Connected to a smartphone app, the analyzer consists of an optical attachment and a disposable device into which the unprocessed semen sample is deposited.
Described in their newly published study as fast, easy to use and inexpensive, it measures sperm concentration and motility and can be used at home just like a pregnancy test for women.
The researchers, who plan to file for US Food and Drug Administration approval of the analyzer, say it’s still in the prototype stage.
Infertility affects up to 12 per cent of the world’s male population, and the cultural and social stigma of the condition hinders many men from getting tested, the researchers write in the US-based journal Science Translational Medicine.
“Men have to provide semen samples in these rooms at a hospital, a situation in which they often experience stress, embarrassment, pessimism and disappointment,” says the head of the study, Hadi Shafiee, a faculty member at Harvard Medical School’s Brigham and Women’s Hospital in Boston.
“Current clinical tests are lab-based, time-consuming and subjective.”
The application processes data obtained by the smartphone camera using the optical attachment. Analysis takes less than five seconds, according to the researchers, who say the total material cost to fabricate the analyzer is 4.45 US dollars.
Shafiee’s team tested the analyzer on 350 semen specimens at a fertility clinic and say its accuracy was very similar to that of computer-assisted laboratory analysis, even when the test was performed by untrained users.
According to the researchers, it detected with nearly 98 per cent accuracy abnormal semen samples based on World Health Organization (WHO) guidelines: sperm concentrations below 15 million sperm per millimetre and with less than 40 per cent motility.
The current standard methods to diagnose male infertility, manual microscope-based testing and computer-assisted semen analysis (CASA), are labour-intensive, expensive, and laboratory-based, the researchers point out.
Many fertility clinics and small hospitals lack CASA-based platforms and so use a time-consuming – and subjective – manual method for semen analysis, they add.
With the smartphone-based analyzer, the analysis can be performed at home or in a remote clinic without access to laboratory equipment, the researchers say.
Another possible target group for the analyzer, they note, is men who have undergone a vasectomy, a permanent method of contraception in which a man’s sperm-carrying ducts are cut and sealed.
To verify the success of the surgical procedure, patients are required to monitor their semen quality for three to six months afterwards. Not having to visit a doctor for this would be a major convenience, the researchers say.
However Hans-Christian Schuppe, president of the German Society for Reproductive Medicine, expressed reservations about the new diagnostic tool.
While it is fascinating and would certainly be useful in some cases to perform a semen analysis without a large infrastructure, he says “home tests like this should serve only as a guide and not a substitute for a professional laboratory diagnosis.”
For one thing, Schuppe says, humans are still superior to computer-aided systems in making an overall assessment of sperm quality.
“A practised examiner always has an eye on parameters other than merely the number of sperm and their motility,” he remarks.
The human expert “also assesses their shape and whether there are other cells in the semen sample that could provide further indications of deficient testicular function or other illnesses.”
How men deal with the results of a home test is also problematic, he says.
“From experience I’ve got the feeling that many men and couples are completely overwhelmed by information from the internet. In this sensitive area, medical consultations must continue to take place.”