Updated February 10, 2015
A new smartphone dongle has been developed to perform point-of-care HIV and syphilis tests from a finger prick in just 15 minutes.
|An inexpensive smartphone compatible device could detect HIV and syphillis.|
A new diagnostic device that works in tandem with your smartphone can perform a point-of-care test to detect major infectious disease markers--including HIV--from a single finger prick of blood, in just 15 minutes time.
According to a team of researchers led by Samuel K. Sia, an associate professor of biomedical engineering at Columbia Engineering, the device replicates all mechanical, optical, and electronic functions of a lab-based blood test. More specifically, it performs an enzyme-linked immunosorbent assay (ELISA) without requiring any stored energy, as all necessary power is drawn from a smartphone, according to details released from the university.
The device performs a triplexed immunoassay in a single test format, something that is not currently available in any other device on the market, testing for HIV antibodies, treponemal-specific antibodies for syphilis, and non-treponemal antibodies for active syphilis infections. The device was designed to be both small and cost-effective, partnering with either a smartphone or computer in an effort to make it more effective in areas with limited resources. Sia estimates that the manufacturing costs for the device will be around $34, a cost significantly lower than typical ELISA equipment that can run over $15,000.
The research team miniaturized and integrated all components needed for an ELISA to run on a smartphone accessory which can simultaneously detect three infectious disease markers from a finger prick of blood in just 15 minutes, according to Tassaneewan Laksanasopin, a PhD student in Sia's lab who was the lead author for the work.
"Point-of-care diagnostic tests have to work reliably not only in the laboratory but also in resource-limited settings. We developed our test to be simple and user-friendly to minimize user errors and increase user acceptability of the new device," Laksanasopin says.
The potential for the technology could be even more far-reaching. "Our technology is capable of detecting any protein markers from infectious diseases to cancers," Laksanasopin says. "We are also working on other complex test (i.e. nucleic acid tests) to be run on a similar platform using a smartphone."
Sia and his team's development is the latest in a string of diagnostic technologies that are moving to smartphone applications, a trend that is picking up speed given the ubiquitous nature of smartphones, and the benefits of operating the devices on limited resources. Just last year researchers from the University of Washington developed a smartphone app that can detect jaundice in newborns using the camera on the smartphone. Smartphones are even being turned into microscopes that can detect DNA molecules, proving that cell phones are becoming much more capable than we could have imagined even a couple of years ago.
It was in this spirit that the Columbia researchers sought an efficient alternative to traditional ELISA diagnostic equipment, miniaturizing hardware for rapid point-of-care diagnostic capabilities, and creating a diagnostic tool that was power-efficient. His team first sought to eliminate the power-consuming electrical pump by using a "one-push vacuum," where users mechanically activate a negative-pressure chamber to move a sequence of reagents pre-stored on a cassette. The process is durable, and requires little training or additional manufacturing.
Sia and his colleagues were also able to successfully remove the need for a battery by using the audio jack for transmitting both power and data between the device and a smartphone. This was a significant breakthrough for the device, as audio jacks now come standard on essentially every smartphone, making the device universally compatible with today's smartphone technology including both iPhone and Android devices.
Recently, in field testing for the device in Rwanda, healthcare workers needed only 30 minutes of training with the device in order to operate it. The device comes with a user-friendly interface, step-by-step pictorial directions, built-in timers that alert the user about the next steps, and records test results for later review. The field tests revealed that 97% of the patients that used the test would recommend the use of the device because of its fast turn-around time, ability to diagnose multiple diseases, and the simplicity of the procedure.
As for the future of the device, Sia and his team hope to take significant steps toward bringing the device to markets in developing nations where early diagnosis and treatment of HIV and syphilis can greatly minimize complications, as well as the spread of these infectious diseases. With manufacturing costs expected to be in the ballpark of $34, Sia hopes this device can be truly transformative in the impoverished areas of developing nations where these diseases run rampant.
Says Laksanasopin: "We are planning to conduct a larger-scale trial, obtain WHO approval, and get the device to the market in the developing countries. We are also exploring how the technology can be adapted for consumer health back home."
|Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.|
Kristopher Sturgis is a contributor to Qmed and MPMN.
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