Check test - 2 devices for sperm count

Product Description

Medical device for the qualitative in vitro estimation of sperm concentration in human semen.

Indications

The rapid test for Sperm Concentration is a biochemical test for the qualitative in vitro estimation of sperm concentration in human semen, as an auxiliary method in the clinical diagnosis of infertility and/or pregnancy planning by self-diagnosis of sperm counts above or below the concentration required to achieve pregnancy.

Directions for use

Sample collection and preparation

• Abstain from sexual activity for a few days to ensure a high volume and maximum quality of sperm (approximately 3/7 days).
• Collect the semen directly into the collection container by masturbation.
• Take care that the semen is not contaminated by contact with hands, tissues or other materials.
• Gently pour the seed in the collection container and let it rest for 15 minutes at room temperature, until does not liquefy.

Detection of concentration and testing

• Remove all objects from the sealed package and place them horizontally on a flat surface.
• Pour a drop of semen into the well using the pipette provided.
• Once the semen has completely entered the well, pour 3 drops of the blue dye solution into it and let it stand for 1/2 minute.
• Pour 2 drops of the clear wash buffer into the well and let it stand for 1/2 minute.
• Read the results obtained.

Reading results

Compare the color of well A with the reference well B.

Normal: the color of well A is darker than the color of well B. Dark or equal to the reference standard color of well B. This 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. This means that the sperm count is less than 15 million/ml. This is known as oligospermia. The possibility of conception is lower with this sperm count and medical advice is recommended.

Note: If well A does not color, this 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 believe it to be inaccurate, repeat the test using the second test included in the package, but make sure you have not ejaculated through any sexual activity for 6 days before performing the test. If the second test is also abnormal, discuss the results with your doctor or specialist.

Warnings

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 samples of other body fluids.
2. The kit must 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 prolonged exposure to air, which may cause the test to malfunction.
4. This kit is intended for preliminary testing only, and repeated abnormal results should be discussed with your doctor or healthcare professional.
5. When pouring the specimens, staining solution, and wash solution, avoid creating bubbles as this may negatively affect the results.
6. Be sure to follow the instructions regarding timing of testing 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 specimen collection container. The powder is located there. to facilitate the liquefaction of the semen sample.

Storage

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

Format

The package contains 2 sperm count tests.