A new test funded by the Centers for Disease Control and Prevention (CDC) and developed in collaboration with a commercial partner has become the first test approved by the Food and Drug Administration (FDA) for detecting antibodies to anthrax. The test, produced by Immunetics Inc. of Boston, provides an easy-to-use clinical laboratory tool for assessing whether patients have been infected with anthrax.
The Anthrax Quick ELISA test, which was recently approved by the FDA, detects antibodies produced during infection with Bacillus anthracis - the bacteria that causes anthrax. The approval shows how cooperative work between government agencies and industry can lead to the development of diagnostic tests for biothreat agents and emerging infectious diseases.
The new test helps confirm a diagnosis of anthrax because it demonstrates that a person's immune system has responded to a protein produced by the infecting bacteria. The test is quicker and easier to interpret than previous antibody testing methods. The new test can be completed in less than one hour, compared to about four hours for previous testing methods. Before FDA approval of the new test, very few laboratories other than the CDC and the U.S. Army had the ability to test blood for antibodies to anthrax. The new test will be available shortly for use in state and private laboratories.
Anthrax is a serious infectious disease that most commonly occurs in wild and domestic cattle, sheep and other herbivores. Humans can contract anthrax by handling products from infected animals or by breathing in or coming in close contact with Bacillus anthracis spores from infected animal products such as unprocessed hides and bones. Anthrax can also be transmitted to humans when anthrax spores are used as a bioterrorist weapon. The anthrax attacks of 2001 sickened 22 people, leading to five deaths.