The OVRY Male Fertility Test is a rapid one step assay designed for qualitative detection of Sperm SP10 Protein in semen.

Intended Use:

The OVRY Male Fertility Test identifies lower than normal sperm concentration in semen. The test is intended for at-home use and provides a qualitative visual result. The OVRY Male Fertility Test indicates if a user’s sperm concentration meets the normal level of 15 million sperm per millilitre (as set by the World Health Organization).

This test alone does not prove whether or not you are fertile. However, since sperm concentration is one of the leading indicators of male infertility, a negative result with an OVRY Male Fertility Test (which would suggest low sperm concentration) can be valuable insight to help inform a proactive decision to visit a physician for further semen analysis.

How does the test detect low sperm concentration?

The OVRY Male Fertility Test is a qualitative immunoassay for the detection of sperm SP10 protein in semen. Based on anatomical, genetic and biochemical characteristics, sperm SP10 protein has been proven as an analyzer for sperm concentration detection. It is only expressed in the testis and is a differentiation marker, the last step in spermatogenesis. Sperm SP10 protein concentration and sperm concentration have a linear relationship; research has shown that when sperm concentration is more than 15 million sperm per milliliter that SP10 protein detection showed positive.

How important is sperm concentration?

According to the World Health Organization (WHO), the main factors affecting male infertility are sperm concentration, semen volume, total sperm count, liquefaction, sperm pH, sperm motility and sperm morphology. Therefore, a definitive diagnosis for male infertility must consider many factors. Since the OVRY Male Fertility Test only measures sperm concentration, using this test alone is not enough to determine whether or not a person is fertile. However, since lower than normal sperm concentration is an important indicator of male infertility, this test is a helpful and proactive step to identify possible obstacles for people trying to conceive.

In the test procedure, SP10 monoclonal antibody is immobilized in the test line region of the device. After a specimen is placed in the specimen well, it reacts with SP10 monoclonal antibody-coated particles that have been applied to the specimen pad. This mixture migrates chromatographically and interacts with the immobilized SP10 monoclonal antibody. This mixture binds to the SP10 monoclonal antibody in the test region (T) and produces a colored line when SP10 protein is equal to or greater than 15 million sperm per milliliter, indicating a positive result. No apparent colored line appears in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region (C) indicating that a proper volume of specimen has been added and membrane wicking has occurred.

How to perform the test Important:

When and how to collect the semen sample Use a fresh semen sample collected 2-7 days from the last ejaculation. The Sample Collection Cup should be clean, dry, and free from any contaminants and detergents.

Additional Materials Required (Not Provided): • Timer (watch, clock or smartphone) 1 x Sample Collection Cup

Precautions

• Do not use after the expiration date.
• Do not reuse.
• Device should remain sealed in its pouch until use Test kit contents should be discarded after use.
• Keep out of children's reach.
• Do not use lubricants or lotions when collecting semen.
• For in vitro diagnostic use only.
• For the most reliable results, masturbation that is free from lubricants and lotions is the recommended method for obtaining the sample.

After the semen sample is collected, it needs to sit for 1 hour (as noted in the following step-by-step procedure) before the test can be performed. Do not perform the test more than 3 hours after the semen sample is collected.