Total PSA in Human Serum and Plasma with Roche e801

Detection of Total PSA in Human Serum and Plasma with Roche e801

Test Name: Immunoassay for the quantitative in vitro diagnostic test for total (free + complexed) prostate‑specific antigen (tPSA) in human serum and plasma.
Method Name: In the Elecsys TPSA assay, a TPSA specific antibody labeled with a ruthenium complex is used to determine the total prostate specific antigen concentration.
Results: Technical Range: 0.014-100 ng/mL
Reportable Range: 0.0164-87.30 ng/mL
Reference Ranges: Men: <4.0 ng/mL
Clinical Significance: Prostate specific antigen (PSA) is a glycoprotein (molecular weight 30000 34000 daltons) having a close structural relationship to the glandular kallikreins. It has the function of a serine proteinase.

The proteolytic activity of PSA in blood is inhibited by the irreversible formation of complexes with protease inhibitors such as alpha 1 antichymotrypsin, alpha 2 macroglobulin, and other acute phase proteins. Besides these complexes, about 30 % of the PSA present in blood occurs in the free form but is proteolytically inactive.

Elevated concentrations of PSA in serum are generally indicative of a pathologic condition of the prostate (prostatitis, benign hyperplasia or carcinoma).6,7

As PSA is also present in para urethral and anal glands, as well as in breast tissue or with breast cancer, low levels of PSA can also be detected in sera from women. PSA may still be detectable even after radical prostatectomy.

The main areas in which PSA determinations are employed are the monitoring of progress and efficiency of therapy in patients with prostate carcinoma or receiving hormonal therapy.

The steepness of the rate of fall in PSA down to no-longer detectable levels following radiotherapy, hormonal therapy or radical surgical removal of the prostate provides information on the success of therapy.

An inflammation or trauma of the prostate (e.g. in cases of urinary retention or following rectal examination, cystoscopy, colonoscopy, transurethral biopsy, laser treatment or ergometry) can lead to PSA elevations of varying duration and magnitude.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum Plasma: Li-heparin and K2-EDTA plasma
Do not use fluoride plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Storage and Stability:    6 months at -20°C
5 days at 2-8°C

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: 1 day.