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      Biological variation and reference change values of serum Mac‐2–binding protein glycosylation isomer (M2BPGi)

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          Abstract

          Background

          Limited data are available with regard to biological variations of the Mac‐2–binding protein glycosylation isomer (M2BPGi), a liver fibrosis biomarker.

          Methods

          Long‐term biological variation of M2BPGi was investigated using longitudinally measured M2BPGi test results from healthy Korean adult subjects. One‐way analysis of variance (ANOVA) tests were used to calculate the reference change value (RCV) of M2BPGi based on biological variation estimates. Furthermore, asymmetric RCV was calculated according to a recent publication of the European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation and Task Group for the Biological Variation Database (EFLM TG‐BVD).

          Results

          A total of 363 test results from 174 Korean subjects undergoing general health checkups were requested from 13 local clinics and hospitals during a 38‐month period. The within‐subjects biological variation (CV I), between‐subject biological variation (CV G), analytical variation (CV A), RCV, and individuality index (II) values for serum M2BPGi were 23.3%, 30.0%, 4.3%, 65.6%, and 0.78, respectively. Asymmetric RCV calculated using formulae by a recent EFLM TG‐BVD publication ranged from −41.9 to 72.0%. Desirable analytical performance specifications for M2BPGi derived from biological variation were as follows: imprecision 11.6%, bias 9.6%, and total allowable error 28.7%.

          Conclusions

          RCV based on biological estimates may be helpful for evaluating and interpreting serial M2BPGi measurements by physicians and in clinical laboratories.

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          Most cited references16

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          Mac-2 binding protein glycan isomer (M2BPGi) is a new serum biomarker for assessing liver fibrosis: more than a biomarker of liver fibrosis

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            The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation.

            Concern has been raised about the quality of available biological variation (BV) estimates and the effect of their application in clinical practice. A European Federation of Clinical Chemistry and Laboratory Medicine Task and Finish Group has addressed this issue. The aim of this report is to (a) describe the Biological Variation Data Critical Appraisal Checklist (BIVAC), which verifies whether publications have included all essential elements that may impact the veracity of associated BV estimates, (b) use the BIVAC to critically appraise existing BV publications on enzymes, lipids, kidney, and diabetes-related measurands, and (c) apply metaanalysis to deliver a global within-subject BV (CVI) estimate for alanine aminotransferase (ALT).
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              Reference change values.

              Reference change values (RCV) provide objective tools for assessment of the significance of differences in serial results from an individual. The concept is simple and the calculation easy, since all laboratories know their analytical imprecision (CV(A)) and estimates of within-subject biological variation (CV(I)) are available for a large number of quantities. Generally, CV(I) are constant over time, geography, methodology and in health and chronic stable disease. The formula is RCV=2(1/2) · Z · (CV(A)(2) + CV(I)(2))(1/2), where Z is the number of standard deviations appropriate to the probability. Correct interpretation of the semantics describing the clinical use of RCV is vital for selection of the Z-score. Many quantities of clinically importance exist for which good estimates of RCV are unavailable. Derivation of CV(I) may be difficult for such quantities: flair and imagination are required in selecting populations with chronic but stable disease on whom CV(I) can be determined. RCV can be used for delta-checking and auto-verification and laboratory information management systems (LIMS) can be adapted to do this. Recently, log-normal transformation to obtain unidirectional RCV has been used. Gaps in knowledge of RCV still require filling since the need for measures of change is clearly expressed in guidelines.
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                Author and article information

                Contributors
                sglee@gclabs.co.kr
                ehlee@gclabs.co.kr
                Journal
                J Clin Lab Anal
                J Clin Lab Anal
                10.1002/(ISSN)1098-2825
                JCLA
                Journal of Clinical Laboratory Analysis
                John Wiley and Sons Inc. (Hoboken )
                0887-8013
                1098-2825
                13 March 2022
                April 2022
                : 36
                : 4 ( doiID: 10.1002/jcla.v36.4 )
                : e24319
                Affiliations
                [ 1 ] Department of Laboratory Medicine Green Cross Laboratories Yongin Republic of Korea
                [ 2 ] Department of Laboratory Medicine and Genetics Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Republic of Korea
                [ 3 ] Department of Infectious Disease Green Cross Laboratories Yongin Republic of Korea
                [ 4 ] Green Cross Laboratories Yongin Republic of Korea
                Author notes
                [*] [* ] Correspondence

                Sang Gon Lee, Department of Laboratory Medicine, Green Cross Laboratories, Yongin 16924, Republic of Korea.

                Email: sglee@ 123456gclabs.co.kr

                Eun Hee Lee, Green Cross Laboratories, Yongin 16924, Republic of Korea.

                Email: ehlee@ 123456gclabs.co.kr

                Author information
                https://orcid.org/0000-0002-8266-2248
                https://orcid.org/0000-0002-4672-5811
                https://orcid.org/0000-0002-2517-175X
                Article
                JCLA24319
                10.1002/jcla.24319
                8993623
                35285104
                8631c736-6d46-4619-959f-2c89a779e380
                © 2022 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 15 February 2022
                : 17 August 2021
                : 17 February 2022
                Page count
                Figures: 1, Tables: 2, Pages: 5, Words: 3430
                Categories
                Brief Report
                Brief Report
                Custom metadata
                2.0
                April 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.3 mode:remove_FC converted:08.04.2022

                Clinical chemistry
                biological variation,health checkup,korea,liver fibrosis,m2bpgi
                Clinical chemistry
                biological variation, health checkup, korea, liver fibrosis, m2bpgi

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