Handy Sara M, Deeds Jonathan R, Ivanova Natalia V, Hebert Paul D N, Hanner Robert H, Ormos Andrea, Weigt Lee A, Moore Michelle M, Yancy Haile F
U.S. Food and Drug Administration, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, College Park, MD 20740, USA.
J AOAC Int. 2011 Jan-Feb;94(1):201-10.
The U.S. Food and Drug Administration is responsible for ensuring that the nation's food supply is safe and accurately labeled. This task is particularly challenging in the case of seafood where a large variety of species are marketed, most of this commodity is imported, and processed product is difficult to identify using traditional morphological methods. Reliable species identification is critical for both foodborne illness investigations and for prevention of deceptive practices, such as those where species are intentionally mislabeled to circumvent import restrictions or for resale as species of higher value. New methods that allow accurate and rapid species identifications are needed, but any new methods to be used for regulatory compliance must be both standardized and adequately validated. "DNA barcoding" is a process by which species discriminations are achieved through the use of short, standardized gene fragments. For animals, a fragment (655 base pairs starting near the 5' end) of the cytochrome c oxidase subunit 1 mitochondrial gene has been shown to provide reliable species level discrimination in most cases. We provide here a protocol with single-laboratory validation for the generation of DNA barcodes suitable for the identification of seafood products, specifically fish, in a manner that is suitable for FDA regulatory use.
美国食品药品监督管理局负责确保美国的食品供应安全且标签准确。对于海产品而言，这项任务尤其具有挑战性，因为海产品种类繁多，大部分此类商品都是进口的，而且加工后的产品很难用传统形态学方法进行识别。可靠的物种鉴定对于食源性疾病调查以及防止欺诈行为（如故意误标物种以规避进口限制或转售为更高价值的物种）都至关重要。需要能够准确、快速进行物种鉴定的新方法，但任何用于监管合规的新方法都必须标准化且经过充分验证。“DNA条形码技术”是一种通过使用短的、标准化基因片段来实现物种区分的过程。对于动物而言，细胞色素c氧化酶亚基1线粒体基因的一个片段（从5'端附近开始的655个碱基对）已被证明在大多数情况下能提供可靠的物种水平区分。我们在此提供一份单实验室验证方案，用于生成适用于鉴定海产品（特别是鱼类）的DNA条形码，其方式适用于美国食品药品监督管理局的监管用途。
