INTENDED USE David Male Fertility Sperm Test is a rapid test for use at home to detect the concentration of sperm in semen. This simple test will quickly let you know whether your sperm count is considered within normal limits. David Male Fertility Sperm Test is a quick screening test that will give you either a positive or negative result. An explanation of how to read and interpret the test results is given in the "Interpret Results" Section. Regardless of the test result, it is important that you fully understand what your test means before deciding whether or not to consult your physician. Use only in accordance with the instructions provided.
PRINCIPLE OF METHOD This assay is a one-step lateral flow two-site sandwich chromatographic immunoassay. The membrane is pre-coated with mouse anti-human sperm antigen monoclonal antibody on the test band region(T line) and goat anti-mouse IgG polycolonal antibody on the control band region(C line). When sample is added, the gold-antibody conjugate is rehydrated and sperm antigens interact with the gold conjugated antibodies. The antigen-antibody-gold complex then migrates towards the test window until the Test region (T) where it will be captured by immobilized antibodies, forming a visible pink line (Test band), indicating a positive result.