Ink Spots to Put an End to Counterfeit Diagnostic Tests

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Could tiny ink spots, the size of a pinhead, fight counterfeiting medical tests? We believe the answer is yes.

ink spots

Optical security codes embedded into a microfluidic devices to ensure protection against counterfeiting.

This week at the Biosensors 2018 conference in Miami, I’m presenting a new research paper demonstrating how optical security codes, created by inkjet spotting patterns, can be used in combination with smartphones for authenticating medical tests. Our technology could put a significant dent in the growing black market for diagnostic tests.

Fraud – a lucrative business

According to the Global Health Care Anti-Fraud Network, healthcare fraud is a financially viable and productive business. An estimated 260 billion USD (180 billion euros) is lost to fraud annually – that’s around six percent of global healthcare spending and the equivalent of the GDP in countries such as Finland or Malaysia.

Sadly, global healthcare fraud takes on many forms, from insurance fraud schemes to prescription drug diversion to counterfeit point-of-care diagnostics (POCDs) and rapid diagnostic tests (RDTs). In developing nations, up to 50 percent of medicines consumed are counterfeit, per recent estimations from the World Health Organization (WHO). The WHO also claims that more than eight percent of the medical devices in circulation in 2010 were fake, a statistic that continues to increase with the growing presence of online pharmacies.

Against the backdrop of these challenges and their detrimental effects on the quality of healthcare, new systems and technologies are needed to combat global healthcare fraud. The WHO has already responded by launching a “test-treat-and-track” campaign to scale up diagnostic testing, treatment and surveillance, specifically for malaria, the single biggest cause of illness and death in the African region.

Classical security features don’t cut it 

While POCDs and RDTs are essential for detecting and treating infectious diseases worldwide, these devices are relatively easy to reproduce and forge. Classical security features such as product numbers, barcodes and QR codes are far from being counterfeit-proof. Among fraudsters, it is common practice to falsify labels and expiration dates on diagnostic tests for diseases such as HIV, malaria, Dengue fever or Ebola and resell them on the black market.

Sophisticated security strategies such as “security printing” and “digital tagging” could prove promising. The former involves developing hard-to-replicate holograms or tags with special links. However, “hard-to-replicate” does not fully guarantee security. Eventually, security printing will be copied. Holograms, for example, can be reproduced at low quality without raising suspicion among non-specialists. Photonic and plasmonic tags can be integrated into microfabricated RDTs, but the manufacturing process is time consuming and costly.

“Digital tagging” seems the most dependable as it secures RDTs through implementation of a security code unique to each device. But such security solutions primarily secure the packaging, not the product itself, which wouldn’t stop people with nefarious intent from tampering with what’s inside. Perhaps, embedding a digital security code in the functional component of a diagnostic device would be one way to achieve stronger security. But research on this method has demonstrated that a QR code takes up too much space and does not allow for device authentication before usage.

Beyond the package

At IBM Research – Zurich, we have taken a new approach to securing diagnostic devices by introducing unique and compact optical security codes in microfluidic devices on nitrocellulose flow paths. Our research focuses on implementing static and dynamic codes where reading the code before and during a test provides sufficient complexity when complemented with a QR code on a package. What makes optical codes convenient and cost-efficient is that they are easy to write using an inkjet spotter filled with low-cost dyes. Moreover, it is easy to decode them on a smartphone by simply taking a picture of the codes with the phone.

ink spots

Through intermittent or continuous connectivity, devices can also be tracked through the supply chain.

With this setup, RTDs can be authenticated with or without network connectivity. Through intermittent or continuous connectivity, devices can also be tracked through the supply chain; such tracking can provide transactions inputs for blockchain transactions. This means suppliers can log device usage and report incidents to regulators in cases where fraudulence is suspected.

In favor of microfluidic POCDs

While there are many reasons why microfluidic POCD devices have yet to take the world by storm (i.e. public health regulations, market competition, acceptance among medical professionals), rethinking traditional microfluidic-based technologies has the potential to push the field into unchartered waters. What makes the use of microfluidic POCD devices quite promising is the decades of basic research in the traditional sciences, including biology, chemistry and materials engineering. Combining this knowledge with information technology has the potential to significantly improve diagnostics, prevention and therapeutic monitoring.

Finally, pairing microfluidic POCD devices with information technology, including the blockchain, has the potential to combat device counterfeiting, a crime much more widespread than one would think – and it is getting progressively worse. It may be wise for those working on new diagnostic devices and biosensors to consider adding security features to their next generation of analytical devices.

We are currently in discussions with several clients and are looking for pilot projects before the end of the year – counterfeiters be warned.

* Onur Gökçe, Cristina Mercandetti, and Emmanuel Delamarche. “High-Content Optical Codes for Protecting Rapid Diagnostic Tests from Counterfeiting.” Analytical Chemistry. DOI: 10.1021/acs.analchem.8b00826

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