Screen Check Test Sperm Count

In vitro diagnostic medical device CE 0123.
For in vitro self-diagnostic use only.
The rapid test for Sperm Concentration is a biochemical test for the in vitro qualitative estimation of the concentration of sperm in human semen, as an auxiliary method in the clinical diagnosis of infertility and/or planning a pregnancy by self-diagnosis of sperm count above or below the concentration required to achieve pregnancy

Precautions
1. This kit can only be used as an in vitro diagnostic device for individual use using human semen as a sample, and cannot be used with other body fluid samples.
2. The kit should be stored at room temperature, avoiding areas of excessive humidity. If the sealed package is damaged or opened, please do not use the test.
3. Once the test package has been opened, the test should be used as soon as possible to avoid long-term exposure to air which could lead to test malfunction.
4. This kit is intended to be used as a preliminary test only and repeated abnormal results should be discussed with your doctor or specialist.
5. When pouring the samples, staining solution and washing solution, avoid the formation of bubbles as this could adversely affect the results.
6. Make sure you follow the instructions on timing the test and observing the results correctly.
7. The kit should not be used beyond the expiration date printed on the outer package.
8. DO NOT remove the light yellow liquefaction powder from the bottom of the sample collection container. The powder is there to help liquefy the semen sample.

Sample Collection and Preparation
1. Before carrying out the test it is important to abstain from sexual activity for 3-7 days. This will ensure that semen volume and quality is at its peak and the test will provide an accurate sperm count assessment.
2. The semen must be collected directly in the collection container, by masturbation.
3. Be careful that the seed is not contaminated by contact with hands or handkerchiefs or other material.
4. Gently pour the semen into the collection container and let it sit for 15 minutes at room temperature, until it liquefies.
Do not use semen stored for more than 12 hours.

Instructions for use
1. Remove all items from the sealed package and arrange them horizontally on a flat surface. Using the pipette provided in the package, pour a drop of seed into the well indicated by the letter 'A'.
2. When the seed has completely entered well 'A', place three drops of the blue staining solution into test well 'A'. Leave to rest for 1-2 minutes.
3. Now put two drops of clear wash solution into well 'A' and let it sit for 1-2 minutes, then read the results immediately.
4. Read the color of well 'A' by comparing it to the reference 'B'. The darker the color of well A, the higher the Sperm Concentration will be.

Reading the results
Compare the color of well A with the reference B.
NORMAL: the color of well A is darker than or equal to the reference standard color of well B. It means that the sperm count is greater than or equal to 15 million/ml. The possibility of conception is high with this sperm count, subject to other conditions, such as favorable ovulation.
ABNORMAL: The color of well A is lighter than the reference standard B. It means that the sperm count is less than 15 million/ml. This is known as oligospermia. The chance of conception is lower with this sperm count and medical advice is recommended.
NOTE: If well A does not stain, it means that the sperm count is less than 5 million/ml or zero. This condition is known as azoospermia or oligospermia. If you are unsure of the result or feel it is inaccurate, repeat the test using the second test included in the pack but making sure you do not ejaculate through any sexual activity for 6 days before testing. If the second test is also abnormal, discuss the results with your doctor or specialist.

Limitations
1. For in vitro qualitative estimation of sperm concentration in human semen.
2. Sperm count is just one of the important tests for fertility.
Other tests for semen, such as motility and morphology, along with female ovulation, are just as important. For cases of infertility, it is recommended to consider other tests as well.

Storage
The test should be stored at room temperature (2-30°C) in its sealed package until the date of deadline. The test should be kept away from direct sunlight, moisture and heat. Do not freeze.

Format
Package containing 2 pieces.