It can deliver results in less than five seconds with over 98 percent accuracy.
New smartphone technology could help millions of men struggling with infertility.
Perhaps the closest competitor for the Harvard smartphone device is the YO Home Sperm Test developed by Medical Electronic Systems.
Manoj Kanakasabapathy led the research team that designed and tested Fertilex.
The new technology - consisting of an external accessory in which sperm samples are inserted and an app that analyzes them - could make testing as straightforward as a home pregnancy test, the scientists say.
The hardware cost is under $5, he added, and the team believes the final product should be able to go on the market at less than $50. Over 40 per cent of fertility problems are due to poor quality sperm. (That classification was based on standards set by the World Health Organization, which dubs semen abnormal if it has less than 15 million sperm per milliliter or if less than 40 percent of the sperm are swimming.) The smartphone-based test correctly classified 303 of those abnormal samples.
The process is pretty simple: The user employs a little device that looks like a tiny turkey baster to put a semen sample onto a disposable microchip.
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"This can make home fertility testing for men as simple as home pregnancy testing for women", she said.
"The device has many advantages: simple, fast, accurate and affordable", Ashok Agarwal, director of the Clinical Andrology Laboratory and Sperm Bank at Cleveland Clinic, said in an email.
Couples trying (or not trying) to conceive could soon use another app to help them with their family planning needs.
A debate has raged for decades over whether male fertility is declining, according to some analyses of studies from recent decades. Men who ejaculate four or more times per month are proven to have better sperm. In a paper published in the journal Science Translational Medicine on Wednesday, he and several researchers from Massachusetts General Hospital's Fertility Center found that when reviewing 350 semen samples, their diagnostic test could measure the concentration and motility of sperm with 98 percent accuracy. The low cost and convenience could prove revolutionary for many couples who otherwise must rely on pricey and time-consuming lab tests to get the most accurate fertility test results-an option that is often out of reach for many low-income families in both industrialized and developing countries. Additionally, a weight microscale - connected wirelessly to the smartphone - measures the total sperm count. Animal breeders could also adapt the kit to regularly test animal semen. This test is low-priced, quantitative, highly accurate and can analyze a video of an undiluted, unwashed semen sample in less than five seconds'.
Hadi Shafiee, co-author of the study and principal investigator at Brigham and Women's Hospital, said the team will continue refining the prototype and eventually file for approval from the Food and Drug Administration (FDA).
The device might also be helpful for men who don't want to father any more children.
"The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game changer".