Laboratory evaluation of twelve portable devices for medicine quality screening

Stephen C. Zambrzycki; Celine Caillet; Serena Vickers; Marcos Bouza; David V. Donndelinger; Laura C. Geben; Matthew C. Bernier; Paul N. Newton; Facundo M. Fernández

doi:10.1371/journal.pntd.0009360

Laboratory evaluation of twelve portable devices for medicine quality screening

Stephen C. Zambrzycki, Celine Caillet, Serena Vickers, Marcos Bouza, David V. Donndelinger, Laura C. Geben, Matthew C. Bernier, Paul N. Newton, Facundo M. Fernández

Research output: Contribution to journal › Article › peer-review

14 Scopus citations

Abstract

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 chromato-graph (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 labo-ratory. 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, requir-ing further technological innovation.

Original language	English
Article number	e0009360
Journal	PLoS Neglected Tropical Diseases
Volume	15
Issue number	9
DOIs	https://doi.org/10.1371/journal.pntd.0009360
State	Published - Sep 2021
Externally published	Yes

Funding

This work has been co-funded by the Regional Malaria and other Communicable Disease Threats Trust Fund, which has been co-financed by the Government of Australia (Department of Foreign Affairs and Trade); the Government of Canada (Department of Foreign Affairs, Trade and Development); and the Government of the United Kingdom (Department for International Development). The grant ( RETA 8763 ) was managed by the Asian Development Bank (https:// www.adb.org/) and awarded to PNN. Additional support was provided by Wellcome Trust Grant N˚ 202935/Z/16/Z (https://wellcome.org/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. For the purpose of Open Access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.

Funders	Funder number
Communicable Disease Threats Trust Fund
Department of Foreign Affairs, Trade and Development
Regional Malaria
Wellcome Trust	N˚ 202935/Z/16/Z
Government of the United Kingdom
Government of Canada
Department for International Development, UK Government	RETA 8763
Department of Foreign Affairs and Trade, Australian Government

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title = "Laboratory evaluation of twelve portable devices for medicine quality screening",

abstract = "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 chromato-graph (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 labo-ratory. 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, requir-ing further technological innovation.",

author = "Zambrzycki, {Stephen C.} and Celine Caillet and Serena Vickers and Marcos Bouza and Donndelinger, {David V.} and Geben, {Laura C.} and Bernier, {Matthew C.} and Newton, {Paul N.} and Fern{\'a}ndez, {Facundo M.}",

note = "Publisher Copyright: {\textcopyright} 2021 Zambrzycki et al.",

year = "2021",

month = sep,

doi = "10.1371/journal.pntd.0009360",

language = "English",

volume = "15",

journal = "PLoS Neglected Tropical Diseases",

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T1 - Laboratory evaluation of twelve portable devices for medicine quality screening

AU - Zambrzycki, Stephen C.

AU - Caillet, Celine

AU - Vickers, Serena

AU - Bouza, Marcos

AU - Donndelinger, David V.

AU - Geben, Laura C.

AU - Bernier, Matthew C.

AU - Newton, Paul N.

AU - Fernández, Facundo M.

PY - 2021/9

Y1 - 2021/9

N2 - 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 chromato-graph (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 labo-ratory. 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, requir-ing further technological innovation.

AB - 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 chromato-graph (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 labo-ratory. 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, requir-ing further technological innovation.

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Laboratory evaluation of twelve portable devices for medicine quality screening

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