Prospective Validation of Clinical Usefulness of a Novel mRNA-based Urine Test (Xpert® Bladder Cancer Monitor) for surveillance in Non Muscle Invasive Bladder Cancer

Elsawy, Amr A.; Awadalla, Amira; El‐Sayed, Asmaa; Abdullateef, Muhammad; Abol‐Enein, Hassan

doi:10.1016/j.urolonc.2020.07.013

Cited by 20 publications

(23 citation statements)

References 20 publications

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“…Twenty-one studies, comprising 7330 patients, were included in the quantitative synthesis. All the studies included in the quantitative synthesis reported on the diagnostic value of UBTs for the detection of recurrence during surveillance: ten studies on Xpert bladder cancer [17][18][19][20][21][22][23][24][25][26], five studies on Bladder EpiCheck [26][27][28][29][30], three on Adxbladder [31][32][33], two on Uromonitor [34,35], and two on Cxbladder Monitor [36,37].…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…Ten studies provided data on the diagnostic values of the Xpert bladder cancer UBT for the diagnosis of recurrence during NMIBC follow-up [17][18][19][20][21][22][23][24][25][26]. The pooled Se, Sp, PPV, and NPV were 0.72 (95% CI 0.63-0.80), 0.76 (95% CI 0.72-0.81), 0.43 (95% CI 0.32-0.54), and 0.92 (95% CI 0.90-0.94), respectively (Fig.…”

Section: Xpert Bladder Cancermentioning

confidence: 99%

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Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis

Laukhtina

Shim

Mori

et al. 2021

European Urology Oncology

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Section: Study Selection and Characteristicsmentioning

confidence: 99%

Section: Xpert Bladder Cancermentioning

confidence: 99%

Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis

Laukhtina

Shim

Mori

et al. 2021

European Urology Oncology

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“…Recently, three detection platforms for surveillance have emerged and presented promising results: the CxBladder Monitor, the Xpert Bladder Monitor (multigene expression markers), and the Bladder EpiCheck (DNA methylation markers). The reported sensitivities and NPVs were respectively, 91–93% and 96–97% for the CxBladder Monitor [23,24], 66–74% and 89–96% the Xpert Bladder Monitor [1,25–27], and 60–80% and 82–90% for the Bladder EpiCheck [28]. Although our unique assay uses cellular biomarkers, combined cVUC and FVUC achieved a sensitivity of 82% and NPV of 98%, demonstrating slightly better performance in the surveillance cohort.…”

Section: Discussionmentioning

confidence: 99%

Hexylaminolevulinate‐mediated fluorescent urine cytology with a novel automated detection technology for screening and surveillance of bladder cancer

et al. 2021

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To evaluate the diagnostic performance of fluorescent voided urine cytology (FVUC) using a novel automated detection technology to screen for primary bladder cancer and for surveillance of recurrent bladder tumour. Patients and MethodsWe created a rapid, objective, automated, and high-throughput detection device for hexylaminolevulinate-mediated FVUC, named the cellular fluorescence analysis unit-II (CFAU-II). Two different cohorts were used in this study: (i) screening test for primary bladder cancer (165 patients with bladder cancer and 52 controls), and (ii) surveillance test for detecting intravesical recurrent tumour (192 patients with treated non-muscle-invasive bladder cancer and 15 with postnephroureterectomy upper urinary tract cancer). Voided urine samples were subjected to urine analysis, conventional VUC (cVUC), and FVUC. Diagnostic performance was compared between cVUC, FVUC, and a combination of the two. ResultsA total of 614 urine samples were successfully collected, processed, and analysed. Comparative analysis of the screening test cohort demonstrated that the overall sensitivity of FVUC (63%, P < 0.001) and combination testing (72%, P < 0.001) was significantly higher than that of cVUC (29%). FVUC was found to be superior in most of the subgroups, especially in lowgrade, Ta, and small tumours. Analysis of the surveillance test cohort showed that combination testing achieved a sensitivity of 82% and a negative predictive value of 98%, whereas those of cVUC were 39% and 96%, respectively. According to the pathological finding of recurrent tumours presenting false-negative result in the FVUC, the majority of the overlooked recurrent diseases were Ta low-grade tumours. Logistic regression analysis suggested an association between the risk of false-positive results and high density of urine white blood cells and alkaluria. ConclusionThe present findings clearly demonstrate that FVUC using the newly developed automation technology has superior sensitivity to cVUC for both screening for primary bladder cancer and recurrent tumour detection. It is essential to confirm the clinical usefulness of this method via further large-scale studies, in addition to ensuring its affordability and availability.

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“…At last, 8 remaining articles were subject to fulltext screening. Finally, eight articles were included, from which data were extracted to construct eight fourfold tables for analysis [5,7,9,11,15,17,22,23]. The detailed flow chart is shown in Additional file 1.…”

Section: Literature Retrieval Processmentioning

confidence: 99%

Pooled analysis of Xpert Bladder Cancer based on the 5 mRNAs for rapid diagnosis of bladder carcinoma

et al. 2021

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Background Xpert Bladder Cancer is a detection method developed in recent years, designed with the functions of integrating sample automatically, nucleic acid amplification, and target sequence detection. It is a urine assay targeting five mRNAs (CRH, IGF2, UPK1B, ANXA10, and ABL1). The purpose of this article is to review the accuracy of Xpert Bladder Cancer in the follow-up diagnosis of bladder cancer and evaluate the role of Xpert Bladder Cancer in detecting the recurrence of non-muscle-invasive bladder cancer in the round. Methods In the database of Embase, PubMed, Web of Science, and Cochrane Library, the articles published up to October 13, 2020, were searched and screened based on the exclusion and inclusion criteria, and data were extracted from the included studies. The sensitivity, specificity, negative likelihood ratio, positive likelihood ratio summary of receiver operating characteristic curves, and diagnostic odds ratio were combined by the Meta-DiSc 1.4 software. The Stata 12.0 software was used to obtain the assessment of publication bias. Results A total of 8 articles involving eight fourfold tables were finally identified. The pooled sensitivity and specificity of Xpert Bladder Cancer in the diagnosis of bladder cancer were 0.71 and 0.81, respectively. The positive likelihood ratio and negative likelihood ratio were 3.74 and 0.34, respectively. The area under the curve was 0.8407. The diagnostic odds ratio was 11.99. Deeks’ funnel plot asymmetry test manifested no publication bias. Conclusions In summary, Xpert Bladder Cancer presents high accuracy and specificity in monitoring bladder cancer compared with cystoscopy. More researches are still required to further confirm this conclusion.

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Prospective Validation of Clinical Usefulness of a Novel mRNA-based Urine Test (Xpert® Bladder Cancer Monitor) for surveillance in Non Muscle Invasive Bladder Cancer

Cited by 20 publications

References 20 publications

Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis

Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis

Hexylaminolevulinate‐mediated fluorescent urine cytology with a novel automated detection technology for screening and surveillance of bladder cancer

Pooled analysis of Xpert Bladder Cancer based on the 5 mRNAs for rapid diagnosis of bladder carcinoma

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