The clinical significance of borderline results of the Elia CTD Screen assay

2018 ◽  
Vol 56 (12) ◽  
pp. 2088-2092
Author(s):  
Christoph Robier ◽  
Omid Amouzadeh-Ghadikolai
Keyword(s):  
Clinical Significance ◽  
Lupus Erythematosus ◽  
Medical Records ◽  
Antinuclear Antibodies ◽  
Solid Phase ◽  
Sequential Screening ◽  
Nuclear Antigens ◽  
Low Concentrations ◽  
Thermo Fisher Scientific ◽  
Fisher Scientific

Abstract Background Data on the clinical relevance of borderline results of solid-phase assays in the screening for antinuclear antibodies (ANA) are sparse. This study aimed to determine the clinical significance of borderline results of the Elia CTD Screen (ECS; Phadia/Thermo Fisher Scientific, Freiburg, Germany), a fluoroenzymeimmunoassay incorporating 17 recombinant human nuclear antigens. Methods We retrospectively examined the medical records of 143 subjects with borderline ECS results for ANA-associated autoimmune disorders (AASARD) and the association with the results of indirect immunofluorescence (IIF) and confirmatory assays for ANA. Results AASARD were diagnosed in 10 patients (7%) with systemic lupus erythematosus (n=5; four patients were prediagnosed and in clinical remission), polymyositis overlap syndromes (n=2), scleroderma, Raynaud’s syndrome and undetermined connective tissue disease (each n=1). Most frequently, homogeneous and nucleolar IIF patterns were found. Positive ANA subsets were observed in three patients. Furthermore, four patients were diagnosed with autoimmune liver diseases and yielded positive IIF in three and positive confirmatory assays in all cases. Taken together, 129 subjects had no AASARD. Within this group, 43 patients were IIF positive and most frequently showed speckled, unspecific nucleolar and only rarely homogeneous patterns. Positive ANA subsets were found in low concentrations near to the upper reference range in 18 subjects. Conclusions AASARD were observed in 7% of the subjects with borderline ECS and showed homogeneous or nucleolar IIF patterns in the majority of these cases. Our findings suggest that borderline results of the ECS can be clinically relevant and support the concept of a parallel or sequential screening for ANA by both ECS and IIF.

scholarly journals CLINICAL SIGNIFICANCE OF ANTI-RO52/TRIM21 ANTIBODIES IN SYSTEMIC AUTOIMMUNE RHEUMATIC DISORDERS: PRELIMINARY RESULTS

2017 ◽  
Vol 26 (3) ◽  
pp. 129-134
Author(s):  
Cristina Pomirleanu ◽  
◽  
Raluca Paiu ◽  
Georgiana Strugariu ◽  
Luiza Petrariu ◽  
...  
Keyword(s):  
Clinical Significance ◽  
Lupus Erythematosus ◽  
Medical Records ◽  
Lung Fibrosis ◽  
Antinuclear Antibodies ◽  
Clinical Manifestations ◽  
Immunoblot Assay ◽  
Therapeutic Outcomes ◽  
Chi Squared ◽  
Patients At Risk

