Performance evaluation of an Indoxyl Sulfate Assay Kit “NIPRO”

Yuki Fushimi; Junko Tatebe; Yuko Okuda; Toshiaki Ishii; Shinji Ujiie; Toshisuke Morita

doi:10.1515/cclm-2019-0218

Article

Performance evaluation of an Indoxyl Sulfate Assay Kit “NIPRO”

Yuki Fushimi , Junko Tatebe , Yuko Okuda , Toshiaki Ishii , Shinji Ujiie and Toshisuke Morita

Published/Copyright: June 7, 2019

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 57 Issue 11

Abstract

Background

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.

Methods

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).

Results

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).

Conclusions

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

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

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.

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Received: 2019-02-24

Accepted: 2019-05-10

Published Online: 2019-06-07

Published in Print: 2019-10-25

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Articles in the same Issue

https://doi.org/10.1515/cclm-2019-0218

Keywords for this article

analytical performance; cardiorenal syndrome; indoxyl sulfate