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Prostate Specific Antigen Rapid Test CE Marking


Product Number: RAPG-PSA-001

Pack size

20 tests

Product Description

The Biopanda Prostate Specific Antigen (PSA) Rapid Test semi-quantitatively detects the presence of prostate specific antigen in whole blood, serum, and plasma samples. This test applies lateral flow immuno-chromatography.

Test Attributes

  • Whole Blood, Serum, or Plasma samples may be used for testing
  • Results available in only 5 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the detection of Prostate Specific Antigen

Test Procedure

  1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
  2. Place the cassette on a clean and level surface.
    For Serum, Plasma, or Venipuncture Whole Blood specimens:
    Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 µl) or 2 drops of venipuncture whole blood (approximately 80 µl) to the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40 µl) and start the timer.
    For Fingerstick Whole Blood specimens:
    To use a capillary tube: Fill the capillary tube and transfer 2 drops of fingerstick whole blood specimen (approximately 80 µl) to the specimen area of test cassette, then add 1 drop of buffer (approximately 40µl) and start the timer.
    To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 80 µl) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 µl) and start the timer.
  3. Wait for the coloured line(s) to appear*. Read results at 5 minutes. Results read after 10 minutes are considered invalid.
    *Note: if migration is not observed in the result window after 30 seconds, add one or two extra drops of buffer.

PSA rapid test

Principle

The Biopanda PSA Rapid Test is a semi-quantitative, membrane based immunoassay for the detection of PSA in whole blood, serum or plasma. The membrane is pre-coated with PSA antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-PSA antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-PSA antibodies on the membrane and generates a coloured line. A test line (T) intensity weaker than the reference line (R) indicates that the PSA level in the specimen is between 3-10ng/ml. A test line (T) intensity equal or close to the reference line (R) indicates that the PSA level in the specimen is approximately 10ng/ml. A test line (T) intensity stronger than the reference line (R) indicates that the PSA level in the specimen is above 10ng/ml. To serve as a procedural control, a coloured line will always appear in the control line region (C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

Performance Characteristics

  • Relative sensitivity: 99.0%
  • Relative specificity: 99.2%
  • Accuracy: 99.1%

Storage Conditions

Store the kit between 2-30┬░C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.


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