Abstract
Aim. To determine survivin content in the urine of patients with different stages of bladder cancer (BC) using the developed bioluminescent immunoassay and to evaluate the suitability of this protein as a marker for BC diagnosis and disease monitoring.
Materials and Methods. Survivin concentration was detected in 128 urine samples from BC patients and 60 samples from healthy volunteers. Patients were examined according to current clinical guidelines. Key clinical and morphological parameters were assessed, including disease stage, grade, tumor size, and number of lesions. Urine survivin levels were quantified using a previously developed bioluminescent immunoassay (detection range: 15.6-1000 pg/ml; limit of detection: 10.6 pg/ml). The relationship between BC clinical and morphological characteristics and urinary survivin concentration was assessed using the Pearson's χ2 test.
Results. Elevated survivin were detected in 79 patients. The sensitivity and specificity of survivin as a tumor marker for BC diagnosing were 61.7 % and 96.7 %, respectively. In the non-muscle-invasive (Ta, Tis, T1) and muscle-invasive (T2-4) BC groups, the sensitivity was 51.9% and 76.5%, respectively. A statistically significant correlation was found between urinary survivin concentration and the pathological stage and tumor size (p < 0.05).
Conclusion. Urinary survivin levels cannot be used as the only diagnostic factor for BC detection. To improve the sensitivity and specificity of laboratory BC testing, it is advisable to use a panel of oncological markers. This tumor marker is of interest for monitoring patients who have completed anticancer treatment, as well as for use as a pre-diagnostic indicator for genitourinary diseases. The developed high-throughput bioluminescence-based immunoassay enables rapid and highly sensitive detection of this marker. All components of the analytical system (antibodies, bioluminescent label, reaction substrate) were developed in Russian laboratories, making the assay widely accessible.
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