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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (e.g., seminal plasma, serum) to determine antibodies to the sperm surface (antisperm antibodies [ASAs]), these antibodies may produce sperm agglutinating and/or immobilizing activities, block sperm-egg interaction, or prevent implantation; ASA may be directed against antigens (e.g., rSMP-B, calpastin, HED-2) produced by different cells of the reproductive tract. The quantity and characteristics associated with one or more ASAs in men or women are associated with the fertilizing capacity of human spermatozoa (immunologic infertility); increased levels of ASA are found in men with sperm pathologies, varicocele, or vasectomy and also in prepubertal boys with testicular failures.
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