Effect of analytical quality on establishing common reference intervals and their use

Scandinavian Journal of Clinical and Laboratory Investigation
Pål Rustad, P Hyltoft Petersen

Abstract

In the Nordic Reference Interval Project (NORIP), reference intervals were established for 25 common clinical biochemical quantities. In the project, samples from more than 3000 reference individuals collected in the 102 participating laboratories from all five Nordic countries were analysed locally. In order to maintain a high level of analytical quality and to document this quality, a common calibrator/reference preparation (CAL) and a number of control samples were analysed together with the reference samples. All these materials were serum pools of unprocessed serum from many donors in order to obtain commutable materials. The CAL was used to harmonize the many different analytical procedures and calibrations by simple recalibration by the factor T/M where T is the target value based on reference methods and M is the mean of 10 replicate measurements of CAL in each laboratory. The analytical quality specifications (analytical goals) were based on specifications created directly for the purpose of sharing common reference intervals and only the bias criteria were used because bias is the dominating problem in transfer of reference intervals. These specifications were different for the evaluation of reference values to create...Continue Reading

References

Dec 1, 1989·Scandinavian Journal of Clinical and Laboratory Investigation·P Hyltoft PetersenM Hørder
Dec 1, 1988·Scandinavian Journal of Clinical and Laboratory Investigation·E M GowansM Hørder
Feb 13, 2001·Clinica Chimica Acta; International Journal of Clinical Chemistry·X Fuentes-ArderiuM R Sánchez-Eixeres

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Citations

Nov 28, 2012·Clinical Chemistry and Laboratory Medicine : CCLM·Gerard SiestPeter Hyltoft Petersen
Feb 6, 2007·Clinica Chimica Acta; International Journal of Clinical Chemistry·Javier TrujillanoAlbert Sorribas
Jan 16, 2010·Scandinavian Journal of Clinical and Laboratory Investigation·Päivikki AlataloOnni Niemelä
Jun 30, 2004·Scandinavian Journal of Clinical and Laboratory Investigation·P RustadP Hyltoft Petersen
Jun 30, 2004·Scandinavian Journal of Clinical and Laboratory Investigation·P RustadA Uldall
Nov 30, 2018·European Journal of Heart Failure·Lauren B CooperLars H Lund

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