Smartphone-Based Assay Can Detect Male Infertility

A smartphone-based device for point-of-care male infertility screening has demonstrated the ability to detect sperm concentration and motility with approximately 98 percent accuracy. The smartphone-based assay is easy to use and can be performed at home or in a remote clinic without access to laboratory equipment. The accuracy of the assay was shown to be very similar to that of computer-assisted laboratory analysis, even when it was performed by untrained users with no clinical background.

Fertilex is an inexpensive smartphone attachment that quickly and accurately evaluates semen samples for fertility testing. Courtesy of M.K. Kanakasabapathy et al., Science Translational Medicine (2017).

The portable device, called Fertilex, was developed by researchers at Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) using the processing power and camera in a smartphone. The analyzer consists of an optical attachment that connects to a smartphone and a disposable microchip with a capillary tip and a rubber bulb used for simple, power-free sample handling. The team also designed a user-friendly smartphone application that guides the user through each step of testing, and a miniaturized weight scale that wirelessly connects to smartphones to measure total sperm count. The device was assembled for a total materials cost of $4.45.

“We wanted to come up with a solution to make male infertility testing as simple and affordable as home pregnancy tests,” said BWH investigator Hadi Shafiee. “Current clinical tests are lab-based, time-consuming and subjective. This test is low cost, quantitative, highly accurate and can analyze a video of an undiluted, unwashed semen sample in less than five seconds.”

To evaluate the device, the research team collected and studied 350 clinical semen specimens at the MGH Fertility Center. Overall, the smartphone-based device was able to detect abnormal semen samples based on WHO thresholds on sperm concentration and motility (sperm concentration <15 million sperm/ml and/or sperm motility <40 percent) with an accuracy of 98 percent. The team also evaluated how well both trained and untrained users performed the test using the Fertilex analyzer. Using the device, 10 volunteers with no formal training, including administrative assistants from a Boston fertility clinic, correctly classified more than 100 semen samples.

“The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game changer," said John Petrozza, M.D., director of the MGH Fertility Center. “More than 40 percent of infertile couples have difficulty conceiving due to sperm abnormalities and this development will provide faster and improved access to fertility care.”

In addition to at-home male fertility testing for couples trying to conceive, the device could be used as an at-home monitoring tool after undergoing a vasectomy, and as a point-of-care diagnostic tool in developing countries. The test could potentially be used by animal breeders to confirm the virility of a sample. Beyond semen analysis, the device is also compatible with testing blood and saliva samples. The researchers look forward to exploring these applications in the near future.

“My job is to try to understand some of the problems patients and physicians face in the clinic and to help develop new solutions. We are always thinking about what’s next and how to develop something new,” said Shafiee.

The smartphone-based analyzer for semen analysis is currently in a prototyping stage. The team plans to perform additional tests and will file for FDA approval.

The research was published in Science Translational Medicine (doi:10.1126/scitranslmed.aai7863).