SpermMar Test IgG

Test for the detection of anti-sperm antibodies

As sperm does not come into contact with the blood circulation, the male reproductive system contains no antisperm antibodies in normal conditions. However, when the blood-testis barrier is breached, the immune system can detect mature sperm as antigenic and form antisperm antibodies that cause sub- or infertility. Antisperm antibodies belong to two immunological classes: immunoglobulin (Ig)A and IgG antibodies, and can be present in the semen sample as well as in male blood serum. In addition, antisperm antibodies are sometimes also found in blood serum of women. Antisperm IgG antibodies are clinically associated with immunological infertility, and screening can therefore provide help in assessing couple’s infertility.

The SpermMar Test IgG is a semi-quantitiative, non-automated, diagnostic kit for detecting antisperm antibodies of the IgG class on spermatozoa in human semen or serum. It is a rapid, easy-to-use microscopic test with an intended testing population of infertile couples.

The test can be performed on fresh, untreated human semen sample when applying the direct SpermMar Test IgG, or on human blood serum (from men and women) when using the indirect SpermMar Test IgG. The SpermMar Test IgG may help in assessing the diagnosis and management of couple infertility.

In the direct SpermMar Test IgG, the diagnosis of immunological infertility is suspected when 10-39% of the motile spermatozoa are covered by latex particles; if 40% or more of the spermatozoa are covered, immunological infertility is highly probable. Additional tests should confirm the diagnosis. Whenever a positive result is obtained it is recommended to perform the SpermMar Test IgA (FertiPro NV) as well.

SpermMar Test IgG has an 18 month shelf life from production date. Information about the composition of the product can be found in the material safety data sheet.

Regulatory

Europe: CE-marked (IVDR, Notified Body number 2797)
USA: registered – Canada: Health Canada license
Brazil: registered – Australia: registered

Product order codes

SPMG_S : SpermMar Test IgG – Single kit – 50 tests
SPMG_C : SpermMar Test IgG – Complete kit – 50 tests
SPMG_P : SpermMar Test IgG – Positive control
SPMG_N : SpermMar Test IgG – Negative control

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Gatimel N., Moreau J., Isus F., et al., Anti-sperm antibodies detection by a modified MAR test: Towards a better definition of its indications, Reproductive biomedicine online (2018),Vol.37,No.6,pp.717-723

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Laudat A., Burc-Struxiano L., Is Absence of Spontaneous Agglutinates of Spermatozoa in Semen a Reliable Indicator of Non-Autosensization against Human Sperm Antigens?, Open Access Library Journal (2016),Vol.3,No.e2978

Lotti F., Baldi E., Corona G., et al., Epididymal more than testicular abnormalities are associated with the occurence of antisperm antibodies as evaluated by the MAR test, Human Reproduction (2018),Vol.33,No.8,pp.1417-1429

Marconi M., Nowotny A., Pantke P., et al., Antisperm antibodies detected by mixed agglutination reaction and immunobead test are not associated with chronic inflammation and infection of the seminal tract, Andrologia (2008),Vol.40,pp.227-234

Marconi M., Pilatz A., Wagenlehner F., et al., Are Antisperm Antibodies Really Associated with Proven Chronic Inflammatory and Infectious Diseases of the Male Reproductive Tract?, European Urology (2009),Vol.56,pp.708-715

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Poppe K., Glinoer D., Tournaye H., et al., Is systematic screening for thyroid disorders indicated in subfertile men?, European Journal of Endocrinology (2006),Vol.154,pp.363-366

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Verón G.L., Molina R.I., Tissera A.D., et al., Incidence of Sperm Surface Autoantibodies and Relationship with Routine Semen Parameters and Sperm Kinematics, Am J Reprod Immunol (2016),Vol.76,pp.59-69

The immunological factor reduces the probability of spontaneous conception, and this is particularly true when ASA of the IgA class are also present

Instructions For Use

Material Safety Data Sheet

SpermMar IgG Test kit
Positive And Negative Controls