An automated smartphone-based diagnostic assay for point-of-care semen analysis

Abstract

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.

Automation of human semen analysis using a novel artificial intelligence optical microscopic technology

“…Therefore, manual assessment of sperm motility is often miscalculated. Based on this rationale, Kanakasabapathy et al (2017) developed a smartphone-based assay for at-home semen analysis that involves an optical attachment and a disposable microfluidic device for handling of the specimen. If accessible semen testing could be carried out at home and provide meaningful preliminary data to the physician in advance, it would benefit a large portion of men suffering from infertility.…”

“…Moreover, different CASA systems use different mathematical algorithms to calculate various sperm quality parameters, leading to the greatest disadvantage in the clinical application of CASA, with unreliability of comparative parameters across all devices (Akashi, Mizuno, Okumura, & Fuse, 2005;Amann & Waberski, 2014;Dearing, Kilburn, & Lindsay, 2014;Kanakasabapathy et al, 2017;Lammers, Splingart, Barriere, Jean, & Freour, 2014). Moreover, different CASA systems use different mathematical algorithms to calculate various sperm quality parameters, leading to the greatest disadvantage in the clinical application of CASA, with unreliability of comparative parameters across all devices (Akashi, Mizuno, Okumura, & Fuse, 2005;Amann & Waberski, 2014;Dearing, Kilburn, & Lindsay, 2014;Kanakasabapathy et al, 2017;Lammers, Splingart, Barriere, Jean, & Freour, 2014).…”

Rapid, label-free CD4 testing using a smartphone compatible device

“…Similarly, in India, cheaper android smartphones have pushed the country to become the second largest user base in the world above the United States, making it one of the largest growing smartphone market 38 . With a fast growing user base, smartphone-based diagnostic alternatives can potentially be used with little to no training 39, 40 . The work we presented here is an example of how smartphones can be used for HIV/AIDS management in resource-limited settings.…”

“…Concurrently, microfluidics has shown a great promise in bringing POC testing to patients over the past decade 9 . Numerous approaches utilizing microfluidics and smartphone/cell phone capabilities for POC disease detection and management have been explored 10–13 . Here, we present an automated CD4 testing using small volume of whole blood by integrating advancements in consumer electronics and microfluidic chip fabrications (Fig.…”

Biosensors for Personal Mobile Health: A System Architecture Perspective

“…The authors validated the performance of the microscope using blood samples from 33 patients and showed that the results were comparable to conventional thick smear counts (94% specificity; 100% sensitivity). Kanakasabapathy et al developed a smartphone‐based semen analyzer for POC male infertility screening . The system consists of a disposable microfluidic device for handling the semen samples and an optical attachment for the smartphone to facilitate image magnification and device alignment (Figure b).…”