Evidence map›Paper›PMID 34820661›Full record

ArticleJournal of mass spectrometry and advances in the clinical lab2021

Validation of a simple liquid chromatography coupled to tandem mass spectrometry method for the simultaneous determination of tacrolimus, sirolimus, everolimus and cyclosporin A in dried matrix on paper discs.

Ignacio Guillermo Bressán, María Isabel Giménez, Susana Francisca Llesuy

Open access · goldAbstract read
In one paragraph

Article in Journal of mass spectrometry and advances in the clinical lab, 2021. 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
1.1field-weighted citation impact, top 25% 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, 14 citations in OpenAlex.

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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

3 authors at 2 institutions in 1 country.

Ignacio Guillermo BressánLaboratory of Mass Spectrometry, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
María Isabel GiménezLaboratory of Mass Spectrometry, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Susana Francisca LlesuyDepartment of Chemistry, Instituto Universitario Escuela de Medicina del Hospital Italiano, Buenos Aires, Argentina.
Hospital Italiano de Buenos Aires · ARInstituto Universitario Hospital Italiano · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDue to its high specificity and sensitivity, liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) is the gold standard method for immunosuppressant quantification in therapeutic drug monitoring. In this context, dried blood spots (DBS) have become a promising strategy as a sample collection procedure. Although the advantages of DBS over venipuncture are well known, this approach has limitations that strongly influence the acceptance of analytical results. Among them, the most important is hematocrit (Ht). The easiest way of overcoming this problem is by analyzing complete spots. In this strategy, called dried matrix on paper discs (DMPD), blood is volumetrically applied on pre-punched discs.

objectivesTo validate an LC-MS/MS method for the quantification of tacrolimus, sirolimus, everolimus and cyclosporin A using DMPD.

methodsThe procedure was validated according to international guidelines using a commercial kit. The following performance parameters were evaluated: selectivity, carryover, linearity, accuracy, precision, lower limit of quantitation, relative recovery, commutability and stability. In addition, a method comparison study was performed to evaluate the clinical influence of Ht on the results.

resultsAll performance parameters were within acceptance criteria and, hence, it was determined that the validated method is fit for the intended purpose. Likewise, calculated bias values on medical decision levels showed that there was no clinical influence of Ht on the results.

conclusionUnlike other similar methodologies that have been published, here, a simple method has been fully validated. This is the first LC-MS/MS methodology adapting a commercial kit to use DMPD as a sampling strategy.

Indexed as

C0, Pre-dose trough concentrationC2, 2-hour post-dose concentrationCS, Calibration standardCV%, Coefficient of variationDBS, Dried blood spotsDMPS, Dried matrix on paper discsDried matrix on paper discs (DMPD)ESI+, Positive electrospray source ionization modeHematocritHt, HematocritICb95%, 95% confidence interval for interceptsICm95%, 95% confidence interval for slopesImmunosuppressantsLC-MS/MS, Liquid chromatography coupled to tandem mass spectrometryLiquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)LLOQ, Lower limit of quantitationLSS, Limited sampling strategyMethod comparison[M+NH4]+, Ammoniated adductmTOR, Mechanistic target of RapamycinPCDBS, Pre-cut dried blood spotsPDBS, Perforated dried blood spotsPIs, Prediction intervalsQC, Quality control samplesRE%, Percentage of the relative errorR%, Relative recoveryZnSO4·7H2O, Zinc sulfate heptahydrate

Identifiers

PMID34820661
PMCPMC8601012
OpenAlexW3126167663

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.