The incidence and 5 year recurrence rate of urothelial carcinomas (UCs), including UC of the bladder (UCB) and upper urinary tract UC (UTUC), have increased annually. There is a great need for a simple and fast point-of-care (POC) test for early diagnosis and amelioration in the survival rate. We present a POC test comprising a new vial-immunosensor, nanoenzyme, and iPhone 7 plus, which detects and quantifies the new biomarker FXYD domain-containing ion transport regulator 3 (FXYD3) in human urine for specific UC screening, tumor-grade classification, and postoperative monitoring by the grayscale value of the photograph taken. The performance of the proposed POC test was then verified using urine from 4 healthy people, 40 UCB patients (10 patients were low-grade and 30 patients were high-grade), and 13 UTUC patients (2 patients were low-grade and 11 patients were high-grade), confirming the accuracy and specificity by comparing the results with those obtained by enzyme-linked immunosorbent assay (ELISA). Moreover, we also designed a correction method that can make the grayscale values calculated by different smartphones close to the values calculated by iPhone 7 plus, resulting in the POC test enabling simple, fast, universal, and portable testing, data storage, and sharing for personal UCs screening and postoperative monitoring.

中文翻译：

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使用基于小瓶的免疫传感器对FXYD3进行无仪器检测，可更快，更快速地诊断尿路上皮癌。

尿路上皮癌（UCs）的发生率和5年复发率，包括膀胱UC（UCB）和上尿路UC（UTUC），每年都在增加。迫切需要一种简单，快速的即时诊断（POC）测试，以早期诊断和改善生存率。我们提出了一种POC测试，其中包括新的样品瓶免疫传感器，纳米酶和iPhone 7 plus，它可以检测和量化人尿液中新的含FXYD域生物标志物的离子转运调节剂3（FXYD3），用于特定的UC筛查，肿瘤分级，并通过所拍摄照片的灰度值进行术后监控。然后，使用来自4名健康人，40名UCB患者（10名低危患者和30名高危患者）的尿液验证了拟议的POC测试的性能，13例UTUC患者（2例为低度，11例为高度），通过与酶联免疫吸附试验（ELISA）的结果进行比较，确认了准确性和特异性。此外，我们还设计了一种校正方法，可以使不同智能手机计算出的灰度值接近iPhone 7 plus计算出的灰度值，从而实现POC测试，从而实现简单，快速，通用和便携式测试，数据存储以及共享。个人UC筛查和术后监测。