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Point of care assay for blood aripiprazole concentrations: development, validation and utility

Published online by Cambridge University Press:  31 May 2023

Matthew Atkins Open the ORCID record for Matthew Atkins [Opens in a new window] ,
David Taylor Open the ORCID record for David Taylor [Opens in a new window] ,
Ana Catalan ,
Neville Desouza ,
Edward Chesney Open the ORCID record for Edward Chesney [Opens in a new window] ,
Thomas J. Reilly ,
Irina Baburina ,
Mary Rose Hilaire ,
Luiz Dratcu Open the ORCID record for Luiz Dratcu [Opens in a new window]  and
Robert Harland
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Matthew Atkins*
Affiliation:
MSc, Pharmacy Department, Maudsley Hospital, South London and Maudsley NHS Foundation Trust, London, UK; and Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK
David Taylor
Affiliation:
PhD, Pharmacy Department, Maudsley Hospital, South London and Maudsley NHS Foundation Trust, London, UK; and Institute of Pharmaceutical Science, King's College London, UK
Ana Catalan
Affiliation:
PhD, Department of Psychiatry, Biocruces Bizkaia Health Research Institute, Barakaldo, Spain; Osakidetza Basque Health Service, Department of Psychiatry, Basurto University Hospital, Bilbao, Spain; and Facultad de Medicina y Odontología, University of the Basque Country UPV/EHU, Leioa, Spain
Neville Desouza
Affiliation:
MSc, Pharmacy Department, Maudsley Hospital, South London and Maudsley NHS Foundation Trust, London, UK
Edward Chesney
Affiliation:
Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK; and South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK
Thomas J. Reilly
Affiliation:
South London and Maudsley NHS Foundation Trust, London, UK; Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK; and Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, UK
Irina Baburina
Affiliation:
PhD, Saladax Biomedical, Inc., Bethlehem, Pennsylvania, USA
Mary Rose Hilaire
Affiliation:
PhD, Saladax Biomedical, Inc., Bethlehem, Pennsylvania, USA
Luiz Dratcu
Affiliation:
FRCPsych, South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK
Robert Harland
Affiliation:
MRCPsych, South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK
Salvatore J. Salamone
Affiliation:
PhD, Saladax Biomedical, Inc., Bethlehem, Pennsylvania, USA
Philip McGuire
Affiliation:
FMedSci, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK; and NIHR Oxford Health Biomedical Research Centre, Oxford, UK
*
Correspondence: Matthew Atkins. Email: matthew.atkins@some.ox.ac.uk
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Abstract

Background

The antipsychotic aripiprazole is often used in the treatment of first-episode psychosis. Measuring aripiprazole blood levels provides an objective measure of treatment adherence, but this currently involves taking a venous blood sample and sending to a laboratory for analysis.

Aims

To detail the development, validation and utility of a new point of care (POC) test for finger-stick capillary blood concentrations of aripiprazole.

Method

Analytical performance (sensitivity, precision, recovery and linearity) of the assay were established using spiked whole blood and control samples of varying aripiprazole concentration. Assay validation was performed over a 14-month period starting in July 2021. Eligible patients were asked to provide a finger-stick capillary sample in addition to their usual venous blood sample. Capillary blood samples were tested by the MyCare™ Insite POC analyser, which provided measurement of aripiprazole concentration in 6 min, and the venous blood sample was tested by the standard laboratory method.

Results

A total of 101 patients agreed to measurements by the two methods. Venous blood aripiprazole concentrations as assessed by the laboratory method ranged from 17 to 909 ng/mL, and from 1 to 791 ng/mL using POC testing. The correlation coefficient between the two methods (r) was 0.96 and there was minimal bias (slope 0.91, intercept 4 ng/ml).

Conclusions

The MyCare Insite POC analyser is sufficiently accurate and reliable for clinical use. The availability of this technology will improve the assessment of adherence to aripiprazole and the optimising of aripiprazole dosing.

Keywords

Aripiprazoleschizophreniacapillary blood samplefinger stickpoint of care
Type
Paper
Information
The British Journal of Psychiatry , Volume 223 , Issue 2 , August 2023 , pp. 389 - 393
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Copyright
Copyright © The Author(s), 2023. Published by Cambridge University Press on behalf of the Royal College of Psychiatrists

