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.
Last Editorial Review: 7/8/2004
