Anti-Spermatozoa Antibody (ASA) serum ELISA

Enzyme immunoassay for the quantitative measurement of anti-bodies directed against human spermatozoa in serum

INTENDED USE:The Demeditec Anti-Spermatozoa Antibody (ASA) serum ELISA is a manual enzyme immunoassay for the quantitative measurement of antibodies directed against human spermatozoa (ASA) in human serum. For in vitro diagnostic use. For laboratory professional use. The device is intended to be used as an aid for the diagnosis of immunologically caused disorders of fertility. The device is not intended to be used for the detection of poly- and monoclonal gammopathies.

GENERAL INFORMATION:Antibodies directed against spermatozoa antigens may cause infertility in women or men. The application of the Anti-Spermatozoa Antibody (ASA) serum ELISA is recommended for the diagnosis of immunologically caused disorders of fertility. Unwanted childlessness is a growing problem with which up to 20% of all couples in the reproductive age are confronted temporarily or long-term. In 5-20 % of these cases the presence of anti-spermatozoa antibodies in the male or the female patient is detectable. The definition of infertility according to the WHO (WHO Laboratory Manual for the Examination of Human Semen and Semen Cervical-Mucus Interaction, 1999) is the absence of a conception within 12 months of unprotected intercourse. The main cause of an immunological fertility disorder is the formation of antibodies directed against spermatozoa antigens. Anti-spermatozoa antibodies (ASA) exert heterogeneous effects on the ability of spermatozoa to fertilize. The inhibiting effect of ASA on the motility of spermatozoa by binding to their surface and by agglutinating processes is well-known. The penetration of the spermatozoa into the cervical mucus is impaired by the presence of ASA in the seminal plasma and/or in the cervical mucus. ASA negatively influence the capacitation and the acrosome reaction of spermatozoa and thereby impede the interaction of the spermatozoa with the oocyte. The interaction of the spermatozoon with the oocyte and the subsequent binding to and penetration of the zona pellucida may be inhibited by ASA. The following fusion of the oocyte and a spermatozoon may also be impaired by the presence of ASA. The rate of pregnancies in couples with ASA on the part of the man or the woman was shown to be 38% lower compared to the control groups [9]. Furthermore, an influence on the implantation and on the early embryological development could be confirmed. An association of ASA and miscarriages is discussed. The frequency of ASA in infertile couples amounts to 20%. ASA may occur dissolved in the ejaculate or bound to the surface of spermatozoa. In addition, ASA can be detected in serum. ASA may be found in men and in women. In women, ASA may be found in cervical mucus, oviduct liquid and follicular liquid. Men having more than 50% of their spermatozoa coated with anti-spermatozoa antibodies show a conspicuously reduced rate of fertility. ASA have been shown to be associated with chronic prostatitis which has a negative effect on male reproductive function.

KIT CHARACTERISTICS:
- Method: ELISA;
- 96 tests
- Incubation Time / Conditions: 1 h, 30 min (37°C), 30 min (RT)
- Standard Range: 31 - 250 U/ml
- Sensitivity analytical: LoD: 8.553 U/ml
- Final Sample Volume: 50 µl
- Sample Type: serum
- Sample Pretreatment: 1:100 dilution
- Isotope / Substrate: TMB 450 nm
- Internal Controls: 1
- Regulatory Status: CE