Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
-
Emilio J. Laserna-Mendieta
, Sara Salvador-Martín
, Laura Arias-González , Miriam Ruiz-Ponce , Luis A. Menchén , César Sánchez , Luis A. López-Fernández and Alfredo J. Lucendo
Abstract
Background
Therapeutic drug monitoring (TDM) of adalimumab (ADA) in inflammatory bowel diseases (IBDs) has gained increased attention since several studies showed a correlation between drug levels and mucosal healing. The limitations of routine usage of enzyme-linked immunoabsorbent assay (ELISA) kits for measuring serum ADA concentrations have prompted the development of rapid methods, such as Quantum Blue (QB). We evaluated the interchangeability and agreement between the QB method and two established ELISA kits, Promonitor (PM) and Lisa-Tracker (LT).
Methods
Fifty samples from patients with IBD were included. Quantitative analysis was performed using the ANOVA test for repeated measures, Deming regression and the Bland-Altman plot. Clinical implications were evaluated by concordance in classifying patients into therapeutic windows according to the proposed cut-off levels for subtherapeutic (either <5 or <7.5 μg/mL) and supratherapeutic (>12 μg/mL) ranges.
Results
Statistical differences were detected between the QB method and the two ELISA kits, with QB overestimating ADA serum values compared to them. A lack of interchangeability was observed between methods, with greater differences as ADA levels increased. An analysis of a sub-set of samples with ADA values below 9 μg/mL (n = 25) showed that QB fulfilled the criteria to be interchangeable with the LT assay. Concordance for patient classification into ADA therapeutic windows was better for QB vs. LT than for QB vs. PM, with high agreement (>75%) for subtherapeutic levels among the three methods.
Conclusions
Although quantitative differences existed between the rapid method and ELISA kits that hampered their interchangeability, the agreement for identifying patients with subtherapeutic values of ADA was high.
Acknowledgments
We are grateful to Melanie Radcliff for English language revision. EJ Laserna-Mendieta is recipient of a Rio Hortega grant (CM17/00003) from Instituto de Salud Carlos III (ISCIII), Spanish Ministry of Health, Social Services and Equality, which is partly funded by the European Social Fund (period 2014–2020). Sara Salvador-Martín was supported by a predoctoral fellowship from the Gregorio Marañón Health Research Institute. Laura Arias González is recipient of a post-doctoral research grant from Fundación Hospital Nacional de Parapléjicos (II-2018_05). Luis A. Menchén was supported by a grant (PI16/02096) from the Ministry of Economy and Competitiveness ISCIII-FIS. Luis A. López-Fernández was supported by a grant (PI16/00559) from the Ministry of Economy and Competitiveness ISCIII-FIS and PEJ16/MED/AI-1260 from the Consejería de Educación y Deporte de la Comunidad de Madrid. All funding from ISCIII was co-funded by European Regional Development Funds from the European Commission, “A way of making Europe”.
Author contribution: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: No specific funding was used to carry out this study. Palex Medical has generously provided half of the determinations performed in the present study for Quantum Blue ADA and Lisa-Tracker ADA.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interest: The funding organization played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2019 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- The re-emergence of dried blood spot sampling – are we ready?
- Review
- The role of platelets in bleeding in patients with thrombocytopenia and hematological disease
- Opinion Paper
- Exertional hematuria: definition, epidemiology, diagnostic and clinical considerations
- Guidelines and Recommendations from Scientific Societies
- A protocol for testing the stability of biochemical analytes. Technical document
- Genetics and Molecular Diagnostics
- Hereditary hyperferritinaemia-cataract syndrome (HHCS) – an underestimated condition: ferritin light chain variant spectrum in German families
- General Clinical Chemistry and Laboratory Medicine
- Performance of a web-based application measuring spot quality in dried blood spot sampling
- Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients
- Plasma and dried blood spot lysosphingolipids for the diagnosis of different sphingolipidoses: a comparative study
- Liquid biopsy of cerebrospinal fluid identifies neuronal pentraxin receptor (NPTXR) as a biomarker of progression of Alzheimer’s disease
- Integrity of serum samples is changed by modified centrifugation conditions
- Heparin and citrate additive carryover during blood collection
- Copeptin – a biomarker of short-term mortality risk (7 days) in patients with end-stage liver disease
- Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
- Measurement of α-dicarbonyl compounds in human saliva by pre-column derivatization HPLC
- Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
- Reference Values and Biological Variations
- A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach
- EGFR and EGFR ligands in serum in healthy women; reference intervals and age dependency
- Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks’ gestation in naturally conceived and uncomplicated pregnancies resulting in live births
- Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
- Hematology and Coagulation
- Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
- Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
- Cardiovascular Diseases
- Fast 0/1-h algorithm for detection of NSTEMI: are current high-sensitivity cardiac troponin assays fit for purpose? An EQA-based evaluation
- Infectious Diseases
- Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis – a pilot study
- Letters to the Editor
- Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example
- Molecular diagnosis of MODY3 permitted to reveal a de novo 12q24.31 deletion and to explain a complex phenotype in a young diabetic patient
- Increased C-reactive protein values in the absence of inflammation: monoclonal immunoglobulin interference in immunonephelometry
- An approach based on simulated hemolysis for establishing the hemolysis index threshold for high-sensitivity cardiac troponin T assay
- Utility of the icteric index for the management of bilirubin test requesting
- Quality control of monocyte volume and distribution width parameters of the Beckman Coulter DxH series
- Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
- Detection of a novel hemoglobin variant Hb Liaoning by matrix assisted laser desorption/ionization-time of flight mass spectrometry
- Appropriateness of repetitive therapeutic drug monitoring and laboratory turnaround time
- Congress Abstracts
- 51th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)