Level 2 Modification (Matrix Extension) Study of the Neogen® Molecular Detection Assay 2 - Salmonella Enteritidis/Salmonella Typhimurium Method: Detection of Salmonella enterica ser. Enteritidis and Salmonella enterica ser. Typhimurium in Cooked Breaded Chicken and Raw Ground Chicken (25 g).
Quynh-Nhi Le, Mark Mozola, Erin Crowley, Andrew Deterding, Brooke Roman
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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 nucleic acid amplification 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. The method was previously validated for testing of chicken carcass rinse and raw ground chicken (325 g).
Objective: The objective of the study was to validate the MDA2-SE/ST method for detection of SE and ST in cooked breaded chicken and raw ground chicken (25 g) as a Level 2 modification for Performance Tested Methods SM certification.
Methods: Inclusivity/exclusivity testing and independent laboratory testing of cooked breaded chicken and raw ground chicken (25 g) were conducted.
Results: In inclusivity testing with BPW-ISO broth at 41.5 °C, 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, there were no significant differences in the number of positive results obtained with the MDA2-SE/ST and reference methods by probability of detection analysis at the 95% confidence level.
Conclusions: Results of the matrix extension study showed that the MDA2-SE/ST method is an accurate method for detection of SE and ST in cooked breaded chicken and raw ground chicken (25 g).
Highlights: Validation of the MDA2-SE/ST method for two additional matrixes provides users with additional capability for specific detection of SE and ST in poultry products.
背景：Neogen® Molecular Detection Assay 2-Salmonella Enteritidis/Salmonella Typhimurium (MDA2-SE/ST) 方法是一种核酸扩增检测方法，用于特异性检测肠炎沙门氏菌（Salmonella enterica ser.肠炎沙门氏菌（SE）和鼠伤寒沙门氏菌（ST）。该方法是一种核酸扩增检测方法，用于特异性检测家禽样本中的肠炎沙门氏菌血清（SE）和鼠伤寒沙门氏菌血清（ST），包括 ST 单相变异株肠炎沙门氏菌 1,4,[5],12:i:-。SE 和 ST 的检测结果分别生成。该方法先前已在鸡肉胴体冲洗和生土鸡肉（325 克）的检测中得到验证：本研究的目的是验证 MDA2-SE/ST 方法，以检测熟面包鸡肉和生土鸡肉（25 克）中的 SE 和 ST，作为性能检测方法 SM 认证的二级修改：方法：对熟面包鸡肉和生土鸡肉（25 克）进行了包容性/排他性测试和独立实验室测试：在使用 BPW-ISO 肉汤（温度为 41.5 °C）进行的包容性测试中，所有 50 株 SE 菌株的 SE 检测结果均为阳性，而 ST 检测结果均为阴性。所有 53 株 ST 菌株（包括单相变体）在 ST 检测中均呈阳性结果，而在 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。在基质检测中，通过 95% 置信度的检测概率分析，MDA2-SE/ST 和参比方法获得的阳性结果数量没有显著差异：基质扩展研究结果表明，MDA2-SE/ST 方法是检测熟面包鸡肉和生土鸡肉（25 克）中 SE 和 ST 的准确方法：重点：MDA2-SE/ST 方法对另外两种基质进行了验证，为用户提供了在家禽产品中特异性检测 SE 和 ST 的额外能力。
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