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Validity and
Reliability of
Diagnostic and
Screening Tests
20
15
Induration
# of Subj.
10
0
0 3 6 9 12 15 18 21 24 27
Biologic Variation of Human
Populations (Unimodal
Curve)
140
120
100
80 S. BP
60 # of Men
40
20
0
<110 120 140 160 >180
Validity of Screening
Tests
• Validity – the ability of the test to
distinguish between who has a
disease and who does not
• 2 Components:
• 1. Sensitivity – the ability of the test
to identify correctly those who have
the disease
• - The proportion of diseased people
who were correctly identified as such
by the test
Factors that Increase
Sensitivity
• 1. Lowering the cut-off and making
criteria for disease definition less
stringent
• 2. Parallel Testing – the
administration of 2 screening tests at
the same time and persons with a
positive result on any of these tests
are considered positive
When Should Sensitivity Be
Increased
• 1. When the disease is serious and a
definitive treatment exists
• 2. When the disease can be spread
• 3. When subsequent diagnostic
evaluations of positive screening
tests are associated with minimal
costs and risks
Validity of Screening
Tests
• 2. Specificity – the ability of the test
to identify correctly those who do not
have the disease
• - proportion of non-diseased people
who are correctly called negative by
the test
• Note : In order to quantitatively
assess the sensitivity and specificity
of a test, we must have another
source of truth with which to
compare the test results
Factors that Increase
Specificity
• 1. Making the criteria for disease
definition more stringent or
increasing the cut-off level
• 2. Series Testing – an initial
screening test is administered and
then, only persons who are positive
on this preliminary test will undergo
a second additional screening
procedure
When Should Specificity Be
Increased
• 1. When the costs or risks
associated with further diagnostic
techniques are substantial
• 2. When the stigma associated with
having the disease is severe
Concept of the Sensitivity
and Specificity of Screening
Exams
Test Dse. No Tota • Sensitivity = 80 x
Dse. l 100
• 100
+ 80 100 180
• = 80%
- 20 800 820
• Specificity = 800 x
100
Tota 100 900 1 • 900
l 000 • = 89%
Comparison of the Results of a
Dichotomous Test with Actual
Disease Status
Test W/ Dse. W/O Sensitivity = TP
Results Dse.
x 100
TP + FN
+ Have No dse.
dse. & & have
have (+) (+) test Specificity = TN
test = = false x 100
true (+) negative
- or (TP)
Have (FP)
No dse. TN + FP
dse. but and
have (-) have (-)
test = test =
false (-) true (-)
or (FN) (TN)
Issues of False Positives
• All people who screened positive are
brought back to a more sophisticated
and more expensive tests
• The anxiety and worry induced in
persons who have been told that
they have tested positive
Importance of Problems in
False Negatives
• Depends on the nature and severity
of the disease being screened for,
the effectiveness of available
intervention measures, and whether
the effectiveness is greater if the
intervention is administered early in
the natural history of the disease
Tests of Continuous
Variables
Diabetics Non-Diabetics
High
Blood
Sugar
Low
Test
Test
Screening Using a
Dichotomous Test
Test Disease Total
Positive Negative
Test + - Tota
• Prevalence = 20%
+ 80 l180
• Sensitivity = 50%
100
• Specificity = 90%
- 720 870
• Predictive Value?
100
Relation of Predictive Value
to the Specificity of the
Test
Interpretation
• Sensitivity = 90%
-90% of those with the disease will be
labeled as positive by the test
• Specificity = 90%
- 90% of those without the disease will be
labeled as negative by the test
Positive Predictive Value = 75%
75% of those who test positive will really
have the disease
Negative Predictive Value = 75%
75% of those who test negative will really
Reliability (Repeatability of
Tests)
• Regardless of the specificity and
sensitivity, if the test results cannot
be reproduced, the value and
usefulness of the test are minimal.
Factors that Contribute to
Variation in Test Results
• 1. Intrasubject Variation – variation
between individual subjects
• - In evaluating any test result, it is
important to take into consideration
the conditions under which the test
was carried out, including the time of
day.
• 2. Interobserver Variation – variation
between those reading the test
results
Relation Between Validity
and Reliability
Exercise 1
• Calculate for the sensitivity, specificity,
positive predictive value, and negative
predictive value
• Interpret your answers
THROAT CULTURE