PathogenDx DetectX Combined Demonstrates Equivalent Performance in Comparison to Four AOAC Certified Methods for the Detection of Aspergillus Species, Salmonella Species, and STEC in Dried Hemp Flower.

IF 1.7 4区农林科学 Q3 CHEMISTRY, ANALYTICAL

Journal of AOAC International Pub Date : 2023-07-17 DOI:10.1093/jaoacint/qsad027

Benjamin A Katchman, Michael Tomchaney, Austin Rueda, Shaun Stice, Mike Hogan

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引用次数: 0

Abstract

Background: The PathogenDx DetectX Combined method is a certified Performance Tested MethodSM (012201) that is enrichment-free and utilizes a DNA microarray-based end point PCR method for the simultaneous detection of Aspergillus (A. flavus, A. fumigatus, A. niger, and A. terreus), Salmonella spp., and a broad range of Shiga toxin-producing Esherichia coli (STEC) from hemp and cannabis flower, edibles, and concentrates.

Objective: This study aimed to compare the PathogenDx DetectX Combined enrichment-free method to four AOAC INTERNATIONAL certified molecular methods that utilize enrichment prior to quantitative PCR (qPCR) amplification in hemp flower for the detection of Aspergillus (A. flavus), S. enterica, and Escherichia coli 026.

Methods: In this method comparison study, each method was evaluated according to the AOAC validated instructions for use (IFU) and the AOAC Appendix J validation guidelines. A total of 16 samples at three levels of contamination (0, 0.7, and 2 CFU/10g test portion) were analyzed by each method. The results for all methods were evaluated by using the probability of detection statistical model (POD).

Results: Results of the validation study demonstrate that the PathogenDx DetectX Combined enrichment-free method is equivalent in performance to the three proprietary methods evaluated in this study.

Conclusion: The method comparison study indicated that the PathogenDx DetectX Combined enrichment-free method provides equivalent detection of the target analytes (A. flavus, Salmonella, and a broad range of STEC) in hemp flower.

Highlights: The performance of The PathogenDx DetectX Combined method is significantly faster and possesses a higher or equivalent degree of sensitivity and specificity. Implementation of this method for routine microbial pathogen analysis in laboratories would save significant time and resources.

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与四种AOAC认证的检测干麻花中曲霉、沙门氏菌和产志贺毒素大肠杆菌的方法相比，PathogenDx DetectX组合显示出相同的性能。

背景:PathogenDx DetectX联合方法是一种经过认证的性能测试方法(012201)，它是无富集的，利用基于DNA微阵列的终点PCR方法同时检测曲霉(a . flavus, a . fumigatus, a . niger和a . terreus)，沙门氏菌和广泛的产志贺毒素大肠杆菌(STEC)从大麻和大麻花，食品和浓缩物。目的:本研究旨在比较PathogenDx DetectX联合无富集方法与四种AOAC国际认证的分子方法，这些方法在大麻花中利用富集前定量PCR (qPCR)扩增来检测曲霉(A. flavus)、肠球菌(S. enterica)和大肠杆菌026。方法:在方法对比研究中，根据AOAC验证使用说明书(IFU)和AOAC附录J验证指南对每种方法进行评价。每种方法共分析了3种污染水平(0、0.7和2 CFU/10g测试部分)下的16份样品。采用概率检测统计模型(POD)对各方法的结果进行评价。结果:验证研究结果表明，PathogenDx DetectX联合无富集方法在性能上与本研究中评估的三种专有方法相当。结论:方法对比研究表明，PathogenDx DetectX联合富集-free方法可对大麻花中黄酮类、沙门氏菌和多种产志贺毒素大肠杆菌等目标物进行等效检测。重点:The PathogenDx DetectX Combined method检测速度明显加快，具有更高或同等程度的灵敏度和特异性。将该方法应用于实验室常规微生物病原分析，可节省大量的时间和资源。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of AOAC International 医学-分析化学

CiteScore

3.10

自引率

12.50%

发文量

144

审稿时长

2.7 months

期刊介绍： The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.