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LABQUALITY

Om Analytisk Imprecision
och
Analysers Totalfel
Vrmte
Lule 250505
Teddy Weber
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Do the current target limits of EQA
schemes serve participants well enough?
interpretation of results
conclusions on analytical
performance
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Target limits
= target value total error
imprecision
bias
method group mean
or
reference method value
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- clinical needs
- state of the art
- statistical methods
- within- and between-subject biological
variation
- suitable part of reference intervals
Different considerations can lead to different
target limits.
The priority may be maximal allowable error or
educational quality goals.
Approaches for defining permissible total error
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imprecision
less than a half of the within-subject biological variation
bias
less than of the biological variation (within + between-
subject variation)
or
less than 1/16 of the reference interval
Biological variation
Common reference intervals
Components of total error are based on
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Target value (bias + 1.65 * imprecision)
Target value ( CV
bt
+ 1.65 * CV
bw
)
bt = total biological variation
bw= within-subject biol.variation
The target limits are set so that when the methods are
performing correctly, the result will be within the target limits
with 95% probability
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sometimes
biological variation approach would lead to too
demanding analytical goals (e.g. Na total error
0.9%)
total error 2%
CV%-target from the analytical performance
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sometimes
biological variation approach would lead to too wide
analytical goals (enzymes e.g. CK 27%, ALT 36%)
CV%-target for enzymes from the analytical
performance
total error 12%
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Examples of Quality specifications in
Labquality clinical chemistry surveys
Albumin 5 % Ca-Ion 3 % CRP 15 %
ALP 12 % Cholesterol 5 % Free T4 12 %
ALT 12 % Chol-HDL 10 % Sodium 2 %
Bilirubin 12 % CK 12 % Triglyserides 15 %
Calcium 3 % Creatinine 8 % TSH 12 %
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Labqualitys target limits are educational
and not administrative.
Labqualitys target limits are quite tight.
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