Although hematuria (blood in urine) is the most common symptom of bladder cancer, 70–98% of hematuria cases are benign. These hematuria patients unnecessarily undergo costly, invasive, and expensive evaluation for bladder cancer. Therefore, there remains a need for noninvasive office‐based tests that can rapidly and reliably rule out bladder cancer in patients undergoing hematuria evaluation. Herein, a clinical assay for matrix metalloproteinases (“Ammps”) is presented, which generates a visual signal based on the collagenase activity (in urine of patients) on the Ammps substrates. Ammps substrates are generated by crosslinking gelatin with Fe(II) chelated alginate nanoparticles, which precipitate in urine samples. The cleavage of gelatin‐conjugated alginate (Fe(II)) nanoparticles by collagenases generates free‐floating alginate (Fe(II)) nanoparticles that participate in Fenton's reaction to generate a visual signal. In a pilot study of 88 patients, Ammps had 100% sensitivity, 85% specificity, and a negative predictive value (NPV) of 100% for diagnosing bladder cancer. This high NPV can be useful in ruling out bladder cancer in patients referred for hematuria evaluation.

中文翻译：

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对进行血尿评估的患者进行膀胱癌的廉价，现场护理尿液检测

尽管血尿（尿中的血液）是膀胱癌的最常见症状，但70–98％的血尿病例是良性的。这些血尿患者不必要地接受昂贵，侵入性和昂贵的膀胱癌评估。因此，仍然需要基于非侵入性办公室的测试，这些测试可以快速可靠地排除接受血尿评估的患者的膀胱癌。在此，提出了一种针对基质金属蛋白酶（“ Ammps”）的临床检测方法，该方法基于在Ammps底物上（患者尿液中）的胶原酶活性产生视觉信号。通过将明胶与Fe（II）螯合的藻酸盐纳米颗粒交联来生成安培底物，该沉淀物会沉淀在尿液样品中。胶原酶切割明胶缀合的藻酸盐（Fe（II））纳米颗粒会产生自由漂浮的藻酸盐（Fe（II））纳米颗粒，这些纳米颗粒参与Fenton反应以产生视觉信号。在一项针对88例患者的初步研究中，Amps对膀胱癌的诊断具有100％的敏感性，85％的特异性和100％的阴性预测值（NPV）。较高的NPV可用于排除血尿评估患者的膀胱癌。