Standardization of measurement procedures for serum uric acid: 8-year experience from Category 1 EQA program results in China

Jiangtao Zhang; Wenbo Luo; Jie Zeng; Tianjiao Zhang; Weiyan Zhou; Haijian Zhao; Ying Yan; Cuihua Hu; Rong Ma; Jing Wang; Wenxiang Chen; Chuanbao Zhang

doi:10.1515/cclm-2018-0274

Article

Standardization of measurement procedures for serum uric acid: 8-year experience from Category 1 EQA program results in China

Jiangtao Zhang , Wenbo Luo , Jie Zeng , Tianjiao Zhang , Weiyan Zhou , Haijian Zhao , Ying Yan , Cuihua Hu , Rong Ma , Jing Wang , Wenxiang Chen and Chuanbao Zhang

Published/Copyright: February 5, 2019

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 57 Issue 4

Abstract

Background

Serum uric acid is a critical clinical indicator, and results without equivalence among laboratories cause troubles for disease diagnosis and patient management. External quality assessment (EQA) is a common tool for enhancing harmonization/standardization, therefore, the National Center for Clinical Laboratories in China has initiated a category 1 EQA for serum uric acid measurement since 2010 for evaluating its process of standardization.

Methods

Commutable EQA samples with target values assigned by reference measurement procedures were sent to participant laboratories. Both concentrations were measured 15 times in 3 days then means and intra-laboratory coefficient of variations (CVs) were reported. Biological variation criteria were used for analysis with CLIA88 criteria as a comparison.

Results

A total of 1250 laboratories participated in EQA programs from 2010 to 2017, pass rates calculated according to desirable specifications in biological variation database were on a rise overall and inter-laboratory mean bias and CVs were on a decrease. Homogeneous systems showed better inter-laboratory CVs and pass rates than heterogeneous systems. For the mostly used measurement systems; Abbott, Beckman, Roche Modular, Siemens and Hitachi showed desirable performances other than Roche Cobas, according to biological variation criteria.

Conclusions

Our study provides reliable information on the standardization of measurement procedures for serum uric acid for manufacturers and laboratories. Further improvements for standardization are still needed to make laboratories more patient-centered.

Keywords: bias; biological variation; coefficient of variation; external quality assessment; serum uric acid; standardization

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: The Leaping Development Project of Beijing Biomedical Industry, Grant Number: No. Z161100001816043. The National High Technology Research and Development Program of China (863 Program), Grant Number: No. 2011AA02A102
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: 2018-03-14

Accepted: 2018-08-12

Published Online: 2019-02-05

Published in Print: 2019-03-26

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Articles in the same Issue

https://doi.org/10.1515/cclm-2018-0274

Keywords for this article

bias; biological variation; coefficient of variation; external quality assessment; serum uric acid; standardization