WASHINGTON – AACC released a position statement today on the need to improve pediatric reference intervals, which play a crucial role in ensuring that children receive accurate medical diagnoses and effective treatment. The statement calls on Congress to mandate and fund a national repository of specimens from healthy children, which the clinical laboratory community needs to develop precise reference intervals.
To correctly interpret clinical test results for pediatric patients, physicians must evaluate results within the context of reference intervals—the range of normal test values appropriate for the age, stage of development, ethnicity, and gender of a child. Laboratory professionals play a vital role in creating and refining pediatric reference intervals and disseminating this information to the medical community. Unfortunately, limited access to samples from healthy children significantly hinders the establishment of precise pediatric reference intervals. Many clinical laboratories and medical device manufacturers must resort to using leftover blood samples from children who were tested for a medical condition to verify or establish reference intervals. However, these specimens are not ideal to determine a normal range of test values for healthy kids, since many of the children were ill when their samples were drawn.
To enable the development of high-quality pediatric reference intervals, AACC recommends that samples for a national repository be collected with informed consent from healthy children age 0–18 years. These samples should be made available to both in vitro diagnostic manufacturers and clinical laboratories, and the results from reference interval studies conducted by manufacturers or labs should be made public. The position statement also advises the laboratory community to share and transfer existing pediatric reference intervals across clinical laboratories and evolutions of technology. In addition, AACC recommends that de-identified leftover specimens should continue to be available without informed consent for quality improvement activities.
“AACC is concerned that the laboratory community does not have the resources necessary to establish and maintain pediatric reference intervals, which physicians need to assess clinical test results and ensure that children receive the right diagnoses and treatment,” said AACC CEO Janet B. Kreizman. “We urge Congress and policymakers to provide access to samples from healthy individuals of all ages, developmental stages, and both sexes to support the improvement of pediatric reference intervals and ensure the health of the nation’s children.”
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.