Prostate (PSA) Test Instructions

The Prostate test is a rapid test for the semi-quantative detection of PSA in human whole blood

INTENDED USE

The Prostate (PSA) Test is a rapid chromatographic immunoassay for semi-quantative detection of prostate specific antigen in whole blood.

PRECAUTIONS

Please read all the information in this package insert before performing the test.

  • For self-testing in vitro diagnostic use only.
  • Do not eat, drink or smoke in the area where the specimens or kits are handled.
  • Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil packaging is damaged or has been opened, please do not use.
  • This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with doctor or medical professional.
  • Follow the indicated time strictly.
  • Use the test only once. Do not dismantle and touch the test window of the test cassette.
  • The kit must not be frozen or used after the expiration date printed on the package.
  • Keep out of the reach of children.
  • The used test should be discarded according to local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.

KIT CONTENTS

  • Test Cassette
  • Buffer
  • Lancet (x2)
  • Alcohol Pad
  • Capillary Dropper
  • Plaster
  • Instructions

MATERIALS REQUIRED BUT NOT PROVIDED

  • Timer

PROCEDURE

  1. Wash your hands with soap and rinse with clear warm water.
  2. Bring the pouch to room temperature before opening it. Open the foil pouch, remove the test cassette and place it on a clean and level surface. Run the test within one hour and best results will be obtained if the test is performed immediately after opening the foil pouch. Remove the dropper, buffer vial, lancet and Alcohol pad, place them close to the test cassette.
  3. Carefully pull off and dispose the released cap of the lancet.
  4. Use the provided Alcohol pad to clean the fingertip of the middle or ring finger as the puncture site. Allow to air dry.
  5. Press the lancet, on the side from where the cap was extracted; the tip retracts automatically and safely after use. Massage the hand without touching the puncture site by massaging the hand towards the fingertip of the middle or ring finger to be punctured.
  6. Keeping the hand down massage the end that was pricked to obtain a blood drop.
  7. Without squeezing the capillary dropper bulb, put it in contact with the blood. The blood migrates into the capillary dropper through the capillarity to the line indicated on the capillary dropper. You may massage again your finger to obtain more blood if the blood does not reach the indicated line. Avoid air bubbles.
  8. Release the blood collected into the Specimen well (S) of the cassette, by squeezing the dropper bulb.
  9. Wait for the blood to be totally dispensed in the well. Unscrew the cap of the buffer bottle and add 1 drop of buffer into the well (S) of the cassette and start a timer.
  10. Wait for the coloured line(s) to appear. Read results at 5 minutes. Do not interpret the results after 10 minutes.

READING THE RESULTS

POSITIVE: Three coloured lines appear. A test line (T) intensity weaker than the reference line (R) indicates a PSA level between 3-10 ng/mL.
A test line (T) intensity equal or close to the reference line (R) indicates a PSA level of approximately 10ng/mL.
A test line (T) intensity stronger than the reference line (R) indicates a PSA level more than 10ng/mL.

NEGATIVE: Coloured lines appear in both the control (C) and reference (R) regions. No coloured line appears in the test line region (T). This indicates a PSA level below 3ng/mL.

INVALID: Control line (C) or reference line (R) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new kit. Please contact us via email at info@checkmywellbeing.co.uk

CONTROL PROCEDURE

A procedural control is included in the test. A coloured line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique.

LIMITATIONS

  1. The PSA Rapid Test Cassette (Whole Blood) is for in vitro diagnostic use only. This test should be used for the detection of PSA in whole blood.
  2. The PSA Rapid Test Cassette (Whole Blood) will only indicate the semiquantitative level of PSA in the specimen and should not be used as the sole criteria for the diagnosis of Prostate Cancer.
  3. A significant numbers of patients with BPH (more that 15%) and less than 1% of healthy individuals have elevated PSA. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.
  4. PSA levels may be unreliable in patients who receive hormone therapy or prostate gland manipulation.
  5. High concentrations of PSA may produce a dose hook effect, resulting in false negative results. High dose hook effect has not been observed with this test up to 30,000ng/mL PSA.
  6. High concentrations of PSA may produce a dose hook effect, resulting in false negative results. High dose hook effect has not been observed with this test up to 30,000ng/mL PSA.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

The PSA Test Cassette has been tested with a leading commercial PSA ELISA Test using clinical samples.

Manufacturer Manufacturer Tests per kit Tests per kit Do not reuse Do not reuse
In Vitro For In Vitro use only Use by Use by Catalogue # Catalogue #
Temperature Store between 2-30 degrees C Lot number Lot number Authorized representative in EU Authorized representative in EU
Package damaged Do not use if package is damaged Instructions for use Consult Instructions for use Caution Caution