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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

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Volume 57, Issue 11


Performance evaluation of an Indoxyl Sulfate Assay Kit “NIPRO”

Yuki Fushimi / Junko Tatebe / Yuko Okuda / Toshiaki Ishii / Shinji Ujiie / Toshisuke Morita
  • Corresponding author
  • Department of Clinical Laboratory, Toho University Omori Medical Center, Tokyo, Japan
  • Department of Laboratory Medicine, Toho University Graduate School of Medicine, Tokyo, Japan
  • Email
  • Other articles by this author:
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Published Online: 2019-06-07 | DOI: https://doi.org/10.1515/cclm-2019-0218



The relationship between renal disease and cardiovascular disease (CVD) is currently known as cardiorenal syndrome. Indoxyl sulfate (IS) is one of the uremic toxins that accelerates the progression of cardiorenal syndrome. This report presents a new method for measuring IS in a simpler way.


We evaluated the analytical performance of an IS Assay Kit “NIPRO” loaded on LABOSPECT 008. The evaluated analytical performances included accuracy, precision, dilution linearity, limit of detection (LOD), limit of quantitation (LOQ), recovery test, interference test and comparison against assays performed by high-performance liquid chromatography (HPLC).


Total precision showed a <5.3% coefficient of variation at IS concentrations of 3.57–277.73 μmol/L, and satisfactory results were observed in the dilution linearity, LOD, LOQ, recovery and interference tests. The IS Assay Kit “NIPRO” showed a high correlation with the HPLC conventional method (r = 0.993).


The IS Assay Kit “NIPRO” demonstrated satisfactory analytical performance, and this suggests it could shortly become another common method to measure circulating IS.

Keywords: analytical performance; cardiorenal syndrome; indoxyl sulfate


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About the article

Corresponding author: Toshisuke Morita, MD, PhD, Department of Laboratory Medicine, Toho University Graduate School of Medicine, 5-21-16, Omori-nishi, Ota-ku, Tokyo 143-8540, Japan; and Department of Clinical Laboratory, Toho University Omori Medical Center, Tokyo, Japan, Phone: +81-3-3762-4151, Fax: +81-3-3762-8714

Received: 2019-02-24

Accepted: 2019-05-10

Published Online: 2019-06-07

Published in Print: 2019-10-25

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: Y.F., J.T., Y.O., T.I. and S.U. have no conflict of interest. T.M. received a research grant from NIPRO.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 11, Pages 1770–1776, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0218.

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