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An introduction to sensitivity, specificity, positive and negative

predictive values

Presentation · April 2017

DOI: 10.13140/RG.2.2.13863.96163

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Pasteur Institute of Iran
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Interpretation of results

An introduction to
Sensitivity, specificity
Positive and negative
predictive values
Ehsan Mostafavi, Epidemiologist
Pasteur Institute of Iran
mostafavi@pasteur.ac.ir
 Outline

• Intrinsic characteristics of a test

– Sensitivity
– Specificity

• Performance of a test in a population

– Predictive value of a positive test
– Predictive value of a negative test
 Sensitivity
The sensitivity of a test in the ability of the test to identify
correctly affected individuals
Proportion of persons testing positive among affected individuals

Affected persons
(Positive by gold standard)

Persons testing positive Persons testing negative

(True positives) (False negatives)

Sensitivity = True positives / Affected persons

Estimate the 95% confidence interval
 Estimating the sensitivity of a test

• Identify affected individuals with a gold standard

• Obtain a wide panel of samples that are representative of the
population of affected individuals
– Recent and old cases
– Severe and mild cases
– Various ages and sexes

• Test the affected individuals

• Estimate the proportion of affected individuals that are
positive with the test
Sensitivity of a rapid test for Disease A

Patients with
Disease A
True positive 148
Rapid test
False negative 2
150

Sensitivity = 148 / (150) = 98.6%

95% confidence interval: 97.5%-100%
 What factors influence
the sensitivity of a test?

• Characteristics of the affected persons?

 YES: Antigenic characteristics of the pathogen in the area
(e.g., if the test was not prepared with antigens reflecting the
population of pathogens in the area, it will not pick up infected
persons in the area)

• Characteristics of the non-affected persons?

 NO: The sensitivity is estimated on a population of affected persons

• Prevalence of the disease?

 NO: The sensitivity is estimated on a population of affected persons

Sensitivity is an INTRINSIC characteristic of the test

 Specificity
The specificity of a test in the ability of the test to identify
correctly non-affected individuals
Proportion of person testing negative among non affected individuals

Non-affected persons
(Negative by gold standard)

Persons testing negative Persons testing positive

(True negatives) (False positives)

Specificity = True negatives / Non-affected persons

Estimate the 95% confidence interval
 Estimating the specificity of a test

• Identify non affected individuals

– Negative with a gold standard
– Unlikely to be infected

• Obtain a wide panel of samples that are representative of the

population of non-affected individuals
– Diverse unaffected population

• Test the non-affected individuals

• Estimate the proportion of non-affected individuals that are
negative with the test
Estimating the specificity of a rapid test
for Diseases A

• Identify persons without Disease A

– Persons without sign and symptoms of the infection, negative with
gold standard
– Persons at low risk of infection, negative with gold standard

• Obtain a wide panel of samples that are representative of the

population of individuals without Disease A
– Persons from neighbouring villages with no transmission and no
infections

• Test the persons without Disease A

• Estimate the proportion of persons without Disease A that
are negative with the rapid test
Specificity of a rapid test for Disease A

Individuals
without
Disease A
False positive 12
Test
True negative 188
200
Specificity = 188 / 200 = 94%
95% confidence interval: 92.3%-95.7%
 What factors influence
the specificity of a test?

• Characteristics of the affected persons?

 NO: The specificity is estimated on a population of non affected

• Characteristics of the non-affected persons?

 YES: The diversity of antibodies to various other antigens in the
population may affect cross reactivity:
If malaria is endemic, polyclonal hyper gammaglobulinemia may
increase the proportion of false positives
If Q-fever is endemic, brucellosis may increase the false positives

• Prevalence of the disease?

 NO: The specificity is estimated on a population of non affected

Specificity is an INTRINSIC characteristic of the test

 Identifying the cut-off to use with a test
on the basis of panel analysis: Ideal case

25

20
Cut-off
Number of tests

15 Sick
10 Well

0
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Possible values of the test
Identifying the cut-off to use with a test
on the basis of panel analysis: Real case

25 Cut-off
20 False False
Number of tests

negatives positives
15 Sick
True
10 negatives Well

True
5
positives
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Possible values of the test
 Outline

• Intrinsic characteristics of a test

– Sensitivity
– Specificity

• Performance of a test in a population

– Predictive value of a positive test
– Predictive value of a negative test
How is the test doing in a real population?

