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Evaluation of a new handheld instrument for the detection of counterfeit artesunate by visual fluorescence comparison.

Ranieri N, Tabernero P, Green MD, Verbois L, Herrington J, Sampson E, Satzger RD, Phonlavong C, Thao K, Newton PN, Witkowski MR - Am. J. Trop. Med. Hyg. (2014)

Bottom Line: Two hundred three samples of the oral antimalarial artesunate were compared with authentic products using the CD-3 by a trainer and two trainees.Interobserver agreement for 203 samples of artesunate was 100%.The CD-3 holds promise as a relatively inexpensive and easy to use instrument for field evaluation of medicines, potentially empowering drug inspectors, customs agents, and pharmacists.

View Article: PubMed Central - PubMed

Affiliation: Forensic Chemistry Center, US Food and Drug Administration, Cincinnati, Ohio; Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic; Worldwide Antimalarial Resistance Network (WWARN), Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom; Division of Parasitic Diseases and Malaria, Center for Disease Control, Atlanta, Georgia; Office of International Programs, Office of Global Regulatory Operations and Policy, US Food and Drug Administration, Silver Spring, Maryland; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Bureau of Food and Drug Inspection (BFDI), Ministry of Health, Government of the Lao People's Democratic Republic, Vientiane, Lao People's Democratic Republic; Food and Drug Quality Control Centre (FDQCC), Ministry of Health, Government of the Lao People's Democratic Republic, Vientiane, Lao People's Democratic Republic Nicola.Ranieri@fda.hhs.gov paul@tropmedres.ac.

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The CD-3 current generation of the instrument.
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Figure 1: The CD-3 current generation of the instrument.

Mentions: The CD-3 is a compact (15.2 × 7.6 cm; 300 g) handheld electronic tool (Figure 1) with multiple single wavelength light-emitting diode (LED) light sources that cover the spectral region from the ultraviolet (UV) to the infrared (IR).29 The CD-3 features two charged couple device (CCD) cameras that provide the user with the ability to view samples in real time and capture images and videos of the suspect samples being screened. One camera operates in the UV-visible (UV-Vis) spectral region, and the second camera operates in the IR spectral region. It can be battery or mains powered, and a separate digital handheld microscope can be used to examine suspect samples at higher magnifications. The batteries will last between 3 and 8 hours depending on the intensity of use. The LEDs are used to illuminate a sample at user-selected wavelengths (375 and 470 nm) and enable the user to directly visualize product differences using either CCD camera. To put it in terms of a traditional spectrometer (e.g., NIR spectroscope), the LEDs are the light source, and the user's eye is the CD-3 detector. No x–y spectral data are generated or saved with the CD-3. The light from the LEDs interacts with the inks and tablet colors on sample packaging and dosage form surfaces. What the user's eye observes are differences between the suspect dosage form and packaging and an authentic drug. The visual differences observed can take the form of changes in colors, shading, contrast, fluorescence, or a combination of all of these changes. The CD-3 can be used (Figure 2) to verify the presence or absence of overt/covert markings on the packaging. The differences observed in the suspect sample can be attributed to chemical differences between the products (e.g., differences in active ingredient and excipients), colors used in the coatings, or packaging materials (e.g., cellulose materials used in boxes and outserts, inks, print type, etc.). Differences between suspect and authentic dosage forms are readily observed through blister packages, facilitating rapid product screening. The greater the number of visual differences observed using the CD-3 in a suspect sample compared with an authentic sample, the stronger the evidence that the product is counterfeit. The device captures jpeg images at 96 dots per inch (DPI) resolution. Dimensions of each captured image are 720 × 576 pixels (width × length) at 24-bit color depth. At these parameters, each captured image averages a file size of approximately 75 Kb. The device storage is an 8-GB (upgradable to 32 GB) flash drive that can hold approximately 107,000 CD-3 images. The drive is accessible using a personal computer through a Universal Serial Bus (USB) cable connection. Files can be uploaded to the drive or downloaded from the drive.


