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25082 PCA3 (FPPCA)

PCA3 (FPPCA)
Test Code: PCA3SO
Synonyms/Keywords
Prostate Cancer Antigen 3
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Urine​ ​PROGENSA Urine Specimen Transport Tubes (two) ​ 20-30 mL​ 5 mL​ ​
Collection Processing Instructions
Collect specimen using PROGENSA Urine Specimen Transport Tube as follows:
1. Perform an attentive digital rectal exam (DRE) immediately prior to specimen collection (specimen should be collected within approximately 1 hour of DRE).
2. Patient should collect the first 20-30 mL voided urine following the DRE.
3. Process specimen within 4 hours of collection (if specimen cannot be processed within 15 minutes, store refrigerated or on ice and process within 4 hours).
    a. Invert specimen cup 5 times to re-suspend cells
    b. Add 2.5 mL of urine to each of the two GEN-PROBE PROGENSA PSA3 Urine Specimen Transport Tubes. (Do NOT puncture the foil seal on the cape 
        the transport tube; the specimen must fall between the two black fill lines on the transport tube.
    c. Tightly re-cap each urine transport tube and gently invert 5 times to mix; do not shake or vortex.
4. Send both GEN-PROBE PROGENSA transport tubes refrigerated.
Specimen Stability Information
Specimen Type Temperature Time
Urine​ (PROGENSA VIAL) ​ ​ ​Ambient ​24 hours
​Frozen ​90 days
​Refrigerated (preferred) ​5 days
Rejection Criteria
 
Rejection Criteria
​Volume <2 mL
​Aptima media
​Hemolysis
​Incorrect collection kit
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories who forwards
to University of Michigan (MLabs)		 ​Monday, Wednesday, Friday ​4-7 days
Transcription-mediated amplification (TMA)
Hybrid protection assay (HPA)​
Reference Lab
Mayo Clinic Laboratories
Test Information

​PCA3 score equals (PCA3 mRNA)/(PSA mRNA) x 100 .
Clinical research data support the clinical value of using PCA3/PSA mRNA ratios as a diagnostic indicator in identifying patients with increased risk of prostate cancer. Prostate tumors showed a 66-fold up-regulation of PCA3 when compared to benign prostate tissue. This up-regulation was found in more than 95% of the prostate cancer specimens studied. Patients positive for CaPDetect: PCA3 have CaPDetect: PCA3 score greater than 35 and are at increased risk for prostate cancer.

Reference Range Information
​A score less than 25 is considered negative.
A scoree greater than or equal to 25 is considered positive.
Interpretation
​Interpretive report
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​81313 ​ ​ ​ ​
Synonyms/Keywords
Prostate Cancer Antigen 3
Ordering Applications
Ordering Application Description
​Centricity ​Prostate Cancer Gene 3 (FPCA3)
​Cerner ​None
​Clinical Order Manager ​Prostate Cancer Gene 3
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Urine​ ​PROGENSA Urine Specimen Transport Tubes (two) ​ 20-30 mL​ 5 mL​ ​
Collection Processing
Collect specimen using PROGENSA Urine Specimen Transport Tube as follows:
1. Perform an attentive digital rectal exam (DRE) immediately prior to specimen collection (specimen should be collected within approximately 1 hour of DRE).
2. Patient should collect the first 20-30 mL voided urine following the DRE.
3. Process specimen within 4 hours of collection (if specimen cannot be processed within 15 minutes, store refrigerated or on ice and process within 4 hours).
    a. Invert specimen cup 5 times to re-suspend cells
    b. Add 2.5 mL of urine to each of the two GEN-PROBE PROGENSA PSA3 Urine Specimen Transport Tubes. (Do NOT puncture the foil seal on the cape 
        the transport tube; the specimen must fall between the two black fill lines on the transport tube.
    c. Tightly re-cap each urine transport tube and gently invert 5 times to mix; do not shake or vortex.
4. Send both GEN-PROBE PROGENSA transport tubes refrigerated.
Specimen Stability Information
Specimen Type Temperature Time
Urine​ (PROGENSA VIAL) ​ ​ ​Ambient ​24 hours
​Frozen ​90 days
​Refrigerated (preferred) ​5 days
Rejection Criteria
 
Rejection Criteria
​Volume <2 mL
​Aptima media
​Hemolysis
​Incorrect collection kit
Reference Range Information
​A score less than 25 is considered negative.
A scoree greater than or equal to 25 is considered positive.
Interpretation
​Interpretive report
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories who forwards
to University of Michigan (MLabs)		 ​Monday, Wednesday, Friday ​4-7 days
Transcription-mediated amplification (TMA)
Hybrid protection assay (HPA)​
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​81313 ​ ​ ​ ​
For most current information refer to the Marshfield Laboratory online reference manual.