Evidence map›Paper›PMID 25551407›Full record

ArticleTherapeutic drug monitoring2015

An Automated Homogeneous Immunoassay for Quantitating Imatinib Concentrations in Plasma.

Jan H Beumer, Daniel Kozo, Rebecca L Harney, Caitlin N Baldasano, Justin Jarrah, Susan M Christner, Robert Parise, Irina Baburina, Jodi B Courtney, Salvatore J Salamone

Abstract readValidation Study
In one paragraph

Article in Therapeutic drug monitoring, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
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

10 authors at 1 institution in 1 country.

Jan H Beumer*Cancer Therapeutics Program, University of Pittsburgh Cancer Institute; †Department of Pharmaceutical Sciences, University of Pittsburgh School of Pharmacy; and ‡Research and Development, Saladax Biomedical, Inc, Bethlehem, Pennsylvania.
Daniel Kozo
Rebecca L Harney
Caitlin N Baldasano
Justin Jarrah
Susan M Christner
Robert Parise
Irina Baburina
Jodi B Courtney
Salvatore J Salamone
UPMC Hillman Cancer Center · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
NCI NIH HHS P30 CA047904NCI NIH HHS P30CA047904
6 · The paper itself

Abstract

backgroundImatinib pharmacokinetic variability and the relationship of trough concentrations with clinical outcomes have been extensively reported. Although physical methods to quantitate imatinib exist, they are not widely available for routine use. An automated homogenous immunoassay for imatinib has been developed, facilitating routine imatinib testing.

methodsImatinib-selective monoclonal antibodies, without substantial cross-reactivity to the N-desmethyl metabolite or N-desmethyl conjugates, were produced. The antibodies were conjugated to 200 nm particles to develop immunoassay reagents on the Beckman Coulter AU480 analyzer. These reagents were analytically validated using Clinical Laboratory Standards Institute protocols. Method comparison to liquid chromatography tandem mass spectrometry (LC-MS/MS) was conducted using 77 plasma samples collected from subjects receiving imatinib.

resultsThe assay requires 4 µL of sample without pretreatment. The nonlinear calibration curve ranges from 0 to 3000 ng/mL. With automated sample dilution, concentrations of up to 9000 ng/mL can be quantitated. The AU480 produces the first result in 10 minutes and up to 400 tests per hour. Repeatability ranged from 2.0% to 6.0% coefficient of variation, and within-laboratory reproducibility ranged from 2.9% to 7.4% coefficient of variation. Standard curve stability was 2 weeks and on-board reagent stability was 6 weeks. For clinical samples with imatinib concentrations from 438 to 2691 ng/mL, method comparison with LC-MS/MS gave a slope of 0.995 with a y-intercept of 24.3 and a correlation coefficient of 0.978.

conclusionsThe immunoassay is suitable for quantitating imatinib in human plasma, demonstrating good correlation with a physical method. Testing for optimal imatinib exposure can now be performed on routine clinical analyzers.

Indexed as

Antibodies, MonoclonalAutomationCalibrationChromatography, High Pressure LiquidHumansImatinib MesylateImmunoassayLimit of DetectionTandem Mass SpectrometryAntibodies, MonoclonalImatinib Mesylate

Identifiers

PMID25551407
PMCPMC4486633
OpenAlexW2319801894

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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.