Validation study published for FDA's CD3 device

Author: Marya Lieberman

The CD3 device shines light of different wavelengths on pharmaceutical packaging and tablets;  authentic samples and falsified samples can look very different under such illumination, particularly when the manufacturers include "secret writing" in fluorescent ink.  In this study, authentic and falsified artesunate and packaging materials were distinguished with excellent sensitivity and selectivity.    Although the test does not detect the chemical makeup of the sample it is complementary to other field tests that detect APIs spectroscopically or colorimetrically.  

Evaluation of a New Handheld Instrument for the Detection of Counterfeit Artesunate by Visual Fluorescence Comparison

  Nicola Ranieri, Patricia Tabernero, Michael D. Green, Leigh Verbois,
  James Herrington, Eric Sampson, R. Duane Satzger, Chindaphone Phonlavong, Khamxay Thao, Paul N. Newton, and Mark R. Witkowski
  Am J Trop Med Hyg 2014; 91:920-924 doi:10.4269/ajtmh.13-0644