EarlyTect BCD Plus:一种基于尿液的双位点PENK甲基化试验,用于基于风险的囊镜分离在血液中
Tae Jeong Oh1, Bo-Ram Bang2, Jae Hee Hwang1
1Genomictree, Inc. Daejeon Republic of Korea.
BJUI compass
|March 9, 2026
概括
早期Tect BCD Plus是一种新型的尿液测定方法,在患有出血症的患者中检测膀癌的高灵敏度和特异性. 这项测试有助于在非侵入性地识别膀癌,可能减少在特定情况下需要囊镜的需要.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 在瘤学瘤学.
- 分子诊断学 分子诊断
背景情况:
- 血液的评估通常涉及侵入性囊镜.
- 早期和准确检测膀癌对于有效治疗至关重要.
- 需要新的非侵入性生物标志物来改善诊断途径.
研究的目的:
- 开发和临床评估EarlyTect BCD Plus,一种用于检测膀癌的基于尿液的测试.
- 根据出血症风险分层来评估测试的诊断性能和临床效用.
- 为了研究测试的检测能力,以检测不同等级的膀癌.
主要方法:
- 针对PENK基因的双标定量甲基化特异PCR试验得到了优化.
- 该试验评估了来自韩国和美国的892名血患者.
- 分析了两个PENK甲基化标记物的尿液DNA,结果使用组合算法解释并按2025年AUA/SUFU风险类别分层.
主要成果:
- 在合并的队列中,EarlyTect BCD Plus的灵敏度为87.7%,特异性为82.5%,NPV为97.0%.
- 对低Ta度 (LG) 瘤的敏感性提高到60.5%,而高度瘤的敏感性提高到96.6%.
- 在中等风险组中,所有膀癌 (BC) 的NPV为99.1%,高度BC为100%.
结论:
- 早期Tect BCD Plus显著提高了Ta-LG膀癌的检测.
- 该试验保持了高的特异性和高的NPV,支持其作为非侵入性辅助的使用.
- 研究结果表明,该试验可以作为分类工具,可能会推迟在精选的血患者中进行囊镜检查.
相关概念视频
01:26Urine Studies II: Urine Culture and Sensitivity Test
1.7K
A urine culture and sensitivity test is a diagnostic procedure used to identify urinary tract bacterial infections and determine the most effective antibiotics for treatment. This test is generally preferred when a patient shows manifestations of a urinary tract infection, such as frequent or painful urination, cloudy or foul-smelling urine, or lower abdominal pain.Purpose of the TestThe primary goals of a urine culture and sensitivity test are to:Determine the specific bacteria causing the...
1.7K
01:28Urologic Endoscopic Procedure: Cystoscopic Examination
4.4K
Meaning of Cystoscopic Examination:Cystoscopy is an essential diagnostic tool in urology that is used to assess the structure and function of the genitourinary system. It provides a direct view of the urethra, bladder, and, in some cases, the ureteral openings. This procedure helps detect structural abnormalities, infections, cancers, and blockages in the urinary tract. There are two types of cystoscopy:Flexible cystoscopy is commonly performed in outpatient settings due to its less invasive...
4.4K
01:22Imaging Studies V: Intravenous Urography and Retrograde Pyelography
2.1K
IntroductionIntravenous Urography (IVU) and Retrograde Pyelography (RP) are important diagnostic imaging techniques used to evaluate the urinary system. These methods help identify structural abnormalities, obstructions, and functional issues in the kidneys, ureters, and bladder. Both procedures use iodine-based contrast media to enhance the visibility of urinary tract structures on X-ray images, though they differ in their methods and indications.1. Intravenous Urography (IVU)Intravenous...
2.1K
01:30Urinary Tract Calculi III: Medical Management
307
The diagnosis of renal calculi involves several imaging techniques, including non-contrast CT scans and ultrasound. These methods help visualize kidney stones, assess their size and location, and detect possible obstructions. Additionally, Measuring urine pH is useful for diagnosing specific stone types, such as struvite (alkaline pH) and uric acid stones (acidic pH). Cystine stones are primarily linked to cystinuria, a genetic condition. A urinalysis helps detect blood in the urine (hematuria)...
307
01:30Urinary Tract Infection III: Diagnostic Studies and Interprofessional Care
378
A healthcare provider can diagnose a urinary tract infection (UTI) through several methods:Medical History and Symptoms: The provider will take a detailed medical history and ask about symptoms such as frequent urination, burning sensation during urination, and lower abdominal pain.Urinalysis: A clean-catch urine sample is collected in a sterile container and tested for the presence of bacteria, white blood cells (leukocytes), nitrites, blood, and protein. The presence of leukocytes and...
378
01:28Acute Pyelonephritis II: Diagnostic Studies and Management
573
Introduction:For diagnosing acute pyelonephritis, a comprehensive patient history is collected to identify symptoms such as dysuria, frequent or urgent urination, flank pain, or costovertebral angle (CVA) tenderness that may suggest a kidney infection.Physical ExaminationDuring the physical examination, CVA tenderness is assessed. This involves gentle percussion over the costovertebral angle, where tenderness often indicates a kidney infection.Diagnostic TestsUrinalysis: Used to identify white...
573