URO-3 Triple Stain™

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CD44 + p53 + CK20 can be used to differentiate urothelial reactive atypia from CIS (carcinoma in situ) in bladders. In normal urothelium, superficial umbrella cell layer shows reactivity for CK20 only, whereas CD44 staining is limited to the basal and parabasal urothelial cells and p53 nuclear staining is absent to focal. For urothelium with reactive atypia, particularly in cases with marked atypia, CD44 shows increased reactivity in all layers of the urothelium and is often absent in neoplastic cells. CK20 and p53 staining remain identical to those seen in normal urothelium. In cases of CIS, diffuse, strong cytoplasmic reactivity for CK20 and diffuse nuclear reactivity for p53 is observed throughout the urothelium.

Intended Use

IVD

Species Reactivity

Human

Source

Mouse Monoclonal, Rabbit Monoclonal

Clone

BC8 (CD44), EP9 (p53), Ks20.8 (CK20) Biocare Clone

Isotype

IgG2a, IgG and IgG2a

Antigen

CD44 + p53 and CK20

Localization

CD44 (Blue or Red): Cytoplasmic p53 (Brown): Nuclear CK20 (Red or Blue): Cytoplasmic

Positive Control

Some p53-positive bladder and colon carcinomas

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Regulatory Notice: Biocare’s IVD-labeled products comply with US-FDA and European IVDD regulation. Other regions may have additional requirements for such labeling, please contact your local distributor.

1. Russo S, Botti G, Vinaccia P, Iaccarino C, Maioli S, Del Prete D, Maiello FM. A useful panel in proliferative urothelial lesions: an analysis of cytokeratin 20, p53, CD44 and Ki-67 antigens. Pathologica. 2007 Apr; 99(2):46-9.
2. McKenney JK, Desai S, Cohen C, Amin MB. Discriminatory immunohistochemical staining of urothelial carcinoma in situ and non-neoplastic urothelium: an analysis of cytokeratin 20, p53, and CD44 antigens. Am J Surg Pathol. 2001 Aug; 25(8):1074-8.
3. Center for Disease Control Manual. Guide: Safety Management, NO. CDC-22, Atlanta, GA. April 30, 1976 “Decontamination of Laboratory Sink Drains to Remove Azide Salts.”
4. National Committee for Clinical Laboratory Standards (NCCLS). Protection of laboratory workers from infectious diseases transmitted by blood and tissue; proposed guideline. Villanova, PA 1991; 7(9). Order code M29-P.

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