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Performance Validation of the Microbiologique MicrofilmTM Test System for AOAC Research Institute Performance Tested MethodSMCertification

机译:用于AOAC研究所性能测试方法Microbiologique Microfilmtm测试系统的性能验证

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The Microfilm™ Test System is intended for quantitative microbiology and consists of three types of Microfilms for aerobic plate count (Microfilm APC), total coliform and Escherichia coli count (Microfilm TCEc), and yeast and mold count (Microfilm YMC). This study evaluatedthe performance of the Microfilm Test System against International Organization for Standardization (ISO) methods on 20 food matrixes and 2 environmental surfaces. Ruggedness, robustness, and stability were also determined, while inclusivity and exclusivity studies were performed on MicrofilmTCEc and YMC. An independent laboratory evaluated the performance on four food matrixes and one environmental surface. No significant differences and high correlation coefficients were observed between the Microfilm Test System and the corresponding ISO methods (ISO 4833-1:2013 for APC, ISO4832:2006 for total coliform count, ISO 16649-2: 2001 for E. coli, and ISO 21527 Part 1 and Part 2 for YMC) in spiked food matrixes and environmental samples. These results were corroborated by the independent laboratory. Inclusivity and exclusivity studies for Microfilm TCEc showedexpected results for all the E. coli strains tested (blue-violet or violet color), while the related coliforms showed the expected blue-green colonies on the Microfilm. Similarly, all 100 fungal strains tested showed typical growth on Microfilm YMC. Exclusivity testing on MicrofilmTCEc and YMC showed no growth of nontarget organisms. Robustness and ruggedness studies showed no significant differences in mean difference counts at varying incubation temperatures and times. Stability studies on three lots of the Microfilm Test System showed that it is stable at 2–25°Cfor 12 months and at 45°C for 6 weeks.
机译:微杂珠和amp;#8482;测试系统旨在用于定量微生物学,由三种类型的微生物组成,用于有氧板数量(微杂物APC),总大肠杆菌和大肠杆菌计数(微杂物TCEC)和酵母和模数(微杂于胶质YMC)。本研究评估了20种食物基质和2个环境表面的标准化(ISO)方法的国际组织的微杂散测试系统的性能。还确定了坚固性,稳健性和稳定性,而在MicrofilMTCEC和YMC上进行包裹性和排他性研究。一个独立的实验室评估了四种食物基质和一个环境表面的性能。在Microfilm测试系统和相应的ISO方法之间没有观察到显着的差异和高相关系数(ISO 483-1:2013,用于APC,ISO4832:2006,用于大肠杆菌的ISO 16649-2:2001,和ISO 21527第1部分和YMC的第2部分)在尖刺食物基质和环境样品中。这些结果被独立实验室得到了证实。用于缩微细胞的微杂物Tcec的含量和排他性研究表达了测试的所有大肠杆菌菌株(蓝紫或紫色)的结果,而相关的大肠杆菌在微杂物上显示出预期的蓝绿菌落。同样,所有100种真菌菌株测试显示典型的微杂环YMC生长。微杂机和YMC上的排他性测试显示Nontarget生物的生长。鲁棒性和坚固性研究显示出在不同孵化温度和时间的平均差异中没有显着差异。关于三种微杂珠测试系统的稳定性研究表明它在2& 25°C至12个月和45℃的25°C稳定。

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