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SCREEN CHECK TEST sperm count Description In vitro diagnostic medical device CE 0123. For in vitro self-diagnostic use only. The rapid sperm concentration test 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-diagnosing sperm counts above or below the concentration necessary to achieve pregnancy. Precautions 1. This kit can only be used as an in vitro diagnostic device for individual use, using human semen as the specimen, and cannot be used with specimens from other body fluids. 2. The kit should be stored at room temperature, avoiding areas with excessive humidity. If the sealed package is damaged or opened, please do not use the test. 3. After opening the test package, the test should be used as soon as possible to avoid prolonged exposure to air, which could cause the test to malfunction. 4. This kit is intended for use 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 may adversely affect the results. 6. Make sure you follow the instructions correctly regarding when to take the test and observing the results. 7. The kit should not be used after the expiration date printed on the outer packaging. 8. DO NOT remove the light yellow liquefaction powder from the bottom of the sample collection container. The powder is used to help liquefy the semen sample. Sample collection and preparation 1. Before taking the test, it is important to abstain from sexual activity for 3-7 days. This will ensure that your sperm volume and quality are at optimal levels and the test will provide an accurate sperm count. 2. Semen must be collected directly into the collection container, by masturbation. 3. Be careful not to contaminate the semen through contact with hands, tissues, or other materials. 4. Gently pour the seeds into the collection container and let them sit for 15 minutes at room temperature, until they liquefy. Do not use sperm stored for more than 12 hours. Instructions for use 1. Remove all items from the sealed packaging and place them horizontally on a flat surface. Using the pipette provided, place a drop of semen into the well marked “A”. 2. After the sperm has completely entered well “A”, add three drops of the blue dye solution to test well “A”. Allow to sit for 1-2 minutes. 3. Now pour two drops of clear wash solution into well “A” and let sit for 1-2 minutes, then read the results immediately. 4. Read the color of well “A” by comparing it to reference well “B.” The darker the color of well A, the higher the sperm concentration. Reading the results Compare the color of well A with reference well B. NORMAL: The color of well A is darker than or equal to the standard reference 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 reference standard B. This indicates a sperm count of less than 15 million/ml. This is called oligospermia. The chances of conception are lower with this sperm count and medical advice is recommended. NOTE: If well A is not colored, 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 believe it is inaccurate, repeat the test using the second test included in the package, but make sure that you do not ejaculate during any sexual activity for 6 days before performing the second test. If the second test is also abnormal, discuss the results with your doctor or specialist. limitation 1. For the qualitative in vitro estimation of sperm concentration in human semen. 2. Sperm count is just one of the important fertility tests. Other sperm tests, such as motility and morphology, along with female ovulation, are equally important. In cases of infertility, other tests are also recommended. Conservation The test should be stored at room temperature (2-30°C) in the sealed pouch until the expiration date. The test should be protected from direct sunlight, moisture and heat. Do not freeze. Format Package containing 2 pieces. BIBLIOGRAPHY: 1. Persson BE, Ronquist G, Ekblom M. Ameliorative effect of allopurinol on nonbacterial prostatitis: a double-blind, parallel-controlled study. JUro, l 1996 2. Jianhua Yang, Diagnosis and Treatment of Modern Male Infertility Shanghai: Shanghai Science and Technology Literature Press, 2007 3. Cheng Liang Xiong, Human Sperm Science Wuhan: Hubei Science and Technology Press, 2002 4. China Biological Products Standardization Committee on Chinese Requirements for Biological Products, 2000 Edition. Beijing: Chemical Industry Press, 2000
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