Evidence map›Paper›PMID 26975570›Full record

ArticleMalaria journal2016

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

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

Open access · goldAbstract readEvaluation Study
In one paragraph

Article in Malaria journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 18 citations in OpenAlex.

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  7. Quality assessment of DiflucanMedicine access @ point of care
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 3 countries.

Benjamin J VisserDepartment of Infectious Diseases, Division of Internal Medicine, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.
Sophia G de VriesDepartment of Infectious Diseases, Division of Internal Medicine, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.
Emmanuel B BacheCentre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon.
Janneke Meerveld-GerritsDepartment of Infectious Diseases, Division of Internal Medicine, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.
Daniëlle KroonDepartment of Infectious Diseases, Division of Internal Medicine, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.
Jimmy BoersmaDepartment of Infectious Diseases, Division of Internal Medicine, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.
Selidji T AgnandjiCentre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon.
Michèle van VugtDepartment of Infectious Diseases, Division of Internal Medicine, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.
Martin P GrobuschDepartment of Infectious Diseases, Division of Internal Medicine, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. m.p.grobusch@amc.uva.nl.
Albert Schweitzer Hospital · GAAcademic Medical Center · NLCentre de Recherche Médicales de Lambaréné · GAPolpharma Biologics (Netherlands) · NLUniversity of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is a need for accurate and field-applicable instruments for the evaluation of the quality of anti-malarial drugs. The aim of this study was to determine the diagnostic accuracy of the NanoRam(®), a handheld Raman spectrometer (RS), to identify anti-malarial drugs.

methodsIn total, 289 anti-malarial drugs collected in a randomized field survey in Gabon were evaluated. The samples were compared with authentic products as supplied by the official manufacturer. To determine the sensitivity and specificity of the handheld NanoRam(®) spectrometer in the identification of anti-malarial drugs, a two-gate reversed-flow design was applied. The standards for reporting of diagnostic accuracy studies (STARD) were followed. The index test was the handheld RS. The reference test standards were thin layer chromatography and high performance liquid chromatography with ultraviolet photo diode array detection.

resultsThe sensitivity [95% confidence interval (95% CI)] and specificity of the RS to correctly identify an anti-malarial drug were 100% (95% CI 94.9-100%) and 96% (95% CI 92.3-99.0%), respectively. The RS could not differentiate between different batches of the same product or different manufacturers of the same product. Intra-observer agreement for 289 samples was 100%. The average time to conduct the RS was 15 s per sample compared to 45 min per sample for TLC.

conclusionThe handheld RS holds promise as an easy-to-use, quick and field-applicable instrument for the evaluation of quality of anti-malarial drugs, potentially empowering pharmacists, drug inspectors and medical regulatory authorities. Trial registration NTR4341 (Dutch Trial Registry).

Indexed as

AntimalarialsGabonPilot ProjectsSensitivity and SpecificitySpectrum AnalysisAntimalarialsArtemisinin combination therapy (ACT)Central AfricaCounterfeitDrug qualityFalsifiedField surveyGabonMalariaMEDQUARGNanoRam®Raman spectroscopySensitivitySpecificity

Identifiers

PMID26975570
PMCPMC4791808
OpenAlexW2296799530

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.