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References

Gómez-Revuelta, M, Pelayo-Terán, JM, Juncal-Ruiz, M, Vázquez-Bourgon, J, Suárez-Pinilla, P, Romero-Jiménez, R, et al. Antipsychotic treatment effectiveness in first episode of psychosis: PAFIP 3-year follow-up randomized clinical trials comparing haloperidol, olanzapine, risperidone, aripiprazole, quetiapine, and ziprasidone. Int J Neuropsychopharmacol 2020; 23: 217–29.CrossRefGoogle ScholarPubMed
Stroup, TS, McEvoy, JP, Ring, KD, Hamer, RH, LaVange, LM, Swartz, MS, et al. A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP). Am J Psychiatry 2011; 168: 947–56.CrossRefGoogle ScholarPubMed
Dufort, A, Zipursky, RB. Understanding and managing treatment adherence in schizophrenia. Clin Schizophr Relat Psychoses [Epub ahead of print] 3 Jan 2019. PMID: 30605043.CrossRefGoogle ScholarPubMed
Olfson, M, Mechanic, D, Hansell, S, Boyer, CA, Walkup, J, Weiden, PJ. Predicting medication noncompliance after hospital discharge among patients with schizophrenia. Psychiatr Serv 2000; 51: 216–22.CrossRefGoogle ScholarPubMed
Jackson, H, McGorry, P. The Recognition and Management of Early Psychosis: A Preventive Approach. Cambridge University Press, 2009.CrossRefGoogle Scholar
Almond, S, Knapp, M, Francois, C, Toumi, M, Brugha, T. Relapse in schizophrenia: costs, clinical outcomes and quality of life. Br J Psychiatry 2005; 184: 346–51.CrossRefGoogle Scholar
Haddad, P, Brain, C, Scott, J. Nonadherence with antipsychotic medication in schizophrenia: challenges and management strategies. Patient Relat Outcome Meas 2014; 5: 43–62.10.2147/PROM.S42735CrossRefGoogle ScholarPubMed
Lam, WY, Fresco, P. Medication adherence measures: an overview. Biomed Res Int 2015; 2015: 217047.10.1155/2015/217047CrossRefGoogle ScholarPubMed
Qi, Y, Liu, G. Ultra-performance liquid chromatography-tandem mass spectrometry for simultaneous determination of antipsychotic drugs in human plasma and its application in therapeutic drug monitoring. Drug Des Devel Ther 2021; 15: 463–79.10.2147/DDDT.S290963CrossRefGoogle ScholarPubMed
Bogers, JP, Bui, H, Herruer, M, Cohen, D. Capillary compared to venous blood sampling in clozapine treatment: patients' and healthcare practitioners' experiences with a point-of-care device. Eur Neuropsychopharmacol 2015; 25: 319–24.CrossRefGoogle ScholarPubMed
Taylor, D, Atkins, M, Harland, R, Baburina, I, MacCabe, JH, Salamone, SJ, et al. Point-of-care measurement of clozapine concentration using a finger-stick blood sample. J Psychopharmacol 2021; 35: 279–83.CrossRefGoogle ScholarPubMed
Atkins, M, Taylor, D, Harland, D, Brewer, A, Williams, S, Chesney, E, et al. Acceptability of point of care testing for antipsychotic medication levels in schizophrenia. J.Psycom 2022; 2(4): 100070.Google Scholar
Cline, DJ, Zhang, H, Lundell, GD, Harney, RL, Riaz, HK, Jarrah, J, et al. Development and evaluation of a nanoparticle-based immunoassay for determining paclitaxel concentrations on routine clinical analyzers. Ther Drug Monit 2013; 35(6): 809–15.CrossRefGoogle ScholarPubMed
Hiemke, C, Bergemann, N, Clement, HW, Conca, A, Deckert, J, Domschke, K, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017. Pharmacopsychiatry 2018; 51(1–2): e1.Google ScholarPubMed
Clinical and Laboratory Standards Institute. Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline – Second Edition (CLSI Document EP05-A3). CLSI, 2014.Google Scholar
Clinical and Laboratory Standards Institute. Evaluation of Linearity of Quantitative Measurement Procedures; Approved Guideline – 2nd Edition (CLSI Document EP06). CLSI, 2020.Google Scholar
Clinical and Laboratory Standards Institute. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition (CLSI Document EP17-A2). CLSI, 2012.Google Scholar
Clinical and Laboratory Standards Institute. Interference Testing in Clinical Chemistry – 3rd edn (CLSI Guideline EP07). CLSI, 2018.Google Scholar
Hastedt, MR, Baselt, C. Disposition of toxic drugs and chemicals in man, 10th edition. Forensic Sci Med Pathol 2015; 11: 147.CrossRefGoogle Scholar
Fisher, DS, van Schalkwyk, GI, Seedat, S, Curran, SR, Flanagan, RJ. Plasma, oral fluid, and whole-blood distribution of antipsychotics and metabolites in clinical samples. Ther Drug Monit 2013; 35: 345–51.CrossRefGoogle ScholarPubMed
Vogeser, M, Seger, C. A decade of HPLC–MS/MS in the routine clinical laboratory — goals for further developments. Clin Biochem 2008; 41: 649–62.CrossRefGoogle ScholarPubMed
Martin, RF. General Deming regression for estimating systematic bias and its confidence interval in method-comparison studies. Clin Chem 2000; 46: 100–4.CrossRefGoogle ScholarPubMed
Giavarina, D. Understanding Bland Altman analysis. Biochem Med (Zagreb) 2015; 25: 141–51.10.11613/BM.2015.015CrossRefGoogle ScholarPubMed
Meyer, JM, Stahl, SM. The Clinical Use of Antipsychotic Plasma Levels: Stahl's Handbooks. Cambridge University Press, 2021.CrossRefGoogle Scholar
McCutcheon, R, Beck, K, Bloomfield, MA, Marques, TR, Rogdaki, M, Howes, OD. Treatment resistant or resistant to treatment? Antipsychotic plasma levels in patients with poorly controlled psychotic symptoms. J Psychopharmacol 2015; 29: 892–7.CrossRefGoogle ScholarPubMed
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