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Influencing factors on the NMP-22 urine assay: an experimental model

BACKGROUND: The commercial NMP-22 urine assays for bladder cancer (BCa) detect nuclear mitotic apparatus protein 1 (NUMA1) using monoclonal antibodies. It remains unclear whether these assays are monitoring a tumor antigen or some other phenomenon associated with the disease state. In this study, we...

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Autores principales: Miyake, Makito, Goodison, Steve, Giacoia, Evan Gomes, Rizwani, Wasia, Ross, Shanti, Rosser, Charles J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3480828/
https://www.ncbi.nlm.nih.gov/pubmed/22928931
http://dx.doi.org/10.1186/1471-2490-12-23
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author Miyake, Makito
Goodison, Steve
Giacoia, Evan Gomes
Rizwani, Wasia
Ross, Shanti
Rosser, Charles J
author_facet Miyake, Makito
Goodison, Steve
Giacoia, Evan Gomes
Rizwani, Wasia
Ross, Shanti
Rosser, Charles J
author_sort Miyake, Makito
collection PubMed
description BACKGROUND: The commercial NMP-22 urine assays for bladder cancer (BCa) detect nuclear mitotic apparatus protein 1 (NUMA1) using monoclonal antibodies. It remains unclear whether these assays are monitoring a tumor antigen or some other phenomenon associated with the disease state. In this study, we investigated the influence of urinary cellular and protein concentration, and hematuria on the performance of the NMP-22 tests in an experimental model. METHODS: Pooled urine from healthy subjects were spiked with varying concentrations of benign (UROtsa) cells, cancer cells (RT4, T24, KU-7 and UM-UC-14), whole blood or serum, prior to analysis with both NMP22® Bladder Cancer ELISA test and the NMP22® BladderChek® point-of-care test. RESULTS: Urines from control subjects were negative for NMP-22. The addition of whole blood at 50ul/10 ml, but not serum, resulted in a false-positive result. Furthermore, the addition of a high concentration of benign urothelial cells (10(6)) or the cell lysate from these cells (306 μg protein) resulted in a false-positive result. High concentrations of pooled-cancer cells (10(6)) or cell lysate (30.6 μg and above) resulted in a positive NMP-22 assay. Concordance between the NMP-22 ELISA assay and the NMP-22 point of care assay was >90%. CONCLUSIONS: Rather than detecting a specific tumor antigen, urinary NMP-22 assays may be measuring the cellularity or amount of cell turnover that may be introduced into the urine by a variety of conditions, including surface shedding from bladder tumors. The absence of significant urinary cellularity in some cases due to lesion characteristics or the timing of sampling may result in false-negative NMP-2 assays.
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spelling pubmed-34808282012-10-27 Influencing factors on the NMP-22 urine assay: an experimental model Miyake, Makito Goodison, Steve Giacoia, Evan Gomes Rizwani, Wasia Ross, Shanti Rosser, Charles J BMC Urol Research Article BACKGROUND: The commercial NMP-22 urine assays for bladder cancer (BCa) detect nuclear mitotic apparatus protein 1 (NUMA1) using monoclonal antibodies. It remains unclear whether these assays are monitoring a tumor antigen or some other phenomenon associated with the disease state. In this study, we investigated the influence of urinary cellular and protein concentration, and hematuria on the performance of the NMP-22 tests in an experimental model. METHODS: Pooled urine from healthy subjects were spiked with varying concentrations of benign (UROtsa) cells, cancer cells (RT4, T24, KU-7 and UM-UC-14), whole blood or serum, prior to analysis with both NMP22® Bladder Cancer ELISA test and the NMP22® BladderChek® point-of-care test. RESULTS: Urines from control subjects were negative for NMP-22. The addition of whole blood at 50ul/10 ml, but not serum, resulted in a false-positive result. Furthermore, the addition of a high concentration of benign urothelial cells (10(6)) or the cell lysate from these cells (306 μg protein) resulted in a false-positive result. High concentrations of pooled-cancer cells (10(6)) or cell lysate (30.6 μg and above) resulted in a positive NMP-22 assay. Concordance between the NMP-22 ELISA assay and the NMP-22 point of care assay was >90%. CONCLUSIONS: Rather than detecting a specific tumor antigen, urinary NMP-22 assays may be measuring the cellularity or amount of cell turnover that may be introduced into the urine by a variety of conditions, including surface shedding from bladder tumors. The absence of significant urinary cellularity in some cases due to lesion characteristics or the timing of sampling may result in false-negative NMP-2 assays. BioMed Central 2012-08-28 /pmc/articles/PMC3480828/ /pubmed/22928931 http://dx.doi.org/10.1186/1471-2490-12-23 Text en Copyright ©2012 Miyake et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Miyake, Makito
Goodison, Steve
Giacoia, Evan Gomes
Rizwani, Wasia
Ross, Shanti
Rosser, Charles J
Influencing factors on the NMP-22 urine assay: an experimental model
title Influencing factors on the NMP-22 urine assay: an experimental model
title_full Influencing factors on the NMP-22 urine assay: an experimental model
title_fullStr Influencing factors on the NMP-22 urine assay: an experimental model
title_full_unstemmed Influencing factors on the NMP-22 urine assay: an experimental model
title_short Influencing factors on the NMP-22 urine assay: an experimental model
title_sort influencing factors on the nmp-22 urine assay: an experimental model
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3480828/
https://www.ncbi.nlm.nih.gov/pubmed/22928931
http://dx.doi.org/10.1186/1471-2490-12-23
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