Christine A. Pillai and Gowri Manickam, PhD, are ORISE Fellow Research Scientists; Nagarajan Thirunavukkarasu, PhD, is a Microbiologist; and Shashi Sharma, PhD, is Principal Investigator; all at the Center for Food Safety and Applied Nutrition, Molecular Methods Development Branch, Division of Microbiology, Office of Regulatory Science, US Food and Drug Administration, College Park, MD. Segaran P. Pillai, PhD, FAAM, SM(NRCM), SM(ASCP), is Director, Office of Laboratory Science and Safety, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD. Stephen A. Morse, PhD, MSPH, is Senior Advisor, CDC Division of Select Agents and Toxins, IHRC, Inc., Atlanta, GA. Julie R. Avila, MS, is Scientific Associate, Biosciences and Biotechnology Division, Lawrence Livermore National Laboratory, Livermore, CA. David R. Hodge, PhD, and Kevin Anderson, PhD, are Program Managers; both in the Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
Health Secur. 2021 Jul-Aug;19(4):431-441. doi: 10.1089/hs.2020.0102. Epub 2021 Jul 2.
In this article, we detail a comprehensive laboratory evaluation of an immunoassay for the rapid detection of abrin using the Meso Scale Diagnostics Sector PR2 Model 1800. For the assay evaluation, we used inclusivity and exclusivity panels comprised of extracts of 11 cultivars and 35 near-neighbor plants, 65 lectins, 26 white powders, 11 closely related toxins and proteins, and a pool of 30 BioWatch filter extracts. The results show that the Meso Scale Diagnostics abrin detection assay exhibits good sensitivity and specificity with a limit of detection of 4 ng/mL. However, the dynamic range of the assay for the quantitation of abrin was limited. We observed a hook effect at higher abrin concentrations, which can lead to potential false negative results. A modification of the assay protocol that incorporates extra wash steps can decrease the hook effect and the potential for false negative results.
在本文中,我们详细介绍了一种使用 Meso Scale Diagnostics Sector PR2 Model 1800 快速检测相思豆毒素的免疫分析的全面实验室评估。为了进行分析评估,我们使用了包含 11 个品种和 35 个近缘植物、65 种凝集素、26 种白色粉末、11 种密切相关的毒素和蛋白质以及 30 种 BioWatch 过滤器提取物的包容性和排他性面板。结果表明,Meso Scale Diagnostics 的相思豆毒素检测分析具有良好的灵敏度和特异性,检测限为 4ng/mL。然而,该分析用于定量检测相思豆毒素的动态范围有限。我们在较高的相思豆毒素浓度下观察到钩状效应,这可能导致潜在的假阴性结果。通过修改分析协议,增加额外的洗涤步骤,可以减少钩状效应和潜在的假阴性结果。