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

Since this type of white blood cell is active in fighting infections, these cells tend to congregate at the site of infection. When the monoclonal antibodies arrive on the scene, they bind to the white blood cells. Because the tagged monoclonal antibodies are radioactive, they form "hot spots" of concentrated radioactivity at the site of infection. A gamma camera can then be used to scan the body for these hot spots. The appearance of hot spots in the gamma camera image means that sites of infection are present.

The NeutroSpec™ test is highly accurate in cases of appendicitis. After one hour, the test was reportedly 98% accurate in ruling out appendicitis. This test could mean that a surgery based on other falsely positive tests and that results in the removal of a normal appendix could become a thing of the past.

A NeutroSpec™ image allows your physician to more rapidly obtain necessary diagnostic information to support patient management decisions. 1

Uniquely Attractive
Binds with a uniquely high affinity to white blood cells.

NeutroSpec™ monoclonal antibody "binds avidly to surface CD 15 antigens that are expressed on human neutrophils in large numbers." 1

In most cases, diagnosis can be made within one hour after injection.

"In patients with appendicitis and positive scans more than 50 percent of the images were positive at 4 minutes, and all were positive by 1 hour." 2

An in vivo imaging agent — requires no blood handling.

"As a result of the in vivo systemic administration of radiolabeled... [NeutroSpec™], radioactivity becomes concentrated in areas of infection or inflammation; thus, the need to withdraw blood from a patient to label WBC's ex vivo is eliminated and the time required to perform the test is reduced significantly." 1

Quick and easy prep kit.

After addition of 20-40 mCi of Tc 99m generator eluant, a 30 minute incubation at 37ºC, and addition of Cenolate™, NeutroSpec™ imaging agent is ready for patient injection. A NeutroSpec™ imaging agent injection is administered in a single dose with 10-20 mCi of Tc 99m, corresponding to 75-125 µg of fanolesomab.

For more information visit, or call Mallinckrodt's Imaging Customer Service at 1.888.744.1414.

1 Rypins E, Kipper S, Weiland F, et al, (99m Tc) Anti-Cd 15 monoclonal antibody imaging improves diagnostic accuracy and clinical management in patients with equivocal presentation of appendicitis. Annals of Surgery, February 2002; Vol. 235, No. 2: 232-239.
2 Rypins E, Kipper S, Scintigraphic Determination of Equivocal Appendicitis. The American Surgeon, September 2000; Vol. 66, No. 9: 891-895.
Cenolate™ is a trademark of Hospira, Inc.

NeutroSpec™ [Technetium (99m Tc) fanolesomab] contains both murine antibodies and sodium hydrosulfite, each of which has been known to induce allergic reactions, including anaphylaxis. The most frequently observed adverse events seen in clinical studies were flushing and dyspnea.

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