Performing this initial screening test will show if there is a low amount of sperm production. Up to 15% of couples experience infertility, which is defined as not becoming pregnant after one year of unprotected, well-timed intercourse. And for 40% of couples experiencing infertility problems, male infertility is the main cause. Because low sperm count is the leading cause of male infertility, an important first step in determining the cause of infertility is to test the sperm count.
The Lomina Male Fertility Test is an in vitro diagnostic test based on the principle of rapid chromatographic immunoassay, which is designed to qualitatively detect the acrosomal protein SP-10, found on sperm, to estimate sperm concentration in human semen above or below 15 million/ml. Sperm concentration can be used to assist in the diagnosis and observation of the therapeutic effect of male infertility and can provide guidance for reproductive planning.
The concentration of sperm or SP-10 protein is one of the main factors that doctors use to diagnose male infertility. There are many reasons why a man may be infertile and therefore unable to fertilize a woman‘s egg during reproduction. One of the main and most common reasons is abnormally low production of viable sperm. Other reasons may be excessive production of inactive, weak or deformed sperm cells, high amounts of other cells in the semen that prevent fertilization, or other physiological factors. Normal sperm cell production may also be disrupted by medical or physical conditions, including high stress, recent high fever or illness experienced within two months prior to testing, and sudden dietary changes. Performing this initial screening test will show if there is a low amount of sperm production. Up to 15% of couples experience infertility, which is defined as not becoming pregnant after one year of unprotected, well-timed intercourse. And for 40% of couples experiencing infertility problems, male infertility is the main cause. Because low sperm count is the leading cause of male infertility, an important first step in determining the cause of infertility is to test the sperm count.
The test is developed and tested from a sperm sample.
Test duration: 5 min
Sensitivity: 98.1% (95%CI:*89.7%-99.9%)
Specificity: 98.3% (95%CI:*91.1%-99.9%)
Accuracy: 98.2% (95%CI:*93.7%-99.8%)
The Lomina Male Fertility Test detects the acrosomal protein SP-10, which is found on sperm. SP-10 is a protein specific to male sex cells and is not found in other cells. This test is very specific for sperm and is now used to estimate the concentration of sperm in semen as an aid in determining the causes of infertility. The Lomina Male Fertility Test detects SP-10 and gives a positive result if the sperm concentration in the semen is greater than 15 million/ml – the level internationally recognised as the minimum sperm level for normal fertility. A low sperm concentration would mean less likelihood of conception It would be advisable to see a specialist doctor who can advise you on what can be done to improve sperm concentration.
A single color line will appear in the control area (C). No color band appears in the test area (T). This result indicates that the concentration of SP-10 protein is below the 15 million/ml threshold; therefore, the concentration is abnormal.
Two coloured lines will appear. One colored line should be in the control area („C“) and the other apparent colored line should be in the test area („T“). This result indicates that the concentration of SP-10 protein is within normal limits, i.e., greater than 15 million/ml. The intensity of the color of the line in the test area („T“) will vary depending on the concentration of SP-10 protein present in the sample. Therefore, any shade of color in the test area (T) should be considered normal.
The control line does not appear. The most likely cause of the control line failure is insufficient sample volume or an incorrect procedure. Check the procedure and repeat the test with a new kit. If the problem persists, stop using the test kit immediately and contact your local distributor. If the results are considered questionable or inaccurate for any reason, the test should be repeated with a different test kit. However, the subject must not ejaculate during any sexual activity for 6 days before performing the second test. If the second test is still abnormal, the results should be consulted with a medical professional – specialist.