Tezted Ltd., Mattilaniemi 6-8, 40100 Jyväskylä, Finland.
Sanoviv Medical Institute, KM 39 Carretera Libre Tijuana-Ensenada s/n Interior 6, Playas de Rosarito, Baja 11 California, Rosarito 22710, Mexico.
Toxins (Basel). 2022 Oct 25;14(11):727. doi: 10.3390/toxins14110727.
Mycotoxin exposure in humans is primarily assessed through its occurrence in external sources, such as food commodities. Herein, we have developed a direct competitive ELISA to facilitate the detection of aflatoxin B1 (AFB1), deoxynivalenol (DON), fumonisin (FUM B1/B2), ochratoxin A (OTA), and zearalenone (ZEA) in human serum. The analytical validation of the assay followed practices endorsed by the international research community and the EU directive 96/23/EC in order to examine detection capability, recovery, and cross-reactivity. The assay demonstrated a lower limit of quantitation (LLOQ) for AFB1 [0.61 ng/mL (hereon ng/mL = ppb)], DON (19.53 ppb), FUM (4.88 ppb), OTA (19.53 ppb), and ZEA (0.15 ppb). Recovery from human serum for all mycotoxins spanned from 73% to 106%. Likewise, the specificity for monoclonal antibodies against cross-reactant mycotoxins ranged from 2% to 11%. This study compares the LLOQ and recovery values with commercial and emerging immuno-based methods for detecting mycotoxins in foodstuffs. The LLOQ values from the present study were among the lowest in commercial or emerging methods. Despite the differences in the extraction protocols and matrices, the recovery range in this study, commercial tests, and other procedures were similar for all mycotoxins. Overall, the assay detected AFB1, DON, FUM, OTA, and ZEA in human serum with excellent accuracy, precision, and specificity.
人类的真菌毒素暴露主要通过其在外部来源中的存在来评估，例如食品商品。在此，我们开发了一种直接竞争 ELISA 方法，以方便检测人血清中的黄曲霉毒素 B1（AFB1）、脱氧雪腐镰刀菌烯醇（DON）、伏马菌素（FUM B1/B2）、赭曲霉毒素 A（OTA）和玉米赤霉烯酮（ZEA）。该测定方法的分析验证遵循国际研究界和欧盟指令 96/23/EC 认可的实践，以检查检测能力、回收率和交叉反应性。该测定法对 AFB1 [0.61ng/mL（下文 ng/mL = ppb）]、DON（19.53ppb）、FUM（4.88ppb）、OTA（19.53ppb）和 ZEA（0.15ppb）的定量下限（LLOQ）。所有真菌毒素从人血清中的回收率范围为 73%至 106%。同样，针对交叉反应真菌毒素的单克隆抗体的特异性范围为 2%至 11%。本研究将 LLOQ 和恢复值与商业和新兴的基于免疫的方法进行了比较，用于检测食品中的真菌毒素。本研究中的 LLOQ 值在商业或新兴方法中处于最低水平。尽管提取方案和基质存在差异，但本研究、商业测试和其他程序中的回收率范围对于所有真菌毒素都相似。总体而言，该测定法在人血清中检测到 AFB1、DON、FUM、OTA 和 ZEA，具有出色的准确性、精密度和特异性。
