Rapid self-test for in-vitro qualitative estimation of sperm concentration in human semen
Male infertility can be defined as the inability to conceive after one year of regular and unprotected sexual intercourse. Male infertility affects nearly 50% of infertile couples worldwide.
We speak of primary infertility when a man has never induced a pregnancy and of secondary infertility when a man has already induced a pregnancy in the past. Insufficient sperm production or abnormalities in the quality of sperm produced are at the origin of male infertility.
WHO IS THIS TEST FOR?
SPERM TEST is useful for men who intend to monitor the concentration of sperm and check for possible anomalies.
Among the different screening tests, sperm count is considered a valid method for identifying possible infertility: a sperm concentration below 15 million/mL (concentration value considered to be the minimum necessary for conception) may have it necessary to consult a specialist for further investigation and advise on how to increase sperm concentration.
SPERM TEST is an in-vitro device for qualitative determination of sperm concentration in human sperm samples, as an aid to clinical diagnosis of infertility and/or an aid to planning a pregnancy. The test uses a membrane made up of inert glass fibers characterized by a high-water absorption capacity and pores for sperm filtration. The spermatozoa are trapped by the first layer of the membrane and the dye solution colors them: the darker the color in the well, the higher the concentration of spermatozoa in the sample.
1 test cassette
1 vial with dropper containing the staining solution
1 vial with dropper containing the washing solution
1 pipette for sperm sampling
1 collection cup with a substance for the sample liquefaction
instructions for use
Collect the semen directly into the collection cup. Shake it and leave it to stand for 15 minutes;
Deposit one drop of semen into the test well A, by using the provided pipette;
Add 3 drops of the staining solution to well A and let it soak for 1-2 minutes;
Apply 2 drops of the washing solution to well A, and let it soak for 1-2 minutes. Read the results immediately by comparing the color of A to B.
if the color of well A is darker than the reference well B, the sperm concentration is greater than 15 million/ml.
if the color of well A is lighter than that of reference well B, it means that the sperm concentration is less than 15 million/ml. It is recommended to contact a specialist for further information.
1. Centola G.M.: Semen assessment. Urol Clin North Am. 2014 Feb;41(1):163-7. doi: 10.1016/j.ucl.2013.08.007. Epub 2013 Sep 13.
2. Cooper T.G., Noonan E., von Eckardstein S., Auger J., Baker H.W., Behre H.M., Haugen T.B., Kruger T., Wang C., Mbizvo M.T., Vogelsong K.M. World Health Organization reference values for human semen characteristics. Hum Reprod Update. 2010 May-Jun;16(3):231-45.
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" secrion of the instructions for use.
As the fresh semen sample is viscous, it must turn into a liquid state for it to be used for testing, as it crosses the membrane more easily. The light-yellow substance at the bottom of the collection container allows the semen to liquefy within 15 minutes. If the sample storage period is excessive, this can lead to sperm lysis, which can affect the accuracy of the test.
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