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Kim, Kim, Chang, Kim, and Lee: Agreement of three commercial anti-extractable nuclear antigen tests: EUROASSAY Anti-ENA Profile, Polycheck Autoimmune Test and FIDIS Connective Profile
Original Article

Kosin Medical Journal 2018;33(3):307-317.

Published online: 19 January 2018

DOI: https://doi.org/10.7180/kmj.2018.33.3.307

Agreement of three commercial anti-extractable nuclear antigen tests: EUROASSAY Anti-ENA Profile, Polycheck Autoimmune Test and FIDIS Connective Profile

Namhee Kim1, 2, In-Suk Kim1, 2, Chulhun L Chang1, 2, Hyung-Hoi Kim1, 3, Eun Yup Lee1, 3

1Department of Laboratory Medicine, School of Medicine, Pusan National University, Busan, Korea

2Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea

3Department of Laboratory Medicine, Pusan National University Hospital, Busan, Korea

Corresponding Author: In-Suk Kim, Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Geumo-ro, 50612 Mulgeum-eup, Yangsan-si, Korea Tel: +82-55-360-1870 Fax: +82-55-360-1880 E-mail: iskim0710@gmail.com

Received 16 December 20155 October 2016       Accepted 20 October 2016

Copyright © 2015 Kosin University School of Medicine Proceedings

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Detection of antibodies to extractable nuclear antigens (ENAs) is needed for the diagnosis in systemic autoimmune diseases. In this study, we compared three reagents using line immunoblot assay (LIA) or multiplex bead immunoassay for detecting the anti-ENAs.

Methods

A total of 89 sera were tested by 3 different assays: EUROASSAY Anti-ENA Profile (Euroimmune, Germany), Polycheck Autoimmune Test (Biocheck GmbH, Germany), and FIDIS™ Connective Profile (Biomedical Diagnostics, France). The following individual ENAs were investigated: Sm, SS-A (Ro), SS-B (La), Scl-70, Jo-1 and RNP. We reviewed medical records to investigate the discrepant results among three methods.

Results

Overall percent agreements were 96.1% between EUROASSAY Anti-ENA Profile and FIDIS™ Connective profile; 90.4% between EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test using the manufacturers’ cutoff; 96.4% between EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test using a upward cutoff; 90.4% between FIDIS™ Connective profile and Polycheck Autoimmune Test the manufacturers’ cutoff; and 96.4% between FIDIS™ Connective profile and Polycheck Autoimmune Test a upward cutoff.

Conclusions

The three assays showed excellent agreement with each other. With appropriate cutoff, the all three assays for six of the anti-ENA tests investigated in this study can be used in clinical laboratories for detecting the anti-ENAs.

Keywords: Anti-extractable nuclear antigen antibodies, Antinuclear antibodies, Autoimmunity

REFERENCES

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Table 1.
Comparison of the results for antibodies to extractable nuclear antigens by EUROASSAY Anti-ENA Profile and Polycheck Autoimmune Test (N = 89)
Cutoff of Polycheck Autoimmune Test = grade 1
Antigen Concordant results Discrepant results Concordance rate (%) Kappa coefficient (95% CI) P-value
EUROASSAY-/ Polycheck- EUROASSAY+/ Polycheck+ EUROASSAY-/ Polycheck+ EUROASSAY+/ Polycheck-
Sm 74 1 14 0 84.3 0.11 (-0.32-0.53) 0.027
SSA 57 22 8 2 88.8 0.74 (0.58-0.89) 0.000
SSB 67 5 17 0 80.9 0.31 (0.01-0.60) 0.000
scl-70 80 4 5 0 94.4 0.59 (0.24-0.94) 0.000
Jo-1 86 0 2 1 96.6 N/A N/A
nRNP 83 2 0 4 95.5 0.48 (-0.01-0.98) 0.000
Cutoff of Polycheck Autoimmune Test = grade 2
Antigen Concordant results Discrepant results Concordance rate (%) Kappa coefficient (95% CI) P-value
EUROASSAY-/ Polycheck- EUROASSAY+/ Polycheck+ EUROASSAY-/ Polycheck+ EUROASSAY+/ Polycheck-
Sm 85 1 3 0 96.6 0.39 (-0.29-1.07) 0.000
SSA 64 21 1 3 95.5 0.88 (0.77-0.99) 0.000
SSB 77 4 7 1 91.0 0.46 (0.10-0.82) 0.000
scl-70 84 4 1 0 98.9 0.88 (0.66-1.11) 0.000
Jo-1 88 0 0 1 98.9 N/A N/A
nRNP 83 2 0 4 95.5 0.48 (-0.01-0.98) 0.000

Abbreviations: CI, confidence interval; N/A, did not calculated; RNP, ribonucleic protein; Scl-70, scleroderma 70.

