The importance of pediatric reference intervals for diagnostic testing

Currently, many pediatric laboratory test results are inappropriately interpreted using reference intervals derived from either adult populations, hospitalized pediatric populations, or from outdated methodologies. Age-specific reference intervals are extremely important for interpreting measurements in the pediatric population but, unfortunately, there are very few studies that provide reference intervals using robust, statistically sound studies and well-characterized healthy populations.

In this on-demand SelectScience^® webinar, Dr. Khosrow Adeli, Head of Clinical Biochemistry at University of Toronto, discusses how to best overcome the challenges involved in establishing reference intervals for proper clinical interpretation of pediatric lab results, aiding the diagnosis and treatment of pediatric patients.

Read on for the highlights of the live Q&A session or register to watch the webinar at any time that suits you.

Q: What is your recommended approach to defining reference intervals? Should we use direct or indirect methods?

KA: The current recommendation by the Clinical Laboratory Standards Institute (CLSI) in the U.S is to use direct methods as much as possible, which means recruiting healthy subjects, whether children or adults, and measuring values, analyze, and then calculating appropriate reference intervals using their recommended statistical methods. Now, there is a great interest in using indirect methods, and this is becoming more popular.

I wanted to indicate that some of the traditional methods used for indirect methods, like the Hoffman method or the Bhattacharya method, are no longer recommended. However, there is a new method called the TML method which was developed by Dr. Zurch and his colleagues in Germany, which is what I would recommend using. As we are using this method in Canada, and for our adult studies, we've starting to use these indirect methods.

CSLI recommends direct methods, although they might be updating their guidelines soon, but indirect methods are becoming more possible and more feasible. Using the appropriate method, my recommendation is the TML method.

Q: Can the caliper data be used to interpret children's test results in other countries or is it only applicable in Canada?

KA: Based on our latest surveys, the caliper data is used by hospitals in over 80 countries. Our recommended approach is that the data is verified for that population, that hospital, and that instrument. If a hospital in Vienna wants to use the data, they should try to do at least a small validation or verification to ensure that the data is applicable to their population and their instrument and platform.

Q: How often is the caliper database updated?

KA: Typically, we wait for new data to be published first, therefore it's peer-reviewed and any errors are detected and removed. Then, the clean data is uploaded. We have updated the database in early January, but it usually happens about twice a year. We wait until sufficient new data is available. I would say the next update probably would be in the spring or summer.

Q: Do you plan to have reference ranges for coagulation markers?

KA: Yes, the coagulation markers are next on our list. We have almost covered test studies and developed data for all chemistry tests, amino acids, hormones, and other endocrine markers, fertility markers, and all the hematology markers have just been studied. We would like to move onto coagulation markers next, and we are currently discussing with two coagulation marker manufacturers to collaborate and develop those reference ranges for coagulation markers.

Watch this on-demand webinar to find out why age-specific reference intervals are extremely important for interpreting measurements in the pediatric population>>