Evaluation of a Fully Automated Antinuclear Antibody Indirect Immunofluorescence Assay in Routine Use

Choi, Hyun-Woo; Kwon, Yong Jun; Park, Ju-Heon; Lee, Seung-Yeob; Chun, Sejong; Won, Eun Jeong; Lee, Jun Hyung; Choi, Hyunjung; Kim, Soo Hyun; Shin, Myung-Geun; Shin, Jong‐Hee; Kee, Seung‐Jung

doi:10.3389/fimmu.2020.607541

Cited by 10 publications

(4 citation statements)

References 37 publications

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“…To overcome labor-intensive and time-consuming clinical work-up procedures and to minimize the variation of pattern and titer estimates, automated reading systems have been proposed. Furthermore, recent studies have demonstrated agreement with conventional IIF interpretation in some cases with a hit rate close to 100% in samples with a clearly negative or positive ANA tests result [ 22 , 24 , 25 ]. However, automated pattern recognition is limited to a few main IIF patterns, to date, and not used in routine practice.…”

Section: Methodological Aspects Related To the Identification Of Ssc ...mentioning

confidence: 77%

Systemic Sclerosis-Specific Antibodies: Novel and Classical Biomarkers

Cavazzana

Vojinovic

Airò

et al. 2022

Clinic Rev Allerg Immunol

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Disease-specific autoantibodies are considered the most important biomarkers for systemic sclerosis (SSc), due to their ability to stratify patients with different severity and prognosis. Anti-nuclear antibodies (ANA), occurring in subjects with isolated Raynuad’s phenomenon, are considered the strongest independent predictors of definite SSc and digital microvascular damage, as observed by nailfold videocapillaroscopy. ANA are present in more than 90% of SSc, but ANA negativity does not exclude SSc diagnosis: a little rate of SSc ANA negative exists and shows a distinct subtype of disease, with less vasculopathy, but more frequent lower gastrointestinal involvement and severe disease course. Anti-centromere, anti-Th/To, and anti-Topoisomerase I antibodies could be considered as classical biomarkers, covering about 60% of SSc and defining patients with well-described cardio-pulmonary complications. In particular, anti-Topoisomerase I represent a risk factor for development of diffuse cutaneous involvement and digital ulcers in the first 3 years of disease, as well as severe interstitial lung disease (ILD). Anti-RNA polymerase III is a biomarker with new clinical implications: very rapid skin thickness progression, gastric antral vascular ectasia, the occurrence of synchronous cancers, and possible association with silicone breast implants rupture. Moreover, novel SSc specific autoantibodies have been globally described in about 10% of “seronegative” SSc patients: anti-elF2B, anti-RuvBL1/2 complex, anti-U11/U12 RNP, and anti-BICD2 depict specific SSc subtypes with severe organ complications. Many autoantibodies could be considered markers of overlap syndromes, including SSc. Anti-Ku are found in 2–7% of SSc, strictly defining the PM/SSc overlap. They are associated with synovitis, joint contractures, myositis, and negatively associated with vascular manifestation of disease. Anti-U3RNP are associated with a well-defined clinical phenotype: Afro-Caribbean male patients, younger at diagnosis, and higher risk of pulmonary hypertension and gastrointestinal involvement. Anti-PM/Scl define SSc patients with high frequency of ILD, calcinosis, dermatomyositis skin changes, and severe myositis. The accurate detection of autoantibodies SSc specific and associated with overlap syndromes is crucial for patients’ stratification. ANA should be correctly identified using indirect immunofluorescent assay and a standardized way of patterns’ interpretation. The gold-standard technique for autoantibodies’ identification in SSc is still considered immunoprecipitation, for its high sensitivity and specificity, but other assays have been widely used in routine practice. The identification of SSc autoantibodies with high diagnostic specificity and high predictive value is mandatory for early diagnosis, a specific follow-up and the possible definition of the best therapy for every SSc subsets. In addition, the validation of novel autoantibodies is mandatory in wider cohorts in order to restrict the gap of so-called seronegative SSc patients.

