【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.

1. 1.Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
   
   4. 2.Place the cassette on a clean and level surface.
   5. 3.Transfer the fully liquefied sample 0.1mL into the diluting tube and rotate at least 5 times to mix well.
   6. 4.Add 2 drops (approximately 80μL) of extraction buffer into sample well(S) and start the timer.
      
      5. 5.Wait for the colored line(s) to appear. Read results at 5 minutes. Do not read results after10 minutes.