1. A new diagnostic test has been developed to Diagnose Disease Y. The new test was compared to the standard diagnostic test ("the gold standard") on the same set of patients, and the following data were obtained:
Number of patients diagnosed by the new test as having Disease Y, who actually had Disease Y = 3,252
Number of patients in the group who were diagnosed by the standard test as having Disease Y = 4,579
Number of patients diagnosed by the new test as not having Disease Y = 4, 737
Number of patients diagnosed by the new test as having Disease Y, who actually do not have Disease Y= 784
The standard diagnostic test is a tissue biopsy, and therefore, is considered to be 100% sensitive and 100% specific for diagnosing Disease Y.
a. Create the 2x2 table that shows this data (4)
b. Calculate:
i. The sensitivity of the new test
ii. The specificity of the new test
iii. The false positive rate of the new test
iv. The false negative rate of the new test
v. The positive predictive value of the new test
vi. The negative predictive value of the new test
vii. The likelihood ratio positive for the new test
viii. The likelihood ratio negative for the new test
ix. If the pre-test probability of Disease Y in the population is 8%, what is the post-test probability of Disease Y in a person who tests positive for the disease, using the new test? (2)
x. What is the post-test probability of a person not having Disease Y if the person tests negative for the disease, using the new test?
2. Two new tests have been developed to diagnose Condition Z. One test (Test A) measures a metabolite "Metabolite A" in the serum. The other test (Test B) measures a different metabolite, "Metabolite B" in the urine. After appropriate preliminary testing, human trials are conducted. Following informed consent, the two tests were run on a group of patients with each patient getting both tests, as well as the "gold standard" test for diagnosing Condition Z. The following data were obtained:
Serum level (metabolite A) # of patients Disease positive Disease negative
(mg / ml) (by gold standard) (by gold standard)
0 - 1.99 25 22 3
2.0 - 3.99 273 201 72
4.0 - 5.99 584 572 12
6.0 - 7.99 538 529 9
8.0 - 9.99 175 170 5
>10.0 14 14 0
Urine level (metabolite B)
(ng/ml)
0 - 2.99 30 5 25
3.0 - 5.99 245 46 199
6.0 - 8.99 423 400 23
9.0 - 11.99 628 620 8
12.0 - 14.99 175 169 6
15.0 - 17.99 99 95 4
>18.0 9 9 0
a) If, for test A, a cutoff value of 2.0 mg / ml of metabolite A is chosen as the boundary between a negative and a positive test result (i.e., values below 2.0 mg / ml are considered "negative" and values of 2.0 mg / ml or greater are considered "positive"), and for test B, a cutoff value of 6.0 ng / ml for metabolite B is chosen as the boundary between a negative and a positive test result (i.e., values below 6.0 ng / ml are considered "negative" and values of 6.0 ng / ml or greater are considered "positive"),
i. Which test is the more sensitive at diagnosing Condition Z? (Show all work)
ii. Which test is the more specific at diagnosing Condition Z? (Show all work)
b) If the pre-test probability of Condition Z in this group is 8%,
a. what is the post-test probability of disease being present in a patient with a positive test result for test A if a cutoff value of 2.0 mg/ml is chosen?
b. what is the post-test probability of disease being present in a patient with a positive test result for test A if a cutoff value of 4.0 mg/ml is chosen?