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

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

Methods: To prepare the MacRM, pooled sera were obtained from healthy Japanese individuals. Target values of the pooled sera for 30 analytes were assigned on the basis of the measurement results of 45 certified clinical laboratories whose calibration was verified by measuring certified reference materials (CRMs) provided by the National Institute of Standards and Technology, the Institute for Reference Materials and Measurements, and JCCLS.

Nationwide multicenter study aimed at the establishment of common reference intervals for standardized clinical laboratory tests in Japan.

Background: The Japanese Association of Medical Technologists (JAMT) sought to establish common reference intervals (RIs) applicable nationwide in Japan for 27 serum constituent analytes for which certified reference materials are available and nine analytes frequently measured in routine tests. More than 100 laboratories certified for metrological traceability collaborated in the recruitment, sampling, and measurement of analytes for the establishment of RIs. No previous attempt has been made to establish RIs by such a large number of laboratories.

Clinical application of the different cross-reactivities of anti-insulin antibodies to insulin lispro to evaluate endogenous insulin secretion.

Background: Insulin analogs are often used to treat patients with diabetes. We evaluated the cross-reactivities of anti-insulin antibodies in two insulin immunoassay kits (Architect and ECLusys) against recombinant human insulin and insulin analogs, and measured insulin concentrations in the serum of the diabetic patients treated with only insulin lispro.

Methods: Ten-fold dilutions of recombinant human insulins and insulin analogs were measured using Architect and ECLusys kits.