Evidence map›Paper›PMID 24909561›Full record

ArticleJournal of the International AIDS Society2014

Evaluation of an immunoassay for determination of plasma efavirenz concentrations in resource-limited settings.

Alemseged Abdissa, Lubbe Wiesner, Helen McIlleron, Henrik Friis, Ase Bengård Andersen, Pernille Kaestel

Open access · goldAbstract readEvaluation Study
In one paragraph

Article in Journal of the International AIDS Society, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 38% 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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. 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

6 authors at 4 institutions in 3 countries.

Alemseged AbdissaDepartment of Medical Laboratory Sciences & Pathology, Jimma University, Jimma, Ethiopia; Department of Infectious Diseases, Odense University Hospital, Odense, Denmark; alemseged.abdisssa@ju.edu.et.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine and Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Helen McIlleronDivision of Clinical Pharmacology, Department of Medicine and Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Henrik FriisDepartment of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.
Ase Bengård AndersenDepartment of Infectious Diseases, Odense University Hospital, Odense, Denmark.
Pernille KaestelDepartment of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.
Odense University Hospital · DKUniversity of Cape Town · ZAUniversity College Copenhagen · DKUniversity of Copenhagen · DK

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

introductionTherapeutic drug monitoring (TDM) may improve antiretroviral efficacy through adjustment of individual drug administration. This could result in reduced toxicity, prevent drug resistance, and aid management of drug-drug interactions. However, most measurement methods are too costly to be implemented in resource-limited settings. This study evaluated a commercially available immunoassay for measurement of plasma efavirenz.

methodsThe immunoassay-based method was applied to measure efavirenz using a readily available Humastar 80 chemistry analyzer. We compared plasma efavirenz concentrations measured by the immunoassay with liquid chromatography tandem mass spectrometry (LC-MS/MS) (reference method) in 315 plasma samples collected from HIV patients on treatment. Concentrations were categorized as suboptimal<1 µg/ml, normal 1-4 µg/ml or high>4 µg/ml. Agreement between results of the methods was assessed via Bland-Altman plot and κ statistic values.

resultsThe median Interquartile range (IQR) efavirenz concentration was 2.8 (1.9; 4.5) µg/ml measured by the LC-MS/MS method and 2.5 (1.8; 3.9) µg/ml by the immunoassay and the results were well correlated (ρ=0.94). The limits of agreement assessed by Bland-Altman plots were -2.54; 1.70 µg/ml. Although immunoassay underestimated high concentrations, it had good agreement for classification into low, normal or high concentrations (K=0.74).

conclusionsThe immunoassay is a feasible alternative to determine efavirenz in areas with limited resources. The assay provides a reasonable approximation of efavirenz concentration in the majority of samples with a tendency to underestimate high concentrations. Agreement between tests evaluated in this study was clinically satisfactory for identification of low, normal and high efavirenz concentrations.

Indexed as

AlkynesAnti-HIV AgentsBenzoxazinesChromatography, LiquidCyclopropanesHIV InfectionsHumansImmunoenzyme TechniquesTandem Mass SpectrometryAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenzantiretroviral therapyefavirenzimmunoassayLC–MS/MSmethod evaluationTDM

Identifiers

PMID24909561
PMCPMC4049128
OpenAlexW2084717294

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.