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FDA approves rapid anthrax blood test

Infection Control Monitor, June 15, 2004

The Food and Drug Administration (FDA) has approved the first commercially available test to help diagnose an anthrax infection in less than an hour, Reuters reports.

Unlike other tests that can take up to four hours, the new process can quickly detect antibodies produced by the body to fight the infection, according to CDC officials.

Previously, few laboratories outside the CDC and U.S. Army could test for such antibodies. The new test can be used by any lab or hospital without the need for special equipment or training.

Another class of anthrax tests includes nasal swabs and environmental checks to detect the actual bacteria, but it cannot tell if a person needs treatment.

The CDC contracted with Boston-based Immunetics Inc., a diagnostics technology firm, to produce the test after anthrax-laced letters caused a scare in the fall of 2001. Twenty-two people were exposed to both inhalational and cutaneous forms of the bacteria, and five died.

The CDC spent $1 million to help develop the test and plans to purchase 50 kits. Each $480 kit contains 96 disposable tests. The test can detect both forms of anthrax, which is considered a top biological weapon threat.

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