Quality Control and Laboratory Issues

While a number of molecular tests have been developed for the detection of recurrent UC in patients, additional carefully designed and controlled studies are needed to further evaluate the performance characteristics of most of these assays before they can be widely introduced into clinical practice. Nonetheless, it is likely that one or more of these tests will be widely used by urologists to improve the management of patients who have been diagnosed with or are being evaluated for UC. Test validation studies should evaluate the diagnostic sensitivity and specificity of these assays relative to standard tests (such as cytology) in well-characterized patient populations. When applicable, receiver-operator curves should be evaluated to determine how different cutoff values affect the diagnostic sensitivity and specificity of the test. Other factors that need to be assessed as a part of test validation include the analytical sensitivity and reproducibility of the test, as well as specimen stability issues. For clinical implementation of a test, appropriate controls should be included with each run. For PCR-based tests, this would include positive, negative, and "no DNA" controls, and possibly analytical sensitivity and precision controls when a quantitative result is produced.


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