Acu-URO17 is a highly sensitive and specific bladder cancer biomarker

IF 1.6 Q3 UROLOGY & NEPHROLOGY

BJUI compass Pub Date : 2024-02-29 DOI:10.1002/bco2.338

Liwu Guo, Alexandra Cid, John Cucci, Brian Kunkel, Lisa Defeis, Michael Matthews

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引用次数: 0

Abstract

Objective

This study evaluates the efficacy of Acu-URO17, a highly sensitive and specific immunocytochemistry (ICC) test targeting Keratin 17, in comparison to urine cytology and UroVysion™ fluorescence in situ hybridization (FISH) for detecting bladder cancer cells in voided urine specimens.

Methods

Acupath conducted a large-scale comparison study using 2378 voided urine specimens. Acu-URO17, urine cytology and UroVysion™ FISH were performed on these specimens according to standardized protocols. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for Acu-URO17 in comparison to urine cytology and UroVysion™ FISH.

Results

In cases diagnosed with high-grade urothelial cancer via urine cytology, Acu-URO17 demonstrated a sensitivity of 96% and a specificity of 82%. When compared to UroVysion™ FISH results, Acu-URO17 exhibited a sensitivity of 97.1% and a specificity of 77.8%, surpassing the sensitivity of UroVysion™ FISH (57.1%). Notably, Acu-URO17 showed a high NPV of 99.9%, indicating its reliability in confirming negative urine cytology results and risk-stratifying atypical and suspicious cytology results.

Conclusion

The results of this large-scale prospective study support Acu-URO17 as a clinically relevant, non-invasive and cost-effective tool for detecting bladder cancer cells in voided urine specimens. Its high sensitivity, specificity and NPV make it a valuable adjunct to urine cytology and UroVysion™ FISH in the diagnosis and management of urothelial carcinoma (UC).

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Acu-URO17 是一种高度灵敏且特异的膀胱癌生物标记物

本研究评估了针对角蛋白 17 的高灵敏度和特异性免疫细胞化学（ICC）检验 Acu-URO17 与尿液细胞学和 UroVysion™ 荧光原位杂交（FISH）在检测排空尿液标本中的膀胱癌细胞方面的功效。Acu-URO17 、尿液细胞学和 UroVysion™ FISH 都是按照标准化方案对这些标本进行检测的。与尿液细胞学检查和 UroVysion™ FISH 相比，计算了 Acu-URO17 的灵敏度、特异性、阳性预测值 (PPV) 和阴性预测值 (NPV)。与 UroVysion™ FISH 结果相比，Acu-URO17 的灵敏度为 97.1%，特异性为 77.8%，超过了 UroVysion™ FISH 的灵敏度（57.1%）。值得注意的是，Acu-URO17 的 NPV 值高达 99.9%，这表明它在确认阴性尿液细胞学结果以及对不典型和可疑细胞学结果进行风险分级方面非常可靠。这项大规模前瞻性研究的结果表明，Acu-URO17 是检测排空尿液标本中膀胱癌细胞的一种临床相关、无创且经济有效的工具。它的高灵敏度、高特异性和高净现值使其成为尿液细胞学和 UroVysion™ FISH 诊断和治疗尿路上皮癌 (UC) 的重要辅助手段。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BJUI compass

CiteScore

2.30

自引率

0.00%

发文量

审稿时长

12 weeks