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Establishment of Reference Intervals: Still a
Challenging Issue! (Beckman Coulter)
Kiyoshi Ichihara and Jeong-Ho Kim (Chairpersons)
1) What is an optimal protocol for the IFCC global study on reference values?
Kiyoshi Ichihara, MD & PhD (Japan)
2) Controversies over statistical methods for derivation of reference intervals.
Swarup A Shah, PhD, and Tester F Ashavaid, PhD (India)
3) Analytical issues in conducting the multicenter studies on reference values.
Kiyohide Ishikura, PhD (Japan)
4) Age-specific reference intervals: derivation for pediatric population from the hospital information
system.
Jeong-Ho Kim, MD & PhD (Republic of Korea)
Although global effort led to standardization of many of the common laboratory tests, their reference
intervals (RI) remain widely variable amongst laboratories. This reflects difficulty in deriving RIs by
individual laboratories and highlights the necessity of deriving it collaboratively for common use. The
guidelines used for defining, establishing and verifying RIs are available, which was published by CLSI
in collaboration with IFCC. There is a strong global need for establishment of proper RIs for common
use by conducting multicenter studies. However, there remain controversies on various aspects of
conducting the study.
In this symposium, Prof. Ichihara presents the common protocol for the global multicenter study on
RIs, which is proposed as well as currently being conducted by Committee on Reference Intervals and
Decision Limits (C-RIDL) of IFCC. In order to validate the protocol, the following aspects will be
discussed: 1) criteria for recruitment of healthy volunteers, 2) ways of controlling pre-analytical
variables, 3) harmonization of results across collaborating countries based on common measurements of
a panel of sera, 4) methods for secondary (posteriori) exclusion based on test results, 5) transference of
the established RIs based on a “mini panel” of sera.
Dr. Ishikura, a member of C-RIDL, will present an overview about the feasibility of the panel-of-sera
strategy in harmonizing results worldwide, and will also discuss the possible use of mini-panel in the
transference of established RIs.
Dr. Shah and Dr. Ashavaid will talk on the controversies over the use of parametric or nonparametric
computation of RIs and secondary exclusion of individuals after obtaining testing results. The issues
based on the simulation study will also be discussed.
Prof. Kim will talk about the difficulty in establishing RIs for the pediatric, and geriatric population.
He will review the issue in the literature and will present his approach in selecting appropriate reference
individuals from large hospital records for deriving the pediatric RIs,
With this overview, we would like to rationally discuss the optimal ways of establishing the RIs at the
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