Sperm Count Test Kit
This NOVA Test ® sperm count rapid test kit is a male fertility rapid test device, which is an immunoassay that uses the double-antibody sandwich method to detect the SP10 protein specifically contained in human male sperm,and is used for quick screen test for males who are suspected of infertility or subfertility by a healthcare provider.
Why Measure Sperm Count
Sperm count, or sperm density, measures the concentration of the sperms in semen, which is an important indicator of the quality of the semen in regards of the fertility level of a male.
Infertility is experienced by 10–15% of couples, and about half of these cases are the result of male infertility. Since the risk of male infertility
and/or sub-fertility increases with decreasing sperm count, a new and convenient sperm test device can provide information on sperm count so as to help in the diagnosis of male infertility.
NOVA Test® sperm density rapid test kit is an immunoassay that uses the double-antibody sandwich method to detect the sperm count in human semen specimen from patients who are suspected of infertility or sub-fertility by a healthcare provider.
A negative test result may occur if the level of antigen in a sample is below the detection limit of the test (15 million sperm cell/mL) or if the sample was collected improperly. However, a negative test result alone cannot be used as proof of infertility. About 10% of fertile men have sperm counts below 15 million per milliliter, suggesting that the sample can still be fertile. Please consult the physician about possible further diagnostics.
Test Principle of Sperm Count Test Kit
The World Health Organization (2010) has defined a reference value of 15 million sperm cells per milliliter (1.5 × 10 7 sperm cells/ml) or more for a normal semen analysis reading. SP10 protein is only expression in human testis and it relate to sperm count with linear relationship. The concentration of SP10 protein is selected for the detection limit for NOVA Test ® Sperm Count Rapid Test Kit.
This Male Fertility Test Kit is an immunoassay that uses the double-antibody sandwich method to detect the SP10 protein antigen from human semen specimen. SP10 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other materials to construct a test strip.
If target antigen is present at higher concentration of this sperm count rapid test kit, it will migrate on membrane, and caught by specific antibody precoated on the test line region, and forming a visible red ribbon on test line (T line). If the quality control line (C line) does not appear, it means that the test result is invalid. This sample needs to be tested again with a new test device.
Semen collection and treatment
NOVA Test ™ Male Fertility Test Kit is easy to perform. The concise introduction of the testing procedures are as follow:
- Wait at least 48 hours, but not more than 7 days since the last ejaculation. Obtain semen specimen by manual stimulation
(masturbation) or other proper ways. Ejaculate the specimen directly into a clean and dry container without losing any portion of the semen.
- Lay the container on flat platform for about 1 hour at room temperature until semen specimen turn into liquid.
- Gently stir the semen specimen with transfer pipette in the specimen container about 10 times until it is well mixed.
- With specimen transfer syringe, transfer 100 μL semen specimen into assay diluent dropper which contains 2 mL assay diluent. Try to avoid any solid or sticky material, and avoid forming air bubbles syringe. If this happens, push the semen back out completely and then draw semen again.
- Close the cap of assay diluent dropper, shake the diluent dropper at least 10 times to guarantee specimen well mixed with solution and place it on a flat platform for 2min.
- Twist off the cap of the assay diluent dropper prepared from the SAMPLE PREPARATION, transfer 3 drops of specimen processing solution (80-100μL) vertically into the cassette sample well (S sign).
- Place the cassette at room temperature for 15 minutes, and read the test result.