Research Article

Evaluation of an Automated Screening Assay, Compared to Indirect Immunofluorescence, an Extractable Nuclear Antigen Assay, and a Line Immunoassay in a Large Cohort of Asian Patients with Antinuclear Antibody-Associated Rheumatoid Diseases: A Multicenter Retrospective Study

Table 2

Overall agreements among the four autoantibody assays, according to the AARD groups.

Group ()AssaysCTD screen, cutoff ratio 0.7CTD screen, cutoff ratio 1.0HEp-2 IIFEliA ENALIA
Concordance (%)KappaMcNemarConcordance (%)KappaMcNemarConcordance (%)KappaMcNemarConcordance (%)KappaMcNemarConcordance (%)KappaMcNemar

Total AARD ()CTD screen, cutoff ratio 0.798.20.94 (0.86–1.02)0.500078.60.41 (0.22–0.60)0.006689.30.70 (0.54–0.85)0.000581.30.32 (0.09–0.55)1.0000
CTD screen, cutoff ratio 1.098.20.94 (0.86–1.02)0.500080.40.47 (0.29–0.65)0.016989.30.70 (0.55–0.86)0.006379.50.29 (0.07–0.51)0.6776
HEp-2 IIF78.60.41 (0.22–0.60)0.006680.40.47 (0.29–0.65)0.016971.40.30 (0.11–0.49)0.860174.10.28 (0.09–0.47)0.0081
EliA ENA89.30.70 (0.54–0.85)0.000589.30.70 (0.55–0.86)0.006371.40.30 (0.11–0.49)0.860175.90.31 (0.11–0.50)0.0192
LIA81.30.32 (0.09–0.55)1.000079.50.29 (0.07–0.51)0.677674.10.28 (0.09–0.47)0.008175.90.31 (0.11–0.50)0.0192
SLE ()CTD screen, cutoff ratio 0.798.50.94 (0.82–1.06)1.000083.60.47 (0.21–0.73)0.065489.60.66 (0.44–0.88)0.015682.10.23 (−0.08 to 0.54)1.0000
CTD screen, cutoff ratio 1.098.50.94 (0.82–1.06)1.000085.10.53 (0.28–0.78)0.109491.00.72 (0.51–0.92)0.031380.60.20 (−0.10 to 0.50)1.0000
HEp-2 IIF83.60.47 (0.21–0.73)0.065485.10.53 (0.28–0.78)0.109476.10.34 (0.08–0.60)1.000077.60.28 (0.01–0.54)0.1185
EliA ENA89.60.66 (0.44–0.88)0.015691.00.72 (0.51–0.92)0.031376.10.34 (0.08–0.60)1.000077.60.28 (0.01–0.54)0.1185
LIA82.10.23 (−0.08 to 0.54)1.000080.60.20 (−0.10 to 0.50)1.000077.60.28 (0.01–0.54)0.118577.60.28 (0.01–0.54)0.1185
SSc ()CTD screen, cutoff ratio 0.7100.01.00 (1.00-1.00)1.000081.00.60 (0.24–0.95)1.000081.00.63 (0.33–0.93)0.125076.20.48 (0.09–0.87)1.0000
CTD screen, cutoff ratio 1.0100.01.00 (1.00-1.00)1.000081.00.60 (0.24–0.95)1.000081.00.63 (0.33–0.93)0.125076.20.48 (0.09–0.87)1.0000
HEp-2 IIF81.00.60 (0.24–0.95)1.000081.00.60 (0.24–0.95)1.000071.40.45 (0.10–0.80)0.218876.20.48 (0.09–0.87)1.0000
EliA ENA81.00.63 (0.33–0.93)0.125081.00.63 (0.33–0.93)0.125071.40.45 (0.10–0.80)0.218866.70.36 (0.02–0.71)0.1250
LIA76.20.48 (0.09–0.87)1.000076.20.48 (0.09–0.87)1.000076.20.48 (0.09–0.87)1.000066.70.36 (0.02–0.71)0.1250
SS ()CTD screen, cutoff ratio 0.794.70.77 (0.35–1.20)1.000057.90.04 (−0.28 to 0.36)0.0703100.01.00 (1.00-1.00)1.000084.2−0.08 (−0.18 to 0.03)1.0000
CTD screen, cutoff ratio 1.094.70.77 (0.35–1.20)1.000063.20.17 (−0.20 to 0.55)0.125094.70.77 (0.35–1.20)1.000078.9−0.09 (−0.22 to 0.05)0.6250
HEp-2 IIF57.90.04 (−0.28 to 0.36)0.070363.20.17 (−0.20 to 0.55)0.125057.90.04 (−0.28 to 0.36)0.070363.20.14 (−0.12 to 0.40)0.0156
EliA ENA100.01.00 (1.00-1.00)1.000094.70.77 (0.35–1.20)1.000057.90.04 (−0.28 to 0.36)0.070384.2−0.08 (−0.18 to 0.03)1.0000
LIA84.2−0.08 (−0.18 to 0.03)1.000078.9−0.09 (−0.22 to 0.05)0.625063.20.14 (−0.12 to 0.40)0.015684.2−0.08 (−0.18 to 0.03)1.0000
MCT ()CTD screen, cutoff ratio 0.7
CTD screen, cutoff ratio 1.0
HEp-2 IIF
EliA ENA60−0.25 (−0.59 to 0.09)1.0000
LIA60−0.25 (−0.59 to 0.09)1.000060−0.25 (−0.59 to 0.09)1.0000
Total ()CTD screen, cutoff ratio 0.797.90.92 (0.89–0.95)<0.000185.60.48 (0.41–0.55)0.269897.60.91 (0.88–0.94)0.000385.70.54 (0.48–0.60)0.0011
CTD screen, cutoff ratio 1.097.90.92 (0.89–0.95)<0.000187.40.52 (0.45–0.59)0.554396.40.86 (0.82–0.90)86.50.55 (0.48–0.61)<0.0001
HEp-2 IIF85.60.48 (0.41–0.55)0.269887.40.52 (0.45–0.59)0.554385.30.45 (0.38–0.52)0.814983.40.45 (0.39–0.52)<0.0001
EliA ENA97.60.91 (0.88–0.94)0.000396.40.86 (0.82–0.90)0.635885.30.45 (0.38–0.52)0.814985.70.53 (0.46–0.59)<0.0001
LIA85.70.54 (0.48–0.60)0.001186.50.55 (0.48–0.61)<0.000183.40.45 (0.39–0.52)<0.000185.70.53 (0.46–0.59)<0.0001

IIF: indirect immunofluorescence; ENA: extractable nuclear antigen; LIA: line immunoassay; AARD: antinuclear antibody-associated rheumatoid disease; SLE: systemic lupus erythematosus; SSc: systemic sclerosis; SS: Sjögren’s syndrome; MCTD: mixed connective tissue disease; NS: not stated because of impractical calculation. Kappa coefficient between the assays are shown (95% confidence interval). values of the McNemar tests.