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Section: Methodological Aspects Related To the Identification Of Ssc ...mentioning

confidence: 77%

Systemic Sclerosis-Specific Antibodies: Novel and Classical Biomarkers

Cavazzana

Vojinovic

Airò

et al. 2022

Clinic Rev Allerg Immunol

View full text Add to dashboard Cite

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“…The anti-nuclear antibody (ANA) test was performed on a Helios automated indirect immunofluorescence assay analyzer using the ANA Hep-2 standard kit (Aesku Diagnostics, Wendelsheim, Germany). The sensitivity and specificity of this assay were reported as 73.3% and 99.4%, respectively [ 13 ]. Autoantibodies including Smith, ribonucleoprotein, Ro/SS-A, La/SS-B, nucleosome, histone, and ribosomal-P autoantibodies were assessed by standalone ELISA using a commercial kit (Alegria; ORGENTEC Diagnostika GmbH, Mainz, Germany).…”

Section: Methodsmentioning

confidence: 99%

Significance of co-positivity for anti-dsDNA, -nucleosome, and -histone antibodies in patients with lupus nephritis

et al. 2023

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Objective The aim of this study was to define the clinical, histopathologic, and prognostic features associated with simultaneous positivity for anti-dsDNA, -nucleosome, and -histone antibodies (3-pos) in Korean patients with biopsy-proven lupus nephritis (LN). Methods The 102 patients included in the study had undergone kidney biopsy prior to the start of induction treatment, were treated with immunosuppressives, and followed-up for >12 months. Results In total, 44 (43.1%) of the 102 LN patients were 3-pos. Patients with 3-pos had a higher SLEDAI-2K score ( p = .002), lower lymphocyte count ( p = .004), and higher rates of proteinuria > 3.5 g/24 h ( p = .039) and positivity for urinary sediments ( p = .005) at the time of renal biopsy than non-3-pos patients. 3-pos patients had a more proliferative form of LN ( p = .045) in the renal histopathologic findings, and as co-positivity gradually increased from 0 to 3, the total activity score in the renal biopsy findings increased significantly ( p = .033). In addition, 3-pos patients had a more rapid eGFR decline than non-3-pos patients after a follow-up of 83.2 months ( p = .016). Conclusions Our findings suggest that 3-pos is related to severe LN and that 3-pos patients are more likely to experience a rapid decline of renal function than non-3-pos patients. KEY MESSAGE Patients with co-positivity for anti-dsDNA, -nucleosome, and -histone antibodies (3-pos) had higher disease activity and a worse renal histopathology than those without co-positivity. 3-pos patients had a more rapid decline of renal function than non-3-pos patients.

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“…Therefore, efforts are being made for automation, but there are still many restrictions. 9 Particularly, the referral to rheumatology for the sole reason of positive ANA tests has been frequently criticized as an unnecessary waste of health care resources. 7 10 In response to these issues, a “Choosing wisely” campaign has recently emerged worldwide.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic Value of Anti-Nuclear Antibodies: Results From Korean University-Affiliated Hospitals

et al. 2022

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Background Unnecessary and inappropriate laboratory testing accounts for a significant portion of waste in health care utilization. The aim of this study was to examine the diagnostic value of the anti-nuclear antibody (ANA) test by examining the rate of ANA associated rheumatic disease (AARD) diagnosis among ANA tested and ANA positive subjects and positive predictive value (PPV) of ANA test leading to AARD diagnosis in different ANA titers and different subsets of patients in 5 hospitals affiliated with a university. Methods We retrospectively extracted data from all subjects who were tested for ANA from year 2010 to 2019. Those who were first evaluated at or referred to rheumatology were further evaluated with extraction of data including ANA titer and ultimate diagnosis. PPVs for ANA test were evaluated after stratification according to clinically relevant key parameters, such as patient age (younger < 65 years vs. older), sex, and requesting department. Results From 2010 to 2019, A total of 94,153 patients were tested for ANA, of which 13,600 (14.4% of the total) were positive. AARD was diagnosed in only 0.69% among all ANA tested patients and 4.74% among ANA positive patients. The AARD diagnosis rate of ANA positive patients varied widely from 0.1% to 8.7% by requesting department. Using cutoff values above 1:320 yielded PPVs of 15.6 and 7.8% for all AARs and systemic lupus erythematosus. The PPV was significantly higher in young age (< 65 years) and in women, and when it was requested from internal medicine vs other departments. Conclusion AARD was diagnosed in less than 1% of all ANA tested patients in university-affiliated hospitals. This result shows that careful consideration before ordering the screening ANA is needed to improve the utility of the test for providers and patients and to reduce health costs spurred by unnecessary testing and its consequences.

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Evaluation of a Fully Automated Antinuclear Antibody Indirect Immunofluorescence Assay in Routine Use

Cited by 10 publications

References 37 publications

Systemic Sclerosis-Specific Antibodies: Novel and Classical Biomarkers

Systemic Sclerosis-Specific Antibodies: Novel and Classical Biomarkers

Significance of co-positivity for anti-dsDNA, -nucleosome, and -histone antibodies in patients with lupus nephritis

Diagnostic Value of Anti-Nuclear Antibodies: Results From Korean University-Affiliated Hospitals

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