July 22, 2014 Kim Krisberg 0Comment

It looks like a simple piece of paper and it’s nearly as cheap, ideally costing just pennies. But despite its small size, it’s poised to make an enormous impact and potentially save thousands of lives.

It’s a new test to spot counterfeit versions of the drug artesunate, which is one of the most important drugs used to treat malaria, a mosquito-borne disease that affects hundreds of millions of people every year. Based on the science of microfluidics, researchers at Oregon State University developed an easy-to-use and inexpensive testing kit that patients and health care providers can use to determine if the malaria drug they receive is genuine and how much artesunate is present. Here’s how it works: a single pill is crushed and dissolved in water and then a drop is placed on the testing paper. Users then consult a simple color chart for the results — if the paper turns yellow, artesunate is present. The test takes just minutes and can be done just about anywhere. Findings on the innovative technique were recently published in the journal Talanta.

As the researchers noted in the journal article, drug counterfeiting is responsible for about 20 percent of the 1 million malaria deaths that happen each year. They also cited surveys finding that artesunate counterfeits make up between 38 percent and 53 percent of malaria drugs in Cambodia, Laos, Myanmar, Thailand and Vietnam. The Fake Malaria Drugs Kill project of the Dutch Malaria Foundation estimates that one-third of all malaria drugs sold in Africa are fake. And if that weren’t awful enough, counterfeit drugs can also contribute to the emergence of multidrug-resistant malaria. That’s why this little test could be a really big deal.

“It’s the first time we’ve tried to tackle a public health problem,” Vincent Remcho, an author of the Talanta study and a professor of chemistry and the Patricia Valian Reser Faculty Scholar in the Oregon State University College of Science, said about himself and his colleagues. “(Microfluidics) is a technology that is near and dear to us…to see it be useful in a public health setting is really gratifying.”

So, where did the idea come from? Interestingly, “it all started with a cool radio story,” Remcho told me. His wife, a veterinarian, was driving home when she heard a radio story about counterfeit medicines and malaria in particular. When she got home, she told Remcho that it reminded her of the kind of problems he tackles in his lab, where he and his colleagues build microfluidic devices that perform chemical analyses. Remcho agreed.

In turn, he and his colleagues set out with the intention of creating a test that was cheap, easy to use and wasn’t dependent on a person’s literacy level. The Centers for Disease Control and Prevention had previously developed a colorimetric test for artesunate, but it involved adding and mixing together chemicals in test tubes and isn’t easy to use outside a laboratory. In contrast, the test Remcho helped develop can be easily conducted in resource-poor settings, in remote locations and in the field. Remcho and study co-authors Myra Koesdjojo, Yuanyuan Wu, Anukul Boonloed and Elizabeth Dunfield write:

The chemicals required to perform the assay cost approximately US $.02 per test, which makes it a very practical solution to detect counterfeits. Since the reagents for the colorimetric test are stored on paper in dry form, they are more stable and easier to transport, which provides advantages of easy handling and longer shelf life. Furthermore, while most counterfeiters are producing fake drugs that lack of artesunate, some drugs are made with significantly lower active ingredients, which are incapable of killing all the parasites. This is an effort by the counterfeiters to misleadingly pass the test when a qualitative (positive/negative) evaluation is made to determine the presence of artesunate in the drug. Our test kit allows for quantitative analysis of artesunate tablets by providing a key that comes along with the kit and allows for comparison of the developed yellow color with the intensity of the yellow color corresponding to the approximate concentration of artesunate.

In addition to the test, students working on the project also developed an iPhone app that can more precisely measure the presence and level of artesunate. The app works by using the phone’s camera to analyze the intensity of the yellow that shows up on the paper strip. Of course depending on the setting, Remcho said the iPhone app may be most useful to health care providers and not necessarily patients. Still, the paper test results can be easily read with the naked eye, he added.

But can the test be cheated? Certainly not easily, Remcho said. If the criminals who manufacture and sell counterfeit malaria drugs wanted to cheat the test badly enough, they might be able to figure out a way. But Remcho hopes the time, effort and cost of finding a way to fool the test will be a deterrent.

Now that the test has been developed and assessed, Remcho is working to get the testing kit out to the people who need it. Beginning this fall and with funding from Grand Challenges Canada, which supports global health projects, Remcho and his colleagues are partnering with the National Institute for Metrology in Thailand to explore the feasibility of widespread use and distribution of the testing kit as well as the ease with which actual malaria patients can use the test. Remcho said he feels very hopeful.

“We want this test to be reliable and trustworthy,” he said. “I’m really hopeful that it goes in that direction. For right now, it kind of remains to be seen how it will evolve…but we’re excited that this technology can do some good.”

According to the World Health Organization, there were an estimated 207 million cases of malaria in 2012 and 627,000 malaria deaths.

To read more about the new counterfeit test, read this press release from Oregon State University or visit the Talanta journal. To watch a video about the toll of counterfeit malaria drugs, visit www.fakedrugskill.org.

Kim Krisberg is a freelance public health writer living in Austin, Texas, and has been writing about public health for more than a decade.

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