The International Consensus on ANA Patterns (ICAP) in 2021—The 6th Workshop and Current Perspectives

Chan, Edward K. L.; Mühlen, Carlos Alberto von; Fritzler, Marvin J.; Damoiseaux, Jan; Infantino, María; Klotz, Werner; Satoh, Minoru; Musset, Lucile; Torre, Ignacio García‐De La; Carballo, Orlando Gabriel; Herold, Manfred; Cruvinel, Wilson de Melo; Mimori, Tsuneyo; Andrade, Luís Eduardo Coelho

doi:10.1093/jalm/jfab140

Cited by 47 publications

(35 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Internationally, the IIF using HEp-2 cells is recommended as the gold standard for screening ANAs. 21,22 When ANA screening is positive by IIF, it is essential to confirm the autoantibody type, which plays a critical role in stratifying patients with AIDs. 23 In recent years, with the increasing use of ANAs to Overall, the kappa coefficients for each autoantibody varied.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Analytical and clinical performance of different platforms simultaneously detecting 15 antinuclear antibodies

Qin

Fan

Wang

et al. 2022

Clinical Laboratory Analysis

View full text Add to dashboard Cite

Background: Antinuclear antibodies (ANAs) are invaluable biomarkers for the diagnosis of autoimmune diseases (AIDs). This study aims to compare the performances of line immunoassay (LIA), multiplex bead-based flow fluorescent immunoassay (MBFFI), and magnetic bar code immunofluorescence assay (MBC-IF) to detect ANA-Profile-15S. Methods: In total, 184 samples from AID patients and 50 healthy controls (HCs) were collected. Fifteen ANAs (anti-dsDNA, nucleosome, histone, Sm, PCNA, ribosomal-P, SS-A/Ro52, SS-A/Ro60, SS-B/La, centromere B [CENP-B], Scl-70, U1-snRNP, AMA-M2, Jo-1, and Pm/Scl) were subjected to parallel detection by the LIA, MBFFI, and MBC-IF. The consistency between assays was analyzed. The discrepant results were further examined by chemiluminescent immunoassay (CLIA). Results: Anti-SS-A/Ro52 and SS-A/Ro60 autoantibodies were the most common autoantibodies in ANA positive-profiles, and were detected with equal efficiency by the LIA, MBFFI, and MBC-IF (p = 0.101 and p = 0.732, respectively). The three assays showed excellent agreement (consistency range: 66.5%-97.5%), and total consistency was 85.8%. The MBFFI and MBC-IF assays were in good agreement in terms of ANA-Profile-15S determination; the kappa coefficient ranged from 0.59 to 0.95, except for the PCNA and PM-Scl. Of the 262 re-assessed divergent results, 124 (47.33%) were positive on CLIA; the various autoantibodies exhibited variable patterns. More importantly, the ANA-Profile-15S results of the MBFFI and MBC-IF accurately identified patients with AID; the area under the curves ranged from 0.642 to 0.919. Conclusions: The novel MBFFI and MBC-IF assay performed well in detecting ANA-Profile-15S. The application of MBFFI and MBC-IF play important roles in laboratory diagnosis of AIDs.

show abstract

Section: Discussionmentioning

confidence: 99%

“…ANA testing is crucial for the diagnosis and management of patients with AID. Internationally, the IIF using HEp‐2 cells is recommended as the gold standard for screening ANAs 21,22 . When ANA screening is positive by IIF, it is essential to confirm the autoantibody type, which plays a critical role in stratifying patients with AIDs 23 .…”

Section: Discussionmentioning

confidence: 99%

Analytical and clinical performance of different platforms simultaneously detecting 15 antinuclear antibodies

Qin

Fan

Wang

et al. 2022

Clinical Laboratory Analysis

View full text Add to dashboard Cite

show abstract

“…The measurement of ANAs should be guided by clinical suspicion since as much as 5% of the asymptomatic adult population tests positive for ANAs at a titer of 1:160 ( Gordon et al, 2018 ). Nowadays, the gold standard method for ANA screening is the indirect immunofluorescence assay (IFA), which has the advantage of providing immunofluorescence patterns suggestive of specific antibodies [see International Consensus on ANA Patterns (ICAP) in website www.ANApatterns.org ( Damoiseaux et al, 2015 ; Chan et al, 2022 )]. In the event of ANA positivity and depending on the IFA pattern, it is recommended to test for double-stranded DNA (dsDNA) and extractable nuclear antigens (ENAs), which are associated with certain ADs or some of the unique clinical manifestations of such diseases.…”

