17.2 - Describing Diagnostic Tests

The following concepts have been developed to describe the performance of a diagnostic test relative to the gold standard; these concepts are measures of the validity of a diagnostic test.

Sensitivity
is the probability that an individual with the disease of interest has a positive test. It is estimated from the sample as a/(a+c).
Specificity
is the probability that an individual without the disease of interest has a negative test. It is estimated from the sample as d/(b+d).
Accuracy
is the probability that the diagnostic test yields the correct determination. It is estimated from the sample as (a+d)/(a+b+c+d).

Tests with high sensitivity are useful clinically to rule out a disease. A negative result for a very sensitive test virtually would exclude the possibility that the individual has the disease of interest. If a test has high sensitivity, it also results in a low proportion of false-negatives. Sensitivity also is referred to as "positive in disease" or "sensitive to disease".

Tests with high specificity are useful clinically to confirm the presence of a disease. A positive result for a very specific test would give strong evidence in favor of diagnosing the disease of interest. If a test has high specificity, it also results in a low proportion of false-positives. Specificity also is referred to as "negative in health" or "specific to health".

Sensitivity and specificity are, in theory, stable for all groups of patients.

In a study comparing FNA to the gold standard (excisional biopsy), 114 women with normal physical examinations (nonpalpable masses) and abnormal mammograms received a FNA followed by surgical excisional biopsy of the same breast (Bibbo M, et al: Stereotaxic fine needle aspiration cytology of clinically occult malignant and premalignant breast lesions. Acta Cytol 1988; 32:193-201.)

 
Cancer
No Cancer
FNA Positive
14
8
FNA Negative
1
91

Sensitivity = 14/15 = 0.93 or 93%
Specificity = 91/99 = 0.92 or 92%
Accuracy = 105/114 = 0.92 or 92%

Example

Using PROC FREQ in SAS for determining an exact confidence interval for sensitivity and specificity Section

Point estimates for sensitivity and specificity are based on proportions. Therefore, we can compute confidence intervals using binomial theory. See SAS Example (18.1_sensitivity_specifi.sas) below for a SAS program that calculates exact and asymptotic confidence intervals for sensitivity and specificity.

***********************************************************************
* This is a program that illustrates the use of PROC FREQ in SAS for  *
* determining an exact confidence interval for sensitivity and        *
* specificity.                                                        *
***********************************************************************;

proc format;
value yesnofmt 1='yes' 2='no';
run;

data sensitivity;
input positive count;
format positive yesnofmt.;
cards;
1 14
2 01
;
run;

proc freq data=sensitivity;
tables positive/binomial alpha=0.05;
weight count;
title "Exact and Asymptotic 95% Confidence Intervals for Sensitivity";
run;

data specificity;
input negative count;
format negative yesnofmt.;
cards;
1 91
2 08
;
run;

proc freq data=specificity;
tables negative/binomial alpha=0.05;
weight count;
title "Exact and Asymptotic 95% Confidence Intervals for Specificity";
run;

For the FNA study, only 15 women with cancer, as diagnosed by the gold standard, were studied. The rule for using the asymptotic confidence interval fails for sensitivity because np(1 - p) = 0.9765 < 5 (the rule does hold for specificity).

As the output shows below, the exact 95% confidence intervals for sensitivity and specificity are (0.680, 0.998) and (0.847, 0.965), respectively.

Exact and Asymptotic 95% Confidence Intervals for Sensitivity
Exact and Asymptotic 95% Confidence Intervals for Sensitivity
The FREQ Procedure
Positive Frequency Percent Cumulative Frequency Cumulative Percent
yes 14 93.33 14 93.33
no 1 6.67 15 100.00
 

Binomial Proportion
for positive = yes

Proportion 0.9333
ASE 0.0644
95% Lower Conf Limit 0.8071
95% Upper Conf Limit 1.0000
Exact Conf Limits  
95% Lower Conf Limit 0.6805
95% Upper Conf Limit 0.9983
 

Test of H0: Proportion = 0.5

ASE Under H0 0.1291
Z 3.3566
One-Sided Pr > Z 0.0004
Two-Sided Pr > |Z| 0.0008

Sample Size = 15

Exact and Asymptotic 95% Confidence Intervals for Specificity
Exact and Asymptotic 95% Confidence Intervals for Specificity
The FREQ Procedure
Positive Frequency Percent Cumulative Frequency Cumulative Percent
yes 91 91.92 91 91.92
no 8 8.08 99 100.00
 

Binomial Proportion
for positive = yes

Proportion 0.9192
ASE 0.0274
95% Lower Conf Limit 0.8655
95% Upper Conf Limit 0.9729
Exact Conf Limits  
95% Lower Conf Limit 0.8470
95% Upper Conf Limit 0.9645
 

Test of H0: Proportion = 0.5

ASE Under H0 0.0503
Z 8.3418
One-Sided Pr > Z <.0001
Two-Sided Pr > |Z| <.0001

Sample Size = 99