Smiths Detection, Baltimore, MD 21202, USA.
J AOAC Int. 2022 Oct 26;105(6):1698-1707. doi: 10.1093/jaoacint/qsac065.
The Salmonella CANARY® Zephyr assay is designed to provide rapid and reliable detection of Salmonella enterica from various types of environmental surfaces, including stainless steel, silicone rubber, high-density polyethylene (HDPE), and glazed ceramic. The assay is using cell- and immuno-based CANARY technology and tested on Smiths Detection's Zephyr platform.
The objective of this validation study was to evaluate the Salmonella CANARY Zephyr assay for its inclusivity/exclusivity, matrix study for 4 claimed environmental surfaces, consistency/stability, and robustness.
The Salmonella CANARY Zephyr assay was compared to the U.S. Food and Drug Administration Bacteriological Analytical Manual (BAM) Chapter 5 "Salmonella" using an unpaired study design for environmental surfaces including stainless steel, silicone rubber, HDPE, and glazed ceramic (1" × 1" test area).
For the inclusivity and exclusivity evaluation, the Salmonella CANARY Zephyr assay correctly identified 101 out of 102 target organism isolates (with one strain of S. enterica subsp. indica not detected) and excluded all 33 non-target strains that were analyzed. For the matrix study, the Salmonella CANARY Zephyr assay demonstrated no statistically significant differences between presumptive and confirmed results or between candidate and reference method results. Probability of detection analysis of the Salmonella CANARY Zephyr method on robustness and product consistency/stability (lot-to-lot) study demonstrated no statistically significant differences.
The Salmonella CANARY Zephyr assay is an effective method for the detection of Salmonella enterica from various environmental surfaces including stainless steel, silicone rubber, HDPE, and glazed ceramic.
The Salmonella CANARY Zephyr assay allows for rapid and sensitive detection of Salmonella enterica on environmental surfaces. It only takes less than 5 min to prepare the sample and 1 min for instrument running/reading.
沙门氏菌 CANARY® Zephyr 检测法旨在快速可靠地检测来自各种环境表面（包括不锈钢、硅橡胶、高密度聚乙烯（HDPE）和釉面陶瓷）的肠炎沙门氏菌。该检测法采用细胞和免疫为基础的 CANARY 技术，在 Smiths Detection 的 Zephyr 平台上进行测试。
本验证研究的目的是评估沙门氏菌 CANARY Zephyr 检测法在包容性/排他性、针对 4 种声称的环境表面的基质研究、一致性/稳定性和稳健性方面的性能。
沙门氏菌 CANARY Zephyr 检测法与美国食品药品监督管理局（FDA）BAM 第 5 章“沙门氏菌”（使用未配对的研究设计）进行比较，涉及环境表面，包括不锈钢、硅橡胶、HDPE 和釉面陶瓷（1" × 1" 测试面积）。
在包容性和排他性评估中，沙门氏菌 CANARY Zephyr 检测法正确识别了 102 个目标生物体分离株中的 101 个（未检测到一个肠炎沙门氏菌亚种。印度菌株），并排除了所有 33 个被分析的非目标菌株。在基质研究中，沙门氏菌 CANARY Zephyr 检测法在推定和确认结果之间或候选和参考方法结果之间没有统计学上的显著差异。对稳健性和产品一致性/稳定性（批间）研究中沙门氏菌 CANARY 方法的检测概率分析表明没有统计学上的显著差异。
沙门氏菌 CANARY Zephyr 检测法是一种从各种环境表面（包括不锈钢、硅橡胶、HDPE 和釉面陶瓷）检测肠炎沙门氏菌的有效方法。
沙门氏菌 CANARY Zephyr 检测法可快速灵敏地检测环境表面的肠炎沙门氏菌。准备样品不到 5 分钟，仪器运行/读数 1 分钟。
