Multianalyte Conventional Reference Material (MacRM): A Useful Tool for Nationwide Standardization of Laboratory Measurements for Medical Care—A Model Study in Japan

Abstract

BACKGROUND:The Japanese Committee for Clinical Laboratory Standards (JCCLS) has developed a multianalyte conventional reference material (MacRM) for nationwide standardization of laboratory measurements.

Analytical Bias Exceeding Desirable Quality Goal in 4 out of 5 Common Immunoassays: Results of a Native Single Serum Sample External Quality Assessment Program for Cobalamin, Folate, Ferritin, Thyroid-Stimulating Hormone, and Free T4 Analyses

“…Further efforts should be made to produce commutable reference materials and to ensure that their use has a clear effect on the harmonization of patient results. It is reassuring that several national and international organizations, including the Joint Committee for Traceability in Laboratory Medicine, the WHO, and International Federation of Clinical Chemistry scientific division, have increased their focus on this issue lately (14,15 ). The large scatter that was seen around the regression line for several of the TSH assays indicates the possibility of different analytical specificity for these assays.…”

An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials

“…Although out of scope for the original C37 protocol, literature reports starting with the C37 protocol or very similar protocols have shown that supplementing a serum pool with a number of analytes has produced pools with elevated concentrations with acceptable commutability properties [11,12].…”

Comparative evaluation of methods to determine intra‐individual reference ranges in nutrition support team (NST)‐related tests

“…Therefore, clinically significant variations may be overlooked if using the inter‐individual reference range alone. Also, observed variation, which may not be clinically significant, in the intra‐individual reference range, could be outside the inter‐individual reference range 1‐8 . Consequently, close monitoring of variations in the clinical laboratory results of an individual is difficult and can lead to unnecessary secondary examinations if the values obtained exceed the general reference range 1‐8 .…”

“…Also, observed variation, which may not be clinically significant, in the intra‐individual reference range, could be outside the inter‐individual reference range 1‐8 . Consequently, close monitoring of variations in the clinical laboratory results of an individual is difficult and can lead to unnecessary secondary examinations if the values obtained exceed the general reference range 1‐8 . For example, serum enzymes, such as γ‐glutamyl transpeptidase and alkaline phosphatase, in addition to uric acid, total cholesterol, and albumin (ALB), have narrower intra‐individual variations than inter‐individual variations; thus, the reference range is consistent with inter‐individual variations.…”

“…Both the intra‐individual and inter‐individual reference ranges can be used for evaluation, although there are differences in the mean value and standard deviation. If each individual subject is healthy, the measured values fall within the statistically established intra‐individual reference range 1‐8 . However, if the measured value is statistically abnormal, an alarm can be triggered sooner than determining it with the intra‐individual reference range.…”