Section: Introductionmentioning

confidence: 99%

Prediction of Immune-Related Adverse Events Induced by Immune Checkpoint Inhibitors With a Panel of Autoantibodies: Protocol of a Multicenter, Prospective, Observational Cohort Study

et al. 2022

View full text Add to dashboard Cite

Introduction: Immune checkpoint inhibitor (ICI) therapy is markedly improving the prognosis of patients with several types of cancer. On the other hand, the growth in the use of these drugs in oncology is associated with an increase in multiple immune-related adverse events (irAEs), whose optimal prevention and management remain unclear. In this context, there is a need for reliable and validated biomarkers to predict the occurrence of irAEs in patients treated with ICIs. Thus, the main objective of this study is to evaluate the diagnostic performance of a sensitive routinely available panel of autoantibodies consisting of antinuclear antibodies, rheumatoid factor, and antineutrophil cytoplasmic antibodies to identify patients at risk of developing irAEs.Methods and Analysis: A multicenter, prospective, observational, cohort study has been designed to be conducted in patients diagnosed with cancer amenable to ICI therapy. Considering the percentage of ICI-induced irAEs to be 25% and a loss to follow-up of 5%, it has been estimated that a sample size of 294 patients is required to detect an expected sensitivity of the autoantibody panel under study of 0.90 with a confidence interval (95%) of no less than 0.75. For 48 weeks, patients will be monitored through the oncology outpatient clinics of five hospitals in Spain. Immune-related adverse events will be defined and categorized according to CTCAE v. 5.0. All the patients will undergo ordinary blood tests at specific moments predefined per protocol and extraordinary blood tests at the time of any irAE being detected. Ordinary and extraordinary samples will be frozen and stored in the biobank until analysis in the same autoimmunity laboratory when the whole cohort reaches week 48. A predictive model of irAEs will be constructed with potential risk factors of immune-related toxicity including the autoantibody panel under study.Ethics and Dissemination: This protocol was reviewed and approved by the Ethical Committee of the Basque Country and the Spanish Agency of Medicines and Medical Devices. Informed consent will be obtained from all participants before their enrollment. The authors declare that the results will be submitted to an international peer-reviewed journal for their prompt dissemination.

show abstract

“…HEp-2 IFA reveals the pattern of immunofluorescent labeling, a key piece of information indicating the possible location of the autoantigens recognized by autoantibodies in the sample. The International Consensus on ANA Patterns (ICAP) <www.anapatterns.org> has classified 30 different HEp-2 IFA patterns (20), including the nucleolar pattern. Although many will report any nucleolar staining as a "nucleolar pattern", in a more detailed analysis one can distinguish three different "sub-patterns": homogeneous nucleolar (AC-8), clumpy nucleolar (AC-9) and punctate nucleolar (AC-10).…”

Section: Introductionmentioning

confidence: 99%

A cell-based assay for detection of anti-fibrillarin autoantibodies with performance equivalent to immunoprecipitation

Keppeke

Satoh²,

Kayser³

et al. 2022

Front. Immunol.

Self Cite

View full text Add to dashboard Cite

Anti-fibrillarin autoantibodies are useful for the diagnosis and prognosis of systemic sclerosis (SSc). Anti-fibrillarin produces a clumpy nucleolar pattern in indirect immunofluorescence assay on HEp-2 cells (HEp-2 IFA). Here we develop and validate a reliable cell-based anti-fibrillarin assay (Fibrillarin/CBA) for use in clinical diagnostic laboratories. A TransMembrane Signal was fused to the human fibrillarin gene (TMS-fibrillarin). HEp-2 cells overexpressing transgenic TMS-fibrillarin at the cytoplasmic membrane were used as IFA substrate in the Fibrillarin/CBA. Sixty-two serum samples with nucleolar pattern in the HEp-2 IFA (41 clumpy; 21 homogeneous/punctate) were tested for anti-fibrillarin using Fibrillarin/CBA, immunoprecipitation (IP), line-blot and ELISA. In addition, samples from 106 SSc-patients were evaluated with Fibrillarin/CBA and the results were correlated with disease phenotypes. Thirty-eight of 41 samples with the clumpy nucleolar pattern (92.7%) were positive in the Fibrillarin/CBA, while all 21 samples with other nucleolar patterns were negative. Fibrillarin/CBA results agreed 100% with IP results. Among the 38 Fibrillarin/CBA-positive samples, only 15 (39.5%) and 11 (29%) were positive for anti-fibrillarin in line-blot and ELISA, respectively. Higher frequency of diffuse cutaneous SSc (dcSSc) phenotype (72.7% vs 36.8%; p=0.022), cardiac involvement (36.4% vs 6.5%; p=0.001) and scleroderma renal crisis (18.2% vs 3.3% p = 0.028) was observed in SSc patients with positive compared to negative Fibrillarin/CBA result. Performance of Fibrillarin/CBA in the detection of anti-fibrillarin autoantibodies was comparable to the gold standard IP. Positive Fibrillarin/CBA results correlated with disease phenotypes known to be associated with anti-fibrillarin autoantibodies, underscoring the clinical validation of this novel assay.

show abstract

The International Consensus on ANA Patterns (ICAP) in 2021—The 6th Workshop and Current Perspectives

Cited by 47 publications

References 18 publications

Analytical and clinical performance of different platforms simultaneously detecting 15 antinuclear antibodies

Analytical and clinical performance of different platforms simultaneously detecting 15 antinuclear antibodies

Prediction of Immune-Related Adverse Events Induced by Immune Checkpoint Inhibitors With a Panel of Autoantibodies: Protocol of a Multicenter, Prospective, Observational Cohort Study

A cell-based assay for detection of anti-fibrillarin autoantibodies with performance equivalent to immunoprecipitation

Contact Info

Product

Resources

About