Optimizing the use of the "state-of-the-art" performance criteria
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Optimizing the use of the "state-of-the-art" performance criteria. / Haeckel, Rainer; Wosniok, Werner; Streichert, Thomas.
In: CLIN CHEM LAB MED, Vol. 53, No. 6, 05.2015, p. 887-91.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Optimizing the use of the "state-of-the-art" performance criteria
AU - Haeckel, Rainer
AU - Wosniok, Werner
AU - Streichert, Thomas
PY - 2015/5
Y1 - 2015/5
N2 - The organizers of the first EFLM Strategic Conference "Defining analytical performance goals" identified three models for defining analytical performance goals in laboratory medicine. Whereas the highest level of model 1 (outcome studies) is difficult to implement, the other levels are more or less based on subjective opinions of experts, with models 2 (based on biological variation) and 3 (defined by the state-of-the-art) being more objective. A working group of the German Society of Clinical Chemistry and Laboratory Medicine (DGKL) proposes a combination of models 2 and 3 to overcome some disadvantages inherent to both models. In the new model, the permissible imprecision is not defined as a constant proportion of biological variation but by a non-linear relationship between permissible analytical and biological variation. Furthermore, the permissible imprecision is referred to the target quantity value. The biological variation is derived from the reference interval, if appropriate, after logarithmic transformation of the reference limits.
AB - The organizers of the first EFLM Strategic Conference "Defining analytical performance goals" identified three models for defining analytical performance goals in laboratory medicine. Whereas the highest level of model 1 (outcome studies) is difficult to implement, the other levels are more or less based on subjective opinions of experts, with models 2 (based on biological variation) and 3 (defined by the state-of-the-art) being more objective. A working group of the German Society of Clinical Chemistry and Laboratory Medicine (DGKL) proposes a combination of models 2 and 3 to overcome some disadvantages inherent to both models. In the new model, the permissible imprecision is not defined as a constant proportion of biological variation but by a non-linear relationship between permissible analytical and biological variation. Furthermore, the permissible imprecision is referred to the target quantity value. The biological variation is derived from the reference interval, if appropriate, after logarithmic transformation of the reference limits.
KW - Clinical Laboratory Techniques
KW - Humans
KW - Observer Variation
KW - Prostate-Specific Antigen
KW - Reference Values
KW - Uncertainty
U2 - 10.1515/cclm-2014-1201
DO - 10.1515/cclm-2014-1201
M3 - SCORING: Journal article
C2 - 25803083
VL - 53
SP - 887
EP - 891
JO - CLIN CHEM LAB MED
JF - CLIN CHEM LAB MED
SN - 1434-6621
IS - 6
ER -