A comparative study between Near-Infrared (NIR) spectrometer and High-Performance Liquid Chromatography (HPLC) on the sensitivity and specificity

It is estimated that 10.5% of medicines in low- and middle-income countries are substandard or falsified (SF), causing approximately 1 million deaths annually. Over the past two decades, there have been significant technological advancements in low-cost, portable screening devices to detect poor-qua...

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Veröffentlicht in:	PloS one Jg. 20; H. 3; S. e0319523
Hauptverfasser:	Maffioli, Elisa M., Anyakora, Chimezie
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States Public Library of Science 25.03.2025 Public Library of Science (PLoS)
Schlagworte:	Algorithms Analgesics Analgesics - analysis Anti-Bacterial Agents - analysis Antibiotics Antihypertensives Antimalarials - analysis Antiparasitic agents Artificial intelligence Biology and Life Sciences Chromatography Chromatography, High Pressure Liquid - methods Comparative studies Computer and Information Sciences Counterfeit Drugs - analysis Counterfeiting Drug stores Engineering and Technology FDA approval High-performance liquid chromatography Human subjects Humans I.R. radiation Infrared analysis Infrared spectrometers Libraries Liquid chromatography Machine learning Medicine and Health Sciences Near infrared radiation Nigeria People and Places Pharmaceuticals Pharmacists Physical sciences Portable equipment Proprietary Public health Research and Analysis Methods Sensitivity Sensitivity analysis Sensitivity and Specificity Software Spectroscopy, Near-Infrared - methods Spectrum analysis Vitamins Nigeria
ISSN:	1932-6203, 1932-6203
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Abstract	It is estimated that 10.5% of medicines in low- and middle-income countries are substandard or falsified (SF), causing approximately 1 million deaths annually. Over the past two decades, there have been significant technological advancements in low-cost, portable screening devices to detect poor-quality medicines, which could be especially beneficial in these countries. The pharmaceutical market in Nigeria is valued at USD 4.5 billion and is growing at over 9% annually. However, SF medicines remain a major public health concern. We compared a novel Near-Infrared (NIR) Spectrometer with high-performance liquid chromatography (HPLC) by analyzing 246 drug samples purchased from retail pharmacies across the six geopolitical regions of Nigeria. We measured the sensitivity and specificity of a patented and Artificial Intelligence (AI) - powered handheld NIR spectrometer, which uses a proprietary machine-learning algorithm as well as hardware and software, across four categories of medicines: analgesics, antimalarials, antibiotics, and antihypertensives. Our findings reveal that the prevalence of SF medicines remains high, with 25% of samples failing the HPLC test. When tested with the NIR spectrometer, only a smaller subset of medicines—specifically analgesics—failed the test. Sensitivity and specificity for all medicines were 11% and 74%, respectively. For analgesics, the sensitivity was 37%, and the specificity was 47%. While these devices hold great potential, regulators should require more independent evaluations of various drug formulations before implementing them in real-world settings. Improving the sensitivity of these devices should be prioritized to ensure that no SF medicines reach patients.
AbstractList	It is estimated that 10.5% of medicines in low- and middle-income countries are substandard or falsified (SF), causing approximately 1 million deaths annually. Over the past two decades, there have been significant technological advancements in low-cost, portable screening devices to detect poor-quality medicines, which could be especially beneficial in these countries. The pharmaceutical market in Nigeria is valued at USD 4.5 billion and is growing at over 9% annually. However, SF medicines remain a major public health concern. We compared a novel Near-Infrared (NIR) Spectrometer with high-performance liquid chromatography (HPLC) by analyzing 246 drug samples purchased from retail pharmacies across the six geopolitical regions of Nigeria. We measured the sensitivity and specificity of a patented and Artificial Intelligence (AI) - powered handheld NIR spectrometer, which uses a proprietary machine-learning algorithm as well as hardware and software, across four categories of medicines: analgesics, antimalarials, antibiotics, and antihypertensives. Our findings reveal that the prevalence of SF medicines remains high, with 25% of samples failing the HPLC test. When tested with the NIR spectrometer, only a smaller subset of medicines—specifically analgesics—failed the test. Sensitivity and specificity for all medicines were 11% and 74%, respectively. For analgesics, the sensitivity was 37%, and the specificity was 47%. While these devices hold great potential, regulators should require more independent evaluations of various drug formulations before implementing them in real-world settings. Improving the sensitivity of these devices should be prioritized to ensure that no SF medicines reach patients. It is estimated that 10.5% of medicines in low- and middle-income countries are substandard or falsified (SF), causing approximately 1 million deaths annually. Over the past two decades, there have been significant technological advancements in low-cost, portable screening devices to detect poor-quality medicines, which could be especially beneficial in these countries. The pharmaceutical market in Nigeria is valued at USD 4.5 billion and is growing at over 9% annually. However, SF medicines remain