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

被引：36

作者：

Ranieri, Nicola ^{[1
]}

Tabernero, Patricia ^{[2
,3
,4
]}

Green, Michael D. ^{[5
]}

Verbois, Leigh ^{[6
]}

Herrington, James ^{[7
]}

Sampson, Eric ^{[5
,6
]}

Satzger, R. Duane ^{[1
]}

Phonlavong, Chindaphone ^{[8
]}

Thao, Khamxay ^{[9
]}

Newton, Paul N. ^{[2
,3
,4
]}

Witkowski, Mark R. ^{[1
]}

机构：

[1] US FDA, Forens Chem Ctr, Cincinnati, OH 45237 USA

[2] Mahosot Hosp, Microbiol Lab, Lao Oxford Mahosot Hosp Wellcome Trust Res Unit L, Viangchan, Laos

[3] Univ Oxford, Nuffield Dept Clin Med, Worldwide Antimalarial Resistance Network WWARN, Oxford, England

[4] Univ Oxford, Churchill Hosp, Nuffield Dept Clin Med, Ctr Trop Med, Oxford, England

[5] Ctr Dis Control & Prevent, Div Parasit Dis & Malaria, Atlanta, GA USA

[6] US FDA, Off Int Programs, Off Global Regulatory Operat & Policy, Silver Spring, MD USA

[7] NIH, Fogarty Int Ctr, Bethesda, MD 20892 USA

[8] Govt Lao Peoples Democrat Republ, BIDI, Minist Hlth, Viangchan, Laos

[9] Govern Lao PDR, FDQCC, Minist Hlth, Viangchan, Laos

来源：

AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE | 2014年 / 91卷 / 05期

基金：

英国惠康基金;

关键词：

OFFSET RAMAN-SPECTROSCOPY; ANTIMALARIAL TABLETS; FAKE ARTESUNATE; SOUTHEAST-ASIA; DRUGS; QUALITY; AUTHENTICATION; MEDICINES; CAMBODIA; AFRICA;

D O I：

10.4269/ajtmh.13-0644

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

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.

引用

页码：920 / 924

页数：5

共 29 条

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