Laboratory evaluation of twelve portable devices for medicine quality screening
Background Post-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 findings We evaluated twelve devices: t...
| Huvudupphovsmän: | , , , , , , , , |
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| Materialtyp: | Journal article |
| Språk: | English |
| Publicerad: |
Public Library of Science
2021
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| _version_ | 1826307894061039616 |
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| author | Zambrzycki, SC Caillet, C Vickers, S Bouza, M Donndelinger, DV Geben, LC Bernier, MC Newton, PN Fernández, FM |
| author_facet | Zambrzycki, SC Caillet, C Vickers, S Bouza, M Donndelinger, DV Geben, LC Bernier, MC Newton, PN Fernández, FM |
| author_sort | Zambrzycki, SC |
| collection | OXFORD |
| description | Background
Post-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 findings
We 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%).
Conclusions
The 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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| first_indexed | 2024-03-07T07:09:52Z |
| format | Journal article |
| id | oxford-uuid:d8946cc7-2380-483b-aa08-68b98e02a2fa |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:09:52Z |
| publishDate | 2021 |
| publisher | Public Library of Science |
| record_format | dspace |
| spelling | oxford-uuid:d8946cc7-2380-483b-aa08-68b98e02a2fa2022-06-14T10:48:50ZLaboratory evaluation of twelve portable devices for medicine quality screeningJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:d8946cc7-2380-483b-aa08-68b98e02a2faEnglishSymplectic ElementsPublic Library of Science2021Zambrzycki, SCCaillet, CVickers, SBouza, MDonndelinger, DVGeben, LCBernier, MCNewton, PNFernández, FMBackground Post-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 findings We 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%). Conclusions The 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. |
| spellingShingle | Zambrzycki, SC Caillet, C Vickers, S Bouza, M Donndelinger, DV Geben, LC Bernier, MC Newton, PN Fernández, FM Laboratory evaluation of twelve portable devices for medicine quality screening |
| title | Laboratory evaluation of twelve portable devices for medicine quality screening |
| title_full | Laboratory evaluation of twelve portable devices for medicine quality screening |
| title_fullStr | Laboratory evaluation of twelve portable devices for medicine quality screening |
| title_full_unstemmed | Laboratory evaluation of twelve portable devices for medicine quality screening |
| title_short | Laboratory evaluation of twelve portable devices for medicine quality screening |
| title_sort | laboratory evaluation of twelve portable devices for medicine quality screening |
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