Comparison of two extractable nuclear antigen testing algorithms: ALBIA versus ELISA/line immunoassay

Dinusha Chandratilleke; Roger Silvestrini; Sue Culican; David Campbell; Karen Byth-Wilson; Sanjay Swaminathan; Ming-Wei Lin

doi:10.1016/j.pathol.2016.04.004

Comparison of two extractable nuclear antigen testing algorithms: ALBIA versus ELISA/line immunoassay

Pathology. 2016 Aug;48(5):491-7. doi: 10.1016/j.pathol.2016.04.004. Epub 2016 Jun 14.

Authors

Dinusha Chandratilleke¹, Roger Silvestrini², Sue Culican², David Campbell², Karen Byth-Wilson³, Sanjay Swaminathan⁴, Ming-Wei Lin⁵

Affiliations

¹ Department of Immunopathology, ICPMR, Westmead Hospital, Westmead, NSW, Australia; Faculty of Medicine, University of Sydney, Sydney, NSW, Australia. Electronic address: cdinusha@gmail.com.
² Department of Immunopathology, ICPMR, Westmead Hospital, Westmead, NSW, Australia.
³ Research and Education Network, Westmead Hospital, Westmead, NSW, Australia.
⁴ Department of Immunopathology, ICPMR, Westmead Hospital, Westmead, NSW, Australia; Faculty of Medicine, University of Sydney, Sydney, NSW, Australia; Faculty of Medicine, Western Sydney University, Sydney, NSW, Australia.
⁵ Department of Immunopathology, ICPMR, Westmead Hospital, Westmead, NSW, Australia; Faculty of Medicine, University of Sydney, Sydney, NSW, Australia.

PMID: 27316331
DOI: 10.1016/j.pathol.2016.04.004

Abstract

Extractable nuclear antigen (ENA) antibody testing is often requested in patients with suspected connective tissue diseases. Most laboratories in Australia use a two step process involving a high sensitivity screening assay followed by a high specificity confirmation test. Multiplexing technology with Addressable Laser Bead Immunoassay (e.g., FIDIS) offers simultaneous detection of multiple antibody specificities, allowing a single step screening and confirmation. We compared our current diagnostic laboratory testing algorithm [Organtec ELISA screen / Euroimmun line immunoassay (LIA) confirmation] and the FIDIS Connective Profile. A total of 529 samples (443 consecutive+86 known autoantibody positivity) were run through both algorithms, and 479 samples (90.5%) were concordant. The same autoantibody profile was detected in 100 samples (18.9%) and 379 were concordant negative samples (71.6%). The 50 discordant samples (9.5%) were subdivided into 'likely FIDIS or current method correct' or 'unresolved' based on ancillary data. 'Unresolved' samples (n = 25) were subclassified into 'potentially' versus 'potentially not' clinically significant based on the change to clinical interpretation. Only nine samples (1.7%) were deemed to be 'potentially clinically significant'. Overall, we found that the FIDIS Connective Profile ENA kit is non-inferior to the current ELISA screen/LIA characterisation. Reagent and capital costs may be limiting factors in using the FIDIS, but potential benefits include a single step analysis and simultaneous detection of dsDNA antibodies.

Keywords: ALBIA; ELISA; ENA; FIDIS; characterisation; connective tissue disease; line immunoassay; multiplex; screening.

Publication types

Comparative Study

MeSH terms

Algorithms*
Antigens, Nuclear / analysis*
Antigens, Nuclear / immunology
Autoantibodies / blood*
Autoantigens / analysis
Autoantigens / immunology
Connective Tissue Diseases / diagnosis
Enzyme-Linked Immunosorbent Assay
Humans
Immunoassay / methods*

Substances

Antigens, Nuclear
Autoantibodies
Autoantigens