Sperm Test Instructions

The Sperm Concentration Rapid Test is a biochemical assay for in vitro qualitative estimation of sperm concentration in humans.

INTENDED USE

The Sperm Concentration Rapid Test is a biochemical assay for in vitro qualitative estimation of sperm concentration in humans as an auxiliary aid in clinical diagnosis of infertility and/or pregnancy planning by self-evaluation of sperm concentration above or below the required concentration for successful pregnancy.

PRECAUTIONS

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

  • This kit can only be used as an in vitro diagnostics test using human semen as the specimen.
  • 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.
  • Once the test cassette’s package is opened, it should be used as soon as possible to avoid being exposed to the air for long periods which could result in the test not working correctly.
  • This test is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with your doctor
  • 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.
  • Do Not remove the light-yellow liquefying powder from the bottom of the sample cup. It is supposed to be in there as it will help the semen to liquefy.
  • 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
  • Collection Cup
  • Staining Solution
  • Procedure Card
  • Dropper
  • Washing Solution

MATERIALS REQUIRED BUT NOT PROVIDED

  • Timer

SPECIMEN COLLECTION AND PREPERATION

  • 1. Before testing, it is important that you refrain from any sexual activity for 3-7 days. This ensures that the volume and quality of sperm are at it’s peak and the test will then be an accurate determinate of sperm concentration.
  • 2. Using masturbation, the semen should be collected directly into the sperm collection cup.
  • 3. Care should be taken that the collected semen is not contaminated by the touch of hands or tissues or any other materials.
  • 4. Shake the semen evenly in the semen collection cup and leave it to stand for 15 minutes at room temperature until the semen liquefies. Do not use semen stored for more than 12 hours.

    PROCEDURE

    1. Using masturbation, collect the semen into the collection dish. Do not contaminate sample by hands, tissues or other materials.
    2. Shake the semen evenly in the collection dish and leave it to stand for 15 minutes at room temperature.
    3. Remove the test cassette from the pouch and lay it horizontally on a flat surface.
    4. Draw up some semen into the pipette, provided.
    5. Dispense 1 drop of semen into the sample well marked ‘A’
    6. Once the semen is soaked into well ‘A’, add 3 drops of the blue staining solution into well ‘A’ and let this soak in for 1-2 minutes.
    7. Now add 2 drops of the clear washing solution into well ‘A’ and let this soak in for 1-2 minutes.
    8. Read the colour of test well ‘A’ and compare to the colour of well ‘B’. The darker the colour of well A compared to well ‘B’, the higher the sperm concentration.

    READING THE RESULTS

    NORMAL: The colour of test well ‘A’ is darker than or the same as the standard colour of reference well ‘B’. This means that the sperm concentration is greater than or equivalent to 15 million/mL. The likelihood of conception is high with this sperm concentration, subject to other conditions, such as ovulation being favourable.

    ABNORMAL: The colour of test well ‘A’ is lighter than the standard colour of reference well ‘B’. This means that the sperm concentration is less than the 15 million/mL. This is known as oligospermia. The likelihood of conception is less with this sperm concentration and further medical consultation is recommended.

    NOTE: If well ‘A’ is colourless. It means the sperm concentration is less than 5 million/mL or zero. This condition is known as severe oligospermia or azoospermia. If you are unsure of the result or feel the result is inaccurate you should repeat the test using a second test but make sure you do not ejaculate through any sexual activity for 6 days before carrying out the second test. If the second test is still abnormal, you should discuss the results with your doctor or medical professional.

    LIMITATIONS

    1. For in vitro qualitative estimation of sperm concentration in human semen.
    2. Sperm concentration is just one of the important tests for fertility, other tests like motility and morphology as well as ovulation in females are also important. FOR FERTILITY, IT IS RECOMMENDED THAT MEDICAL PROFESSIONAL ADVICE IS SOUGHT AND OTHER TESTS ARE ALSO CONSIDERED
    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