Diagnostic and Screening in

Public Health

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 Learning objectives
• You will be able to set up a contingency table to asses
the quality of screening test
• You will be able to capture &interpret sensitivity
&specificity of screening test
• You will be able to compute and interpret positive
&negative predictive value

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 What is Screening?
Basic Public Health Concepts

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 Screening test

• Is search of unrecognized disease or defect by

means of rapidly applied test ,examination or
other procedure in apparently healthy individual.
• Screening test are not diagnostic test but rather
identify individual likely to have a disease ,and
thus good candidate for deeper investigation
• There must be an objective measure of “truth” or
actual disease diagnosis
– Home pregnancy test ultrasound

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 Screening test

▪ Screening test are meant to identify disease in

population early ,thus enabling earlier
intervention and management ,in the hopes of
reducing mortality and suffering
▪ The aim is
- Early detection and treatment
- To prevent transmission
- To prevent further disease and complexity
▪ May be based on:
Standardized interviews(standard questioners)
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 Screening tests
Example:
- Reporting Questionnaire for Children (RQC) –mental
health problem screening tool for children
- Michigan Alcohol Screening Test (MAST) - is a set of
questions that used to identify individuals at risk of
alcoholism.
▪ Physical examinations(checking blood pressure)
▪ Laboratory tests –For malaria
▪ More sophisticated measurements
• radiography
• electro-cardiograph etc…

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 Diagnostic test
Diagnostic test – performed in a person with
specific sign and symptom
▪ Screening Test – is performed in apparently
healthy individual
For example,
- A blood sugar test in someone that is healthy
would
be a screening test.
- The same test in someone with symptoms of
diabetes
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would be diagnostic test
 Natural history of disease and time of
screening

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 The Screening pathway

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 Aim of screening program
▪ To reduce morbidity and mortality through early
detection and treatment
▪ To alter the natural course of disease for a better
outcome
▪ To reverse, halt, or slow the progression of a
disease to its severe form and to improve quality
of life
▪ Research: study on natural history of disease
▪ Selection of healthy individuals usually for
employment
E. g: Military and driving license …
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For fair allocation of resource 10
Examples of Screening Tests
• Pap smear
• Mammogram

• Clinical breast exam

• Blood pressure determination
• Cholesterol level
• Eye examination/ visual test
• Urinalysis
 The Principles of Screening
• The choice of disease for which
to screen;
• The nature of the screening
test or tests to be used;
• The availability of a treatment
for those found to have the
disease;
• The relative costs of the
screening.
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 • The disease must be an important health
problem.
• There should be a recognizable latent or early
symptomatic stage.
• The natural history of the disease, including
latent to declared disease, should be adequately
understood.

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• There should be a suitable test or
examination.

• The test should be acceptable to the

population.

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• There should be an acceptable treatment for the
patients with recognized disease.

• There should be facilities for diagnosis and

treatment should be available.

• There should be an agreed policy on whom to

treat as patients.

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• The cost of case finding (including diagnosis and
treatment of patients diagnosed) should be
economically balanced in relation to possible
expenditure on medical care as a whole.
• Case finding should be a continuing process and not a
"once for all" project.

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 Types of screening program
1. Mass/population screening
– It is offered to all, irrespective of the particular risk factors
2. Multiple/multi-phase screening
– The purpose of two or more screening tests in
combination to a large number of people at one time
– Parallel and series test(VCT)
3. Case finding/opportunistic screening
– It is restricted to patients who consult a health
professional for
some other purposes –ex STD screening in OPD
4. Targeted screening
– High risk or selective screening- nutritional screening for
children
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 Characteristics
of a good screening test

• Valid (e.g., sensitive and specific)

• Reliable (gives consistent results; no random errors)
• Yield (number of cases identified per thousand
screened)
• Cost – benefit (compare costs avoided due to early
detection of the disease against cost of the
screening. Does the test merely uncover more
disease that is expensive to treat without appreciable
advantage?)
• Acceptable (discomfort, hassle, cost of obtaining test)
• Follow-up services (plan needed to deal with positive
results)
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 Logic of screening
Apparently well population

Screening test

Positive results:
Negative results Diagnostic test

Disease No disease Disease No disease

(False negative) (True negative) (True positive) (False positive)

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 Accuracy of screening test

▪ A test should be unbiased, precise, and be able

to determine the disease status of an individual
without error
▪ Accuracy is the ability of the test to correctly
classify
individuals according to their disease status

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 Criteria for instituting a screening
program
Criteria for instituting a screening • Serious
program • High prevalence of preclinical
1. Disease stage
•Natural history understood
•Long period between first sign
and overt disease

