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Clin Chim Acta. 2013 Sep 23;424:141-7. doi: 10.1016/j.cca.2013.05.011. Epub 2013 May 30.

Clinical performance evaluation of a novel rapid response chemiluminescent immunoassay for the detection of autoantibodies to extractable nuclear antigens.

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1
INOVA Diagnostics, Inc., San Diego, CA, United States.

Abstract

BACKGROUND:

We analyzed the performance of a novel ENA screening chemiluminescent immunoassay (CIA) and the confirmation QUANTA Flash tests.

METHODS:

Sera (n=1079) from patients referred to a rheumatology clinic were screened by QUANTA Flash ENA7 (INOVA Diagnostics). All positive (n=89) and a matched control group (n=90) were reflexed for autoantibodies to the individual antigens. Moreover, sera from patients with systemic lupus erythematosus (SLE, n=252), systemic sclerosis (SSc, n=64), polymyositis/dermatomyositis (PM/DM, n=72), Sjögren's syndrome (SjS, n=39) as well as disease controls (n=605) were tested by ENA7 CIA and by Quanta Lite ENA6 ELISA (INOVA).

RESULTS:

89/1079 (8.3%) samples were ENA7 CIA positive with the following reactivity profile: RNP (36.0%), Sm (13.5%), Scl-70 (9.0%), Jo-1 (0.0%), Ro60 (44.9%), Ro52 (39.3%) and SS-B (24.7%). In the negative group, the reactivity profile was: RNP (1.1%), Sm (1.1%), Scl-70 (2.2%) and 0.0% for Jo-1, Ro60, Ro52 and SS-B. The positive/negative/total agreements (ENA7 CIA vs. confirmation assays) were 95.3%/91.5%/93.3%. The sensitivity of the ENA7 CIA was 62.3% in SLE, 54.7% in SSc, 92.3% in SjS, 50.0% in PM/DM, and 61.8% in the total systemic autoimmune rheumatic disease (SARD) population (specificity 95.0%).

CONCLUSION:

The QUANTA Flash ENA7 CIA is a reliable screening test.

KEYWORDS:

ALBIA; AMR; Autoantibodies; CIA; CLSI; CTD; Clinical and Laboratory Standards Institute; Connective tissue disease; ELISA; ENA; LIA; PBC; PM/DM; SARD; SLE; SSc; SjS; Sjögren's syndrome; Systemic lupus erythematosus; addressable laser bead assays; analytical measuring range; chemiluminescent immunoassay; connective tissue disease; line immunoassays; polymyositis/dermatomyositis; primary biliary cirrhosis; systemic autoimmune rheumatic disease; systemic lupus erythematosus; systemic sclerosis

PMID:
23727029
DOI:
10.1016/j.cca.2013.05.011
[Indexed for MEDLINE]
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