PSA

Intended Use

The SERATEC® PSA SEMIQUANT test serves the rapid detection of PSA in seminal fluid. Originally the test was developed for the determination of PSA in blood serum to allow the detection of elevated levels of PSA that might be an indication of prostatic cancer. The interpretation occurs visual by the recognition of a test line in the case of a PSA positive sample. If required the intensity of the test line can be correlated to the intensity of an internal standard which is adjusted to resemble the color intensity of the test result line at 4 ng PSA/ml.

Specificity

The test shows no cross reactivity with other proteins of the seminal fluid. An immunoblot with seminal fluid using the respective PSA antibodies resulted only in one reactive line at the height of PSA. No cross reactivity was observed with the seminal fluid of other mammals (dog, cat, horse, bull, pig)1 except for the seminal fluid of primates.
No cross reactivity was observed with blood serum. Female blood has a PSA content below the detection limit and showed no reactivity.

Sensitivity

Qualitative Analysis (without SeraQuant): cut-off at 2 ng/mL PSA.
Quantitative Analysis (SeraQuant): down to 0.5 ng/mL PSA.