Test for Appendicitis Approved by FDA

NOTE: On December 19, 2005, Palatin Technologies and the FDA agreed on the immediate suspension of sales and marketing of NeutroSpec [Technetium (99m Tc) fanolesomab] in the United States, due to reports of serious and life-threatening cardiopulmonary events following the administration of the drug. For more information, please read the FDA Press Release.

Medical Authors and Editors: Barbara K. Hecht, PhD and Frederick Hecht, MD

On July 7, 2004, the US Food and Drug Administration (FDA) announced that it has approved a diagnostic test called NeutroSpec. The NeutroSpec test employs a mouse monoclonal antibody which is radioactive and binds to a specific type of activated white blood cell.

How the test works

Since this type of white blood cell is active in fighting infections, these cells tend to congregate at the site of infection. (Think of them as firefighters.) When the monoclonal antibodies arrive on the scene, they bind to the white blood cells. A gamma camera can then be used to scan the body for any "hot spots." The hot spots mean that the radioactive monoclonal antibodies and hence, the white blood cells are concentrated at the site of infection.

Diagnosing appendicitis

The NeutroSpec test appears to be highly accurate in cases of appendicitis. After one hour, the test was reportedly "nearly 100% accurate" in diagnosing appendicitis. This test could mean that surgeries that end up removing a normal appendix could become a thing of the past.

Other uses for the test

The NeutroSpec test may be useful in a number of other situations. For example, in osteomyelitis (deep bone infection), a pulmonary abscess, or inflammatory bowel disease.

Note: At the present time, the NeutroSpec test is approved for people 5 years and older.

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