An automated smartphone-based diagnostic assay for point-of-care semen analysis.
Male infertility affects up to 12% of the world's male population and is linked to various environmental and medical conditions. Manual microscope-based testing and computer-assisted semen analysis (CASA) are the current standard methods to diagnose male infertility; however, these methods are labor-intensive, expensive, and laboratory-based. Cultural and socially dominated stigma against male infertility testing hinders a large number of men from getting tested for infertility, especially in resource-limited African countries. We describe the development and clinical testing of an automated smartphone-based semen analyzer designed for quantitative measurement of sperm concentration and motility for point-of-care male infertility screening. Using a total of 350 clinical semen specimens at a fertility clinic, we have shown that our assay can analyze an unwashed, unprocessed liquefied semen sample with <5-s mean processing time and provide the user a semen quality evaluation based on the World Health Organization (WHO) guidelines with ~98% accuracy. The work suggests that the integration of microfluidics, optical sensing accessories, and advances in consumer electronics, particularly smartphone capabilities, can make remote semen quality testing accessible to people in both developed and developing countries who have access to smartphones.
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Manoj Kumar
0000-0002-0756-8585
MK
Kanakasabapathy
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Magesh
0000-0001-9752-5695
M
Sadasivam
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Anupriya
0000-0003-4345-2683
A
Singh
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Collin
0000-0002-0438-7156
C
Preston
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Prudhvi
0000-0002-0573-0243
P
Thirumalaraju
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Maanasa
0000-0001-8543-8463
M
Venkataraman
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
Charles L
CL
Bormann
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA.
Mohamed Shehata
0000-0001-8734-0443
MS
Draz
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
John C
0000-0001-5864-2119
JC
Petrozza
Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02139, USA. hshafiee@bwh.harvard.edu.|Department of Medicine, Harvard Medical School, Boston, MA 02115, USA.
Hadi
0000-0003-2240-7648
H
Shafiee
D015925:Cryopreservation; D019937:Diagnostic Techniques and Procedures; D006801:Humans; D008297:Male; D019095:Point-of-Care Systems; D055101:Semen Analysis / Q000379:methods*; D000068997:Smartphone; D013076:Sperm Count