Prostate Specific Antigen (PSA) Rapid Test

INTENDED USE

The Prostate Specific Antigen (PSA) Rapid Test is a rapid visual immunoassay for the qualitative presumptive detection of prostate specific antigens in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of prostate cancer.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (1530°C) before use.

1. 1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. 2. Transfer 1 drops of serum/plasma to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer, and start the timer.

OR

Transfer 2 drops of whole blood to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer, and start the timer.

OR

Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, then add 1 drop of buffer, and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

3. LIMITATIONS OF THE TEST

   1. 1. The Prostate Specific Antigen (PSA) Rapid Testis for professional in vitro diagnostic use, and should only be used for the qualitative detection of PSA. No meaning should be inferred from the color intensity or width of any apparent bands.

   2. The Prostate Specific Antigen (PSA) Rapid Test will only indicate the presence of PSA in the specimen and should not be used as the sole criteria for the diagnosis of prostate cancers.

   1. 3. A significant numbers of patients with BPH (more that 15%) and less than 1% of healthy individuals have elevated PSA. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
   2. 4. Specimens from patients who have received mouse monoclonal antibodies for diagnostic or therapeutical use may contain human anti-mouse antibodies. Such specimens may show either elevated or depressed values when tested with assay kits that utilize mouse monoclonal antibodies.
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