Self-diagnostic male fertility test

Product Description

Male Fertility Self-Test.

Indications

The Munus Medical Self-Test Male Fertility Test is a rapid chromatographic immunoassay for the qualitative in vitro detection of the acrosomal protein SP-10 found on spermatozoa to estimate the sperm concentration in human semen above or below 15 million/mL.

The sperm concentration can be used for supportive diagnosis and observation of the curative effect of male infertility and provide guidance for reproductive planning of suitable couples. During the test, SP-10, if present in the sample, binds to the conjugated anti-SP-10 antibodies, and the mixture migrates up the membrane by capillary action after the sample is added to the well.

The membrane is pre-coated with anti-SP-10 antibodies in the test line region of the strip. The conjugated antigen-antibody complex binds to the anti-SP-10 antibodies coated in the test region and produces a colored line if the sperm concentration is greater than or equal to 15 million/mL of semen. The colored line thus formed indicates that the sperm count in the semen is equal to or greater than 15 million/mL. Failure to appear on the test line indicates that the sperm concentration is less than 15 million/mL.

As a procedural control, a colored line will always appear in the control line region, indicating that the correct volume of sample has been added and that membrane wicking has occurred.

Directions for Use and Dosage

Sample Collection and Preparation

Before testing, it is important for the subject to abstain from any sexual activity for 3-7 days. This ensures that sperm volume and quality are at their maximum, and the test will therefore be an accurate determination of sperm concentration. Using masturbation, semen should be collected directly into the sperm collection cup. Care must be taken to ensure that the collected semen is not contaminated by contact with hands, tissues, or any other material. Shake the semen evenly in the semen collection cup and let it sit for 1 hour at room temperature until the semen liquefies. Do not use semen stored for more than 12 hours after liquefaction.

Test Procedure

Before testing, read the instructions carefully and completely. Allow the test sample to reach room temperature (15-30°C) before performing the test. Remove the test cassette from the foil pouch and lay it flat on a flat surface. A semen sample is collected in the collection cup provided. The sample must then be left to sit for 60 minutes, until the semen is completely liquefied. Using the semen transfer device provided with the kit, fill the semen transfer device to the 0.1 mL indicated on the device with the semen sample. The semen sample is then added to the vial of sample dilution buffer provided. Mix the semen sample and test solution by inverting the vial 5-10 times. Hold the diluted sample swab tube upright and open the cap on the sample collection tube. Invert the sample collection tube and transfer 2 full drops of the diluted sample (approximately 80 mcL) into the sample well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the sample well (S). Read the results 5 minutes after dispensing the sample. Do not read the results after 10 minutes.

Warnings

Read all information in the package insert carefully before performing the test. Keep out of reach of children. The kit can only be used as an in vitro diagnostic test using human semen as the sample and cannot be used with samples of other bodily fluids. The sample should be collected within 3-7 days after the last ejaculation. Semen collected less than 3 days after the last ejaculation or more than 7 days after the last ejaculation will affect the accuracy of the test. Collection containers must be clean, dry, waterproof, and free of media, preservatives, and detergents. Semen liquefaction is a process in which semen rapidly changes from a gelatinous state to a liquefied state. Freshly collected samples generally liquefy within 60 minutes, and failure to liquefy within 60 minutes indicates an abnormal result. Do not use if the package is damaged or has been opened. Once the test cassette package is opened, it should be used as soon as possible to avoid prolonged exposure to air, which may cause the test to malfunction. This kit is intended for preliminary testing only, and repeatedly abnormal results should be discussed with a doctor or healthcare professional. The timing must be followed strictly. The kit should not be frozen or used after the expiration date printed on the outer foil. Sperm concentration is only one of the important tests for fertility. But other sperm tests, such as motility and morphology, as well as ovulation in women, are also important. For cases of infertility, it is recommended to also consider other tests. It is recommended to use fresh samples. Any collected lubricant or lotion and semen obtained from condoms will affect the test results.

Reading the Results

Normal: Two colored lines appear, one colored line appears in the control line region (C), and another colored line appears in the test region (T). The color intensity of the test line (T) will vary depending on the concentration of SP-10 protein present in the sample. Any shade of color present in the test line region (T) should be considered normal.

Abnormal: One colored line appears in the control line region (C). No colored line appears in the test region (T).

Invalid: The control line does not appear. Insufficient specimen volume or incorrect procedural techniques are the most likely causes of the absence of the control line. Review the procedure and repeat the test with a new test device. If the problem persists, immediately discontinue use of the test kit and contact your local distributor.

If for any reason, the results are considered equivocal or inaccurate, the test should be repeated with another test cassette. However, the subject should not ejaculate through any sexual activity for 6 days before taking the second test. If the second test is still abnormal, the results should be discussed with a physician or medical professional.

Storage

Store as packaged in the sealed pouch at either room temperature or refrigerated (2-30°C). Do not freeze. The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not use after the expiration date. Shelf life: 24 months if packaged intact.

Format

The kit contains: test cassette, collection cups, workstation, sperm transfer devices, specimen dilution solution, and package insert.