MUNUS MEDICAL SELF-DIAGNOSTIC MALE FERTILITY TEST MUNUS

Description
Rapid chromatographic immunoassay for the qualitative in vitro detection of the acrosomal protein SP-10 found on spermatozoa to estimate the concentration of sperm in human semen above or below 15 million/mL.
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 number of sperm in the semen is equal to or greater than 15 million/mL.
Failure to see 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 membrane wicking has occurred.

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

Test procedure
Before testing, read the instructions carefully and completely. Allow the test sample to reach room temperature (15-30°C) before testing.
Remove the test cassette from the foil pouch and lay it flat on a flat surface. A semen sample is collected in the collection cups provided. The sample should then be left to stand for 60 minutes, until the semen is completely liquefied.
Using the sperm transfer device provided with the kit, fill the sperm transfer device to the 0.1 mL indicated on the device with the sperm sample. The sperm sample is then added to the provided Sample Dilution Buffer vial. Mix the sperm 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 results 5 minutes after sample dispensing. Do not read results after 10 minutes.

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 line region (T). The color intensity of the test line (T) will vary depending on the concentration of SP-10 protein present in the specimen. Any shade of color present in the test line region (T) should be considered normal.

ABNORMAL: A colored line appears in the control region (C). No colored line appears in the test region (T).

INVALID: No control line appears. Insufficient specimen volume or improper procedural techniques are the most likely causes of a missing control line. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.

If for any reason the results are considered questionable 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 doctor or medical professional.

Warnings
Please read all information in the package leaflet 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 sperm as a sample and cannot be used with samples of other body fluids.
The sample should be collected within 3-7 days after the last ejaculation, semen obtained 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 from media, preservatives and detergents.
Semen liquefaction is a process in which semen rapidly changes from a gelatinous appearance to a liquefied state. Freshly collected samples are usually liquefied within 60 minutes and if they do not liquefy within 60 minutes it means an abnormal result.
Do not use if package is damaged or opened.
Once the test cassette package is opened, it should be used as soon as possible to avoid being exposed to air for long periods, which may cause the test to not function properly.
This kit is intended for use as a preliminary test only and repeatedly abnormal results should be discussed with a physician or healthcare professional.
The timing must be followed correctly.
The kit must not be frozen or used after the expiration date printed on the outer film.
Sperm concentration is just 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. In cases of infertility, it is recommended to consider other tests as well.
It is recommended to use fresh samples. Any collected lubricant or lotion and semen obtained from condoms will affect the test results.

Conservation
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.
Validity with intact packaging: 24 months.

Format
The kit contains:
- test cassette;
- collection cups;
- workstation;
- sperm transfer devices;
- sample dilution solution;
- package leaflet.

Bibliography
1. Jianhua Yang, Modern diagnosis and treatment of male infertility Shanghai: Shanghai Science and Technology Literature Press, 2007.
2. Cheng liangXiong, Human sperm science Wuhan: Hubei Science and Technology Press, 2002.

Cod. MM-OSP-902H