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Volume 14
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10.3390/diagnostics14182061
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Article

Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma

by
Justin C. Harvey
1,*,
Lisa M. Cambridge
1,2,
Charles W. Ellen
1,
Megan Colonval
1,
Jody A. Hazlett
1,
Jordan Newell
3,
Xin Zhou
1 and
Parry J. Guilford
1,4
1
Pacific Edge Diagnostics NZ, Ltd., 87 St. David Street, Dunedin 9016, New Zealand
2
Cambridge Quality Consulting, T/A Check Electric Ltd., 204 Coast Road, Waikouaiti 9471, New Zealand
3
Pacific Edge Diagnostics USA, Ltd., 1214 Research Boulevard, Hummelstown, PA 17036, USA
4
Department of Biochemistry, University of Otago, 710 Cumberland Street, Dunedin 9016, New Zealand
*
Author to whom correspondence should be addressed.
Diagnostics 2024, 14(18), 2061; https://doi.org/10.3390/diagnostics14182061
Submission received: 18 July 2024 / Revised: 13 September 2024 / Accepted: 13 September 2024 / Published: 17 September 2024
(This article belongs to the Section Pathology and Molecular Diagnostics)
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Abstract

Background: Cxbladder® assays are reverse transcription-quantitative polymerase chain reaction (RT-qPCR) tests incorporating five genetic biomarkers (CDK1, MDK, IGFBP5, HOXA13, and CXCR2) to provide risk stratification for urothelial carcinoma (UC) in patients with hematuria or undergoing surveillance for recurrent disease. This study evaluated the analytical validity of the Cxbladder Detect, Triage, and Monitor assays. Methods: Pre-specified acceptance criteria, including the assays’ fundamental aspects (sample and reagent stability, RNA extraction quality, RT-qPCR linearity, and analytical sensitivity and specificity), accuracy and precision, and reproducibility between laboratories. Results: Cxbladder had an analytical sensitivity of 12.5–31.1 RNA copies/mL urine for the CDK1, MDK, IGFBP5, and HOXA13 UC biomarkers and 68.9 RNA copies/mL for the inflammatory biomarker CXCR2. All the pre-specified analytical criteria were met. Cxbladder had diagnostic sensitivity, specificity, positive predictive value, and negative predictive values of 77%, 94%, 68%, and 96%, respectively, for Detect; 95%, 46%, 20%, and 98% for Triage; and 91%, 39%, 21%, and 96% for Monitor. Cxbladder had high analytical accuracy (≤10.63% inaccuracy across all biomarkers) and good reproducibility (>85% concordance between laboratories). Conclusions: Cxbladder accurately and reproducibly detects UC biomarker expression and can aid clinicians in risk stratification of hematuria patients or those undergoing surveillance for recurrent UC.
Keywords: analytical validation; biomarkers; hematuria; monitoring; reverse transcription-quantitative PCR; urothelial carcinoma; urinary tests analytical validation; biomarkers; hematuria; monitoring; reverse transcription-quantitative PCR; urothelial carcinoma; urinary tests

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MDPI and ACS Style

Harvey, J.C.; Cambridge, L.M.; Ellen, C.W.; Colonval, M.; Hazlett, J.A.; Newell, J.; Zhou, X.; Guilford, P.J. Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics 2024, 14, 2061. https://doi.org/10.3390/diagnostics14182061

AMA Style

Harvey JC, Cambridge LM, Ellen CW, Colonval M, Hazlett JA, Newell J, Zhou X, Guilford PJ. Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics. 2024; 14(18):2061. https://doi.org/10.3390/diagnostics14182061

Chicago/Turabian Style

Harvey, Justin C., Lisa M. Cambridge, Charles W. Ellen, Megan Colonval, Jody A. Hazlett, Jordan Newell, Xin Zhou, and Parry J. Guilford. 2024. "Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma" Diagnostics 14, no. 18: 2061. https://doi.org/10.3390/diagnostics14182061

APA Style

Harvey, J. C., Cambridge, L. M., Ellen, C. W., Colonval, M., Hazlett, J. A., Newell, J., Zhou, X., & Guilford, P. J. (2024). Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics, 14(18), 2061. https://doi.org/10.3390/diagnostics14182061

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