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Recommendations when to order or not order the test. May include related or preferred tests.
Aid in detection of prostate cancer in men age 50 and older when used in conjunction with a digital rectal exam. May also be used as an aid to manage and monitor prostate cancer patients.
New York DOH Approval Status
Indicates whether a test has been approved by the New York State Department of Health.
This test is New York state approved.
Specimen Required
Patient PreparationInstructions patient must follow before/during specimen collection.
CollectSpecimen type to collect. May include collection media, tubes, kits, etc.
Plain red or serum separator tube.
Specimen PreparationInstructions for specimen prep before/after collection and prior to transport.
Transfer 1.0 mL serum to an ARUP standard transport tube. (Min: 0.5 mL)
Storage/Transport TemperaturePreferred temperatures for storage prior to and during shipping to ARUP. See Stability for additional info.
Refrigerated.
Unacceptable ConditionsCommon conditions under which a specimen will be rejected.
Hemolyzed specimens. Any specimens other than serum.
RemarksAdditional specimen collection, transport, or test submission information.
StabilityAcceptable times/temperatures for specimens. Times include storage and transport time to ARUP.
Expected turnaround time for a result, beginning when ARUP has received the specimen.
1-8 days
Reference Interval
Normal range/expected value(s) for a specific disease state. May also include abnormal ranges.
Effective August 16, 2021 Less than or equal to 3.6 ng/mL
Interpretive Data
May include disease information, patient result explanation, recommendations, or details of testing.
This test uses the Siemens' Atellica® IM cPSA methodology, which is FDA approved for use as an aid in the detection of prostate cancer in men age 50 and older when used in conjunction with a digital rectal exam. This methodology is also approved as an aid in the management/monitoring of prostate cancer patients. Results obtained with different assay methods or kits cannot be used interchangeably. Prostatic biopsy is required for the diagnosis of cancer. cPSA is generally not elevated in healthy men or with non-prostatic carcinoma. cPSA concentrations may be elevated in benign prostatic hyperplasia or inflammatory conditions of the prostate. Prostate cancer patients under treatment with antiandrogens and LHRH agonists and antagonists may exhibit markedly reduced levels of cPSA. Care should be taken when interpreting values from these individuals.
Compliance Category
FDA
Note
Additional information related to the test.
Hotline History
N/A
CPT Codes
The American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ. CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
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