Abuhasanein Suleiman, Radmann Jonatan, Jahnson Staffan, Kjölhede Henrik
Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.
Department of Surgery, Urology Section, NU Hospital Group, Region Västra Götaland Health System, Uddevalla, Sweden.
Eur Urol Open Sci. 2024 Nov 2;70:158-166. doi: 10.1016/j.euros.2024.10.016. eCollection 2024 Dec.
Our objective was to assess whether GeneXpert BC can be used as a triage test to exclude urinary bladder cancer (UBC) for patients with macroscopic hematuria.
We conducted a prospective study that include consecutive patients being evaluated for macroscopic hematuria between September 2020 and December 2022. Before cystoscopy, study participants provided a voided urine sample for GeneXpert BC analysis according to a case-control design with an emphasis on UBC detection. Descriptive statistics are reported for patient and tumor characteristics. To assess the diagnostic accuracy of the GeneXpert BC test, the sensitivity, specificity, and negative predictive value (NPV) were calculated, using the histopathologically proven UBC as the ground truth.
In total, 1505 subjects presenting with macroscopic hematuria were enrolled in the study. After randomization and exclusions, GeneXpert BC testing was carried out for 312 participants. Of these, 151 patients from the case arm had UBC, 122 patients from the control arm (random 10%) were negative for UBC, and 39 patients from the case arm did not have malignancy. Using a predefined linear discriminant analysis (LDA) threshold of ≥0.22, the test had sensitivity of 0.94 (95% confidence interval [CI] 0.90-0.97), specificity of 0.52 (95% CI 0.42-0.59), and NPV of 0.99 (95% CI 0.98-0.99). All false-negative tumors were of low grade (Ta grade 1-2). Cystoscopy and computed tomography urography could have been omitted in 44% of the patients with macroscopic hematuria. At a secondary LDA threshold of ≥0.45, the test had sensitivity of 0.79 (95% CI 0.73-0.86), specificity of 0.83 (95% CI 0.76-0.89), and NPV of 0.97 (95% CI 0.96-0.98).
GeneXpert BC is a reliable triage test for deciding on whether further investigations are necessary in patients with macroscopic hematuria.
We assessed a test called GeneXpert BC for the detection of bladder cancer in patients with blood in their urine. GeneXpert BC performed well in ruling out bladder cancer for patients who did not have cancer according to further tests. Use of GeneXpert BC could help in avoiding scans and invasive tests for patients with a negative result.
我们的目的是评估GeneXpert BC能否作为一种分流检测方法，用于排除肉眼血尿患者的膀胱癌（UBC）。
我们进行了一项前瞻性研究，纳入了2020年9月至2022年12月期间因肉眼血尿接受评估的连续患者。在膀胱镜检查前，研究参与者根据病例对照设计提供一份晨尿样本，用于GeneXpert BC分析，重点是检测UBC。报告了患者和肿瘤特征的描述性统计数据。为评估GeneXpert BC检测的诊断准确性，以组织病理学证实的UBC为金标准，计算了敏感性、特异性和阴性预测值（NPV）。
共有1505例肉眼血尿患者纳入本研究。经过随机分组和排除后，对312名参与者进行了GeneXpert BC检测。其中，病例组的151例患者患有UBC，对照组的122例患者（随机抽取10%）UBC检测为阴性，病例组的39例患者没有恶性肿瘤。使用预先定义的线性判别分析（LDA）阈值≥0.22时，该检测的敏感性为0.94（95%置信区间[CI]0.90 - 0.97），特异性为0.52（95%CI 0.42 - 0.59），NPV为0.99（95%CI 0.98 - 0.99）。所有假阴性肿瘤均为低级别（Ta 1 - 2级）。44%的肉眼血尿患者可以省略膀胱镜检查和计算机断层扫描尿路造影。在二级LDA阈值≥0.45时，该检测的敏感性为0.79（95%CI 0.73 - 0.86），特异性为0.83（95%CI 0.76 - 0.89），NPV为0.97（95%CI 0.96 - 0.98）。
GeneXpert BC是一种可靠的分流检测方法，可用于决定肉眼血尿患者是否需要进一步检查。
我们评估了一种名为GeneXpert BC的检测方法，用于检测血尿患者的膀胱癌。根据进一步检测，GeneXpert BC在排除未患癌症的患者的膀胱癌方面表现良好。对于检测结果为阴性的患者，使用GeneXpert BC有助于避免扫描和侵入性检查。
