Title: International standards for IgG and IgM anti-β2glycoprotein antibody measurement
Authors: WILLIS RohanGROSSI ClaudiaBORGHI Maria OriettaMARTOS SEVILLA GUSTAVOZEGERS IngridSHELDON JoannaMERONI Pierluigi
Citation: LUPUS vol. 23 no. 12 p. 1317-1319
Publisher: SAGE PUBLICATIONS LTD
Publication Year: 2014
JRC N°: JRC90876
ISSN: 0961-2033
URI: http://lup.sagepub.com/content/23/12/1317
http://dx.doi.org/10.1177/0961203314544535
http://publications.jrc.ec.europa.eu/repository/handle/JRC90876
DOI: 10.1177/0961203314544535
Type: Articles in periodicals and books
Abstract: International standards for anti-beta2 glycoprotein I (anti-beta2GPI) testing are needed. We evaluated the suitability of polyclonal/monoclonal candidate reference materials (RM) for the assay. IgG/IgM anti-beta2GPI were affinity-purified (AP) from high-positive antiphospholipid syndrome sera and IgG from HCAL clone supernatant. Igs were tested for purity by SDSPAGE, pooled, concentrated, sterile-filtered and the protein concentration determined. One unit was defined as the binding activity of 1 microgram/ml of AP anti-beta2GPI Ig. IgG/IgM RM were each assigned a unit value using the respective AP material as a calibrator. Polyclonal/monoclonal RM and 30 samples were evaluated for linearity, unit equivalency and commutability. Polyclonal AP material was assigned a value of 100 U IgG and 15U IgM anti-beta2GPI, respectively. IgG-RM had a value of 270 IgG and the IgM-RM of 220.3 IgM anti-beta2GPI U. The linearity (R2) of each RM curve for the various assays ranged from 0.96 to 0.99. Commutability samples fit very well within 95% prediction intervals and had excellent correlation when comparing assays. IgG and IgM polyclonal and IgG monoclonal RM displayed excellent linearity and commutability, being good candidates for better standardization of anti-beta2GPI immunoassays.
JRC Directorate:Health, Consumers and Reference Materials

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