Leyh H, Marberger M, Conort P, Sternberg C, Pansadoro V, Pagano F, Bassi P, Boccon-Gibod L, Ravery V, Treiber U, Ishak L
Technical University of Munich, Germany.
Eur Urol. 1999 Jan;35(1):52-6. doi: 10.1159/000019819.
To compare the BTA stat test (BTA stat), a new one-step immunochromatographic assay that can be performed in the urologist's office or in the laboratory, to voided urine cytology and bladder wash cytology (cytology) in the diagnosis and monitoring of cancer of the bladder (BC).
BTA stat and cytology were performed in a double-blinded, prospective, clinical study on specimens from 240 subjects (68 females; mean age of subjects: 64 years) suspected of having BC.
In 107 subjects with final diagnoses of BC confirmed by cystoscopy or cystoscopy and biopsy, the overall sensitivities of BTA stat and cytology were 65 and 33%, respectively. For tumor grades I, II, and III, the sensitivities of BTA stat were 39, 67 and 83%, respectively. Those of cytology were 4, 20 and 69%. Nine subjects had a diagnosis of 'suspicious for bladder cancer'. The specificities of BTA stat and cytology in the 124 subjects without BC were 64 and 99%, respectively. In the subjects with a history of BC (n = 74), the specificities of BTA stat and cytology were 72 and 99%, respectively. The specificity of BTA stat was lower in subjects with benign or malignant genitourinary disease other than BC (46%) than in subjects without genitourinary disease (71%).
The BTA stat test is considerably more sensitive than cytology in the detection of BC and can replace cytology as an adjunct to cystoscopy in the diagnosis and follow-up of patients with BC. However, due to low specificity, BTA stat should not be used without first ruling out potential interferences such as infections, renal disease and cancer, or genitourinary trauma.
比较BTA stat检测（BTA stat），一种可在泌尿科医生办公室或实验室进行的新型一步免疫层析检测法，与晨尿细胞学检查及膀胱冲洗液细胞学检查（细胞学检查）在膀胱癌（BC）诊断和监测中的效果。
在一项双盲、前瞻性临床研究中，对240名疑似患有BC的受试者（68名女性；受试者平均年龄：64岁）的样本进行BTA stat检测和细胞学检查。
在107名经膀胱镜检查或膀胱镜检查及活检确诊为BC的受试者中，BTA stat检测和细胞学检查的总体敏感性分别为65%和33%。对于I、II和III级肿瘤，BTA stat检测的敏感性分别为39%、67%和83%。细胞学检查的敏感性分别为4%、20%和69%。9名受试者被诊断为“疑似膀胱癌”。在124名无BC的受试者中，BTA stat检测和细胞学检查的特异性分别为64%和99%。在有BC病史的受试者（n = 74）中，BTA stat检测和细胞学检查的特异性分别为72%和99%。BTA stat检测在患有除BC以外的良性或恶性泌尿生殖系统疾病的受试者中的特异性（46%）低于无泌尿生殖系统疾病的受试者（71%）。
BTA stat检测在检测BC方面比细胞学检查敏感得多，在BC患者的诊断和随访中可作为膀胱镜检查的辅助手段替代细胞学检查。然而，由于特异性较低，在未首先排除感染、肾脏疾病、癌症或泌尿生殖系统创伤等潜在干扰因素之前，不应使用BTA stat检测。
