It is intended to measure natural levels of fertility in couples trying to conceive and serve as an early warning that there may be a problem.
The kit is the brainchild of the London medical devices company, Genosis, working with a research team from the University of Birmingham.
Details of the male test will be presented this afternoon (Monday 2 July) by Professor Christopher Barratt of the University of Birmingham, to the annual conference of the European Society of Human Reproduction and Embryology in Lausanne.
It enables men to measure the concentration of motile (active) sperm in their semen - the most predictive indicator of natural fertility.
The female test measures follicle stimulating hormone (FSH) levels as an indicator of ovarian reserve (the number of eggs in the ovary).
The prototypes of the two tests have already been tested on 118 men and 243 women and Genosis are currently scaling up production for clinical trials in the UK and the USA during the autumn. The kit should be available over the counter early next year.
The male test kit reproduces the temperature conditions of a woman's body. Sperm are deposited into a container. A button is pressed to release a column of artificial cervical mucus which is heated automatically to 37°C. Only the motile sperm are able to swim through the mucus column to a point where they are automatically collected, tagged with gold-labelled antibodies and detected on a nitro-cellulose strip. If there are adequate numbers of sperm present and if they are sufficiently motile, the test will produce an easy-to-read red line. This appears when the semen sample has greater than 10 million motile sperm per ml - equivalent to the WHO guidelines for normality.
"It takes an established technology that is usually employed in the laboratory and embodies that know-how into a simple to use format for the lay person," explained Professor Barratt. "The test cannot diagnose all causes of male infertility: However, it will identify the vast majority of cases and the instructions will make that very clear."
"It is aimed at couples who are attempting to conceive. The current screen for infertility is to try for 12 months and then seek medical advice. But 40 per cent of all cases of infertility are due to male factors and this test can indicate early on if there is potentially a problem with the man that indicates the couple should seek advice. This is particularly important given that many couples are choosing to defer childbearing until later in life."
He said another benefit of the test was that it would save men from the embarrassment many felt producing semen specimens in a clinic setting.
"Almost everybody I speak to about Fertell knows a friend or a relative that has experienced difficulty in trying to conceive," said Paul Bateman, CEO of Genosis. "Infertility is a very common and extremely emotionally traumatic issue. We believe that by providing couples accurate and early confirmation of their fertility status, in the privacy of their own home, Fertell can help identify many of those couples that would find it difficult to conceive and would benefit from seeking medical advice. Importantly, early diagnosis and treatment of infertility increases a couple's chances of successfully conceiving and having a healthy baby."
The Female device is a lateral flow rapid dipstick that measures follicle-stimulating hormone ("FSH") in an in-stream urine sample. The test is performed two days after the onset of menses (day 3 of the menstrual cycle) and is similar in design and use to a pregnancy test or an ovulation prediction test. It uses a monoclonal antibody to one FSH antigenic determinant that is conjugated with colloidal gold and a second monoclonal antibody to a different antigenic determinant, the latter antibody being immobilized as a line on a nitrocellulose strip.
FSH present in the urine reacts with the conjugated antibody and immobilized antibody, forming a 'sandwich' immunocomplex at the site of the immobilized antibody. Unreacted conjugate is washed from the strip by the flow of excess sample. The appearance of a clear red line (test result) indicates the presence of FSH in the urine sample. The intensity of this test line is proportional to the FSH concentration.
The nitrocellulose strip also has a reference line of fixed intensity that is calibrated to the urine concentration corresponding to a serum FSH value of 10 IU/L. A test line of color intensity greater than or equal to the reference line indicates an elevated FSH concentration and diminished ovarian reserve.
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