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Assessment of the effectiveness of the CD3+ tool to detect counterfeit and substandard anti-malarials

Overview of attention for article published in Malaria Journal, February 2016
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Title
Assessment of the effectiveness of the CD3+ tool to detect counterfeit and substandard anti-malarials
Published in
Malaria Journal, February 2016
DOI 10.1186/s12936-016-1180-2
Pubmed ID
Authors

JaCinta S. Batson, Daniel K. Bempong, Patrick H. Lukulay, Nicola Ranieri, R. Duane Satzger, Leigh Verbois

Abstract

The 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(®). A 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. CD3+ 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. The 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.

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 45 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 45 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 8 18%
Student > Ph. D. Student 5 11%
Researcher 3 7%
Lecturer 2 4%
Other 2 4%
Other 4 9%
Unknown 21 47%
Readers by discipline Count As %
Pharmacology, Toxicology and Pharmaceutical Science 10 22%
Medicine and Dentistry 4 9%
Biochemistry, Genetics and Molecular Biology 2 4%
Engineering 2 4%
Chemistry 2 4%
Other 5 11%
Unknown 20 44%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 27 February 2016.
All research outputs
#18,444,553
of 22,852,911 outputs
Outputs from Malaria Journal
#5,049
of 5,573 outputs
Outputs of similar age
#216,732
of 298,590 outputs
Outputs of similar age from Malaria Journal
#151
of 173 outputs
Altmetric has tracked 22,852,911 research outputs across all sources so far. This one is in the 11th percentile – i.e., 11% of other outputs scored the same or lower than it.
So far Altmetric has tracked 5,573 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.8. This one is in the 4th percentile – i.e., 4% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 298,590 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 15th percentile – i.e., 15% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 173 others from the same source and published within six weeks on either side of this one. This one is in the 5th percentile – i.e., 5% of its contemporaries scored the same or lower than it.