The Nordic Trueness Project 2002: use of reference measurement procedure values in a general clinical chemistry survey

• Published in: Scandinavian journal of clinical and laboratory investigation 2004-06, Vol.64 (4), p.309-320
• Main Authors: Pedersen, M. M., Örnemark, U., Rustad, P., Steensland, H., Loikkanen, M., Ólafsdóttir, E., Henriksen, G. M., Jørgensen, N., Uldall, A., Nordin, G., Nordberg, U.-R.
• Format: Article
• Language: English
• Subjects: Blood Chemical Analysis - standards; Chemistry, Clinical - standards; Clinical Chemistry Tests - standards; Clinical Medicine - standards; Commutability; Europe; external quality assurance; frozen serum; Humans; International Cooperation; Laboratories, Hospital - standards; lyophilized serum; matrix effects; NORIP; Plasma; reference measurements; Reference Values; Reproducibility of Results; value transfer
• ISSN: 0036-5513; 1502-7686
• DOI: 10.1080/00365510410002805

Up to 136 laboratories participated in a joint effort to assess the trueness of routine measurements for 14 serum components. An unmodified, fresh-frozen human serum ("IMEP-17 Material 1"), produced for an international inter-laboratory comparison, served as the "master material". The serum had assigned values of the highest available metrological quality, and is assumed to involve no or negligible commutability problems. The material was used in the assignment of traceable values to two other reference sera, "CAL" and "X", through parallel measurements on the three materials according to a common protocol. In this transfer process, uncertainty estimates were provided for all values. The material CAL had been supplied with reference measurement procedure values in 1997, and the two sets of assigned values agreed well. A lyophilized control serum "HK02" was also included in the routine analysis series. It, too, had assigned values based on reference measurement procedures. Significant matrix effects were found. The project has provided: Assigned traceable values for 14 components in a fresh-frozen serum, available to Nordic laboratories for the coming years as "NFKK reference serum X". Confirmation of earlier assigned reference measurement procedure values for a number of components in CAL, the main calibrator in the Nordic Reference Interval Project (NORIP). The transferred values will now serve as the primary reference. Evidence of long-term stability (≥5 years) of the fresh-frozen serum CAL when stored at −80°C. Evidence of substantial matrix effects in the processed serum HK02. The findings should be used to discuss to what extent reference measurement procedure values are useful and cost-efficient for this type of material.