Development of a certified reference material for anti-β2-glycoprotein I IgG - commutability studies.
autoimmune testing
certified reference materials
harmonization
proteinase 3
standardization
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
01 10 2020
01 10 2020
Historique:
received:
29
06
2020
accepted:
16
09
2020
pubmed:
2
10
2020
medline:
22
9
2021
entrez:
1
10
2020
Statut:
epublish
Résumé
In this paper, we describe the steps followed for the development of a certified reference material for immunoglobulin G antibodies against β2-glycoprotein I (also known as apolipoprotein H). These steps include processing of the material, commutability, the impact of dilution, the appropriate reconstitution conditions, homogeneity and stability during transport and storage. We analysed 69 clinical samples from patients suffering from antiphospholipid syndrome with several commercial enzyme-linked immunosorbent assays (ELISA) purchased from in vitro diagnostic manufacturers. Analysis of the results indicated that the candidate reference material can be safely freeze-dried, and that the user should carefully follow the reconstitution instructions as small changes in e.g. temperature may have unwanted effects. The statistical analysis of the commutability studies indicated that the analytical response of the reference material upon dilution is similar to that of clinical samples, and that correlation between results may differ from assay to assay. Finally yet importantly, the presented and developed candidate reference material is commutable for most assays tested, homogeneous and stable. Immunoglobulin G antibodies against β2-glycoprotein I are associated with a higher risk of thrombosis and pregnancy complications. Their measurement is essential for the diagnosis and monitoring of antiphospholipid syndrome. These antibodies are detected by specific immunoassays, routinely used in clinical diagnostics, but various of these methods show enormous variability, in part due to the lack of a reference material.
Identifiants
pubmed: 33001848
doi: 10.1515/cclm-2020-0995
pii: cclm-2020-0995
doi:
Substances chimiques
Immunoglobulin G
0
beta 2-Glycoprotein I
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
325-332Références
Brusch, A. The significance of anti-beta-2-glycoprotein I antibodies in antiphospholipid syndrome. Antibodies 2016;5:16. https://doi.org/10.3390/antib5020016.
Cohen, D, Berger, SP, Steup-Beekman, GM, Bloemenkamp, KWM, Bajema, IM. Diagnosis and management of the antiphospholipid syndrome. BMJ 2010;340:c2541. https://doi.org/10.1136/bmj.c155.
Miyakis, S, Lockshin, MD, Atsumi, T, Branch, DW, Brey, RL, Cervera, R, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemostasis 2006;4:295–306. https://doi.org/10.1111/j.1538-7836.2006.01753.x.
Chighizola, CB, Raimondo, MG, Meroni, PL. Management of thrombotic antiphospholipid syndrome. Semin Thromb Hemost 2018;44:419–26. https://doi.org/10.1055/s-0036-1597282.
Chamley, LW, McKay, EJ, Pattison, NS. Cofactor dependent and cofactor independent anticardiolipin antibodies. Thromb Res 1991;61:291–9. https://doi.org/10.1016/0049-3848(91)90106-7.
Monogioudi, E, Martos, G, Hutu Dana, P, Schimmel, H, Meroni Pier, L, Sheldon, J, et al. Standardization of autoimmune testing – is it feasible? Clin Chem Lab Med 2018;25;56:1734–42. https://doi.org/10.1515/cclm-2017-1077.
Miller, WG, Schimmel, H, Rej, R, Greenberg, N, Ceriotti, F, Burns, C, et al. IFCC working group recommendations for assessing commutability part 1: general experimental design. Clin Chem 2018;64:447–54. https://doi.org/10.1373/clinchem.2017.277525.
Vesper, H, Emons, H, Gnezda, M, Jain, CP, Miller, WG, Rej, R, et al. C53-A – characterization and qualification of commutable reference materials for laboratory medicine – approved guideline. CLSI IFCC 2010;30.
Miller, WG, Myers, GL, Rej, R. Why commutability matters. Clin Chem 2006;52:553–4. https://doi.org/10.1373/clinchem.2005.063511.
Van Blerk, M, Van Campenhout, C, Bossuyt, X, Duchateau, J, Humbel, R, Servais, G, et al. Current practices in antinuclear antibody testing: results from the Belgian external quality assessment scheme. Clin Chem Lab Med 2009;47:102–8. https://doi.org/10.1515/cclm.2009.021.
Meroni, PL, Biggioggero, M, Pierangeli, SS, Sheldon, J, Zegers, I, Borghi, MO. Standardization of autoantibody testing: a paradigm for serology in rheumatic diseases. Nat Rev Rheumatol 2014;10:35–43. https://doi.org/10.1038/nrrheum.2013.180.
Dawson, B, Trapp, RG. Research questions about relationships among variables. In: Dawson, B, Trapp, RG, editors Basic & clinical biostatistics, 4th ed. USA, McGraw-Hill Companies, Inc; 2004.
Zegers, I, Schreiber, W, Sheldon, J, Blirup-Jensen, S, Muñoz, A, Merlini, G, et al. Certification of proteins in the human serum – certified reference material ERM®-DA470k/IFCC. Luxembourg: Office for Official Publications of the European Communities; 2008. Report nr EUR 23431 EN. Available from: https://web.jrc.ec.europa.eu/rmcatalogue/detailsrmcatalogue.do?referenceMaterial=DA470k.
Kutteh, WH, Franklin, RD. Assessing the variation in antiphospholipid antibody (APA) assays: comparison of results from 10 centers. Am J Obstet Gynecol 2004;191:440–8. https://doi.org/10.1016/j.ajog.2004.03.010.
Hutu, DP, Tuddenham, E, Monogioudi, E, Meroni, P, Schimmel, H, Sheldon, J, et al. First steps in the standardization of immunoglobulin IgG myeloperoxidase-anti-neutrophil cytoplasmic antibody measurements. Clin Exp Immunol 2016;183:193–205. https://doi.org/10.1111/cei.12707.
Monogioudi, E, Hutu, DP, Martos, G, Sheldon, J, Schimmel, H, Meroni, PL, et al. Development of a certified reference material for myeloperoxidase-anti-neutrophil cytoplasmic autoantibodies (MPO-ANCA). Clin Chim Acta 2017;467:48–50. https://doi.org/10.1016/j.cca.2016.05.031.
Merlini, G, Blirup-Jensen, S, Johnson, AM, Sheldon, J, Zegers, I. Standardizing plasma protein measurements worldwide: a challenging enterprise. Clin Chem Lab Med 2010;48:1567–75. https://doi.org/10.1515/cclm.2010.314.