PSA TEST    KIT COMPONENTS    COMPONENT OPERATION    RESULTS

• About the Prostate Specific Antigen (PSA) cartridge

(1)        PE-carrier

(2)        Membrane

(3)        monoclonal anti-PSA-antibody

(4)        polyclonal anti-mouse antibody

(5)        Glass fiber pad with gold labeled monoclonal anti-PSA-antibody

(6)        polyclonal anti-mouse antibody, adjusted to color intensity of 4 ng PSA/mL

(7)        Adsorbent pad

• About the Prostate Specific Antigen (PSA) test
  • The membrane contains two monoclonal murine anti-PSA antibodies as active compounds. One of these antibodies is immobilized at the test region on the membrane. The upstream control region and the region of the internal standard (between control and test region) contain immobilized polyclonal goat anti-mouse antibodies. The amount of antibody at the internal standard is adjusted to a color intensity of the line, which is equal to the color intensity of the test line at a PSA concentration of 4 ng/mL. A glass fiber pad downstream of the
    membrane is used for sample loading and transmission to a second fiber pad with the dried and gold labeled second monclonal murine anti-PSA antibody.
  • PSA at the sample will bind to the re-mobilized gold-labeled antibody and form a PSA-gold-labeled-anti-PSA-antibody-complex. Through the capillary effect of the membrane, the reaction mixture including the complex is carried upwards with the fluid. In any case the colored gold labeled anti-PSA-antibody will bind to the anti-mouse-antibody at the control region and the region of the internal standard thus developing two red lines (one at the control region ant one at the region of the internal standard). These two lines are independent of the existence of PSA at the sample and indicate only the correct execution of the test. 
  • If the sample contains PSA the PSA-gold-labeled anti-PSA-antibody complex will bind to the immobilized monoclonal antibody of the test region that recognizes another epitope on the PSA molecule. The binding is indicated by the formation of an additional line. Thus a PSA positive sample will show three colored lines in the result well. The line in the middle (internal standard) correlates with an amount of 4 ng/ml PSA. In some cases it might be helpful to estimate the amount of PSA in the sample by comparison of the result line with the internal standard line.

   

• Components of the kit

  Click on picture for enlarged image
  Packaging	PSA Cartridge	Instructions & non-destructive collection	Surgical Gloves and sterile work surface mat

   

  mixing components with cutting mat	Cutting device with cutting mat	Specimen pouch, evidence tape, and chain of custody form.

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