Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care

  • Keum, Changjoon; 
  • Yeom, Haejin; 
  • Noh, Tae Il; 
  • Yi, Seung Yong; 
  • Jin, Soyeong; 
  • ... Lee, Kwan Hyi; 
  • 외 6명
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초록

Diagnostic kits for the optical detection of bladder cancer in urine can facilitate effective screening and surveillance. However, the heterogeneity of urine samples, owing to patients with bladder cancer often presenting with haematuria, interfere with the transduction of the optical signal. Here we describe the development and point-of-care performance of a device for the detection of bladder cancer that obviates the need for sample processing. The device leverages the enzymatic release of organogel particles carrying solvatochromic fluorophores in the presence of urinary hyaluronidases-a bladder cancer biomarker. Owing to buoyancy, the particles transfer from the urine sample into the organic phase, where the change in fluorescence can be measured via a smartphone without interference from blood proteins. In a double-blind study with 80 unprocessed urine samples from patients with bladder cancer (including samples with haematuria) or other genitourinary diseases and with 25 samples from healthy participants, our system distinguished the cancerous samples, including those with early-stage bladder cancer, with accuracies of about 90%. Obviating the need for sample pretreatment may facilitate the at-home detection of bladder cancer. A point-of-care diagnostic device for the detection of early-stage bladder in urine obviates the need of sample pretreatment and enhances diagnostic accuracy.

키워드

Hyaluronidase; Biomarkers, Tumor; K-6000; Lsm 800; Nicolet Is20; Nmp22 Bladderchek; Quanta 3d; S-3100; Spectramax M2; Diagnosis; Bladder Cancers; Diagnostic Kit; Optical Detection; Optical Signals; Organogels; Performance; Point Of Care; Sample Processing; Solvatochromic; Urine Sample; Diseases; Hyaluronidase; Tumor Marker; Article; Bladder Cancer; Cancer Diagnosis; Cancer Staging; Controlled Study; Diagnostic Accuracy; Double Blind Procedure; Female; Fluorescence Intensity; Hematuria; Human; Limit Of Detection; Major Clinical Study; Male; Point Of Care Testing; Signal Transduction; Transurethral Resection Of The Bladder; Urine Sampling; Urogenital Tract Disease; Aged; Bladder Tumor; Diagnosis; Early Cancer Diagnosis; Middle Aged; Pathology; Point Of Care System; Procedures; Smartphone; Urine; Aged; Biomarkers, Tumor; Double-blind Method; Early Detection Of Cancer; Female; Humans; Male; Middle Aged; Neoplasm Staging; Point-of-care Systems; Smartphone; Urinary Bladder Neoplasms; HYALURONIC-ACID; MARKERS; BIOMARKERS; HEMATURIA; ACCURACY
제목
Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care
저자
Keum, Changjoon; Yeom, Haejin; Noh, Tae Il; Yi, Seung Yong; Jin, Soyeong; Kim, Chaekyu; Shim, Ji Sung; Yoon, Sung Goo; Kim, Hojun; Lee, Kwan Hyi; Kang, Seok Ho; Jeong, Youngdo
DOI
10.1038/s41551-024-01298-0
발행일
2024-11-28
유형
Article; Early Access
저널명
Nature Biomedical Engineering
권
9
호
7
페이지
1026 ~ 1038