Initial Evaluation of the Diagnostic Performance of the New Urinary Bladder Cancer Antigen Test as a Tumor Marker for Transitional Cell Carcinoma of the Bladder

Sänchez‐Carbayo, Marta; Herrero, Enrique; Megías, Julián; Mira, Antonio; Espasa, Antonia; Chinchilla, Virtudes Chinchilla; Soria, Federico

doi:10.1097/00005392-199904000-00016

Cited by 7 publications

(7 citation statements)

References 16 publications

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“…Comparing BSI to the bead-based assay is difficult in this case, but the BSI LOQ (not the LOD at 2σ) exhibits >1.5-fold improvement and is performed as a free-solution and label-free method. 49 , 50 Electrochemiluminescence assays have demonstrated detection limits comparable to ours reported here, 25 , 49 , 50 yet these assays are expensive and require substantial chemical complexity in both the assay discovery and analytical validation phase.…”

Section: Results and Discussionsupporting

confidence: 64%

“…Furthermore, the large sample consumption associated with some of these methods impedes validation of promising biomarkers due to the preciousness of the available banked samples on relevant patient populations. 10 , 25 As shown from Table 1 , backscattering interferometry (BSI) represents the most sensitive label-free method and can give comparable detection limits to fluorescent assays.…”

mentioning

confidence: 99%

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Toward Rapid, High-Sensitivity, Volume-Constrained Biomarker Quantification and Validation using Backscattering Interferometry

et al. 2014

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Realizing personalized medicine, which promises to enable early disease detection, efficient diagnostic staging, and therapeutic efficacy monitoring, hinges on biomarker quantification in patient samples. Yet, the lack of a sensitive technology and assay methodology to rapidly validate biomarker candidates continues to be a bottleneck for clinical translation. In our first direct and quantitative comparison of backscattering interferometry (BSI) to fluorescence sensing by ELISA, we show that BSI could aid in overcoming this limitation. The analytical validation study was performed against ELISA for two biomarkers for lung cancer detection: Cyfra 21-1 and Galectin-7. Spiked serum was used for calibration and comparison of analytical figures of merit, followed by analysis of blinded patient samples. Using the ELISA antibody as the probe chemistry in a mix-and-read assay, BSI provided significantly lower detection limits for spiked serum samples with each of the biomarkers. The limit of quantification (LOQ) for Cyrfa-21-1 was measured to be 230 pg/mL for BSI versus 4000 pg/mL for ELISA, and for Galectin-7, it was 13 pg/mL versus 500 pg/mL. The coefficient of variation for 5 day, triplicate determinations was <15% for BSI and <10% for ELISA. The two techniques correlated well, ranging from 3–29% difference for Cyfra 21-1 in a blinded patient sample analysis. The label-free and free-solution operation of BSI allowed for a significant improvement in analysis speed, with greater ease, improved LOQ values, and excellent day-to-day reproducibility. In this unoptimized format, BSI required 5.5-fold less sample quantity needed for ELISA (a 10 point calibration curve measured in triplicate required 36 μL of serum for BSI vs 200 μL for ELISA). The results indicate that the BSI platform can enable rapid, sensitive analytical validation of serum biomarkers and should significantly impact the validation bottleneck of biomarkers.

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Section: Results and Discussionsupporting

confidence: 64%

mentioning

confidence: 99%

Toward Rapid, High-Sensitivity, Volume-Constrained Biomarker Quantification and Validation using Backscattering Interferometry

et al. 2014

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“…Since the emitters are bound to the analyte of interest, the amount of luminescence can be correlated with the concentration of the analyte. Tumor markers, [294][295][296][297][298][299][300][301][302][303][304][305][306] fertility and hormone tests, 296,[307][308][309] thyroid function, 296,[310][311][312][313][314] cardiac, 296,[315][316][317][318] heptatitis, [319][320][321] bone markers, [322][323][324] Alzheimer's disease, 325 anemia, 326 diabetes, 327 tests for infectious diseases, 296,320,321,[328][329][330][331][332][333] cancer research assays, [290]…”

Section: Clinical Applicationsmentioning

confidence: 99%

ECL—Electrochemical luminescence

Pyati

Richter

2007

Annu. Rep. Prog. Chem., Sect. C: Phys. Chem.

122

146

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“…Urothelial cytokeratins are predictors of cell death that can be released into the urine in the presence of cancer. Cytokeratin 8 (KRT8) and 18 (KRT18) are the most studied ones, detected by immunological assays (ELISA), with sensitivity ranging from 50 to 61% and specificity ranging from 63 to 97%, but with high false-positive rates, being positive in many epithelial cancers, and limited sensibility to low-grade tumors (31)(32)(33). The Urinary Bladder Cancer assay (UBC-enzyme--linked immunosorbent assay, IDL Biotech, Borlange, Sweden) is a test that evaluates cytokeratins 8 and 18 in the urine from urothelial tumors, and some studies suggested it performed better than BTA stat test and NMP22 (34).…”

Section: Non-fda Approved Urine Protein Biomarkersmentioning

confidence: 99%

Proteomic research and diagnosis in bladder cancer: state of the art review

et al. 2021

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Purpose: Proteomic biomarkers have been emerging as alternative methods to the gold standard procedures of cystoscopy and urine cytology in the diagnosis and surveillance of bladder cancer (BC). This review aims to update the state of the art of proteomics research and diagnosis in BC. Materials and Methods: We reviewed the current literature related to BC research on urinary, tissue, blood and cell line proteomics, using the Pubmed database. Findings: Two urinary protein biomarkers are FDA-approved (NMP22® and BTA® tests), only if performed along with cystoscopy for surveillance after initial diagnosis, but not in the primary diagnostic setting due to high false-positive rates in case of infections, stones and hematuria. There are a great number of non-FDA approved proteins being studied, with good preliminary results; panels of proteins seem valuable tools to be refined in ongoing trials. Blood proteins are a bigger challenge, because of the complexity of the serum protein profile and the scarcity of blood proteomic studies in BC. Previous studies with the BC tissue proteome do not correlate well with the urinary proteome, likely due to the tumor heterogeneity. Cell line proteomic research helps in the understanding of basic mechanisms that drive BC development and progression; the main difficulty is culturing low-grade tumors in vitro, which represents the majority of BC tumors in clinical practice. Conclusion: Protein biomarkers have promising value in the diagnosis, surveillance and prognostic of BC. Urine is the most appropriate body fluid for biomarker research in BC due to its easiness of sampling, stability and enrichment of shed and secreted tumor-specific proteins. Panels of biomarkers may exhibit higher sensitivity than single proteins in the diagnosis of BC at larger populations due to clinical and tumor heterogeneity. Prospective clinical trials are warranted to validate the relevance of proteomic data in the clinical management of BC.

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Initial Evaluation of the Diagnostic Performance of the New Urinary Bladder Cancer Antigen Test as a Tumor Marker for Transitional Cell Carcinoma of the Bladder

Abstract: Urinary bladder cancer antigen might have a role as a potential tumor marker for diagnosing transitional cell carcinoma of the bladder.

Cited by 7 publications

References 16 publications

Toward Rapid, High-Sensitivity, Volume-Constrained Biomarker Quantification and Validation using Backscattering Interferometry

Toward Rapid, High-Sensitivity, Volume-Constrained Biomarker Quantification and Validation using Backscattering Interferometry

ECL—Electrochemical luminescence

Proteomic research and diagnosis in bladder cancer: state of the art review

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