Desirable routine analytical goals for quantities assayed in serum. Discussion paper from the members of the external quality assessment (EQA) Working Group A on analytical goals in laboratory medicine.
The aim of the Working Group was to describe guidelines for deriving desirable analytical goals in laboratory medicine. First, a literature review is given of the different approaches used until now, and some of the most important studies are presented in detail. These approaches are then discussed critically, and the analytical goals proposed by the group are outlined with respect to monitoring and diagnostic testing. The group recommends that, most realistically, analytical quality specifications be biologically based. For diagnostic testing, the aim is achievement of accuracy, allowing the use of common reference intervals when populations are homogeneous for a given quantity. For monitoring (within an individual laboratory and performed with the same instrument), analytical performance should aim at stable operation and low imprecision compared with the within-subject biological variation. Method accuracy is also very important for the comparability of results from different laboratories or instruments.
Stöckl
D
D
Institut für Standardisierung und Dokumentation im medizinischen Laboratorium e. V. (INSTAND e. V.), Düsseldorf, Germany.
Baadenhuijsen
H
H
Fraser
C G
CG
Libeer
J C
JC
Petersen
P H
PH
Ricós
C
C
D001774:Blood Chemical Analysis / Q000592:standards*; D002624:Chemistry, Clinical / Q000458:organization & administration / Q000592:standards; D006801:Humans; D011786:Quality Control