Improving children's health through better pediatric reference intervals

In July 2023, we changed our name from AACC (short for the American Association for Clinical Chemistry) to the Association for Diagnostics & Laboratory Medicine (ADLM). The following page links to resources that were written prior to the rebranding and/or mentions events that took place prior to the rebranding and that contain mentions of the association’s old name.

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.

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.

ADLM 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, ADLM calls on Congress to fund efforts to obtain specimens from healthy children, which can be used to develop precise reference intervals.

• Pediatric Reference Intervals: The Need for Normal

Additional Resources

Policy Report

• Advancing Children's Health Through Pediatric Laboratory Medicine

Policy Brief

• Improving Children’s Health Through Better Pediatric Reference Intervals

Fact Sheet

• PRI Questions and Answers

From Other Organizations

• CALIPER Reference Interval Database
• CHILDx Program (ARUP Laboratories)

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
• American Academy of Pediatrics
• American Association of Nurse Practitioners
• American Clinical Laboratory Association
• American College of Clinical Pharmacy
• American Medical Technologists
• American Society of Andrology
• American Society for Bone and Mineral Research
• American Society for Clinical Laboratory Science
• American Society for Clinical Pathology
• American Society of Hematology
• American Society of Pediatric Hematology/Oncology
• American Urological Association
• ARUP Laboratories
• Association of Maternal & Child Health Programs
• Association of Pathology Chairs
• Association of Pediatric Hematology/Oncology Nurses
• Association of Public Health Laboratories
• Association of Schools and Programs of Public Health
• Avalon Healthcare Solutions
• Children’s Healthcare of Atlanta
• Children’s Hospital Association
• Children’s Hospital Colorado 
• Children’s Hospital of Philadelphia
• Children’s National Hospital
• Children’s Pathology Chiefs
• COLA, Inc.
• College of American Pathologists
• Endocrine Society
• International Society of Andrology
• Laboratory Corporation of America Holdings
• National Association of Pediatric Nurse Practitioners
• National Hispanic Medical Association
• National Rural Health Association
• PCOS Challenge: The National Polycystic Ovary Syndrome Association
• Pediatric Endocrine Society
• Quest Diagnostics
• Seattle Children's Hospital
• Siemens Healthineers
• Society for Reproductive Investigation
• Society for Pediatric Pathology
• University of Pittsburgh Medical Center (UPMC) Health System