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J Transl Med. 2016 Jan 30;14:31. doi: 10.1186/s12967-016-0783-2.

A multiplex immunoassay for the non-invasive detection of bladder cancer.

Author information

1
University of Hawaii Cancer Center, 701 Ilalo St, Rm 327, Honolulu, HI, 96813, USA. yoshikos@hawaii.edu.
2
Department of Molecular Biosciences and Bioengineering, University of Hawaii at Manoa, Honolulu, HI, USA. yoshikos@hawaii.edu.
3
University of Hawaii Cancer Center, 701 Ilalo St, Rm 327, Honolulu, HI, 96813, USA. hfuruya@cc.hawaii.edu.
4
University of Hawaii Cancer Center, 701 Ilalo St, Rm 327, Honolulu, HI, 96813, USA. pgreenwood@queens.org.
5
University of Hawaii Cancer Center, 701 Ilalo St, Rm 327, Honolulu, HI, 96813, USA. ochan@cc.hawaii.edu.
6
Department of Biostatistics, University of Florida, Gainesville, FL, USA. ydai@ichp.ufl.edu.
7
Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. mthornqu@fredhutch.org.
8
Nonagen BioScience Corp, Jacksonville, FL, USA. goodison.steven@mayo.edu.
9
Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL, USA. goodison.steven@mayo.edu.
10
University of Hawaii Cancer Center, 701 Ilalo St, Rm 327, Honolulu, HI, 96813, USA. cjrosser@hawaii.edu.
11
Nonagen BioScience Corp, Jacksonville, FL, USA. cjrosser@hawaii.edu.

Abstract

BACKGROUND:

Urine based assays that can non-invasively detect bladder cancer (BCa) have the potential to reduce unnecessary and invasive procedures. The purpose of this study was to develop a multiplex immunoassay that can accurately and simultaneously monitor ten diagnostic urinary protein biomarkers for application as a non-invasive test for BCa detection.

METHODS:

A custom electrochemiluminescent multiplex assay was constructed (Meso Scale Diagnostics, LLC, Rockville, MD, USA) to detect the following urinary proteins; IL8, MMP9, MMP10, ANG, APOE, SDC1, A1AT, PAI1, CA9 and VEGFA. Voided urine samples from two cohorts were collected prior to cystoscopy and samples were analyzed blinded to the clinical status of the participants. Means (±SD) and receiver operating characteristic (ROC) curve analysis were used to compare assay performance and to assess the diagnostic accuracy of the diagnostic signature.

RESULTS:

Comparative diagnostic performance analyses revealed an AUROC value of 0.9258 for the multiplex assay and 0.9467 for the combination of the single-target ELISA assays (p = 0.625), so there was no loss of diagnostic utility for the MSD multiplex assay. Analysis of the independent 200-sample cohort using the multiplex assay achieved an overall diagnostic sensitivity of 0.85, specificity of 0.81, positive predictive value 0.82 and negative predictive value 0.84.

CONCLUSIONS:

It is technically feasible to simultaneously monitor complex urinary diagnostic signatures in a single assay without loss of performance. The described protein-based assay has the potential to be developed for the non-invasive detection of BCa.

PMID:
26830497
PMCID:
PMC4736707
DOI:
10.1186/s12967-016-0783-2
[Indexed for MEDLINE]
Free PMC Article

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