Quantitative Analysis of Keratin 18 in the Urine of Patients with Bladder Cancer

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Abstract
The level of urinary keratin was compared in patients with and without bladder cancer using the newly developed IRMAK-18. Patients with bladder cancer had higher levels of keratin (74.6 .+-. 146.9) than normals (2.5 .+-. 4.7). When the upper limit of normal was set at kertin (< 20 ng./ml.), the test was highly specific (98%) for bladder cancer but had a sensitivity of only 46%. Adjusting to keratin < 10 ng/ml increased the sensitivity to 57% but decreased the specificity to 91%. Elevated keratins were associated with stage and grade aneuploidy and disease history. The IRMAK-18 assay for keratin may be useful for monitoring the clinical progress of some patients.