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.
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 when SP10 protein is equal to or greater than 15 million sperm per milliliter, indicating a positive result.