2. diagnostic test • Sensitive and specific

•Simple and cheap
•Safe and acceptable
•Reliable

3. Diagnosis and • Facilities are adequate

treatment •Effective, acceptable and safe

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 Screening tests
1. Validity (accuracy) of test
a. Sensitivity b. Specificity
2. Performance of screening test
a. Predictive Value Positive (PV+)
b. Predictive Value Negative (PV-)

3. Reliability
Percent agreement
 VALIDITY OF A DIAGNOSTIC
TEST
• A central issue in evaluating a test is its validity,
or the ability to differentiate accurately between
those who have the disease and those who do not
have.
• The validity of the test refers to the extent to
which the test is capable of correctly diagnosing
the presence or absence of the disease
concerned.
• Sensitivity and Specificity are two measures of
the validity of a screening test.
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 Measures of accuracy of screening
tests
▪ Validity:
▪ The application of a screening test is to identify
correctly individuals who do and do not have
preclinical disease
▪ Those who have preclinical disease should test
positive, and those who do not have it should test
negative
▪ It is expressed by its sensitivity and specificity
▪ Reliability
▪ Is the ability of a test to come up with similar
values
upon repeated measurements in similar occasions
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 Reliability versus validity of a
test

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 Evaluation of Screening test
It is usually done using two-by-two table

• Two conditions are important

1. Actual occurrence of a disease (usually measured by
the best diagnostic instrument called (gold standard)
2. The new diagnostic instrument to be evaluated

Disease Status (Gold Standard)

Test Result
Present Absent

Positive True Positive (a) False Positive (b)

Negative False Negative (c) True Negative (d)

 Sensitivity of test:
▪ The ability of the test to recognize people with disease
▪ When the probability of disease is relatively low & the
purpose of the test is to discover disease
▪ Can be used to “rule out” disease
▪ When there is a great need not to miss a disease e.g. TB,
Syphilis.
▪ Is most helpful when the test result is negative
▪ It describes its ability to correctly identify people who have
the characteristic that is being measured
Sensitivity = TP x 100
TP + FN
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Sensitivity of a Screening Test

Sensitivity: Proportion of people with a disease

who tested positive for the screening test

True Positive
e

Sn =
True Positive + False Negative
 Specificity of test:
▪ The ability of the test to recognize people without
disease
▪ Is most helpful when the test result is positive
▪ Useful to confirm or to “rule in “a diagnosis that has been
suggested by other data
▪ Highly specific test are particularly needed when false
positive result can harm the patient physically
,emotionally or financially e.g. HIV, Cancer
▪ The proportion of people who do not have the condition
who are correctly classified as non cases
Specificity = TN x 100
TN + FP

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Specificity of a Screening Test

• Specificity: is the proportion of people without a

disease who tested negative for the screening test

d
Sp = b +d
True Negative
Sp =
True Negative +False Positive
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 Balance in choosing a screening
test

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 Positive predictive value

▪ The probability that the person tested positive

by this specific test truly has the disease
▪ It is defined as the proportion of people with the
condition among all those who received a
positive test result
Predictive value positive = TP x 100
TP + FP

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 Positive Predictive Value

Positive predictive value:

• is the proportion of cases with a disease out
of people who tested positive on the
screening

a True Positive
PV+ =a +b
True Positive + False Positive
 Negative predictive value

▪ The probability no disease in person with a

negative test
▪ It is the proportion of people without the
condition
among all those who received a negative test
result
▪ Show degree of confidence the disease can be
ruled out by using this specific test

Predictive value Negative = TN x 100

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TN + FN
Negative Predictive Value of a
Screening Test
Disease Status (Gold Standard)
Test Result Present Absent
Positive True Positive (a) False Positive (b)
Negative False Negative (c) True negative (d)

Negative predictive value :

is the proportion of actual non-cases among
those who tested Negative for the screening
d
Sp c= +d True Negative
Sp =True Negative + False Negatives
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 Predictive values of screening test

• Depends on:-
–Sensitivity of the test
–Specificity of the test
–Prevalence of the disease in that community
▪ Positive predictive value is influenced by test
specificity and TRUE prevalence of the disease
▪ Negative predictive value is influenced by test
sensitivity and TRUE prevalence of the disease

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 Prevalence of disease versus predictive
values

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 Cost of a screening program

• What is the anticipated outcome in relation to

resources expended? i.e. how many people with
the disease of interest are detected by the
program out of all screened?
▪ Number of case detected by the screening test .
• This measure of cost effectiveness of a screening
program is known as.
YIELD = TP X 100
TP + TN + FP + FN
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 Strategies to increase yield of a
test
▪ Select disease with high prevalence of
preclinical stage
▪ Target high risk group for screening program
▪ Select a test with high validity

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 Exercise. 1
• Suppose a new test named “Test X “is developed for
screening of lung cancer .this new test was applied on
500 known early case of lung cancer and 550 women
with out lung cancer .the test was positive for 450
women with lung cancer and 30 women with out lung
cancer.
1. Show the result by 2x2 table
2. Determine the validity of test X
3. Determine the predictive value of test X?
4. Determine the yield of test X?

