NEW YORK – Home fertility tests aren't just for women anymore.A new device that looks a lot like those home ovulation and home pregnancy tests but checks sperm count will soon be available in Europe, and is undergoing Food and Drug Administration (FDA) review for marketing in the U.S.
The test targets couples who have been trying to get pregnant for a few months, but aren't ready to seek professional help, Dr. John C. Herr of the University of Virginia in Charlottesville, who helped develop the new test, told Reuters Health.
The test helps couples sort out if the male is a factor in the infertility "and to do that in privacy with some cost savings," he said. "The product will retail for about $25. That's a lot cheaper than going in and having a full semen analysis."
Depending on where you are in the country, he added, semen analysis can cost from around $65 to $250, and may or may not be covered by insurance.
In the journal Human Reproduction, Herr and his team report on a study comparing the accuracy of their SpermCheck Fertility test with standard laboratory sperm count methods, using 225 semen samples. The tests were accurate 96 percent of the time, the researchers found. Ninety-five percent of the time a laboratory professional and a lay person got the same result when reading a single test independently.
Sperm counts of 20 million per milliliter of semen and above are considered normal. The test will tell a man whether or not his sperm count meets this cutoff, and if it doesn't whether he has a severely low sperm count (below 5 million sperm per milliliter). "It basically tells the man how deep the infertility is," Herr explains. "If both strips are negative it's important that they then seek medical treatment for the infertility."
The test works by detecting an antigen found on the surface of the head of a sperm cell known as SP-10, which Herr and his colleagues discovered. "There's a lot of cell biology and molecular biology behind the project," the researcher said, adding that the work of discovering SP-10 and developing the test — much of it funded by the National Institutes of Health — took about 10 years.
While women only need to dip a test stick in their urine to see if they're pregnant or close to ovulation, the SpermCheck Fertility test requires a few more steps.
Users let the semen rest for 20 minutes, collect 100 microliters using a pipette, and mix the semen with a detergent-containing substance known as a buffer, which releases the SP-10 protein from the sperm. Users then put a few drops of this mix into the two sample wells. Within seven minutes, the test results will appear in test windows above the wells.