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2 Quality Assessment Lec. 2 Final
2 Quality Assessment Lec. 2 Final
Lecture 2
Laboratory Analysis
Specimens mix – up
Incorrect volume of specimen
Interfering substances present
Instrument precision problem
Post Analytical errors
Test interpretation
Previous values not available for
comparison
Water quality
Calibration of analytical balances
Calibration of volumetric glassware and pipettes
Stability of electrical power
Stability of temperature of heating baths,
refrigerators, freezers and centrifuges
Standard operating procedures
Procedure name
Clinical significance
Principle of method
Specimen of choice
Reagents and equipments
Procedure
Reference values
Comments
References
Method Validation
Method validation should be performed
before a test procedure is placed into routine
use.
Validation may be accomplished by
thoroughly testing reference materials or by
comparison of results of tests performed by
an alternative method.
Method Validation
Accuracy
- the closeness of the estimated value to the true mean
- can be checked by the use of reference materials
which have been assayed by independent methods of
known precision
Precision
- reproducibility of a results, whether accurate or
inaccurate within a define frame time ( eg: within the
same day, from week to week etc )
- can be controlled by replicate tests, check tests on
previously measured specimens and statistical
evaluation of results
Good Accuracy Good Neither Good
Good Precision precision Nor
Precision Only Accuracy
Accuracy: both are
equally precise, but in
method D the mean value
differs from the true value.
The mean for method C is
equal to the true value.
Both methods are equally
precise, but method C is
more accurate.
The graph shows the
distribution of results for
repeated analysis of the
same sample by different
methods.
Precision: the mean value is
the same in each case, but
the scatter about the mean
is less in method A than in
method B.
Method A is, therefore,
more precise.
Specificity
The specificity of a test is a measure of the
incidence of negative results in persons known
to be free of a disease, that is 'true negative'
(TN).
A specificity of 90% implies that 10% of disease-
free people would be classified as having the
disease on the basis of the test result:
they would have a 'false positive' (FP) result.
Sensitivity
Sensitivity is a measure of the incidence of
positive results in patients known to have a
condition, that is 'true positive' (TP).
A sensitivity of 90% implies that only 90% of
people known to have the disease would be
diagnosed as having it on the basis of that
test alone:
10% would be 'false negatives' (FN).
Calculations
Specificity and sensitivity are calculated as
follows:
Specificity
Ability to correctly identify individuals without disease
TN /(TN + FP)
Specificity = 100/(100+275) = .27 or 27%
Sensitivity
Ability to correctly identify individuals with disease