Although antibodies targeting Ro52 protein/TRIM21 are commonly detected in systemic autoimmune rheumatic disorders (SARDs), their clinical significance and pathobiologic role remains incompletely understood. Objectives. We aimed to define clinical relevance and immunological associations of anti-Ro52/TRIM21 positivity in a cohort of patients with SARDs. Methods. We retrospectively reviewed medical records of 97 consecutive SARDs who attended at least once our Rheumatology Department between March 2016 and June 2017. Clinical manifestations, rheumatoid factor (RF) (Latex and Waalter-Rose tests), antinuclear antibodies (ANA>1:100, immunofluorescence assays) as well as detailed ANA profile (nRNP/Sm, Sm, SS-A/Ro, Ro52/TRIM21, SS-B/La, Scl-70, PM/Scl, Jo-1, CENP-B, PCNA, dsDNA, nucleosome, histone, P-ribosomal protein, AMA-M2, DFS70) (line immunoblot assay) were systematically evaluated. Statistical analysis was performed in SPSS19.0, assuming significance for p<0.05; the chi-squared test was applied to determine the association between anti-Ro52/TRIM21 status and clinical manifestations of SARDs. Results. Only 27 patients (23.7%) had anti-Ro52/TRIM21 positive disease and were further analyzed. Isolated anti-Ro52/TRIM21 were detected in 7/27 (25.9 %) cases, while the majority had dual anti-Ro52/TRIM21 positivity and anti-Ro (n=7/20; 35%), anti-dsDNA (n=3/20, 15%), anti-Jo1 (n=3/20, 15%), anti-centromere B (n=2/20; 10%), anti-Scl70 (n=2/20; 10%), anti-RNP/Sm (n=2/20, 10%), anti-Pm/Scl (n=1/20, 5%), and RF (n=13; 65%). Patients were classified as Sjögren’s syndrome (n=7/27, 25.9%), myositis (n=3/27, 11.1%), systemic lupus erythematosus (n=3/27, 11.1%), systemic sclerosis (n=4/27,15.2%), mixed (n=3/27, 11.1%) or undifferentiated connective tissue disease (n=7/27, 25.9%). More than half of anti-Ro52/TRIM21 positive patients presented with interstitial lung fibrosis (18/27, 66.6%), insolated (33.3%) or in association with anti-Jo1 (33.3%). Conclusions. Anti-Ro52/TRIM21 antibodies should be systematically evaluated in patients with SARDs, as anti-Ro52 positivity (either isolated or in combination with different other ANA specificities) may be associated with definite clinical features. Anti-Ro52/TRIM21 may be useful in identifying a subgroup of patients at risk for developing certain symptoms (particularly interstitial lung disease) of SARDs, with specific therapeutic outcomes.

scholarly journals Relationships among Antibodies against Extractable Nuclear Antigens, Antinuclear Antibodies, and Autoimmune Diseases in a Brazilian Public Hospital

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Fernanda Weyand Banhuk ◽  
Bruna Corrêa Pahim ◽  
Alex Sandro Jorge ◽  
Rafael Andrade Menolli
Keyword(s):  
Autoimmune Diseases ◽  
Lupus Erythematosus ◽  
Medical Records ◽  
Public Hospital ◽  
Antinuclear Antibodies ◽  
Test Results ◽  
Common Pattern ◽  
Negative Results ◽  
Nuclear Antigens ◽  
Different Types

One characteristic of autoimmune diseases (ADs) is the production of autoantibodies for extractable nuclear autoantigens, which may aid in the discrimination of the different types of autoimmune diseases and is related to different antinuclear antibody (ANA) patterns. The present study verified the profile of patient samples tested for extractable nuclear antigens (ENA) antibodies in a public hospital and correlated the ENA results with ANA patterns and patient diagnoses. The study reviewed data in the medical records of patients who underwent anti-ENA tests at a public hospital in the West of the State of Paraná from February 2011 to January 2017. Patients were classified according to age, ethnicity, gender, anti-ENA test results, ANA results, and the presence or absence of AD. Thirty-six (20.9%) samples of the 172 anti-ENA tests were positive, seven (4.1%) samples were undetermined, and 129 (75%) exhibited negative results. The ANA reagent was found in 84.3% of the anti-ENA-positive samples. The anti-SSA/Ro autoantibody exhibited the highest frequency in the group, 41.7% (15/36). The most common pattern was nuclear fine speckled, which was found in 24.3% of the samples. The association results indicated a significant relationship between ANA titer and diagnosis in the anti-ENA- and ANA-positive patients. The anti-ENA-negative patients were diagnosed with an AD in 35% (45/129) of the cases, and 75% (27/36) of the anti-ENA-positive patients were diagnosed with an AD. Systemic lupus erythematosus and scleroderma were the most common pathologies in the antigen-positive patients. The anti-ENA test is a good marker to aid in the complex clinical diagnosis of patients with autoimmune diseases.

