Solution for Medical Test Strip Counterfeiting

An electronics manufacturer is proposing the use of Flash-based microcontrollers as a means of authenticating medical test strips for diabetes. If successful, the technique could help eliminate the problem of counterfeit test strips and, as a result, provide more accurate home glucose readings for diabetics.

The development could be coming at the right time for the pharmaceutical industry, which has recently been beset by a proliferation of counterfeit medicines and test systems. Pharmaceutical companies, in some cases, have alerted drug store chains to the possible presence of fake glucose test strips. The test strips are typically used by diabetics for home-testing of blood sugar levels.

In its solution to the problem, Microchip Technology Inc., a maker of microcontrollers and analog semiconductors, has proposed using an electronic token on boxes of test strips. The token contains a low pin-count microcontroller incorporating a small memory, which stores an authentication algorithm and instructions. To prove a token is authentic, users would simply place the token in a glucose meter, which would send a string of data to the token. The token would then use its on-board algorithm and microcontroller to perform calculations on the data string, and send those calculations back to the meter. By examining the returned calculations, the meter could tell if the token is authentic, and then "decide" if it should turn itself on.

"This would be slightly more expensive than the way it's done now," says Steve Kennelly, manager of Microchip's Medical Group. "But considering the potential benefits and risks of using counterfeit strips, we think it's worth the extra cost."

The new technique would take test strip technology a step further than is typically done today. The current state-of-the-art boxes of test strips often incorporate tokens with EEPROM memories, which can be used to help calibrate glucose meters. Those EEPROMs, however, can't perform calculations, and therefore can't determine whether test strips are authentic. To prove authenticity, Microchip engineers are suggesting that tokens incorporate microcontrollers, as well as memories.

Microchip is proposing the tokens would incorporate its eight-bit, six-pin PIC10F20x microcontrollers in the solution. The company says the extra cost would be a "minimal addition" to the box of strips, which typically retail for $30-$40.

The incorporation of microcontrollers would help ensure home glucose meter readings are accurate, because authentic test strips tend to be more accurate than the counterfeit versions.

"The more you can control your blood sugar, the better off you are as a diabetic patient," Kennelly says. "If you're getting incorrect data from your meter, you can't have tight control."