Table 2.
Comparison of the results for antibodies to extractable nuclear antigens by EUROASSAY Anti-ENA Profile and FIDIS Connective Profile (N = 89)
Antigen Concordant results Discrepant results Concordance rate (%) Kappa coefficient (95% CI) P-value
EUROASSAY-/ FIDIS EUROASSAY+/ FIDIS+ EUROASSAY-/ FIDIS+ EUROASSAY+/ FIDIS-
Sm 85 1 0 3 96.6 0.39 (-0.29-1.07) 0.000
SSA 61 19 6 3 89.9 0.74 (0.58-0.90) 0.000
SSB 80 5 4 0 95.5 0.69 (0.40-0.99) 0.000
scl-70 84 4 1 0 98.9 0.88 (0.66-1.11) 0.000
Jo-1 88 0 0 1 98.9 N/A N/A
RNP 83 3 0 3 96.6 0.65 (0.26-1.04) 0.000

Abbreviations: CI, confidence interval; N/A, did not calculated; RNP, ribonucleic protein; Scl-70, scleroderma 70.

Table 3.
Comparison of the results for antibodies to extractable nuclear antigens by Polycheck Autoimmune Test FIDIS Connective Profile (N = 89)
Cutoff of Polycheck Autoimmune Test = grade 1
Antigen Concordant results Discrepant results Concordance rate (%) Kappa coefficient (95% CI) P-value
Polycheck-/ FIDIS- Polycheck+/ FIDIS+ Polycheck-/ FIDIS- Polycheck+/ FIDIS+
Sm 74 1 0 14 84.3 0.11 (-0.32-0.54) 0.026
SSA 57 19 2 11 85.4 0.65 (0.47-0.82) 0.000
SSB 66 8 1 14 83.1 0.44 (0.17-0.70) 0.000
scl-70 79 4 1 5 93.3 0.54 (0.18-0.90) 0.000
Jo-1 87 0 0 2 97.8 N/A N/A
nRNP 86 2 1 0 98.9 0.79 (0.40-1.20) 0.000
Cutoff of Polycheck Autoimmune Test = grade 2
Antigen Concordant results Discrepant results Concordance rate (%) Kappa coefficient (95% CI) P-value
Polycheck-/ FIDIS- Polycheck+/ FIDIS+ Polycheck-/ FIDIS- Polycheck+/ FIDIS+
Sm 85 1 3 0 96.6 0.39 (-0.29-1.07) 0.000
SSA 64 21 1 3 92.1 0.79 (0.63-0.94) 0.000
SSB 77 4 7 1 93.3 0.66 (0.40-0.92) 0.000
scl-70 84 4 1 0 97.8 0.79 (0.50-1.08) 0.000
Jo-1 88 0 0 1 100.0 N/A N/A
nRNP 83 2 0 4 98.9 0.79 (0.39-1.20) 0.000

Abbreviations: CI, confidence interval; N/A, did not calculated; RNP, ribonucleic protein; Scl-70, scleroderma 70.

Table 4.
Comparison of the results for antibodies to extractable nuclear antigens by EUROASSAY Anti-ENA Profile and FIDIS Connective profile in the systemic autoimmune disorder (n = 33).
Antigen Concordant results Discrepant results Concordance rate (%) Kappa coefficient (95% CI) P-value
EUROASSAY-/ FIDIS EUROASSAY+/ FIDIS+ EUROASSAY-/ FIDIS+ EUROASSAY+/ FIDIS-
Sm 32 1 0 0 100.0 1.00 (1.00-1.00) 0.000
SSA 16 15 0 2 93.9 0.88 (0.72-1.04) 0.000
SSB 27 4 2 0 93.9 0.77 (0.45-1.08) 0.000
scl-70 30 3 0 0 100.0 1.00 (1.00-1.00) 0.000
Jo-1 33 0 0 0 100.0 N/A N/A
RNP 29 2 0 2 93.9 0.64 (0.15-1.12) 0.000

Abbreviations: SLE, systemic lupus erythematosus; CI, confidence interval; N/A, did not calculated; RNP, ribonucleic protein; Scl-70, scleroderma 70.

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