• The test is now used in a real population

• This population is made of
– Affected individuals
– Non-affected individuals

• The proportion of affected individuals is the prevalence

Status of persons
Affected Non-affected
Positive A (True +) B (False +) A+B
Test
Negative C (False -) D (True -) C+D
A+C B+D A+C+B+D
 Predictive value of a positive test
(Positive Predictive value)
The predictive value of a positive test is the probability that
an individual testing positive is truly affected
Proportion of affected persons among those testing positive
Persons testing positive
(Positive by test)

Persons affected Persons not affected

(True positives) (False positives)

Predictive value of a positive test =

True positives / Persons testing positive
Estimate the 95% confidence interval
 Predictive value of a positive test

Status of persons
Affected Non-affected
Positive A B A+B
Test
Negative C D C+D
A+C B+D A+C+B+D

PVP = A / (A+B)
This is only valid for the sample of specimens tested
 What factors influence
the predictive value positive of a test?

• Specificity?
 YES: The more the test is specific, the more it will be negative for
non affected persons. Thus, when the test is positive, it is probably
truly positive (All non affected were correctly identified as testing
negative).

• Sensitivity?
 YES: To some extend.

• Prevalence of the disease?

 YES: Low prevalence: The test will pick up more false positives
 YES: High prevalence: The test will pick up more true positives
 Predictive value positive of a test
according to prevalence and specificity

100 Specificity
90
80
PVP % 70 70%
60 80%
50
40 90%
30 95%
20
10
0
10
20
30
40
50
60
70
80
90

0
0

10
Prev ale nc e ( %)
Predictive value of a negative test
(Negative Predictive value)
The predictive value of a negative test is the probability that
an individual testing negative is truly non-affected
Proportion of non-affected persons among those testing negative
Persons testing negative
(Negative by test)

Persons non affected Persons affected

(True negatives) (False negatives)

Predictive value of a negative test =

True negatives / Persons testing negative
Estimate the 95% confidence interval
 Predictive value of a negative test

Status of persons
Affected Non-affected
Positive A B A+B
Test
Negative C D C+D
A+C B+D A+C+B+D

PVN = D / (C+D)
This is only valid for the sample of specimens tested
 What factors influence
the predictive value negative of a test?

• Sensitivity?
 YES: The more the test is sensitive, the more it captures affected
persons. Thus, when the test is negative, it is probably truly
negative.

• Specificity?
 YES: But to a lesser extend.

• Prevalence of the disease?

 YES: Low prevalence: The test will pick up more true negatives
 YES: High prevalence: The test will pick up more false negatives
 Predictive value negative of a test
according to prevalence and sensitivity

100
90
Sensitivity
80
70 70%
60 80%
PVN % 50 90%
40 95%
30
20
10
0
0 10 20 30 40 50 60 70 80 90 100
Prevalence (%)
 Relation between predictive values and
(1) sensitivity and (2) specificity

Se.P
PVP 
Se.P  (1  Sp)(1  P)

Sp(1- P)
 PVN 
Sp(1- P)  (1Se).P
 Positive (PPV) and negative (NPV) predictive
values of a test according to the prevalence
(95% sensitivity and specificity)

100
Predictive value (%)

80
NPV
60

40

20
PPV
0
0 25 50 75 100
Prevalence (%)
 Accuracy of a test
• Accuracy = (TN + TP)/(TN+TP+FN+FP) = (Number of correct
assessments)/Number of all assessments)
= (A +D) / (A+B+C+D)

Status of persons
Affected Non-affected
Positive A B A+B
Test
Negative C D C+D
A+C B+D A+C+B+D
 Screening Tests
• Screening tests are laboratory tests that help
to identify people with increased risk for a
condition or disease before they have
symptoms or even realize they may be at risk
so that preventive measures can be taken.
They are an important part of preventive health
care.
 Population screening
• Phenylketonuria (PKU),hypothyroidism, and favism
 Screening Tests
• Serial tests
• Parallel tests
Serial tests
Parallel tests
 Receiver operating characteristic(ROC)

ROC Space: shadow area represents better diagnostic classification

Cut off point
 Correlation between two diagnostic tests

• Observed proportion(OP) = (a +d)/N

 ab ac   cd bd 
• Expected proportion (EP) by chance  (
 n
)(
n
)   (
  n
)(
n
)


• kappa measures agreement beyond what would be expected by

chance:  OP  EP
1  EP
 Summary

• Sensitivity and specificity matter to laboratory specialists

– Look into the intrinsic characteristics of the test:
• Capacity to pick affected
• Capacity to pick non affected

• Predictive values matter to clinicians and epidemiologists

– Look into the performance of the test in real life:
• What to make of a positive test
• What to make of a negative test

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