Test Code PSAFT 
Methodology Electrochemiluminescence (ECLIA) 
Description In men over 50 with total PSA between 4.00 and 10.0 ng/mL, the measurement of the % free PSA may aid in avoiding unnecesasry biopsies. A number of studies have found that the % free PSA was significantly lower in patients having prostate cancer than those with benign disease. Elevated levels of prostate specific antigen (PSA) have been associated with benign and malignant prostate disorders. Studies show that in men 50 years or older, measurement of PSA is a useful addition to the digital rectal exam in the early detection of prostate cancer. In addition, PSA decreases to undetectable levels following complete resection of the tumor and may rise again with recurrent disease or persist with residual disease. Thus % free PSA has been demonstrated to improve the sensitvity and specificity in patients with tPSA values in the "gray zone" of 4.00-10.0 ng/mL.

No sample should be collected on patients receiving therapy with high biotin doses(i.e. biotin therapy for Multiple Sclerosis or oncology patients; skin, hair and nail supplements, or multivitamins containing > 5 mg/day) until at least 12 hours after the last biotin administration. If unsure, or if the clinical picture does not fit the results please contact the laboratory . We have methods to check for biotin interference as well as for any other interferences and for the accuracy of the results.

Biotin interference would falsely decrease the result of this assay.

NOTE: This test, when ordered on Medicare patients, is subject to the CMS Medicare Coverage Issues Manual (MCIM) Diagnostic Services policy "Prostate Specific Antigen (Screening)", Please verify that the diagnosis code (ICD-9) you have chosen demonstrates medical necessity for the test as documented in the physician's patient record. The CMS web site or the NorDx Limited Coverage Documentation Guide are available to assist you with this verification. A properly executed Advance Beneficiary Notice (ABN) must be submitted with the specimen if medical necessity is not demonstrated by the ICD-9 code chosen. 

Specimen Draw blood in a plain, red-top tube(s) or serum gel tube(s). Spin down and send 1.0 mL (minimum: 0.5 mL) of refrigerated serum in plastic vial. 
Reference Values PSAG 4.00 - 10.0 ng/mL
% Free PSA: > 25 
Analytic Time 1 Day 
Day(s) Test Set Up Sunday through Saturday 
CPT Code(s) 84153  PSAG total PSA
84154  PSAGF, Free PSA