The diagnostic accuracy of the hand-held Raman spectrometer for the identification of anti-malarial drugs

Visser, Benjamin J.; Vries, Sophia G. de; Bache, Emmanuel B.; Meerveld-Gerrits, Janneke; Kroon, Daniëlle; Boersma, Jimmy; Agnandji, Selidji Todagbé; Vugt, Michèle van; Grobusch, Martin P.

doi:10.1186/s12936-016-1212-y

Cited by 17 publications

(21 citation statements)

References 37 publications

(44 reference statements)

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“…The NanoRam (B&W Tek) showed 100% sensitivity and 96% specificity (against TLC, with HPLC used to confirm samples which failed TLC) in the investigation of 289 antimalarial samples (including 24 falsified and 22 experimental ‘wrong API fakes’ containing paracetamol). 43 44 …”

Section: Resultsmentioning

confidence: 99%

“…Almost 30% (n=114) of antimalarials collected in one study could not undergo Raman analysis because the authentic comparators could not be obtained by the investigators. 43 Discussion on industry standards for spectra file format and transferability between devices using the same technology will be important.…”

Section: Discussionmentioning

confidence: 99%

“…We found only two studies in which the Standards for Reporting Diagnostic Accuracy studies were followed. 43 48 Standardised guidance on how to assess and compare the performance of screening devices would be of great benefit. A recent article from the US Pharmacopoeial Convention addresses this.…”

Section: Discussionmentioning

confidence: 99%

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Field detection devices for screening the quality of medicines: a systematic review

et al. 2018

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BackgroundPoor quality medicines have devastating consequences. A plethora of innovative portable devices to screen for poor quality medicines has become available, leading to hope that they could empower medicine inspectors and enhance surveillance. However, information comparing these new technologies is woefully scarce.MethodsWe undertook a systematic review of Embase, PubMed, Web of Science and SciFinder databases up to 30 April 2018. Scientific studies evaluating the performances/abilities of portable devices to assess any aspect of the quality of pharmaceutical products were included.ResultsForty-one devices, from small benchtop spectrometers to ‘lab-on-a-chip’ single-use devices, with prices ranging from US$20 000, were included. Only six devices had been field-tested (GPHF-Minilab, CD3/CD3+, TruScan RM, lateral flow dipstick immunoassay, CBEx and Speedy Breedy). The median (range) number of active pharmaceutical ingredients (APIs) assessed per device was only 2 (1–20). The majority of devices showed promise to distinguish genuine from falsified medicines. Devices with the potential to assay API (semi)-quantitatively required consumables and were destructive (GPHF-Minilab, PharmaChk, aPADs, lateral flow immunoassay dipsticks, paper-based microfluidic strip and capillary electrophoresis), except for spectroscopic devices. However, the 10 spectroscopic devices tested for their abilities to quantitate APIs required processing complex API-specific calibration models. Scientific evidence of the ability of the devices to accurately test liquid, capsule or topical formulations, or to distinguish between chiral molecules, was limited. There was no comment on cost-effectiveness and little information on where in the pharmaceutical supply chain these devices could be best deployed.ConclusionAlthough a diverse range of portable field detection devices for medicines quality screening is available, there is a vitally important lack of independent evaluation of the majority of devices, particularly in field settings. Intensive research is needed in order to inform national medicines regulatory authorities of the optimal choice of device(s) to combat poor quality medicines.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Field detection devices for screening the quality of medicines: a systematic review

et al. 2018

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“…Over the past decade, there have been numerous reports detailing the use of Raman spectroscopy to screen for drugs , and more recently a very few exploratory studies investigated the identification of NPS . The identification of NPS aimed at risk assessment and drug control poses a great analytical challenge, due to the wide number of NPS already identified, the presence of adulterants in them, or the presence of NPS themselves as adulterants added to traditional drugs (e.g.…”

Section: Introductionmentioning

confidence: 99%

On‐site identification of psychoactive drugs by portable Raman spectroscopy during drug‐checking service in electronic music events

