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Published on: March 22, 2022
Annual biological variation and personalized reference intervals of clinical chemistry and hematology analytes
Shuo Wang1, Min Zhao1, Zihan Su1
1Department of Laboratory Medicine, The First Hospital of China Medical University, National Clinical Research Center for Laboratory Medicine, Shenyang, Liaoning, P.R. China.
Insights
Annual biological variation (BV) data offers more accurate lab result evaluation for health checkups. Personalized reference intervals (RIper) derived from long-term BV are valuable for individualized health assessments.
Area of Science:
- Clinical Chemistry
- Hematology
- Biostatistics
Background:
- Accurate laboratory criteria for evaluating health status during annual checkups are limited.
- Annual biological variation (BV) and derived parameters are crucial for precise interpretation of laboratory results in healthcare populations.
Purpose of the Study:
- To determine annual biological variation (BV) and key parameters for common laboratory analytes.
- To establish personalized reference intervals (RIper) for improved health assessment accuracy.
Main Methods:
- Collected annual laboratory data from 43 healthy individuals over six years.
- Calculated annual BV, reference change value (RCV), index of individuality (II), and RIper.
- Compared annual data parameters with weekly data and population-based reference intervals (RIpop).
Main Results:
- Established annual BV (CV I), RCV, II, and RIper for 24 clinical chemistry and hematology analytes.
- Annual CV I estimates were higher than weekly for 11 analytes.
- Limited utility of RIpop for ~50% of analytes due to low II (<0.6); RIper showed limited overlap with RIpop.
Conclusions:
- Annual BV and related parameters provide more accurate laboratory result evaluation for annual healthcare individuals compared to weekly BV.
- RIper, based on long-term BV data, is highly valuable for personalized diagnosis in annual health assessments.
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.
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