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Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects
Chenbin Li1,2, Mingting Peng1,2,3, Ji Wu4
1National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China.
Insights
This study defines biological variation for complete blood count (CBC) parameters in a Chinese population, providing essential data for analytical performance specifications. Findings align with global estimates, aiding clinical laboratory standardization.
Area of Science:
- Clinical Chemistry
- Hematology
- Biostatistics
Background:
- The complete blood count (CBC) is a fundamental diagnostic test.
- Reliable biological variation (BV) data are crucial for establishing analytical performance specifications for CBC tests.
- This study aimed to define CBC parameter BV using a BIVAC-compliant protocol.
Purpose of the Study:
- To determine the biological variation (BV) of 13 complete blood count (CBC) parameters.
- To establish gender-stratified within-subject (CVI) and between-subject (CVG) BV estimates.
- To ensure the safe clinical application of CBC tests through reliable performance specifications.
Main Methods:
- Blood samples from 41 healthy Chinese adults were collected monthly for 6 months.
- 13 CBC parameters were analyzed in duplicate using an ABX Pentra 80 instrument.
- Nested ANOVA was employed after data assessment for outliers, normality, and variance homogeneity.
Main Results:
- Gender-stratified within-subject variation (CVI) showed no significant differences.
- Between-subject variation (CVG) differed significantly between genders for 10 of 13 parameters.
- BV estimates were comparable to those reported for Europid populations.
Conclusions:
- Biological variation estimates in BIVAC-compliant studies are generally consistent.
- Consideration of blood cell turnover time and participant age distribution is important for CBC BV studies.
- This research contributes valuable data to global BV estimates and informs future studies.
Abstract:
Background The complete blood count (CBC) is a basic test routinely ordered by physicians as a part of initial diagnostic work-up on their patients. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are needed to establish analytical performance specifications. Our aim was to define the BV of CBC parameters using a rigorous protocol that is compliant with the Biological Variation Data Critical Appraisal Checklist (BIVAC) provided by the European Federation of Clinical Chemistry and Laboratory Medicine. Methods Blood samples drawn from 41 healthy Chinese subjects (22 females and 19 males; 23-59 years of age) once monthly for 6 consecutive months were analyzed using an ABX Pentra 80 instrument. The instrument was precisely calibrated. All samples were analyzed in duplicate for 13 CBC parameters. The data were assessed for outliers, normality, and variance homogeneity prior to nested ANOVA. Gender-stratified within-subject (CVI) and between-subject (CVG) BV estimates were calculated. Results The number of remaining data for each subject was 442-484 after removing outliers. No significant differences existed between female/male CVI estimates. Except for leukocytes, neutrophils, and lymphocytes, the mean values of 10 parameters differed significantly between genders, rendering partitioning of CVG data between genders. No significant differences were detected between most BV estimates and recently published estimates representing a Europid population. Conclusions Most BV estimates in BIVAC-compliant studies are similar. The turnover time of blood cells and age distribution of participants should be considered in a CBC BV study. Our study will contribute to global BV estimates and future studies.
