Sc re eni ng a nd

Dia gnos tic

Te st
 Definition of Screening:
Th e pre sump tiv e ide ntificatio n of
unrecogniz ed disease or def ect by
th e app lica tion of te sts,
exa mina tions or other proce dure s
which ca n be ap plie d rapi dly.
 Screening program
 Goa l: secon da ry p reven tion
 det ec t di sea se befo re clini cal
poi nt for cure or impr ov ed
ou tcome
 ge t peop le with di se ase int o
appr op ri ate trea tm ent
1. Design of screening test
 gol d stan dard
 Se lect ion of objecti ves
 Samp le siz e
cas es: zα2 Se(1 − Se)
n1 =
d2
co nt rols zα2 Sp (1 − Sp )
n2 =
d2
 Asse ssing th e validity an d
rel iab ility
2. Assessment of Screening Test

 valid ity
 reliabil ity
 predictive
valu e
 True value and test results
(True value: gold standard)

True results in
the populations
Screening Disease No disease Total
test results
Positive a b a+b
(true positive) (false positive)
Negative c d c+d
(false (true negative)
negative)
Total a+c b+d a+b+c+d
(1) Validity of screening test
The abi lity of a tes t to
disting uish bet ween who has a
disease an d wh o does not have
th e di sease.

 Two m ain comp on en ts:

sen sitiv ity an d sp ecif icity
 Sensitivity (Se):
Pro portion of positiv e test
wh o have th e disease.
Se = a / (a+c )

 Specificity (Sp) :
Pro portion of neg ative test
wh o do n ot h ave th e diseas e.
Sp = d / (b+ d)
 False positive rate (FP):
FP = b / (b +d) = (1 - S p)
 False negative rate (FN):
FN = c / (a +c) = (1 -
Se )
 Youden’s index (YI):
YI = (Se + Sp) - 1
 Likelihood
 a /(a + c ) ratio
Se (LR):  c /(a + c )  1 − Se
+ LR =   = − LR =   =
 b /(b + d )  1 − Sp  d /(b + d )  Sp
 Agreement rate:
a+d
Agreement rate = ×100%
a+b+c+d
 Diagnostic index (DI):
a d
DI = Se + Sp = +
a+c b+d

 Diagnostic availability (DA):

DA = 2( Se 2 + Sp 2 ) − 1
ROC c urve a nd i ts
applic ati ons
 ROC cur ve (Recei ve Oper at or
Char act er isti c cu rve) ca n show the
rel ati ons hi p bet we en sens it ivi ty
and spec ifi city i nt ui ti vel y.

Ap pli cation s:
 Se lect ion of cut off value (cu t poi nt )
 Diag no st ic val ue co mpar is on amo ng
se ver al di agno st ic tes ts
 (2) reliability ( Repeatability )
 The test is reli abl e or
rep ea table.
 Intra-subject variation (var iati on
wi thin i ndivi du al sub jec ts)
 Va riance , sta nda rd dev iati on ,
C. V. etc .
 Inter-observer variation (var iati on
between th ose rea di ng th e test
resu lts)
 agr ee men t, Kap pa val ue
 Dr. A
Positive Negative
Dr. B Positive a b
agreement
Negative c d
agreement

Agreement = (a+d) / (a+b+c+d)

Ka ppa va lue: (sel f readi ng )

Kappa = 2(ad-bc)/(a+b)(b+d)(a+c)(c+d)
 (3) predictive value (PV)
 Positive PV (+ PV):
The likel ih ood th at a pati ent
wi th a pos itive test resu lt really
has th e diseas e.
+ PV = a / (a+b)
 Negative PV (- PV) :
The likel ih ood th at a pati ent
wi th a nega ti ve test result really
does not ha ve th e di sea se.
- PV = d / (c +d)
PV and disease prevalence
P : disease prevalence
 3.Two-stage screening
 To increase sen siti vity or
sp ec ifi city :
Two-stage screening
 Series Test: mo re sp ec ifi ci ty
( eg. di abe tes, HIV
inf ect ion )
 Parallel Test: mor e sensi tivi ty
( eg . blood do no r
sc ree ni ng )
 Multiple test

multiple test Test 1 Test 2 Result

+ + +
in parallel + - +
- + +
- - -
+ + +
in series + - -
- Not necessary -