The clinical relevance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative indirect immunofluorescence on the HEp-2 cell

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Christoph Robier ◽  
Maximiliane Haas ◽  
Franz Quehenberger
Keyword(s):  
Indirect Immunofluorescence ◽  
Lupus Erythematosus ◽  
Medical Records ◽  
Clinical Relevance ◽  
Solid Phase ◽  
Clinical Importance ◽  
Discoid Lupus Erythematosus ◽  
Combined Use ◽  
Significant Difference ◽  
Dsdna Antibodies

AbstractObjectivesData on the clinical importance of the detection of anti-dsDNA antibodies in patients with negative indirect immunofluorescence on the HEp-2 cell (IIF) are sparse and are especially not available for all common commercially available assays. This study aimed to assess the clinical significance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative IIF.MethodsWe retrospectively examined the medical records of 234 consecutive subjects with detectable anti-dsDNA antibodies determined by the Elia™ dsDNA assay.ResultsA total of 124 subjects with detectable anti-dsDNA autoantibodies were IIF-negative, but yielded positive or borderline results in the Elia™ CTD screen assay for antinuclear antibodies (ANA). Within this group, 6/49 IIF-negative patients (12%) with ANA-associated systemic autoimmune rheumatic disorders (AASARD) and 118/185 subjects (64%) with various other diseases (Non-AASARD) were identified. There was no statistically significant difference with regard to the concentrations of anti-dsDNA antibodies (p=0.53) between the AASARD and the Non-AASARD group. Within the AASARD group, four patients diagnosed with systemic lupus erythematosus (SLE, treated), discoid lupus erythematosus (untreated), indetermined connective tissue disease (untreated) and polymyositis (treated) had positive anti-dsDNA autoantibodies, whereas two patients with treated SLE, thereby one in remission, had borderline concentrations of anti-dsDNA antibodies.ConclusionsOur findings suggest that the detection of anti-dsDNA antibodies in IIF-negative patients can be of clinical relevance in some cases. Our results further support the combined use of IIF and solid-phase assays in screening algorithms for ANA, in order to avoid overlooking potentially important autoantibody entities.

Enzyme-linked immunosorbent assay for detection of antibodies to extractable nuclear antigens in systemic lupus erythematosus, with nylon as solid phase.

1983 ◽  
Vol 29 (5) ◽  
pp. 823-827 ◽  
Author(s):  
M Ishaq ◽  
R Ali
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Immunosorbent Assay ◽  
Lupus Erythematosus ◽  
Solid Phase ◽  
Enzyme Linked Immunosorbent Assay ◽  
Prolonged Storage ◽  
Antibody Activity ◽  
Systemic Lupus ◽  
Nuclear Antigens ◽  
As Solid Phase

Abstract In this enzyme-linked immunosorbent assay (ELISA) for detection of antibodies against extractable nuclear antigens (ENA) in sera of patients with systemic lupus erythematosus (SLE), nylon is used as solid phase for antigen binding instead of the commonly used polystyrene surface. Optimal conditions for activation of the nylon beads, antigen coating, and other relevant factors have been investigated. We compared the incidence of anti-ENA antibodies in SLE, using chromogenic and fluorogenic enzyme substrates. Of SLE patients, 54% were positive for anti-ENA antibodies when chromogenic substrate was used as compared with 68% for fluorogenic substrate. Antibody activity against Sm and RNP antigens was distinguished on the basis of ribonuclease sensitivity of the RNP antigen. The method described offers advantages such as decreased background activity, increased surface area, facility for prolonged storage of antigen-coated solid phase, and miniaturization of the assay.

scholarly journals Male-only Systemic Lupus

2010 ◽  
Vol 37 (7) ◽  
pp. 1480-1487 ◽  
Author(s):  
RACHNA AGGARWAL ◽  
BAHRAM NAMJOU ◽  
SHIBO LI ◽  
ANIL D’SOUZA ◽  
BETTY P. TSAO ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Medical Records ◽  
Antinuclear Antibodies ◽  
White Women ◽  
White Men ◽  
Toll Like Receptor ◽  
Systemic Lupus ◽  
Male Fish ◽  
Susceptibility Factors

