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Test ID: FPCA3    
PCA3 Assay

Method Description Describes how the test is performed and provides a method-specific reference

The PCA3 assay is performed utilizing the PROGENSA assay kit from Gen-Probe, comprised of two quantitative nucleic acid amplification tests, one for PCA3 RNA, one for PSA RNA. In both, the target RNA molecules are isolated from urine specimens utilizing complementary RNA oligonucleotides and a magnetic separation system to capture the target sequences. A reverse transcriptase is utilized to make DNA copies (template) of the target RNA, and an RNA polymerase is utilized to produce multiple RNA copies (amplicon) of the template (transcription-mediated amplification or TMA). Chemiluminescence-labeled complementary probes are utilized to detect the amounts of amplicon present. PCA3 and PSA mRNA are quantiated by comparison with standard curves generated with every assay. The PCA3 score is calculated as 1000 times the ratio of the concentration of PCA3 RNA to the concentration of PSA RNA ([PCA3 mRNA]/[PSA mRNA] x 1000).

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Varies, Monday through Saturday

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

3 - 7 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

5 - 9 days

Performing Laboratory Location The location of the laboratory that performs the test

DIANON Systems, Inc