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 | ||||
---|---|---|---|---|
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 |
|
---|---|
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 | ||||
---|---|---|---|---|
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 |
|
---|---|
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