a major public health concern. We compared a novel Near-Infrared (NIR) Spectrometer with high-performance liquid chromatography (HPLC) by analyzing 246 drug samples purchased from retail pharmacies across the six geopolitical regions of Nigeria. We measured the sensitivity and specificity of a patented and Artificial Intelligence (AI) - powered handheld NIR spectrometer, which uses a proprietary machine-learning algorithm as well as hardware and software, across four categories of medicines: analgesics, antimalarials, antibiotics, and antihypertensives. Our findings reveal that the prevalence of SF medicines remains high, with 25% of samples failing the HPLC test. When tested with the NIR spectrometer, only a smaller subset of medicines-specifically analgesics-failed the test. Sensitivity and specificity for all medicines were 11% and 74%, respectively. For analgesics, the sensitivity was 37%, and the specificity was 47%. While these devices hold great potential, regulators should require more independent evaluations of various drug formulations before implementing them in real-world settings. Improving the sensitivity of these devices should be prioritized to ensure that no SF medicines reach patients.It is estimated that 10.5% of medicines in low- and middle-income countries are substandard or falsified (SF), causing approximately 1 million deaths annually. Over the past two decades, there have been significant technological advancements in low-cost, portable screening devices to detect poor-quality medicines, which could be especially beneficial in these countries. The pharmaceutical market in Nigeria is valued at USD 4.5 billion and is growing at over 9% annually. However, SF medicines remain a major public health concern. We compared a novel Near-Infrared (NIR) Spectrometer with high-performance liquid chromatography (HPLC) by analyzing 246 drug samples purchased from retail pharmacies across the six geopolitical regions of Nigeria. We measured the sensitivity and specificity of a patented and Artificial Intelligence (AI) - powered handheld NIR spectrometer, which uses a proprietary machine-learning algorithm as well as hardware and software, across four categories of medicines: analgesics, antimalarials, antibiotics, and antihypertensives. Our findings reveal that the prevalence of SF medicines remains high, with 25% of samples failing the HPLC test. When tested with the NIR spectrometer, only a smaller subset of medicines-specifically analgesics-failed the test. Sensitivity and specificity for all medicines were 11% and 74%, respectively. For analgesics, the sensitivity was 37%, and the specificity was 47%. While these devices hold great potential, regulators should require more independent evaluations of various drug formulations before implementing them in real-world settings. Improving the sensitivity of these devices should be prioritized to ensure that no SF medicines reach patients.
Author	Maffioli, Elisa M. Anyakora, Chimezie
AuthorAffiliation	2 Bloom Public Health, No 4, Thabo Mbeki Close, Off TY Danjuma Street, Asokoro, Abuja, Nigeria and School of Science and Technology, Pan Atlantic University, Lagos, Nigeria Kampala International University - Western Campus, UGANDA 1 Department of Health Management and Policy, University of Michigan, School of Public Health, Washington Heights, Ann Arbor, Michigan, United States of America
AuthorAffiliation_xml	– name: 1 Department of Health Management and Policy, University of Michigan, School of Public Health, Washington Heights, Ann Arbor, Michigan, United States of America – name: Kampala International University - Western Campus, UGANDA – name: 2 Bloom Public Health, No 4, Thabo Mbeki Close, Off TY Danjuma Street, Asokoro, Abuja, Nigeria and School of Science and Technology, Pan Atlantic University, Lagos, Nigeria
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BackLink	https://www.ncbi.nlm.nih.gov/pubmed/40131989$$D View this record in MEDLINE/PubMed
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Cites_doi	10.1136/bmjgh-2022-008587 10.1371/journal.pone.0090601 10.1136/bmjgh-2018-000725 10.3390/medicina57050503 10.1371/journal.pntd.0009539 10.1038/s41467-023-41542-w 10.2471/BLT.19.249508 10.1371/journal.pone.0289865 10.7189/jogh.14.03029 10.1371/journal.pntd.0009360 10.1001/jamanetworkopen.2018.1662 10.1371/journal.pmed.1003747 10.1136/bmjopen-2013-002923 10.1016/S2214-109X(24)00442-X
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SubjectTerms	Algorithms Analgesics Analgesics - analysis Anti-Bacterial Agents - analysis Antibiotics Antihypertensives Antimalarials - analysis Antiparasitic agents Artificial intelligence Biology and Life Sciences Chromatography Chromatography, High Pressure Liquid - methods Comparative studies Computer and Information Sciences Counterfeit Drugs - analysis Counterfeiting Drug stores Engineering and Technology FDA approval High-performance liquid chromatography Human subjects Humans I.R. radiation Infrared analysis Infrared spectrometers Libraries Liquid chromatography Machine learning Medicine and Health Sciences Near infrared radiation Nigeria People and Places Pharmaceuticals Pharmacists Physical sciences Portable equipment Proprietary Public health Research and Analysis Methods Sensitivity Sensitivity analysis Sensitivity and Specificity Software Spectroscopy, Near-Infrared - methods Spectrum analysis Vitamins
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Title	A comparative study between Near-Infrared (NIR) spectrometer and High-Performance Liquid Chromatography (HPLC) on the sensitivity and specificity
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Volume	20
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