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CLINICAL LAB SCIENEC

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CHAPTER 10: QUALITY ASSURANCE 249

for comparing two different tests, rather than two different methodologies. The

precision for the two tests might be different, and the test with the greatest

degree of precision would most likely be chosen. The t-test and the F-test are the

two most common methods for comparing precision (reproducibility) for two

methods and two different procedures (Table 10-3).

Predictive Value

Predictive analysis is important in that it attempts to match laboratory test values

with the actual incidence of disease in a given population. False positive

results in a population with a low level of a certain disease state would incorrectly

increase the percentage of persons deemed to have the disease.

Sensitivity and specificity are important in this area. These concepts are discussed

later in this chapter in the section on clinical and statistical significance.

Briefly, a test that is too sensitive would yield an increased number of false positives

where extremely low levels of a certain metabolite may be present, and a

test that is not specific may measure entities unrelated to a disease process. If

a condition has a low prevalence (number of cases of a specific disease present in

a given population) and the test methodology is not 100% specific, false-positive

results will be higher than the predictive value. The predictive value refers to a

test result that might be substantially elevated or found at a lower level than

would be expected for certain disease states. Procedures should be highly specific

to avoid large numbers of false positives, because some tests will yield a positive

result in the presence of chemicals found in certain foods and medications. False

positives may cause undue mental stress and treatment for a disease that is not

present.

On the other hand, if a test is not specific enough, false positive results may

arise due to other conditions. An example of this is the common test for syphilis.

It is a serological test that may provide false positives for a number of illnesses

not related to syphilis. But screening tests for large populations must be sensitive

enough to identify those who may have the disease, and further definitive testing

and physical examinations could then be performed only on those who might

have the ailment. Most laboratory procedures will include information regarding

Table 10-3 Types of Comparisons for Laboratory Procedures by

Analysis of Results

t-Test The t-test measures reproducibility and is also called the paired t-test. This process

compares the accuracy of two methods because it tests the difference between the

mean value for each testing method. Remember that there are numerous methods for

performing any laboratory test. The reference or current method is considered to refl ect

true value. A null hypothesis results when there is no difference in the two methods.

F-test The F-test measures method accuracy (accuracy of test results is determined by

performing proficiency testing). The F-test compares the precision or reproducibility for

two procedures. The SD of the method showing the larger variance divided by the SD of

method showing smaller variance = % difference.

NOTE: Method refers to how a test is performed. Procedure refers to a different test, e.g., a total protein and a calcium.

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