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. 2021 Nov 15;60(4):606-617.
doi: 10.1515/cclm-2021-0479. Print 2022 Mar 28.

Annual biological variation and personalized reference intervals of clinical chemistry and hematology analytes

Shuo Wang  1 , Min Zhao  1 , Zihan Su  1 , Runqing Mu  1
Affiliations
Free article

Annual biological variation and personalized reference intervals of clinical chemistry and hematology analytes

Shuo Wang et al. Clin Chem Lab Med. .
Free article

Abstract

Objectives: A large number of people undergo annual health checkup but accurate laboratory criterion for evaluating their health status is limited. The present study determined annual biological variation (BV) and derived parameters of common laboratory analytes in order to accurately evaluate the test results of the annual healthcare population.

Methods: A total of 43 healthy individuals who had regular healthcare once a year for six consecutive years, were enrolled using physical, electrocardiogram, ultrasonography and laboratory. The annual BV data and derived parameters, such as reference change value (RCV) and index of individuality (II) were calculated and compared with weekly data. We used annual BV and homeostatic set point to calculate personalized reference intervals (RIper) which were compared with population-based reference intervals (RIpop).

Results: We have established the annual within-subject BV (CVI), RCV, II, RIper of 24 commonly used clinical chemistry and hematology analytes for healthy individuals. Among the 18 comparable measurands, CVI estimates of annual data for 11 measurands were significantly higher than the weekly data. Approximately 50% measurands of II were <0.6, the utility of their RIpop were limited. The distribution range of RIper for most measurands only copied small part of RIpop with reference range index for 8 measurands <0.5.

Conclusions: Compared with weekly BV, for annual healthcare individuals, annual BV and related parameters can provide more accurate evaluation of laboratory results. RIper based on long-term BV data is very valuable for "personalized" diagnosis on annual health assessments.

Keywords: biological variation; index of individuality; personalized reference intervals; reference change value; reference intervals.

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References

    1. Liuxin, W. Annual report on development of health management and health industry in China No. 2. Beijing: Social Sciences Academic Press; 2019.
    1. Liuxin, W. Report on development of health management and health industry in China – new subject and new format No. 1. Beijing: Social Sciences Academic Press; 2018.
    1. Jonker, N, Aslan, B, Boned, B, Marques-Garcia, F, Ricos, C, Alvarez, V, et al.. Critical appraisal and meta-analysis of biological variation estimates for kidney related analytes. Clin Chem Lab Med 2022;60:469–78. https://doi.org/10.1515/cclm-2020-1168.
    1. Gonzalez-Lao, E, Corte, Z, Simon, M, Ricos, C, Coskun, A, Braga, F, et al.. Systematic review of the biological variation data for diabetes related analytes. Clin Chim Acta 2019;488:61–7. https://doi.org/10.1016/j.cca.2018.10.031.
    1. Diaz-Garzon, J, Fernandez-Calle, P, Minchinela, J, Aarsand, AK, Bartlett, WA, Aslan, B, et al.. Biological variation data for lipid cardiovascular risk assessment biomarkers. A systematic review applying the biological variation data critical appraisal checklist (BIVAC). Clin Chim Acta 2019;495:467–75. https://doi.org/10.1016/j.cca.2019.05.013.

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