【INTENDED USE】
The SP-10 Male Fertility Rapid Test Cassette is a rapid chromatographic immunoassay for in vitro qualitative estimation of sperm concentration in human semen as an auxiliary aid in clinical diagnosis of the infertility and/or pregnancy planning by professional-evaluation of sperm concentration above or below the required concentration for successful pregnancy.
【PRINCIPLE】
The SP-10 Male Fertility Rapid Test Cassette (Sperm) is a qualitative, lateral flow immunoassay for the detection of the concentration of sperm in semen. The membrane is pre-coated with anti-sp10 antibody on the test line region of the test. During testing, the specimen reacts with the particle coated with anti-sp10 antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-sp10 antibody on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【REAGENTS】
The test contains anti-sp10 antibody particles and anti-sp10 antibody coated on the membrane.
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer to reach room temperature (15-30°C) prior to testing.