ArticlePLoS neglected tropical diseases2021
Laboratory evaluation of twelve portable devices for medicine quality screening.
Article in PLoS neglected tropical diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 24 citations in OpenAlex.
- Article
- Relationship between Prices and Quality of Essential Medicines from Different Manufacturers Collected in Cameroon, the Democratic Republic of the Congo, and Nigeria.The American journal of tropical medicine and hygiene · 2024Article
- Quality of Essential Medicines from Different Sources in Enugu and Anambra, Nigeria.The American journal of tropical medicine and hygiene · 2024Article
- Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel.Journal of pharmaceutical policy and practice · 2024Article
- Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study.PloS one · 2023Article
- Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance.PloS one · 2023Article
- Portable NIR spectroscopy: the route to green analytical chemistry.Frontiers in chemistry · 2023Review
- An open-source smartphone app for the quantitative evaluation of thin-layer chromatographic analyses in medicine quality screening.Scientific reports · 2022Article
- Surveillance for substandard and falsified medicines by local faith-based organizations in 13 low- and middle-income countries using the GPHF Minilab.Scientific reports · 2022Article
- Evaluation of portable devices for medicine quality screening: Lessons learnt, recommendations for implementation, and future priorities.PLoS medicine · 2021Article
- A comparative field evaluation of six medicine quality screening devices in Laos.PLoS neglected tropical diseases · 2021Article
- Implementation of field detection devices for antimalarial quality screening in Lao PDR-A cost-effectiveness analysis.PLoS neglected tropical diseases · 2021Article
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Authors and funding
9 authors at 2 institutions in 3 countries.
Funding
Abstract
backgroundPost-market surveillance is a key regulatory function to prevent substandard and falsified (SF) medicines from being consumed by patients. Field deployable technologies offer the potential for rapid objective screening for SF medicines. METHODS AND
findingsWe evaluated twelve devices: three near infrared spectrometers (MicroPHAZIR RX, NIR-S-G1, Neospectra 2.5), two Raman spectrometers (Progeny, TruScan RM), one mid-infrared spectrometer (4500a), one disposable colorimetric assay (Paper Analytical Devices, PAD), one disposable immunoassay (Rapid Diagnostic Test, RDT), one portable liquid chromatograph (C-Vue), one microfluidic system (PharmaChk), one mass spectrometer (QDa), and one thin layer chromatography kit (GPHF-Minilab). Each device was tested with a series of field collected medicines (FCM) along with simulated medicines (SIM) formulated in a laboratory. The FCM and SIM ranged from samples with good quality active pharmaceutical ingredient (API) concentrations, reduced concentrations of API (80% and 50% of the API), no API, and the wrong API. All the devices had high sensitivities (91.5 to 100.0%) detecting medicines with no API or the wrong API. However, the sensitivities of each device towards samples with 50% and 80% API varied greatly, from 0% to 100%. The infrared and Raman spectrometers had variable sensitivities for detecting samples with 50% and 80% API (from 5.6% to 50.0%). The devices with the ability to quantitate API (C-Vue, PharmaChk, QDa) had sensitivities ranging from 91.7% to 100% to detect all poor quality samples. The specificity was lower for the quantitative C-Vue, PharmaChk, & QDa (50.0% to 91.7%) than for all the other devices in this study (95.5% to 100%).
conclusionsThe twelve devices evaluated could detect medicines with the wrong or none of the APIs, consistent with falsified medicines, with high accuracy. However, API quantitation to detect formulations similar to those commonly found in substandards proved more difficult, requiring further technological innovation.
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