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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Zusammenfassung: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.
Bibliographie:ObjectType-Article-1
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Competing Interests: The authors have declared that no competing interests exist.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0319523