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 Solution
Lung cancer by “gold
standard “test

Test X result Present Absent Total

Positive TP(450) FP(30) 480 all who

test +

Negative FN(50) TN(520) 570 All who

test -

Total All with All with out 1050

disease 500 disease 550

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 solution
Sensitivity = TP x 100 = 450/500 x100
TP + FN
Specificity = TN x 100 = 520/550 x 100
TN + FP
PPV= TP x 100 =450/480 X 100
TP + FP
NPV= TN x 100=520/570 X100
TN + FN
Yield =TP/ALL =450/1050 X 100
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 Reliability
• The result of the test are identical or closely
similar each time it is conducted .
• Reliability/repeatability /reproducibility/precision
• Because of variation in laboratory procedure
,observers or changing condition of test subject
(such as time ,location),a test may be not
consistently give the same result when repeated
resulting in variation of results

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 Reliability cont.…
1. Biological variation
• inherent in the actual manifestation being
measured such as BP
• which varies considerably for a given individual
with time and other circumstances
2. Variation due to the test method or
measurement which relates to the reliability of
the instrument itself, such as standard mercury
sphygmomanometer for BP

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 Reliability cont…
3. Intra-observer variability which refers to differences in
repeated measurements by the same screener
4. Inter-observer variation which refers to inconsistencies
attributable to differences in the way different screeners
apply or interpret test results
The agreement between intra and inter observer Can be
measured by percent agreement
Observer 2 Observer 1

Positive Negative

Positive a b

Negative c d
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 Reliability
▪ Reliability is measured using Percent
agreement
▪ Percent agreement is the ability of a
screening program to correctly classify
individuals either as truly affected or truly
unaffected .
– It is proportion of correctly categorizing of
individuals among the total tested individuals

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 Percent agreement

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 Reliability
▪ A perfect agreement occurs when :b =0 and c=0
Percent agreement
▪ Overall percent agreement =a+d /a+b+c+d x100
▪ Positive percent agreement =a/a+b+c x 100

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 Cont.…

• Its value usually ranges between 0 and 100%

(ie, the more it is nearer to 100%, the more both
instruments agree to each other)

• Percent agreement is directly related with

increment in proportion of true negatives and true
positivity of a test

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 Reliability cont.…
These variations can usually be reduced by:
1. careful standardization of procedures
2. an intensive training period for all observers
(or interviewers)
3. periodic checks on their work
4. the use of two or more observers making
independent observations.

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 Multiple test parallel Vs. serial
Multiple test can be done in:
• Parallel (i.e .,all at once )and a positive result of
any test considered evidence for disease or
• Serially (i.e. Consecutively) each based o the
results of the previous test .for serial testing all test
must gives a positive result for the diagnosis to be
made, because the diagnostic process is stopped
when a negative result is obtained .
• Its two stage screening :re screening positive from
the first test
• Serial testing leads to less laboratory utilization
than parallel test because additional evaluation is
contingent on prior test result.
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 Parallel test
• Parallel test when rapid emergency and patient
come from long distance assessment need

▪ Net effect amore sensitive diagnostic strategy

Ds is less likely to be missed, yet likelihood of
having false positive is also increased (leading
to Rx of some patients without the disease)
– Increase Sn &NPV
– Lower SP&PPV

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 Serial test
• Serial test the rapid assessment is not
needed , when some of the test are
expensive or risky and ambulatory
patient followed over time
• Useful when none of the individual
test available to clinician is highly
specific
• Increase Sp &PPV
• Lower Sn&NPV

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 Evaluation of screening program

• Evaluation of a screening program involves

consideration of two issues: first, whether the program is
feasible, and second, whether it is effective.
• Both must be considered carefully.
• No matter how effective a screening procedure is in
reducing subsequent morbidity and mortality, it will not
be accepted if it can not be conducted efficiently
• the implementation of a screening program, no matter
how cost-effective, will not be warranted if it does not
accomplish its goal of reducing morbidity and mortality.

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 Feasibility

• The feasibility of a screening program is

determined by a number of factors related to
program performance which measure:
- the acceptability of the program to the potential
screeners,
-cost-effectiveness
-the subsequent diagnosis and treatment
-the yield of cases.

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 Effectiveness

• evaluation of effectiveness of a screening

program must be based on measures that reflect
the impact of a program on the course of a
disease.
• An effective screening program should result in
reduction of morbidity, mortality and disability.
• The most definitive measure of the efficacy of a
screening program is a comparison of the
cause-specific mortality rates among those
whose disease was picked up by screening and
those whose diagnosis was related to the58
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 Thanks a lot

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