Laboratory evaluation of twelve portable devices for medicine quality screening.

<h4>Background</h4>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.<h4>Methods and findings<...

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Autores principales:	Stephen C Zambrzycki, Celine Caillet, Serena Vickers, Marcos Bouza, David V Donndelinger, Laura C Geben, Matthew C Bernier, Paul N Newton, Facundo M Fernández
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/1b4cae14dc04440d863eba3cc2483985
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spelling	oai:doaj.org-article:1b4cae14dc04440d863eba3cc24839852021-12-02T20:24:00ZLaboratory evaluation of twelve portable devices for medicine quality screening.1935-27271935-273510.1371/journal.pntd.0009360https://doaj.org/article/1b4cae14dc04440d863eba3cc24839852021-09-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009360https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>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.<h4>Methods and findings</h4>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%).<h4>Conclusions</h4>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.Stephen C ZambrzyckiCeline CailletSerena VickersMarcos BouzaDavid V DonndelingerLaura C GebenMatthew C BernierPaul N NewtonFacundo M FernándezPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 9, p e0009360 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Stephen C Zambrzycki Celine Caillet Serena Vickers Marcos Bouza David V Donndelinger Laura C Geben Matthew C Bernier Paul N Newton Facundo M Fernández Laboratory evaluation of twelve portable devices for medicine quality screening.
description	<h4>Background</h4>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.<h4>Methods and findings</h4>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%).<h4>Conclusions</h4>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.
format	article
author	Stephen C Zambrzycki Celine Caillet Serena Vickers Marcos Bouza David V Donndelinger Laura C Geben Matthew C Bernier Paul N Newton Facundo M Fernández
author_facet	Stephen C Zambrzycki Celine Caillet Serena Vickers Marcos Bouza David V Donndelinger Laura C Geben Matthew C Bernier Paul N Newton Facundo M Fernández
author_sort	Stephen C Zambrzycki
title	Laboratory evaluation of twelve portable devices for medicine quality screening.
title_short	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_sort	laboratory evaluation of twelve portable devices for medicine quality screening.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/1b4cae14dc04440d863eba3cc2483985
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Laboratory evaluation of twelve portable devices for medicine quality screening.

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