J Lab Med Qual Assur.  2019 Mar;41(1):13-23. 10.15263/jlmqa.2019.41.1.13.

Accuracy-Based Proficiency Testing of Creatinine Measurement: 7 Years' Experience in Korea

Affiliations
  • 1Department of Laboratory Medicine, Ewha Womans University School of Medicine, Seoul, Korea. tdjeong@ewha.ac.kr
  • 2Clinical Trial Center, Ewha Womans University Mokdong Hospital, Seoul, Korea.
  • 3Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 4Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.

Abstract

BACKGROUND
Standardization of creatinine assay is consistently performed and much effort has been put into improving the accuracy of the results. We aimed to analyze the results of accuracy-based proficiency testing of creatinine assays performed by the Korea Association of External Quality Assessment Service from 2011 to 2017 to assess the current state of creatinine assays in Korea.
METHODS
From 2011 to 2017, the accuracy-based proficiency testing of creatinine was performed twice a year. We analyzed the results obtained from the participating laboratories and calculated the year-wise bias. The acceptable limit of bias was as follows: ±11.4% for creatinine concentration >1.0 mg/dL, and 0.114 mg/dL for creatinine concentration ≤1.0 mg/dL. The trend of bias with the major instruments and reagent manufacturers were analyzed.
RESULTS
The number of participating laboratories was 54 in 2011, which gradually increased to 146–178 after 2015. For each of the three samples used in the survey, the percentage of laboratories whose biases in the results were within the acceptable limits was 33.3% for the first time in 2011, which gradually increased to 74.7%–85.0% after 2014. The mean biases in all the results of the participating laboratories were 11.1% in 2011 (1st trial) and 2.4% in 2017 (2nd trial). The biases in the results with the major instruments and reagents differed according to the manufacturers.
CONCLUSIONS
The mean bias in the results obtained from the participating laboratories in the accuracy-based proficiency testing of creatinine surveys showed a decreasing trend.

Keyword

Accuracy; Bias; Creatinine; Proficiency testing
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