Product description Sperm concentration test Sperm Test A rapid test for the qualitative detection of SP-10 in human semen. An in vitro diagnostic medical device for self-testing. The Male Fertility Test is a rapid in vitro diagnostic chromatographic immunoassay for the qualitative detection of the acrosomal protein SP-10 found in sperm to estimate sperm concentrations above or below 15 million/ml in human semen. Information on sperm concentration is important in diagnosing male infertility, allows for the assessment of treatment outcomes, and supports couples in family planning. The male fertility test works by detecting the acrosomal protein SP-10 in sperm in the semen. After adding a semen sample to the sample well, SP-10, if present in the sample, binds to conjugated anti-SP-10 antibodies, and the mixture migrates upward on the membrane by capillary action. The membrane is pre-coated with anti-SP-10 antibodies in the test line region. If the sperm concentration is greater than or equal to 15 million/ml in the semen sample, the antigen-antibody conjugate complex binds to the anti-SP-10 antibodies coated in the test line region, forming a colored line. This line indicates that the sperm count in the semen is equal to or greater than 15 million/ml. The absence of a test line indicates that the sperm concentration is less than 15 million/ml. A colored line will always appear in the control line region as a procedural control, indicating that the appropriate volume of sample has been added and membrane wicking has occurred. PRECAUTIONS This test is intended for external use only, for in vitro diagnostic purposes. This product is intended for self-testing purposes. Keep out of the reach of children. This kit can only be used as an in vitro diagnostic test using human semen as a sample and cannot be used with samples of other body fluids. The sample must be collected within 3-7 days of the last ejaculation, semen collected less than 3 or more than 7 days will affect the accuracy of the test. The sample collection container should be clean, dry and free from contaminants, preservatives and detergents. Semen liquefaction is the process by which semen rapidly changes from a gelatinous appearance to a liquid. Fresh samples are typically liquefied within 60 minutes, and if the sample does not liquefy within 60 minutes and is used, it may result in an inaccurate test result. Store the kit at room temperature, avoiding excessive humidity. If the foil packaging is damaged or has been opened, do not use it. Once you have opened the test cassette package, use it as soon as possible to avoid exposing it to moisture for an extended period of time, which may cause the test to malfunction. The test is intended for use as a preliminary screening test only; repeated abnormal results should be consulted with a physician. When performing the test and reading the results, please strictly adhere to the time frames specified in the instructions for use. The kit must not be frozen or used after the expiration date printed on the test foil pouch. PACKAGING COMPOSITION Cassette test Sperm transfer device Tube with sample dilution buffer Sample container Stand for performing the test Instructions for use of the product SAMPLE PREPARATION AND COLLECTION Before the test, its important for the patient to refrain from any sexual activity for 3-7 days. This ensures that the semen volume and quality will be at their highest and the test results will be most accurate. When using masturbation, the semen should be collected directly into the sample container. Care should be taken to ensure that the collected semen is not contaminated by touching hands, tissues or other materials. The semen should be shaken evenly in the container and left for 1 hour at room temperature until the semen liquefies. Do not use semen stored for longer than 12 hours after liquefaction. PERFORMING THE TEST Before starting the test, please read the instructions carefully and completely. Allow the sample to reach room temperature (15-30°C) before testing. Remove the test cassette from the foil pouch and place it horizontally on a flat surface. Collect semen into a sample container. The sample should then be allowed to stand for 60 minutes until the semen has completely liquefied. Fill the transfer device with the semen sample to the 0.1 ml mark on the device. Then add the measured semen sample to the tube containing the sample dilution buffer. Mix the semen sample and buffer solution by inverting the vial upside down 5-10 times. Hold the buffer tube upright and open the cap. Invert the tube and add 2 full drops of the diluted sample (approximately 80 μl) to the sample well (S) of the test cassette, then start the timer. Avoid air bubbles in the sample well (S). Read results 5 minutes after adding the sample. Do not read results after 10 minutes. POSITIVE: Two colored lines appear. One colored line is in the control line region (C) and the other colored line is in the test line region (T). ATTENTION: The intensity of the color in the test line region (T) will vary depending on the concentration of SP-10 protein present in the sample. Therefore, any shade of color in the test line region (T) should be considered a positive result. NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). VOID: The control line does not appear. The most likely causes for the control line not appearing are insufficient specimen volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. ATTENTION: If for any reason the results are questionable or inaccurate, the test should be repeated using a new kit. However, before taking the second test, the patient must not ejaculate through any sexual activity for six days. If the second test is still abnormal, the results should be discussed with a doctor. Producer: HYDREX DIAGNOSTICS SP. Z OO CE 0123 This is a medical device. Use it according to the instructions for use or label. Important information about the medical device: Medical device - has the CE marking. It has an EU declaration of conformity Includes user manual in Polish Includes label in Polish Storage and transport of medical devices are in accordance with the conditions specified by the manufacturer. Related articles Advice, Diseases and ailments, Gynecology I cant have children. What are the possible causes of infertility? How can infertility be treated? 2021-06-24 Read