FDA Assesses New Nanotechnology Test to Detect Anthrax

The Food and Drug Administration recently completed a "proof-of-concept" study of a test that quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.

"The FDA findings could form the basis of a test that allows earlier diagnosis of anthrax infection than currently possible," said Indira Hewlett, Ph.D., the senior author of the study and chief of the Laboratory of Molecular Virology, Office of Blood Research and Review, at FDA's Center for Biologics Evaluation and Research (CBER). "The earlier those infected with anthrax can be treated, the better."

A proof-of-concept study is an initial investigation that aims to determine if a new scientific idea or concept holds promise for further development. A report on the results of this study appears in the March issue of Clinical and Vaccine Immunology.

Anthrax is an infectious disease caused by the bacterium Bacillus anthracis, a bacteria that forms spores, or dormant cells, which can come to life under the right temperature, nutrients, and other conditions to allow growth. Anthrax occurs in humans after exposure to an infected animal or infected animal tissue, or when anthrax spores are used as a bioterrorist weapon.

The study developed by FDA researchers relies on a nanotechnology-based test platform built from tiny molecular-sized particles. This assay, the europium nanoparticle-based immunoassay (ENIA), was able to detect the presence of a protein made by the anthrax bacteria known as protective antigen (PA). PA combines with another protein called lethal factor to form anthrax lethal factor toxin, the protein that enters cells and causes toxic effects.

The researchers showed that ENIA is capable of detecting PA in quantities that are 100 times lower than current tests, such as the enzyme-linked immunosorbent assay (ELISA). Both the ELISA and ENIA rely on antibodies that have an affinity for the anthrax protein of interest.

The FDA test is a modified version of ELISA, which is already commonly used to detect anthrax and other infections. The researchers call their new test "europium nanoparticle-based immunoassay" because atoms of europium are key to the assay's sensitivity.

ENIA uses molecular spheres (called nanospheres) covered with thousands of light-emitting atoms of europium that emit light, which acts as a signal that PA is present. The CBER team further enhanced the signal by modifying the nanospheres so they held additional atoms of europium, making the test more sensitive. ENIA detected PA in 100 percent of samples of mouse plasma compared to 36.4 percent through ELISA.

The researchers developed the ENIA for PA in response to the increased interest in the scientific community for new anthrax assays following the 2001 U.S. anthrax attack that killed five people.

Co-authors of the article, "Detection of Anthrax Toxin by an Ultrasensitive Immunoassay Using Europium Nanoparticles," include Jiangqin Zhao (CBER), Mahtab Moayeri, Zhaochun Chen, Haijing Hu, Robert H. Purcell, Stephen H. Leppla (National Institute of Allergy and Infectious Diseases, National Institutes of Health), and Harri Harma (University of Turku, Finland).

Download Center

  • Industrial Premium Library

    Empower your workforce with the manufacturing, industrial maintenance, operations, HSE, compliance, and professional development skills they need to complete their tasks efficiently and safely. Not only will you boost productivity, reliability, skills, and morale but you’ll also onboard faster, and retain your best employees while meeting regulatory standards. Vector Solutions offers over 1,800 award-winning eLearning courses designed to keep your employees safe, transfer knowledge of fundamentals, and develop industry and job-specific skills that reduce downtime, maintenance costs and more.

  • Safety Metrics & Insights Webinar

    EHS professionals have been tackling the subject of how to best measure performance for many years. Lagging indicators like the Total Recordable Incident Rate (TRIR) and Days Away Restricted Transfer Rate (DART) are a good place to start, but you shouldn’t forget about the leading indicators that your workforce does every day to prevent incidents from occurring. Learn about some of the most common KPIs of safety programs and how Vector EHS Management software can be used to track these metrics in this webinar.

  • Risk Matrix Guide

    Understanding the components of a risk matrix will allow you and your organization to manage risk effectively. Download this guide for details on risk matrix calculations including severity, probability, and risk assessment.

  • OSHA Recordkeeping Guide

    In case you missed it, OSHA recently initiated an enforcement program to identify employers who fail to electronically submit Form 300A recordkeeping data to the agency. When it comes to OSHA recordkeeping, there are always questions regarding the requirements and ins and outs. This guide is here to help! We’ll explain reporting, recording, and online reporting requirements in detail.

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - September 2022

    September 2022

    Featuring:

    • ESG
      EHS Will Guide Future ESG Success for Many Organizations
    • MACHINE GUARDING
      Handling Material Handlers: Training Beyond PIT Requirements
    • EHS SOFTWARE
      The Missing Link with EHS Software
    • HEARING PROTECTION
      Noise Surveys from the Trenches
    View This Issue