A new device that works in tandem with a smartphone app has been shown to measure sperm concentration and motility in less than 5 seconds, and with quality evaluation accuracy of ~98% based on the World Health Organization guidelines.
Current Food and Drug Administration (FDA) approved home male infertility tests include FertilMARQ and SpermCheck, which both use chemical staining to detect proteins on the sperm head. Another FDA-approved test is Trak, which uses centrifugal force to estimate sperm concentration on a microfluidic device. However all these devices measure sperm concentration only and not motility, which is a marker for infertility.
The current clinical standard for assessing male fertility is either manual microscope-based testing or computer-assisted semen analysis (CASA). Both of these methods have their disadvantages in terms of labor, cost and result subjectivity.
Researchers at Brigham and Women’s Hospital and Harvard Medical School have devised a new automated smartphone diagnostic assay. The kit consists of an optical attachment, for image magnification and device positioning, and a disposable microfluidic device for sample handling. This device requires a small semen sample (<35μl) on a disposable microchip which is then placed into a slot in the optical attachment. Using the phone’s camera as a miscroscope the app can analyze the sperm.
The researchers tested the device for performance, sensitivity, specificity and accuracy by comparing results gained from CASA to those from the smartphone-based assay, in 164 semen samples from patients at the Massachusetts General Hospital (MGH) fertility clinic. Results showed that overall repeatability of CASA for measuring sperm concentration and motility was >90%.
To assess usability, the researchers conducted a double-blind evaluation of semen analysis in trained and untrained users. In a Passing-Bablok analysis, the researchers found that performance of the smartphone device was similar to that of CASA when calculating sperm concentration.
The device may also be used to test sperm count after vasectomy, a procedure many men skip.
The device costs roughly $5 to make in the lab. Lead author of the study, Hadi Shafiee, assistant professor at Harvard Medical School, told NPR that he is “confident that this [the smartphone assay] can go to customers at below 50 dollars when it is ready.”
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