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《AtlasTMCampylobacter 检测试剂盒验证:AOAC 性能测试方法标准 032101》。

Validation of the AtlasTMCampylobacter Detection Assay: AOAC Performance Tested MethodSM 032101.

机构信息

RokaBio, Inc. 15300 Bothell Way NE, Lake Forest Park, WA 98155, USA.

Molecular Epidemiology, Inc., 15300 Bothell Way NE, Lake Forest Park, WA 98155, USA.

出版信息

J AOAC Int. 2021 Dec 11;104(6):1620-1633. doi: 10.1093/jaoacint/qsab056.

DOI:10.1093/jaoacint/qsab056
PMID:33871637
Abstract

BACKGROUND

Campylobacter spp. are a major causal agent for diarrheal illness in humans. Detection of Campylobacter spp. in food is critical to reduce foodborne illness, and to provide safe foods.

OBJECTIVE

The aim was to evaluate the Atlas Campylobacter Detection Assay for AOAC Performance Tested MethodsSM certification for detecting C. jejuni, C. coli, and C. lari in foods after 12 h enrichment.

METHOD

The Atlas Campylobacter Detection Assay was compared to the ISO 10272-1:2017 reference culture method for chicken carcass rinse, turkey carcass sponge, raw ground poultry, raw ground pork, and ready-to-eat (RTE) meats. Inclusivity, exclusivity, product consistency, product stability, and robustness studies were also performed. An independent laboratory evaluated the performance of the Atlas Campylobacter Detection Assay method on chicken carcass rinse.

RESULTS

No significant differences were observed between the Atlas Campylobacter Detection Assay and the reference ISO method in spiked food matrixes. The Atlas Campylobacter Detection Assay detected all 50 inclusive organisms and none of the 30 exclusive organisms. Product consistency and stability studies showed no statistical differences between lots or over the term of the shelf-life using accelerated method study. Finally, the robustness study showed no statistical difference between different sample volumes, enrichment times, and storage time after sample transfer.

CONCLUSIONS

The results of this study indicate that the Atlas Campylobacter Detection Assay is comparable to ISO 10272-1:2017 for detecting Campylobacter in chicken carcass rinse, turkey carcass sponge, raw ground poultry, raw ground pork, and RTE meats.

HIGHLIGHTS

The Atlas Campylobacter Detection Assay is a rapid, accurate molecular method able to detect C. jejuni, C. coli, and C. lari in in chicken carcass rinse, turkey carcass sponge, raw ground poultry, raw ground pork, and RTE meats within 12-18 h.

摘要

背景

空肠弯曲菌属是人类腹泻病的主要病原体。在食品中检测空肠弯曲菌属对于减少食源性疾病和提供安全食品至关重要。

目的

本研究旨在评估 Atlas Campylobacter Detection Assay 用于检测食品中鸡胴洗液、火鸡胴海绵、生禽肉、生猪肉和即食(RTE)肉中的空肠弯曲菌、大肠弯曲菌和空肠弯曲菌的 AOAC 性能测试方法 SM 认证。

方法

将 Atlas Campylobacter Detection Assay 与 ISO 10272-1:2017 参考培养方法进行比较,用于鸡胴洗液、火鸡胴海绵、生禽肉、生猪肉和即食肉的检测。还进行了包容性、排他性、产品一致性、产品稳定性和稳健性研究。一个独立的实验室评估了 Atlas Campylobacter Detection Assay 方法在鸡胴洗液中的性能。

结果

在添加食物基质中,Atlas Campylobacter Detection Assay 与参考 ISO 方法之间没有观察到显著差异。Atlas Campylobacter Detection Assay 检测到所有 50 种包容性生物,而没有检测到 30 种排他性生物。产品一致性和稳定性研究表明,在使用加速方法研究的保质期内,批次之间或批次之间没有统计学差异。最后,稳健性研究表明,在不同的样品体积、富集时间和样品转移后的储存时间之间没有统计学差异。

结论

本研究结果表明,Atlas Campylobacter Detection Assay 与 ISO 10272-1:2017 相比,能够检测鸡胴洗液、火鸡胴海绵、生禽肉、生猪肉和 RTE 肉中的空肠弯曲菌属。

重点

Atlas Campylobacter Detection Assay 是一种快速、准确的分子方法,能够在 12-18 小时内检测鸡胴洗液、火鸡胴海绵、生禽肉、生猪肉和 RTE 肉中的空肠弯曲菌、大肠弯曲菌和空肠弯曲菌。

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