Creation of a low-risk reference group and referenceinterval of fasting venous plasma glucose
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Abstract
Reference intervals are recommended for naturally occurring quantities and required in the evaluation of new components in order to provide clinically useful information.
The aim of the present study is to present a method for selecting reference individuals for the determination of fasting venous plasma glucose (f-vPG) reference intervals and ways to determine if disease groups can share reference intervals with an ideal reference population.
Reference subjects were randomly selected, eligibility was judged according to predetermined inclusion and exclusion criteria. Using the literature we selected risk indicators for diabetes mellitus (DM) and used these indicators to rule out high-risk individuals in order to obtain a reference distribution of f-vPG determined using individuals with low risk of DM. The distributions of f-vPG in the high-risk individuals was compared with that determined for the low-risk group. We then estimated the ability of the high-risk individuals to share the reference interval of the low risk individuals, and calculated the fraction that was outside this interval. Distributions were also investigated for linearity in the cumulated frequency rankit distribution of ln-values. The allowable difference between two reference limits could not exceed 0.375 times the population biological variation.
Most risk indicators were powerful predictors of high f-vPG values. Subgroups with these risk indicators should not be included in the homogeneous ln-normally distributed reference distribution. Distributions of f-vPG concentrations in individuals with risk factors were not homogeneous and varying percentages of individuals were outside the reference distribution, having f-vPG greater than 7.0 mmol/l.
We conclude that randomisation is only useful to recruit candidate reference subjects. To rule out subjects according to clinical risk factors for diabetes, it is necessary to identify a reference population with low risk of exhibiting increased f-vPG concentrations. This method may be used to validate a reference interval for a particular analyte with respect to an investigated disease, and to stratify risk factors of importance.
Copyright (c) 2004 by Walter de Gruyter GmbH & Co. KG
Articles in the same Issue
- Editors introduction
- Reference values: from philosophy to a tool for laboratory medicine
- The evolution of the reference value concept
- Normality: the unreachable star?
- Selecting clinically relevant populations for reference intervals
- The IFCC recommendation on estimation of reference intervals. The RefVal Program
- Graphical interpretation of confidence curves in rankit plots
- Partitioning biochemical reference data intosubgroups: comparison of existing methods
- Parametric methods for estimating covariate-dependent reference limits
- Reference regions of two or more dimensions
- Should we maintain the 95 percent reference intervals in the era of wellness testing? A concept paper
- Clinical interpretation of reference intervals and reference limits. A plea for assay harmonization
- Inherent biological variation and reference values
- Intraindividual reference values
- Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences
- Proposal for guidelines to establish common biological reference intervals in large geographical areas for biochemical quantities measured frequently in serum and plasma
- Reference intervals for plasma proteins: similarities and differences between adult Caucasian and Asian Indian males in Yorkshire, UK
- Diagnostic and epidemiological implications of regional differences in serum concentrations of proteins observed in six Asian cities
- Study of reference values and biological variation: a necessity and a model for Preventive Medicine Centers
- Creation of a low-risk reference group and referenceinterval of fasting venous plasma glucose
- Establishment of a serum thyroid stimulating hormone (TSH) reference interval in healthy adults. The importance of environmental factors, including thyroid antibodies
- Difficulties in establishing reference intervals for special fluids: the example of 5-hydroxyindoleacetic acid and homovanillic acid in cerebrospinal fluids
- Metrological traceability of calibration in the estimation and use of common medical decision-making criteria
- Creation of the necessary analytical quality for generating and using reference intervals
- Analytical quality specifications for common reference intervals
- Design of internal quality control for reference value studies
- The NEXUS vision: an alternative to the reference value concept
- Meetings and Awards
Articles in the same Issue
- Editors introduction
- Reference values: from philosophy to a tool for laboratory medicine
- The evolution of the reference value concept
- Normality: the unreachable star?
- Selecting clinically relevant populations for reference intervals
- The IFCC recommendation on estimation of reference intervals. The RefVal Program
- Graphical interpretation of confidence curves in rankit plots
- Partitioning biochemical reference data intosubgroups: comparison of existing methods
- Parametric methods for estimating covariate-dependent reference limits
- Reference regions of two or more dimensions
- Should we maintain the 95 percent reference intervals in the era of wellness testing? A concept paper
- Clinical interpretation of reference intervals and reference limits. A plea for assay harmonization
- Inherent biological variation and reference values
- Intraindividual reference values
- Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences
- Proposal for guidelines to establish common biological reference intervals in large geographical areas for biochemical quantities measured frequently in serum and plasma
- Reference intervals for plasma proteins: similarities and differences between adult Caucasian and Asian Indian males in Yorkshire, UK
- Diagnostic and epidemiological implications of regional differences in serum concentrations of proteins observed in six Asian cities
- Study of reference values and biological variation: a necessity and a model for Preventive Medicine Centers
- Creation of a low-risk reference group and referenceinterval of fasting venous plasma glucose
- Establishment of a serum thyroid stimulating hormone (TSH) reference interval in healthy adults. The importance of environmental factors, including thyroid antibodies
- Difficulties in establishing reference intervals for special fluids: the example of 5-hydroxyindoleacetic acid and homovanillic acid in cerebrospinal fluids
- Metrological traceability of calibration in the estimation and use of common medical decision-making criteria
- Creation of the necessary analytical quality for generating and using reference intervals
- Analytical quality specifications for common reference intervals
- Design of internal quality control for reference value studies
- The NEXUS vision: an alternative to the reference value concept
- Meetings and Awards
