REF:

C1202 (Cassette)

INTENDED PURPOSE:

NOVAtest® Male Fertility Home Test is an immunoassay that uses double-antibody sandwich method for qualitative detection of human sperm count in human semen specimens. It’s used for aid to diagnosis infertility or subfertility. This device is performed manually.

INTENDED USER:

Performance of the test is limited to self-testing at home. The test can be applied to men who is suspected infertility or subfertility.

SUMMARY:

Infertility is experienced by 10-15% of couples, and half of these cases are a result of male infertility. Since the risk of male infertility and/or subfertility increases further with decreasing sperm count, a new and convenient sperm test can provide sperm count information for diagnosis.

The World Health Organization (2010) has defined a reference value of 15 million sperm cell/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 NOVAtest® Male Fertility Home Test.