Laboratory Corporation of America®/MedTox, 402 County Road D West, St. Paul, MN 55112, USA.
Laboratory of America Corporation®/National Genetics Institute, 2440 Sepulveda Blvd., Suite 235, Los Angeles, CA 90064, USA.
J AOAC Int. 2021 Dec 11;104(6):1609-1619. doi: 10.1093/jaoacint/qsab036.
The PhageDx™ Listeria Assay is a simple, specific, and sensitive assay based on the infection of Listeria spp. by selected bacteriophages and the resultant expression of a luciferase reporter gene. Results are generated in as little as 24.5 h for stainless steel and ceramic environmental surfaces.
An AOAC Performance Tested MethodsSM (PTM) study was conducted to validate the PhageDx Listeria Assay for the detection of Listeria on stainless steel and ceramic surfaces.
The performance of the PhageDx method was compared to that of the U.S. Food and Drug Administration (FDA) Bacterial Analytical Manual (BAM) Ch. 10. Inclusivity/exclusivity, product consistency and stability, and robustness testing also were conducted.
Inclusivity testing demonstrated that the reporter bacteriophages were specific for Listeria ssp. and detected 58/61 Listeria strains tested, including all 34 L. monocytogenes strains. The reporter bacteriophage also was shown to not detect 46/47 non-Listeria bacteria in exclusivity testing. Robustness testing showed that the method performed well with specific deviations from the standard protocol. Consistency and stability testing demonstrated that the recombinant phage gave consistent results across three production lots and was stable when stored under appropriate conditions for at least 6 months. Matrix studies on stainless steel and ceramic surfaces showed that there was no significant difference between the PhageDx Listeria Assay and the FDA/BAM Chapter 10 reference method.
The validation study demonstrates that the PhageDx Listeria Assay is an effective method for the detection of Listeria spp. on stainless steel and ceramic environmental surfaces and meets the qualifications for AOAC PTM status.
PhageDx™李斯特菌检测法是一种基于特定噬菌体感染李斯特菌属并表达荧光素酶报告基因的简单、特异和敏感的检测方法。不锈钢和陶瓷环境表面的结果可在 24.5 小时内生成。
进行了一项 AOAC 性能验证方法（PTM）研究，以验证 PhageDx 李斯特菌检测法用于检测不锈钢和陶瓷表面李斯特菌的性能。
将 PhageDx 方法的性能与美国食品和药物管理局（FDA）Bacterial Analytical Manual（BAM）第 10 章进行比较。还进行了包容性/排他性、产品一致性和稳定性以及稳健性测试。
包容性测试表明，报告噬菌体对李斯特菌属具有特异性，检测到 61 株李斯特菌中的 58 株，包括所有 34 株单核细胞增生李斯特菌。在排他性测试中，报告噬菌体也未检测到 47 株非李斯特菌中的 46 株。稳健性测试表明，该方法在特定偏离标准方案时表现良好。一致性和稳定性测试表明，重组噬菌体在三个生产批次中均能给出一致的结果，在适当条件下储存至少 6 个月时保持稳定。不锈钢和陶瓷表面的基质研究表明，PhageDx 李斯特菌检测法与 FDA/BAM 第 10 章参考方法之间无显著差异。
验证研究表明，PhageDx 李斯特菌检测法是一种有效的方法，可用于检测不锈钢和陶瓷环境表面的李斯特菌属，并且符合 AOAC PTM 状态的资格。
