News Feature | March 27, 2017

Testing Male Fertility At Home? There's An App For That

By Suzanne Hodsden

harvard-sperm-tester
This smartphone-based semen analyzer can be used to test for male infertility. Image courtesy of Shafiee Lab / Harvard Gazette

New smartphone technology has made at-home fertility testing for men as simple as pregnancy testing for women, according to Harvard scientists. The novel device uses an optical attachment, disposable microchip sample slides, and algorithms based on World Health Organization (WHO) standards to deliver data — with 98 percent reported accuracy — to a smartphone app within five seconds.

Male infertility exists at rates as high as female infertility but it often is underdiagnosed, according to a Harvard research team’s recent study, published in Science Translational Medicine. Researchers cite socio-economic factors, such as stigma, and access — both financial and geographic — to laboratory facilities. The embarrassment and stress of the in-lab examination also can limit how many men are properly diagnosed.

“Current clinical tests are lab-based, time-consuming, and subjective,” said Hadi Shafiee, principal investigator of the study at Brigham Women’s Hospital (BWH), to the Harvard Gazette. Shafiee explained that his team wanted to develop an alternative that could make testing as convenient and private as home-pregnancy tests.

The testing system consists of an optical attachment and a microchip slide, which fits into the device once the sample has been collected. Using analysis based on the WHO’s definitions of healthy sperm motility and concentration, a specially designed app can produce results within seconds. The study, which tested the system on 350 samples from Massachusetts General Hospital (MGH), demonstrated 98 percent accuracy.

Shafiee explained that the samples do not require additional processing or preparation before they are tested, and the test is just as effective on “unwashed and undiluted” samples.  Though initial results are promising, researchers said they plan to do additional testing before applying for FDA approval.

FDA already has approved products that test male fertility in the home, such as SpermCheck and FertilMARQ, reported The Verge. But, the Harvard test stands apart from existing technology because it tests not only the number of sperm, it evaluates their movement. The YO Sperm Test, which was released earlier this year, tests samples based on its own parameters, and not those outlined by the WHO, according to Shafiee.

Though many fertlility specialists agree that at-home fertility tests are a “good first step” in treatment, some experts have expressed concern that these tests might prevent patients from getting a more thorough examination by a doctor, reported Vocativ.

The market for at-home or point-of-care (POC) diagnostics and therapeutics has been boosted by advances in biosensors and the proliferation of smartphone technology. Recent research estimates that nearly 37 percent of the global population will own a smartphone by 2020.  Though percentages are significantly lower in developing economies,  initiatives targeted at bringing 21st century healthcare to low-resource nations or communities have looked to smartphone-based diagnostics that are more affordable and easy to transport than bulky lab equipment.

Israeli scientists are working on a breathalyzer attached to a smartphone that can “sniff out” diseases, and have demonstrated that the technology can diagnose lung cancer with 90 percent accuracy. An implanted biochip developing in Switzerland could one day monitor blood and transmit data to smartphones to reduce the frequency of invasive blood draws.