Test Name

PSA

Test Code

570

Unit

ng/ml

Station

Chemistry

CPT Code

84153

Performing Facility

American Medical Labs, Herzliya
Pituah

Analyzer

Roche cobas 6000

Test Method

Electrochemiluminescence immunoassay
(ECLIA)

AML Preferred Tube

5 mL SST gel

Storage Instructions

Refrigerated;
Stability:

5 days at 2 to 8 ^oC

6 months at -20 ^oC , Freeze only once.

Min. Volume

1 mL

Turn-Around-Time

One day.

Intended Use

This assay, a quantitative in vitro diagnostic test for total (free + complexed) prostate-specific antigen (tPSA) in human serum and plasma, is indicated for the measurement of total PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer. The test is further indicated for serial measurement of tPSA to aid in the management of cancer patients.

Limitations

Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration. It is known that in rare cases PSA isoforms do exist which may be measured differently by different PSA tests. Findings of this kind have occasionally been reported for PSA tests from various manufacturers. For diagnostic purposes, the results should always be assessed in conjunction with the patient�s medical history, clinical examination and other findings.

Patient Preparation

No patient preparation needed.

Reasons for Rejection

Do not use sodium citrate tube, Improper labelling.

Adult Reference Ranges

0 – 4 ng/ml