TES DIAGNOSTIK

Tri Nur Kristina

Studi Tes Diagnostik

Desain penelitian untuk mengetahui

seberapa baik alat diagnostik dapat
membedakan antara pasien yang
menderita/ tidak menderita penyakit

Tes Diagnostik
- Memprediksi adaya penyakit

- Tes Diagnostik yang ideal memberi jawaban yang

benar:
Hasil (+) pada org yang menderita penyakit
Hasil (-) pada orang yang tidak menderita penyakit
- Murah, cepat, aman, sederhana, tidak menyakitkan,
reliabilitasnya baik (reliable)

Struktur tes diagnostik

- Predictor variable: Hasil tes

- Outcome variable: Ada / tidak adanya penyakit

Hasil tes predictor variable:

Dichotomous: Test (+) or (-)

Categorical:
Glycosuria (++++); (+++); (++); (+); (-)

Continuous: ..mg of glucose/ dl

Adanya Penyakit sebagai outcome variable:

Outcome variable pada studi tes diagnostik adalah ada/
tidak adanya penyakit yang ditentukan oleh alat
diagnostik yang menjadi standar baku emas ( a gold
standard)

Standar baku emas selalu (+) pada pasien dengan

penyakit dan (-) pada yang tidak menderita penyakit

Sensitivitas:
Proporsi dari subjek penelitian dengan penyakit yang memiliki
hasil (+) mengindikasikan seberapa baik alat diagnostik
yang dites dalam mengidentifikasi orang yang menderita
Penyakit

Specifisitas:
Proporsi dari subjek penelitian tanpa penyakit yang memiliki
hasil (-) mengindikasikan seberapa baik alat diagnostik
yang dites dalam mengidentifikasi orang yang tidak menderita
penyakit

Tes Diagnostik
(Hasil Test)

Sensitivity:

Gold Standard
Penyakit (+)

Penyakit (-)

(+)

TP
a

FP
b

(-)

FN
c

TN
d

a
a+c

Specificity:

d
b+d

Choice of a cutoff point

If the result of diagnstic test yield in continuous data, a
decision must be made as to what will constitute a (+)
test, a value called cutoff point
This decision requires trading an increase in sensitivity
for a decrease in specificity, or vice versa
The investigator must weigh the relative importance of
the sensitivity and specificity of the diagnostic test, and
set the cutoff point accordingly

 One way to do this is to consider the implications of the

two possible errors
If false (+) must be avoided (e.g. to determine dangerous
surgery), the cutoff point might be set to maximize the
test specificity
If false (-) must be avoided (e.g. screening for neonatal
phenil ketonuria), the cutoff point should be set to ensure
a high test sensitivity

ROC curves
Another way to set the cutoff point is to use
receiver operator characteristic (ROC) curves.
The investigator selects several cutoff points,
and determines the sensitivity and specificity at
each point
Graph sensitivity as function of (1 specificity)
or false (+) rate

Serum ALT (U/L) among patients with and without hepatitis

100

(50)

80

(100)

(25)

Sensitivity
(200)

60

(400)

40

20

20

40

60

80

1- Specificity

100

 Usually the best cutoff point is where the ROC

curve turns the corner in this case, when ALT is
about 50 U/L
The curves for different diagnostic test can be
compared, in which the better a test, the closer
its curve is to the upper left corner

Positive Predictive Value

PPV (Positive Predictive Value):
The probability that a person with a (+) test, actually has
a disease

a
PPV =
a+c

Negative Predictive Value

NPV (Negative Predictive Value):
The probability that a person with a (-) test, actually does
not has a disease

NPV =

d
c+d

Jumlah sampel untuk Tes Diagnostik

N=

( Z2 1- /2 ) P Q
d2
P = sensitifitas (diharapkan 80 %)
Q = 1 - P = 0,2
d = 0,2 ( hasil penelitian tak jauh dari 20 % dari
proporsi yang sebenarnya)
Dari tabel, Z2 1-a/2 adalah 1,96 (tingkat kepercayaan
95% )
N=

(1,96)2 (0,8) (0,2)

( 0,2 ) 2

0,615
0,04

Jumlah sampel dari penderita = 15

15,37

 Bila Prevalensi penyakit = 35 % ----> Jumlah sampel

yang tidak menderita
100 - 35 X 15 = 28
35
Jumlah sampel untuk tes diagnostik = 15 + 28 = 43

Measurement bias
The risk of bias increases if the outcome is known to the
person who measuring the predictor
Bias even possible if predictor is measured first (new
promising tool result +), can influence the person who
measuring the gold standard Especially if the test is difficult
to classify
Borderline result (common in a person with borderline
disease)
Strategy: BLINDING

7 Steps in planning a diagnostic test study

1. Determine whether there is a need for a new diagnostic test
2.

Set the sampling criteria:

Describe the way in which patient will be selected

3. Define the test and the gold standard:

Have a reasonable gold standard
(feasible, ethical, affordable for both DX test & gold standard)
4. Gold standard and Diagnostic test can be applied in a standardized
and blinded
5. Estimate the sample size required to achieve 95% CI for the test sensitivity
and specificity
6. Ensure that enough subjects are available
7. Report the result in term of sensitivity, specificity, and predictive value