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      Is Open Access

      Recent Trends in Creatinine Assays in Korea: Long-Term Accuracy-Based Proficiency Testing Survey Data by the Korean Association of External Quality Assessment Service (2011–2019)

      research-article
      , M.D., Ph.D. 1 , , M.D., Ph.D. 2 , , M.D., Ph.D. 3 , , M.D., Ph.D. 4 , , M.D., Ph.D. 5 , , M.D., Ph.D. 4 , , M.D., Ph.D. 3 , , M.D., Ph.D. 4
      Annals of Laboratory Medicine
      Korean Society for Laboratory Medicine
      Accuracy, Bias, Creatinine, Proficiency testing, Survey

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          Abstract

          Background

          Accurate serum creatinine (Cr) concentration measurement is essential for evaluating kidney function. In 2011, the Korean Association of External Quality Assessment Service (KEQAS) launched an accuracy-based Cr proficiency testing (ABCr PT) survey. We analyzed long-term data of the KEQAS ABCr PT survey collected between 2011 and 2019 to assess recent trends in Cr assays in Korea.

          Methods

          The ABCr PT survey including three commutable fresh-frozen serum samples was performed twice a year. The target Cr concentration was assigned using isotope-dilution mass spectrometry. We analyzed data obtained from the participating laboratories, calculated the yearly bias, and evaluated bias trends for the major reagents and instruments. Outliers were excluded from all analysis.

          Results

          The mean percentage bias based on the total data of all participating laboratories was 10.8% in the 2011-A survey and 0.2% in 2019-B survey. Bias for the major reagents and instruments differed depending on the manufacturer. Enzymatic assays generally showed desirable bias ranging from –3.9% to 3.2% at all Cr concentrations and lower interlaboratory variability than non-enzymatic assays (enzymatic vs. non-enzymatic, 3.3%–7.2% vs. 6.3%–9.1%).

          Conclusions

          Although the mean percentage bias of Cr assays tends to decrease over time, it is necessary to continuously strive to improve Cr assay accuracy, especially at low concentrations.

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          Most cited references19

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          KDIGO Clinical Practice Guidelines for Acute Kidney Injury

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            National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification.

            Chronic kidney disease is a worldwide public health problem with an increasing incidence and prevalence, poor outcomes, and high cost. Outcomes of chronic kidney disease include not only kidney failure but also complications of decreased kidney function and cardiovascular disease. Current evidence suggests that some of these adverse outcomes can be prevented or delayed by early detection and treatment. Unfortunately, chronic kidney disease is underdiagnosed and undertreated, in part as a result of lack of agreement on a definition and classification of its stages of progression. Recent clinical practice guidelines by the National Kidney Foundation 1) define chronic kidney disease and classify its stages, regardless of underlying cause, 2) evaluate laboratory measurements for the clinical assessment of kidney disease, 3) associate the level of kidney function with complications of chronic kidney disease, and 4) stratify the risk for loss of kidney function and development of cardiovascular disease. The guidelines were developed by using an approach based on the procedure outlined by the Agency for Healthcare Research and Quality. This paper presents the definition and five-stage classification system of chronic kidney disease and summarizes the major recommendations on early detection in adults. Recommendations include identifying persons at increased risk (those with diabetes, those with hypertension, those with a family history of chronic kidney disease, those older than 60 years of age, or those with U.S. racial or ethnic minority status), detecting kidney damage by measuring the albumin-creatinine ratio in untimed ("spot") urine specimens, and estimating the glomerular filtration rate from serum creatinine measurements by using prediction equations. Because of the high prevalence of early stages of chronic kidney disease in the general population (approximately 11% of adults), this information is particularly important for general internists and specialists.
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              Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program.

              G. Myers (2006)
              Reliable serum creatinine measurements in glomerular filtration rate (GFR) estimation are critical to ongoing global public health efforts to increase the diagnosis and treatment of chronic kidney disease (CKD). We present an overview of the commonly used methods for the determination of serum creatinine, method limitations, and method performance in conjunction with the development of analytical performance criteria. Available resources for standardization of serum creatinine measurement are discussed, and recommendations for measurement improvement are given. The National Kidney Disease Education Program (NKDEP) Laboratory Working Group reviewed problems related to serum creatinine measurement for estimating GFR and prepared recommendations to standardize and improve creatinine measurement. The NKDEP Laboratory Working Group, in collaboration with international professional organizations, has developed a plan that enables standardization and improved accuracy (trueness) of serum creatinine measurements in clinical laboratories worldwide that includes the use of the estimating equation for GFR based on serum creatinine concentration that was developed from the Modification of Diet in Renal Disease (MDRD) study. The current variability in serum creatinine measurements renders all estimating equations for GFR, including the MDRD Study equation, less accurate in the normal and slightly increased range of serum creatinine concentrations [<133 micromol/L (1.5 mg/dL)], which is the relevant range for detecting CKD [<60 mL.min(-1).(1.73 m2)(-1)]. Many automated routine methods for serum creatinine measurement meet or exceed the required precision; therefore, reduction of analytical bias in creatinine assays is needed. Standardization of calibration does not correct for analytical interferences (nonspecificity bias). The bias and nonspecificity problems associated with some of the routine methods must be addressed.
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                Author and article information

                Journal
                Ann Lab Med
                Ann Lab Med
                Annals of Laboratory Medicine
                Korean Society for Laboratory Medicine
                2234-3806
                2234-3814
                01 July 2021
                01 July 2021
                01 July 2021
                : 41
                : 4
                : 372-379
                Affiliations
                [1 ]Department of Laboratory Medicine, Ewha Womans University College of Medicine, Seoul, Korea
                [2 ]Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea
                [3 ]Department of Laboratory Medicine, Seoul National University Bundang Hospital and College of Medicine, Seongnam, Korea
                [4 ]Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea
                [5 ]Department of Laboratory Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Korea
                Author notes
                Corresponding author: Won-Ki Min, M.D., Ph.D. Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea Tel: +82-2-3010-4503 Fax: +82-2-478-0884 E-mail: wkmin@ 123456amc.seoul.kr
                Author information
                https://orcid.org/0000-0002-3873-3117
                https://orcid.org/0000-0003-1907-9639
                https://orcid.org/0000-0002-3154-0347
                https://orcid.org/0000-0003-3956-6397
                https://orcid.org/0000-0002-5485-8331
                https://orcid.org/0000-0002-5792-973X
                https://orcid.org/0000-0003-0576-9938
                https://orcid.org/0000-0002-5158-2130
                Article
                alm-41-4-372
                10.3343/alm.2021.41.4.372
                7884186
                33536355
                fbc2926f-a356-4d00-b761-949f87b472ea
                © Korean Society for Laboratory Medicine

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 July 2020
                : 17 August 2020
                : 11 January 2021
                Categories
                Original Article
                Clinical Chemistry

                Clinical chemistry
                accuracy,bias,creatinine,proficiency testing,survey
                Clinical chemistry
                accuracy, bias, creatinine, proficiency testing, survey

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