Objective.Systemic lupus erythematosus (SLE) is more common among women than men, a ratio of about 10 to 1. We undertook this study to describe familial male SLE within a large familial SLE cohort.Methods.SLE families (2 or more patients) were identified from the Lupus Multiplex Registry and Repository. Genomic DNA and blood samples were obtained using standard methods. Autoantibodies were determined by multiple methods. Medical records were abstracted for SLE clinical data. Fluorescentin situhybridization (FISH) was performed with X and Y centromere-specific probes, and a probe specific for the Toll-like receptor 7 gene on the X chromosome.Results.Among 523 SLE families, we found 5 families in which all the SLE patients were male. FISH found noyaagene equivalent in these families. SLE-unaffected primary female relatives from the 5 families with only-male SLE patients had a statistically increased rate of positive antinuclear antibodies compared to SLE-unaffected female relatives in other families. White men with SLE were 5 times more likely to have an offspring with SLE than White women with SLE, but there was no difference in this likelihood among Black men.Conclusion.Because women in the all-male families had positive antinuclear antibodies, and men are more likely to have children with SLE, these data suggest genetic susceptibility factors that act only in men.

scholarly journals Genetic Modifiers of Systemic Lupus Erythematosus in FcγRIIB−/− Mice

2002 ◽  
Vol 195 (9) ◽  
pp. 1167-1174 ◽  
Author(s):  
Silvia Bolland ◽  
Young-Sun Yim ◽  
Katalin Tus ◽  
Edward K. Wakeland ◽  
Jeffrey V. Ravetch
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Antinuclear Antibodies ◽  
Susceptibility Gene ◽  
Genetic Modifiers ◽  
Systemic Lupus ◽  
Nuclear Antigens ◽  
Loss Of Tolerance ◽  
Significant Disease ◽  
Compound Heterozygotes

FcγRIIB is a potent lupus susceptibility gene as demonstrated by the observation that mice deficient in this molecule develop spontaneous antinuclear antibodies (ANA) and fatal glomerulonephritis when on the C57BL/6 background. To determine the mechanisms underlying the epistasis displayed by this gene we have constructed hybrids between FcγRIIB−/− and the systemic lupus erythematosus (SLE) modifiers yaa and lpr and the susceptibility locus Sle1. Sle1 and B6.RIIB−/− are both physically and functionally coupled; compound heterozygotes of Sle1 and B6.RIIB−/− develop significant disease, while single heterozygotes display no evidence of autoimmunity or disease, indicating that these genes lie on the same genetic pathway resulting in the loss of tolerance to nuclear antigens. However, the generation of ANA in itself is insufficient to account for the severity of autoimmune disease in this model, as demonstrated by analysis of yaa and lpr hybrids. Thus, B6.RIIB−/−/lpr mice are protected from disease progression, despite equivalent titers of ANA. In contrast, B6.RIIB−/−/yaa mice have significantly enhanced disease despite reduced ANA titers. Yaa modifies the specificity and thus the pathogenicity of the B6. RIIB−/− ANA, by converting them to antinucleolar antibodies. In addition to these known modifier pathways, we have discovered two novel, recessive loci contributed by the C57BL/6 genome that are required for the ANA phenotype, further indicating the epistatic properties of this SLE model.

scholarly journals Screening for connective tissue disease-associated antibodies by automated immunoassay

2018 ◽  
Vol 56 (6) ◽  
pp. 909-918 ◽  
Author(s):  
Philippe Willems ◽  
Ellen De Langhe ◽  
Jolien Claessens ◽  
René Westhovens ◽  
Erna Van Hoeyveld ◽  
...  
Keyword(s):  
Connective Tissue ◽  
Connective Tissue Disease ◽  
Lupus Erythematosus ◽  
Medical Records ◽  
Antinuclear Antibodies ◽  
Double Negative ◽  
Double Positive ◽  
Single Positive ◽  
Automated Immunoassay ◽  
Selection Of

