Performance Validation of the CytoQuant? Mobile Flow Cytometry
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.
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