CytoQuant?便携式流式细胞仪性能验证
Performance Validation of the CytoQuant? Mobile Flow Cytometry
吴丽娜 1殷培军 1武茂苍 2王小叶 1段效辉 3杨爽 4唐静 1贾俊涛1
作者信息
- 1. 青岛海关技术中心 青岛 266109
- 2. 青岛大港海关 青岛 266000
- 3. 烟台海关 烟台 264000
- 4. 天津海关动植物与食品检测中心 天津 300000
- 折叠
摘要
CytoQuant®便携式流式细胞仪是一种新的活菌快速计数设备.本研究以GB 4789.2-2022《食品安全国家标准食品微生物学检验 菌落总数测定》为参照方法,依据ISO 16140-2:2016《食物链的微生物学 方法验证 第2部分:参考法替代(专有)方法验证协议》和GB 4789.45-2023《食品安全国家标准 微生物检验方法验证通则》,对CytoQuant®便携式流式细胞仪的活菌计数性能进行验证,包括仪器的线性和检出限、精密度、包容性,并通过检测水、乳酸菌、环境涂抹、食品等样品验证其快速检测效果.结果显示,CytoQuant®便携式流式细胞仪的活菌计数结果与国标法计数结果无显著性差异,定量范围为104～107 CFU/mL.结果表明,CytoQuant®便携式流式细胞仪可有效快速地计数微生物数量,且与国标法微生物检测相比,流程简单,耗时短,可提高检测效率,满足样品快速检测的需要.
Abstract
The CytoQuant® mobile flow cytometer is a novel device for rapid counting of viable bacteria.This study aimed to validate the performance of the CytoQuant mobile flow cytometer in viable cell counting,using National Food Safety Standard-Food Microbiological Examination:Aerobic Plant Count(GB 4789.2-2022)as the reference method.The validation was conducted in accordance with Microbiology of the Food Chain-Method Validation-Part 2:Protocol for the Validation of Alternative(Proprietary)Methods against a Reference Method(ISO 16140-2:2016)and National Food Safety Standard-General Rules for Validation of Microbiological Test Methods(GB 4789.45-2023).The validation included assessment of the instrument's linearity and detection limit,precision,inclusivity,and its rapid detection effectiveness was verified through the examination of samples such as water,lactic acid bacteria,environmental swabs,and food.The results showed that there was no significant difference between the cell counts obtained by the CytoQuant mobile flow cytometer and those by the national standard method,with a quantitative range of 104 to 107 CFU/mL.The findings indicate that the CytoQuant mobile flow cytometer can effectively and rapidly count microbial numbers,and compared with the national standard method for microbial detection,it has a simpler procedure,shorter time consumption,and can improve detection efficiency,meeting the needs for rapid sample detection.
关键词
流式细胞仪/验证/快速检测Key words
flow cytometry/validation/rapid detection引用本文复制引用
出版年
2024
NETL
NSTL
万方数据