What is the role of the ImmunoCyt/uCyt+ test in the diagnosis of bladder cancer?

Updated: Nov 01, 2018
  • Author: Gary David Steinberg, MD, FACS; Chief Editor: Bradley Fields Schwartz, DO, FACS  more...
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The ImmunoCyt/uCyt+ test (Scimedex; Denville, NJ) was originally developed in 1997 by Fradet and Lockhard as an immunohistochemical test with 3 fluorescent monoclonal antibodies directed at urothelial cell antigens found on exfoliated cells. Two antibodies, LDQ10 and M344, are directed against mucins, specifically glycoproteins found on epithelial cell surfaces in malignancy, and labeled with fluorescein. [23, 24, 25] The other antibody is labeled Texas red and directed against a high molecular weight glycosylated form of carcinoembryonic antigen 19A211. M344 and CEA 19A211 have been found to be expressed in 71% and 90% of Ta-T1 tumors, respectively. [23]

However, the test is limited in that it requires processing in laboratories with properly trained personnel. Additionally, it requires a minimum of 500 negative cells on the slide in order for the sample to be deemed negative. [24] As is common with other protein-based assays, false positives are common in the setting of urinary tract infection, urolithiasis, and benign prostatic hyperplasia.

The use of Immunocyt/uCyt+ improves sensitivity at a minimum of 15% over cytology alone and ranges from 53.8-94.1%, with greater improvements in low-grade tumors. This improves further with the combination of cytology and Immunocyt/uCyt+. Specificity is slightly lower than that of cytology, at 61-80.7%. The negative predictive value is improved with the use of Immunocyt/uCyt+, at 81-96.2%, whereas the positive predictive value is worse (26-63.2%). [24] In a recent analysis, Comploj et al. noted that the sensitivity of Immunocyt/uCyt+ increased from 63% for a pTa tumor to 80% for a pT1 tumor and in combination with cytology it increased from 65% to 88%. Conversely, poorer sensitivity was noted in T2 tumors (68%), likely because the 19A211, M344, and CEA 19A211 antigens are not found in muscle-invasive tumors. [25]

Nomograms using immunocytology (Immunocyt/uCyt+) have been created for the detection of bladder cancer. According to the authors, the addition of immunocytology improved the diagnostic accuracy of the nomogram and outperformed cytology with a significantly higher sensitivity and negative predictive value.

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