title: Evaluation of a new handheld instrument for the detection of counterfeit artesunate by visual fluorescence comparison.
abstract: There is an urgent need for accurate and inexpensive handheld instruments for the evaluation of medicine quality in the field. A blinded evaluation of the diagnostic accuracy of the Counterfeit Detection Device 3 (CD-3), developed by the US Food and Drug Administration Forensic Chemistry Center, was conducted in the Lao People's Democratic Republic. Two hundred three samples of the oral antimalarial artesunate were compared with authentic products using the CD-3 by a trainer and two trainees. The specificity (95% confidence interval [95% CI]), sensitivity (95% CI), positive predictive value (95% CI), and negative predictive value (95% CI) of the CD-3 for detecting counterfeit (falsified) artesunate were 100% (93.8-100%), 98.4% (93.8-99.7%), 100% (96.2-100%), and 97.4% (90.2-99.6%), respectively. 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.
authors.forename: Nicola
authors.initials: N
authors.lastname: Ranieri
authors.forename: Patricia
authors.initials: P
authors.lastname: Tabernero
authors.forename: Michael D
authors.initials: MD
authors.lastname: Green
authors.forename: Leigh
authors.initials: L
authors.lastname: Verbois
authors.forename: James
authors.initials: J
authors.lastname: Herrington
authors.forename: Eric
authors.initials: E
authors.lastname: Sampson
authors.forename: R Duane
authors.initials: RD
authors.lastname: Satzger
authors.forename: Chindaphone
authors.initials: C
authors.lastname: Phonlavong
authors.forename: Khamxay
authors.initials: K
authors.lastname: Thao
authors.forename: Paul N
authors.initials: PN
authors.lastname: Newton
authors.forename: Mark R
authors.initials: MR
authors.lastname: Witkowski
mesh_terms: D000962:Antimalarials / Q000032:analysis*; D037621:Artemisinins / Q000032:analysis*; D000077332:Artesunate; D002851:Chromatography, High Pressure Liquid; D016001:Confidence Intervals; D058110:Counterfeit Drugs / Q000032:analysis*; D005453:Fluorescence; D007812:Laos; D008288:Malaria / Q000188:drug therapy; D061848:Optical Imaging / Q000295:instrumentation* / Q000379:methods; D012680:Sensitivity and Specificity
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D058110:Counterfeit Drugs; D000077332:Artesunate