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Partitioning reference intervals by use of genetic information.
Brian H Shirts1, Andrew R Wilson, Brian R Jackson
1Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT 84112, USA. brian.shirts@hsc.utah.edu
Clinical Chemistry
|December 18, 2010
Summary
Incorporating genetic information into reference intervals can improve test result accuracy. A new method determines if partitioning reference intervals by genetic effects, like dominant or recessive variants, is statistically justified.
Area of Science:
- Clinical Chemistry
- Genetics
- Laboratory Medicine
Background:
- Genetic variations can cause unusual test results, complicating diagnosis.
- Subdividing reference intervals by genetic effects may increase endpoint uncertainty due to smaller sample sizes.
Purpose of the Study:
- To develop a method for partitioning reference intervals based on genetic variants.
- To evaluate the statistical justification for genetic partitioning using CLSI guidelines.
Main Methods:
- Evaluated CLSI guidelines for partitioning reference intervals by dominant or recessive genetic effects.
- Developed a method using pre-recruitment information for partitioning decisions.
- Applied the method to assess Gilbert syndrome as a case study.
Main Results:
- Partitioning is statistically justified when genetic polymorphism variance exceeds 4%.
- Decision curves were developed based on subgroup differences, SD, and allele frequencies.
- Partitioned intervals for Gilbert syndrome were warranted for White and African-American populations, but not Asian.
Conclusions:
- A straightforward method exists to evaluate the statistical justification of partitioning reference intervals by genetic effects.
- Limitations exist in integrating genetic, laboratory, and clinical data.
- Further research is needed for personalized medicine, considering complex genetic effects on patient normality.
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