Evidence map›Paper›PMID 37943382›Full record

Observational studyDigestive diseases and sciences2024

Performance of a New Rapid Point-of-Care Test for Infliximab Levels in Patients with Inflammatory Bowel Disease: A Comparison to ELISA.

Teresa Valdés-Delgado, Alicia Aguado-Paredes, Vicente Merino-Bohórquez, Jesús Martín-Manzanares, María Mercedes Alonso, Belén Maldonado, Luisa Castro, María Belvis, Beatriz Benítez, Ángel Caunedo and 2 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.8field-weighted citation impact, top 6% 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

4 citing papers in PubMed, 12 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

12 authors at 1 institution in 1 country.

Teresa Valdés-DelgadoGastroenterology Department, Hospital Universitario Virgen Macarena, C/Dr. Fedriani, 3, 41009, Seville, Spain.
Alicia Aguado-ParedesPharmacy Department, Hospital Universitario Virgen Macarena, Seville, Spain.
Vicente Merino-BohórquezPharmacy Department, Hospital Universitario Virgen Macarena, Seville, Spain.
Jesús Martín-ManzanaresNursing, Hospital Virgen Universitario Virgen Macarena y de Sán Lázaro, Seville, Spain.
María Mercedes AlonsoNursing, Hospital Virgen Universitario Virgen Macarena y de Sán Lázaro, Seville, Spain.
Belén MaldonadoGastroenterology Department, Hospital Universitario Virgen Macarena, C/Dr. Fedriani, 3, 41009, Seville, Spain.
Luisa CastroGastroenterology Department, Hospital Universitario Virgen Macarena, C/Dr. Fedriani, 3, 41009, Seville, Spain.
María BelvisGastroenterology Department, Hospital Universitario Virgen Macarena, C/Dr. Fedriani, 3, 41009, Seville, Spain.
Beatriz BenítezGastroenterology Department, Hospital Universitario Virgen Macarena, C/Dr. Fedriani, 3, 41009, Seville, Spain.
Ángel CaunedoGastroenterology Department, Hospital Universitario Virgen Macarena, C/Dr. Fedriani, 3, 41009, Seville, Spain.
Miguel Ángel CallejaPharmacy Department, Hospital Universitario Virgen Macarena, Seville, Spain.
Federico Argüelles-AriasGastroenterology Department, Hospital Universitario Virgen Macarena, C/Dr. Fedriani, 3, 41009, Seville, Spain. farguelles1@us.es.ORCID http://orcid.org/0000-0003-3646-8919
Hospital Universitario Virgen Macarena · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTherapeutic drug monitoring of infliximab levels in patients with inflammatory bowel disease (IBD) optimizes patients' treatment. The reference technique is based on enzyme-linked immunosorbent assay (ELISA) although point of care (POC) assays are being developed.

aimsTo assess the performance of a new rapid immunochromatographic POC assay (Promonitor Quick IFX) compared with ELISA technique to measure infliximab levels in patients with IBD.

methodsA prospective, observational, unicentric study was performed on capillary blood samples from patients with IBD before infliximab infusion (trough levels). Infliximab levels and anti-infliximab antibodies were measured using the ELISA technique (Promonitor IFX) and the POC assay. Correlation between both techniques was assessed by Pearson's coefficient. Quantitative differences were evaluated by Bland-Altman analysis. Samples were stratified according to infliximab therapeutic ranges (< 3 μg/mL, 3-8 μg/mL, and > 8 μg/mL).

resultsA total of 135 experimental samples were assessed. Infliximab levels showed a high correlation between POC and ELISA tests (r = 0.84, P < 0.001). The mean difference between tests was 1.46 μg/mL (P < 0.001), being minimal for concentrations < 8 μg/mL. POC and ELISA assays showed an overall concordance of 87.4%. Most samples were in the same therapeutic range, which lead to equivalent therapeutic decisions. POC and ELISA assays detected the presence of anti-infliximab antibodies in 2.2% and 3.7% of the samples, respectively.

conclusionsPOC assay results in blood samples from patients with IBD were comparable to those obtained with the reference ELISA technique. The POC assay could be considered for routine testing based on its ease of use and rapidity.

Indexed as

Inflammatory Bowel DiseasesDrug MonitoringEnzyme-Linked Immunosorbent AssayGastrointestinal AgentsHumansInfliximabPoint-of-Care TestingProspective StudiesGastrointestinal AgentsInfliximabELISAInflammatory bowel diseaseInfliximabPoint-of-careTherapeutic drug monitoring

Identifiers

PMID37943382
PMCPMC10787688
OpenAlexW4388539950

What OpenQuestion holds

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LicenceCC BY-NC
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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.