AbstractBackground:Antinuclear antibodies (ANAs) are useful for the diagnosis of ANA-associated systemic rheumatic disease (AASRD). The objective of this study was the evaluation of an immunoassay that detects antibodies to a mixture of 17 antigens as an alternative to indirect immunofluorescence (IIF).Methods:Nine thousand eight hundred and fifty-six consecutive patients tested for ANAs were tested by IIF and EliA connective tissue disease screen (Thermo-Fisher). Medical records were reviewed for 2475 patients, including all patients that tested positive/equivocal by either test and a selection of 500 patients that tested negative.Results:Concordance between IIF and EliA was 83.1%. AASRD was found in 12.8% of IIF-positive patients, 30.2% of EliA-positive patients and 0.4%, 46.6%, 5.8% and 3.0% of patients that tested, respectively, double negative, double positive, single positive for EliA and single positive for IIF. The association with AASRD increased with increasing antibody level. IIF and EliA were positive in, respectively, 90.4% and 69.9% of systemic lupus erythematosus (n=83), 100% and 84.1% of systemic sclerosis (n=63), 86.7% and 93.3% of Sjögren’s syndrome (n=45), 88.2% and 52.9% of polymyositis/dermatomyositis (n=17), and in all cases of mixed connective tissue disease (n=8). The specificity was projected to be 94%–96% for EliA and 86% for IIF. When all AASRDs were taken together, the areas under the curve of receiver operator curves were similar between IIF and EliA.Conclusions:The positive predictive value for AASRD was higher for EliA than for IIF, but, depending on the disease, EliA might fail to detect antibodies that are detected by IIF. Combining immunoassay with IIF adds value.

scholarly journals Systemic lupus erythematosusmyositis overlap syndrome: report of 6 cases

2011 ◽  
Vol 1 (4) ◽  
pp. 89 ◽  
Author(s):  
Fatma Maazoun ◽  
Faten Frikha ◽  
Mouna Snoussi ◽  
Neila Kaddour ◽  
Hatem Masmoudi ◽  
...  
Keyword(s):  
Muscle Weakness ◽  
Lupus Erythematosus ◽  
Medical Records ◽  
Antinuclear Antibodies ◽  
Inflammatory Myopathy ◽  
Overlap Syndrome ◽  
Muscle Disease ◽  
Systemic Lupus ◽  
Distal Muscle ◽  
High Doses

The incidence of myositis in patients with systemic lupus erythematosus (SLE) is low among different series. Here we attempt to describe the main features of SLE/myositis overlap syndrome. We retrospectively reviewed the medical records of 174 patients with SLE seen over 15-year period. All the patients fulfilled the revised American Rheumatology Association criteria for SLE. Patients who met The Bohan and Peter criteria for definite myositis were included in this study. Among those patients, six patients had an associated myositis (3.4% overall). They were 6 women with a mean age of 29 years (20-41 years). At the initial evaluation, 3 patients (50%) were complained from myalgia, and all patients had symmetrical muscle weakness (proximal muscle weakness in 6 cases with distal muscle weakness in 2 cases). The muscle disease was severe in 1 case. Involvements of muscles of the pharynx and upper esophagus were noted in 4 patients (66.6%). The creatine kinase (CK) levels were elevated in 4 cases with a mean rate of 2153.5 UI/L. The electromyogram (EMG) revealed signs of myositis in 5 cases. Muscle biopsy, performed in 5 patients, revealed an inflammatory myopathy changes in 4 cases. Antinuclear antibodies (ANA) were positive in all cases. All our patients were treated with high doses of corticosteroids with favorable outcome. Relapse of SLE disease had occurred in 2 patients. The association SLEmyositis is rare with heterogeneous presentation. Through our observations and literature data we will specify the characteristics of this association.

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