Validation of the Neogen® Molecular Detection Assay 2 - Salmonella Enteritidis/Salmonella Typhimurium Method for Specific Detection of Salmonella enterica Ser. Enteritidis and Salmonella enterica Ser. Typhimurium in Chicken Carcass Rinse and Raw Ground Chicken AOAC Performance Tested MethodSM 122302.
Quynh-Nhi Le, Toni Bartling, Mark Mozola, Cynthia Zook, Christina Barnes, Brooke Roman, Preetha Biswas, Susan Noe, Robert Donofrio
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引用次数: 0
Abstract
Background: The Neogen® Molecular Detection Assay 2-Salmonella Enteritidis/Salmonella Typhimurium (MDA2-SE/ST) method is a rapid, nucleic acid amplification-based test for specific detection of Salmonella enterica ser. Enteritidis (SE) and Salmonella enterica ser. Typhimurium (ST), including the ST monophasic variant Salmonella enterica 1,4 , [5] , 12: i:-, in select poultry samples. Results for SE and ST are generated separately.
Objective: The objective of the study was to validate the MDA2-SE/ST method for detection of SE and ST in chicken carcass rinse and raw ground chicken (325 g) for Performance Tested Methods SM (PTM) certification.
Methods: The study consisted of inclusivity/exclusivity testing and independent laboratory testing of chicken carcass rinse and raw ground chicken using inoculated matrixes. Data were analyzed using a paired probability of detection model to determine if differences in the number of positive results obtained with the MDA2-SE/ST and reference methods were significant.
Results: In inclusivity testing, all 50 SE strains produced positive results in the SE assay and negative results in the ST assay. All 53 ST strains (including the monophasic variant) produced positive results in the ST assay and negative results in the SE assay. All 35 exclusivity strains produced negative results in both assays. The exclusivity panel included multiple non-SE group D1 Salmonella serovars, multiple non-ST group B serovars, Salmonella spp. from other somatic groups, and other Enterobacteriaceae. In matrix testing, results for the MDA2-SE/ST and reference methods were in complete agreement for both matrixes.
Conclusions: Results of the validation study showed that the MDA2-SE/ST method is an accurate, specific method for detection of SE and ST in select poultry matrixes.
Highlights: The data were reviewed by the AOAC PTM Program and approval was granted for certification of the Molecular Detection Assay 2-Salmonella Enteritidis/Salmonella Typhimurium method as PTM 122302.
背景：Neogen® Molecular Detection Assay 2-Salmonella Enteritidis/Salmonella Typhimurium (MDA2-SE/ST) 方法是一种基于核酸扩增的快速检测方法，用于特异性检测肠炎沙门氏菌（Salmonella enterica ser.Enteritidis (SE) 和 Salmonella enterica ser.该方法是一种基于核酸扩增的快速检测方法，用于特异性检测家禽样本中的肠炎沙门氏菌（SE）和鼠伤寒沙门氏菌（ST），包括 ST 单相变异株肠炎沙门氏菌 1、4、[5] 、12: i:-。SE 和 ST 的结果分别生成：本研究的目的是验证 MDA2-SE/ST 方法在鸡肉胴体冲洗液和生土鸡（325 克）中检测 SE 和 ST 的有效性，以获得性能检测方法 SM（PTM）认证：研究包括包容性/排他性测试和使用接种基质对鸡肉胴体冲洗液和生土鸡进行的独立实验室测试。采用配对检测概率模型对数据进行分析，以确定 MDA2-SE/ST 和参考方法获得的阳性结果数量是否存在显著差异：结果：在包容性测试中，所有 50 株 SE 菌株在 SE 检测法中均呈阳性结果，而在 ST 检测法中呈阴性结果。所有 53 株 ST 菌株（包括单相变异株）在 ST 检测中均呈阳性结果，在 SE 检测中呈阴性结果。所有 35 株排他性菌株在两种检测中均呈阴性结果。排他性样本包括多个非 SE 组 D1 沙门氏菌血清型、多个非 ST 组 B 血清型、其他体细胞组的沙门氏菌属和其他肠杆菌科细菌。在基质测试中，MDA2-SE/ST 和参比方法对两种基质的测试结果完全一致：验证研究结果表明，MDA2-SE/ST 方法是一种准确、特异的方法，可用于检测特定家禽基质中的 SE 和 ST：重点：AOAC PTM 项目对数据进行了审核，并批准将分子检测测定 2-肠炎沙门氏菌/鼠伤寒沙门氏菌方法认证为 PTM 122302。
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