate and the pass rate of monitoring results, χ2 = 0.234, P> 0.05, no statistical significance. Conclusion The reactivity of the monitoring points at the outlet of the NAT detection workstation will not increase the false positive rate of the experimental results. The cleaning and disinfection work in equipment maintenance can effectively remove the pollution. The existing cleaning and disinfection methods in NAT laboratories are effective and meet the requirements of biosafety laboratories.