Dhivya Shanmughanandhan, Ragupathy Subramanyam, Kesanakurti Prasad, Jeevitha Shanmughanandhan, Noce Isabella Della, Newmaster Steven G
University of Guelph, College of Biological Sciences, NHP Research Alliance, Guelph, ON N1G 2W1, Canada.
Hyris Ltd, Lower Ground Floor, One George Yard, EC3V 9DF London, United Kingdom.
J AOAC Int. 2019 Nov 1;102(6):1779-1786. doi: 10.5740/jaoacint.18-0319. Epub 2019 May 2.
There is considerable risk of adulteration of herbal products in the natural health product (NHP) industry. Authentication of products is challenging because of the standard, complex, analytical chemistry methods that may be too costly and not appropriate for both raw and finished products. We sought to develop and validate an alternative method to authenticate herbal dietary supplements, based on the use of a species-specific hydrolysis PCR probe assay. A species-specific hydrolysis probe assay was developed, validated, and evaluated for the performance of the assay in accurately identifying the species of interest using the following analytical validation criteria: () specificity (accuracy) in identifying the target species ingredient, while not identifying other nontarget species, () sensitivity in detecting the smallest amount of the target material, and () reliability (repeatability and reproducibility) in detecting the target species in raw materials on a real-time PCR platform. The species-specific hydrolysis probe assay was successfully developed for raw materials of The specificity of the assay was 100% to the target species. Efficiency of the assay was observed to be 99%, and the reliability of the assay was 100% for the raw/starting materials. The method developed in this study is simple, rapid, and easy for supplement manufacturers to perform in their laboratories to ensure that their supplements are authentic.
天然健康产品（NHP）行业中，草药产品存在相当大的掺假风险。由于标准、复杂的分析化学方法可能成本过高且不适用于原材料和成品，产品认证具有挑战性。我们试图开发并验证一种基于物种特异性水解PCR探针检测法的替代方法，用于鉴定草药膳食补充剂。开发了一种物种特异性水解探针检测法，并根据以下分析验证标准对该检测法在准确鉴定目标物种方面的性能进行了验证和评估：（）在鉴定目标物种成分时的特异性（准确性），同时不鉴定其他非目标物种；（）检测目标物质最小量的灵敏度；（）在实时PCR平台上检测原材料中目标物种的可靠性（重复性和再现性）。已成功开发出针对[具体草药名称]原材料的物种特异性水解探针检测法。该检测法对目标物种的特异性为100%。观察到该检测法的效率为99%，对于原材料/起始材料，该检测法的可靠性为100%。本研究中开发的方法简单、快速，便于补充剂制造商在其实验室中操作，以确保其补充剂是正品。
