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Evaluation of an Electrochemiluminescence Assay for the Rapid Detection of Ricin Toxin
Gowri Manickam1, Christine A Pillai1, Nagarajan Thirunavukkarasu1
1Gowri Manickam, PhD, and Christine A. Pillai are ORISE Research Scientists; Nagarajan Thirunavukkarasu, PhD, is a Regulatory Research Biologist; and Shashi Sharma, PhD, is a Research Microbiologist and Select Agent Program Coordinator; all in the Predictive Toxicology Branch, Office of Chemistry and Toxicology, Human Foods Program, US Food and Drug Administration, College Park, MD. Segaran P. Pillai, PhD, FAAM, SM(NRCM), SM(ASCP), is Director, Office of Laboratory Safety, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD. Julie R. Avila, MS, is a Scientific Associate, Biosciences and Biotechnology Division, Lawrence Livermore National Laboratory, Livermore, CA. David R. Hodge, PhD, and Kevin Anderson, PhD, were Program Managers; both recently retired from the Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
Abstract:
In this article, we detail a comprehensive laboratory evaluation of an immunoassay for the rapid detection of ricin using the Meso Scale Diagnostics Sector PR2 Model 1800. For the assay evaluation, we used inclusivity, exclusivity, and informational panels comprised of extracts of 35 near-neighbor plant cultivar-extracts, 66 lectins, 26 white powders, 16 closely related toxins and proteins/toxoids, and a pool of 30 BioWatch filter extracts. The results show that the Meso Scale Diagnostics ricin detection assay exhibits good sensitivity and specificity with a limit of detection of 1.2 ng/mL. However, the dynamic range of the assay for the quantitation of ricin was limited. We observed a hook effect at higher ricin 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.
