ArticleMalaria journal2016
Assessment of the effectiveness of the CD3+ tool to detect counterfeit and substandard anti-malarials.
Article in Malaria journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Quality evaluation of cephalexin, cefuroxime, and ceftriaxone medicines marketed in Addis Ababa city, Ethiopia with three tier level approach and anti-microbial assays.BMC pharmacology & toxicology · 2025Article
- An open-source smartphone app for the quantitative evaluation of thin-layer chromatographic analyses in medicine quality screening.Scientific reports · 2022Article
- Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method.Malaria journal · 2019Article
- Regulatory framework in Pakistan: situation analysis of medicine quality and future recommendations.Journal of pharmaceutical policy and practice · 2019Review
- Global landscape assessment of screening technologies for medicine quality assurance: stakeholder perceptions and practices from ten countries.Globalization and health · 2018Article
- Field detection devices for screening the quality of medicines: a systematic review.BMJ global health · 2018Article
- Future Information Technology Tools for Fighting Substandard and Falsified Medicines in Low- and Middle-Income Countries.Frontiers in pharmacology · 2018Review
- Cost savings of paper analytical devices (PADs) to detect substandard and falsified antibiotics: Kenya case study.Medicine access @ point of careArticle
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe US FDA recently developed CD3+, a counterfeit detection tool that is based on sample illumination at specific wavelengths of light and visual comparison of suspect sample and packaging materials to an authentic sample. To test performance of the CD3+ in field conditions, a study was conducted in Ghana which compared the CD3+ side-by-side with two existing medicine quality screening technologies-TruScan™ Portable Raman spectrometer and GPHF Minilab(®).
methodsA total of 84 anti-malarial test samples comprising artemether-lumefantrine tablets and artesunate-amodiaquine tablets were used. The technologies were evaluated for sensitivity in determining counterfeit/substandard (The term counterfeit or falsified is used in this article to refer to medicines that carry a false representation of identity or source or both. The term substandard is used to refer to medicines that do not meet the quality specifications given in the accepted pharmacopeia.) medicines, specificity in determining authentic products, and reliability of the results. Authentic samples obtained from manufacturers were used as reference standards. HPLC analysis data was used as the "gold standard" for decisions regarding a sample being authentic or substandard/counterfeit.
resultsCD3+ had a sensitivity of 1.00 in detecting counterfeit/substandard products compared to Minilab (0.79) and TruScan (0.79). CD3+ had a lower specificity (0.53) in determining authentic products compared to the specificities reached by Minilab (0.99) and TruScan (1.00). High sensitivity in this context means that the technology is effective in identifying substandard/counterfeit products whereas the low specificity means that the technique can sometimes mischaracterize good products as substandard/counterfeit. Examination of dosage units only (and not packaging) using CD3+ yielded improved specificity 0.64. When only assessment of sample identification was done, the TruScan provided sensitivity (1.00) and specificity (0.99); and the Minilab provided sensitivity (1.00) and specificity (1.00). All three technologies demonstrated 100 % reliability when used to analyse the same set of samples over 3 days by a single analyst and also when used to determine the same set of samples by three different analysts. Eight of the field samples were confirmed to be counterfeits with no active pharmaceutical ingredient content. All three technologies identified these samples as counterfeits.
conclusionsThe study revealed the relative effectiveness of the technologies as quality control tools. Using a combination of CD3+, with either the Minilab or TruScan, to screen for medicine quality will allow for complete examination of both the dosage units and the packaging to decide whether it is authentic or counterfeit.
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