Evidence map›Paper›PMID 37757461›Full record

ArticleThe Journal of antimicrobial chemotherapy2023

Development and validation of a bioanalytical assay for the measurement of total and unbound teicoplanin in human serum.

J W A Mouton, J Raaijmakers, M Botterblom, M Toonen, R Ter Heine, R L Smeets, R J M Brüggemann, L Te Brake, N G L Jager

Open access · hybridAbstract read
In one paragraph

Article in The Journal of antimicrobial chemotherapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 19% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Observational
  5. Article
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 1 institution in 1 country.

J W A MoutonDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0009-0005-3925-9161
J RaaijmakersDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0001-7250-5647
M BotterblomDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
M ToonenDepartment of Laboratory Medicine, Radboudumc Laboratory for Diagnostics, Radboud University Medical Centre, Nijmegen, The Netherlands.
R Ter HeineDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
R L SmeetsDepartment of Laboratory Medicine, Radboudumc Laboratory for Diagnostics, Radboud University Medical Centre, Nijmegen, The Netherlands.
R J M BrüggemannDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-7618-725X
L Te BrakeDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
N G L JagerDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-4524-9892
Radboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe glycopeptide teicoplanin is considered first-line treatment for severe infections caused by Gram-positive bacteria. Individualized treatment of teicoplanin is gaining interest. As only protein-unbound drug is pharmacologically active, a sensitive assay measuring unbound and total teicoplanin is indispensable for pharmacological research and dose optimization.

objectivesTo develop and validate a UPLC-MS/MS method to quantify unbound and total teicoplanin in human serum.

methodsThe developed assay was validated according to the ICH guideline M10 on Bioanalytical Method Validation and study sample analysis. Unbound teicoplanin was obtained by ultrafiltration. The assay was cross-validated with a quantitative microsphere (QMS) immunoassay in a side-by-side comparison using 40 patient samples.

resultsWith the developed and validated method, all main teicoplanin components (A2-1, A2-2/A2-3, A2-4/A2-5 and A3-1) can be quantified. Total run time was 5.5 min. Concentration range was 2.5-150 mg/L for total and 0.1-25 mg/L for unbound teicoplanin. Precision (coefficient of variation) and accuracy (bias) of total teicoplanin were 5.97% and 107%, respectively, and 7.17% and 108%, respectively, for unbound teicoplanin.Bland-Altman analysis showed total concentrations measured with the UPLC-MS/MS method were equivalent to the results of the QMS immunoassay. A total of 188 samples from 30 patients admitted to the ICU and haematology department were measured; total concentrations ranged between 2.92 and 98.5 mg/L, and unbound concentrations ranged between 0.37 and 30.7 mg/L.

conclusionsThe developed method provided rapid, precise and accurate measurement of unbound and total teicoplanin. The developed method is now routinely applied in pharmacological research and clinical practice.

Indexed as

Tandem Mass SpectrometryTeicoplaninChromatography, LiquidGlycopeptidesHumansGlycopeptidesTeicoplanin

Identifiers

PMID37757461
PMCPMC10631822
OpenAlexW4387080621

What OpenQuestion holds

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Registered trials

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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.