Evaluation of a new handheld instrument for the detection of counterfeit artesunate by visual fluorescence comparison.

Ranieri N, Tabernero P, Green MD, Verbois L, Herrington J, Sampson E, Satzger RD, Phonlavong C, Thao K, Newton PN, Witkowski MR - Am. J. Trop. Med. Hyg. (2014)

The CD-3 current generation of the instrument.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4228888&req=5

Figure 1: The CD-3 current generation of the instrument.
Mentions: The CD-3 is a compact (15.2 × 7.6 cm; 300 g) handheld electronic tool (Figure 1) with multiple single wavelength light-emitting diode (LED) light sources that cover the spectral region from the ultraviolet (UV) to the infrared (IR).29 The CD-3 features two charged couple device (CCD) cameras that provide the user with the ability to view samples in real time and capture images and videos of the suspect samples being screened. One camera operates in the UV-visible (UV-Vis) spectral region, and the second camera operates in the IR spectral region. It can be battery or mains powered, and a separate digital handheld microscope can be used to examine suspect samples at higher magnifications. The batteries will last between 3 and 8 hours depending on the intensity of use. The LEDs are used to illuminate a sample at user-selected wavelengths (375 and 470 nm) and enable the user to directly visualize product differences using either CCD camera. To put it in terms of a traditional spectrometer (e.g., NIR spectroscope), the LEDs are the light source, and the user's eye is the CD-3 detector. No x–y spectral data are generated or saved with the CD-3. The light from the LEDs interacts with the inks and tablet colors on sample packaging and dosage form surfaces. What the user's eye observes are differences between the suspect dosage form and packaging and an authentic drug. The visual differences observed can take the form of changes in colors, shading, contrast, fluorescence, or a combination of all of these changes. The CD-3 can be used (Figure 2) to verify the presence or absence of overt/covert markings on the packaging. The differences observed in the suspect sample can be attributed to chemical differences between the products (e.g., differences in active ingredient and excipients), colors used in the coatings, or packaging materials (e.g., cellulose materials used in boxes and outserts, inks, print type, etc.). Differences between suspect and authentic dosage forms are readily observed through blister packages, facilitating rapid product screening. The greater the number of visual differences observed using the CD-3 in a suspect sample compared with an authentic sample, the stronger the evidence that the product is counterfeit. The device captures jpeg images at 96 dots per inch (DPI) resolution. Dimensions of each captured image are 720 × 576 pixels (width × length) at 24-bit color depth. At these parameters, each captured image averages a file size of approximately 75 Kb. The device storage is an 8-GB (upgradable to 32 GB) flash drive that can hold approximately 107,000 CD-3 images. The drive is accessible using a personal computer through a Universal Serial Bus (USB) cable connection. Files can be uploaded to the drive or downloaded from the drive.

Bottom Line: Two hundred three samples of the oral antimalarial artesunate were compared with authentic products using the CD-3 by a trainer and two trainees.Interobserver agreement for 203 samples of artesunate was 100%.The CD-3 holds promise as a relatively inexpensive and easy to use instrument for field evaluation of medicines, potentially empowering drug inspectors, customs agents, and pharmacists.

View Article: PubMed Central - PubMed

Affiliation: Forensic Chemistry Center, US Food and Drug Administration, Cincinnati, Ohio; Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic; Worldwide Antimalarial Resistance Network (WWARN), Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom; Division of Parasitic Diseases and Malaria, Center for Disease Control, Atlanta, Georgia; Office of International Programs, Office of Global Regulatory Operations and Policy, US Food and Drug Administration, Silver Spring, Maryland; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Bureau of Food and Drug Inspection (BFDI), Ministry of Health, Government of the Lao People's Democratic Republic, Vientiane, Lao People's Democratic Republic; Food and Drug Quality Control Centre (FDQCC), Ministry of Health, Government of the Lao People's Democratic Republic, Vientiane, Lao People's Democratic Republic Nicola.Ranieri@fda.hhs.gov paul@tropmedres.ac.

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