Gerace¹,

Seganti²,

Luciano³

et al. 2019

Drug and Alcohol Review

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Introduction and Aims. Hundreds of new psychoactive substances (NPS) have burst into the marketplace, making both the scientific community and people who use drugs lacking of adequate information about their diffusion and effects. In this scenario, drug-checking services have been recently proposed to assist harm reduction policies and provide a global description of the circulating drugs. Design and Methods. The results obtained by a portable Raman spectroscopy device on 472 alleged drugs within the first formal implementation of drug checking in Italy, are reported. The testing was made through a plastic bag held by the applicant and containing the alleged drug. The substance identification was executed by comparison with a spectral library. Results. Illicit substances were detected in 304 samples. Findings included MDMA (106 samples), ketamine (87 samples), cocaine (51 samples), amphetamine (47 samples), methamphetamine (two samples), heroin (two samples) and NPS (nine samples). Two samples were identified as precursors of psychoactive substances. Identification of a noncontrolled substance occurred in 38 samples. Output of inconclusive result was recorded from 128 samples tested on-site, from which the applicant allowed us to collect a small portion in 68 cases, for a delayed laboratory analysis by GC-MS or LC-MS/MS. Discussion and Conclusions. Drug checking by Raman spectroscopy proved effective to identify psychoactive drugs including NPS and track the drug distribution in various recreational settings. The field testing activity revealed the presence of several NPS in the nightlife scenario, often in replacement of traditional illicit drugs, thus posing a high overdose risk and a life-threatening situation. [Gerace E, Seganti F, Luciano C, Lombardo T, Di Corcia D, Teifel H, Vincenti M, Salomone A. On-site identification of psychoactive drugs by portable Raman spectroscopy during drug-checking service in electronic music events. Drug Alcohol Rev 2019;38:50-56]

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“…6 , 7 Its use has been supported by the WHO and the United States Pharmacopeia Drug Quality Information program. 6 , 7 In light of its widespread use, even as the reference test to evaluate the diagnostic accuracy of a handheld Raman spectrometer, 8 several studies have investigated the performance reliability of the Minilab. 7 , 9 – 15 Most of these studies focused mainly on anti-malarial drugs 9 , 10 , 12 , 14 , 15 and few studies on other antimicrobials.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials

Pan

Ba-Thein

2018

The American Journal of Tropical Medicine and Hygiene

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Abstract.Global Pharma Health Fund (GPHF) Minilab™, a semi-quantitative thin-layer chromatography (TLC)–based commercially available test kit, is widely used in drug quality surveillance globally, but its diagnostic accuracy is unclear. We investigated the diagnostic accuracy of Minilab system for antimicrobials, using high-performance liquid chromatography (HPLC) as reference standard. Following the Minilab protocols and the Pharmacopoeia of the People’s Republic of China protocols, Minilab-TLC and HPLC were used to test five common antimicrobials (506 batches) for relative concentration of active pharmaceutical ingredients. The prevalence of poor-quality antimicrobials determined, respectively, by Minilab TLC and HPLC was amoxicillin (0% versus 14.9%), azithromycin (0% versus 17.4%), cefuroxime axetil (14.3% versus 0%), levofloxacin (0% versus 3.0%), and metronidazole (0% versus 38.0%). The Minilab TLC had false-positive and false-negative detection rates of 2.6% (13/506) and 15.2% (77/506) accordingly, resulting in the following test characteristics: sensitivity 0%, specificity 97.0%, positive predictive value 0, negative predictive value 0.8, positive likelihood ratio 0, negative likelihood ratio 1.0, diagnostic odds ratio 0, and adjusted diagnostic odds ratio 0.2. This study demonstrates unsatisfying diagnostic accuracy of Minilab system in screening poor-quality antimicrobials of common use. Using Minilab as a stand-alone system for monitoring drug quality should be reconsidered.

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The diagnostic accuracy of the hand-held Raman spectrometer for the identification of anti-malarial drugs

Cited by 17 publications

References 37 publications

Field detection devices for screening the quality of medicines: a systematic review

Field detection devices for screening the quality of medicines: a systematic review

On‐site identification of psychoactive drugs by portable Raman spectroscopy during drug‐checking service in electronic music events

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials

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