Reference intervals are the range of normal test values appropriate for a healthy individual and are vital for the proper interpretation of medical test results and accurate diagnoses. Clinicians rely on them to inform their treatment decisions and more precise reference intervals mean better patient outcomes.
Laboratories establish reference intervals using patient samples collected for testing. Different intervals are developed for different ages, genders, ethnicities, and on the basis of other factors, which allows healthcare providers to determine what normal test results should be for a variety of demographics. For intervals to be accurate, enough samples need to be collected to be representative of these various demographics.
The wide availability of samples from adults makes it easy for laboratories to establish quality reference intervals for adult groups. However, the establishment of quality reference intervals for pediatric groups has been a major challenge. Many samples that laboratories have for the youngest demographics are taken from children who are being tested for a medical condition or illness. This means that while general reference ranges can be established using these samples, they are not representative of healthy populations..jpg?h=249&w=188&la=en&hash=4CDF3118A48A29068B9D8119D0C3EE568F06040F)
Initiatives such as the Children’s Health Improvement through Laboratory Diagnostics (CHILDx) program initiated by ARUP Laboratories and the University of Utah Department of Pathology, as well as the Canadian Laboratory Initiative in Pediatric Reference Intervals (CALIPER) have made great strides improving children’s reference intervals. However, the large scope of the problem means much more work needs to be done.
The Association for Diagnostics & Laboratory Medicine (formerly AACC) is leading an ad hoc coalition of major healthcare groups that includes several pediatric organizations and medical device manufacturers in an effort to address this issue. Together, the association and its partners are working with lawmakers, their staff, and other stakeholders to improve the quality of children’s healthcare.
ADLM Position Statement on Pediatric Reference Intervals
In this position statement, the Association for Diagnostics & Laboratory Medicine (ADLM) calls on Congress to fund efforts to obtain specimens from healthy children, which can be used to develop precise reference intervals.
Additional Resources
Policy Report
Policy Brief
Fact Sheet
From Other Organizations
ADLM's Pediatric Reference Interval Partners
ADLM would like to thank the following organizations for their support of the association's efforts to improve children's reference intervals.
Academy of Clinical Laboratory Physicians and Scientists
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American Urological Association
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American Academy of Pediatrics
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ARUP Laboratories
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COLA
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Quest Diagnostics
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American Clinical Laboratory Association
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Association of Pediatric Hematology/Oncology Nurses
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College of American Pathologists
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Seattle Children's Hospital
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American Medical Technologists
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Association of Public Health Laboratories
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Endocrine Society
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Siemens Healthineers
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American Society for Bone and Mineral Research
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Children's Healthcare of Atlanta
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Laboratory Corporation of America Holdings
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Society for Reproductive Investigation
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American Society for Clinical Laboratory Science
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Children's Hospital Association
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National Association of Pediatric Nurse Practitioners |
Thermo Fisher Scientific
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American Society for Clinical Pathology
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Children's Hospital of Philadelphia
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PCOS Challenge: The National Polycystic Ovary Syndrome Association
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American Society of Hematology |
Children’s National Hospital
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Pediatric Endocrine Society
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American Society of Pediatric Hematology/Oncology |
Children's Pathology Chiefs
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