Smartphones and IVD: Early, But Getting There

The current developments, product launches and company plans in IVD testing on smartphone platforms has been detailed by Kalorama Information in a recent report by Kalorama’s Rob Camp:

We summarize some of the findings of our study here.  This represents a fraction of the findings of the report:

The techniques that can most successfully harness mobile phone technology look to be lateral flow immunoassay-based tests, ELISAs, and spectrophotometry, as they are methodologies that use a tool that has become ubiquitous in the developed world and is on the rise globally, the smartphone camera. In recent years, researchers have been developing algorithms and machine learning systems that can scan and analyze colorimetric tests as accurately as a sophisticated piece of laboratory machinery, but at a fraction of the cost. While the technology appears yet to be in its nascent stages, there are quite a few examples of devices under development that employ these techniques

According to the GSM Association, two-thirds of the world’s population have a mobile phone service plan, but growth is slowing as the market matures; it took four years to go from 4 to 5 billion subscribers. It is projected to take even longer to reach another billion; estimates are 5.7 billion unique subscribers by 2020, representing 72% total market penetration. However, the number of subscriptions per person is widely distributed. On average, there are 1.04 subscriptions for every person worldwide, ranging from only 0.08 per capita in Eritrea to nearly 2.5 in Hong Kong and over three in nearby Macau. The table below highlights the growth of mobile services in twenty-four selected countries, and the map illustrates the overall global distribution of subscriptions in 2017.

Formed out of the University of Colorado-Boulder, Mobile Assay is a startup that produces a smartphone-compatible lateral flow assay reader that is stated to be able to read test strips of any type; the mReader imaging system transforms qualitative tests into highly sensitive quantitative tests. The company’s universal Lab-on Mobile-Device (LMD) platform uses Mobile Image Radiometry (MIR), an image analysis algorithm that converts the analog visual signals of a rapid diagnostic test into a normalized and calibrated digital signal.

The platform improves the quantification of RDTs by increasing sensitivity over a hundredfold, comparable to ELISA. Mobile Assay has partnered with companies like Alere/Abbott and Rapid Medical Diagnostics to validate a number of tests for their platform, focusing primarily on insect-borne tropical diseases, including lymphatic filariasis, malaria, onchocerciasis, and schistosomiasis.

Novarum (Cardiff, Wales, UK) develops smartphone-based mobile POCT platforms customized to users’ specifications and made to work for any number of applications. Users work with Novarum to develop an app designed for specific testing needs; the app is then used to scan a code to identify the type of test to be conducted, then to scan the test results. Results can be sent to a database of the user’s choosing via email, SMS, web, Bluetooth, or USB.

iXensor’s Eveline ovulation test also uses a dipstick test, but is instead a single-use LH-detecting colorimetric test unit that attaches to a clip set over the front camera of a
smartphone. The included app uses iXensor’s adaptive algorithm to present data in a three-tiered snapshot of the user’s fertility, and stores the information in a Fertility Calendar that gives the dates the user will likely be at her most fertile. Reminders can be set to take tests to more accurately pinpoint peak fertility.

Fertility Tech (Las Vegas, NV) takes a different approach to ovulation testing: the company’s Ovatel is a saliva-based test that functions more as a microscope than a lateral flow assay analyzer. Users place a saliva sample on a lens that attaches to the smartphone camera, which analyzes the image for a certain fern-like physical pattern, formed by salt crystals, that appears in the sample due to spikes in a woman’s estrogen levels during her cycle. No basal body temperature measures or urine samples are necessary, nor are additional purchases, as Ovatel is reusable.

BACtrack released the BACtrack Mobile Smartphone Breathalyzer in April 2013. The device uses Xtend Fuel Cell Sensor technology offered in their professional-grade
analyzers, which detect the electrochemical process that oxidizes the alcohol in a breath sample and produces an electrical current, which is then relayed back to the analyzer’s sensor to determine the user’s BAC; the device also features a mini solenoid pump to ensure the most accurate and efficient breath capture for testing.

The BACtrack Mobile breathalyzer is compatible with most Apple devices running iOS 8.0 or newer, including iPod Touch, as well as most Android smartphones by Samsung and Google. The device connects wirelessly to the phone via Bluetooth and operates through the BACtrack Companion App, which features the company’s ZeroLine technology, which estimates when the user’s BAC will return to 0.00%. The app also helps the user to call a ride sharing service when necessary.

For more information on smartphone IVD combinations, Kalorama’s recent report is available here: