Harmonization of anti-nuclear antibody testing (ANA) by indirect immunofluorescence assay: Results from ten years of UK NEQAS external quality assessment

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Clinica Chimica Acta Pub Date : 2025-02-01 DOI:10.1016/j.cca.2024.120088

Maria Infantino , Teresa Carbone , Dina Patel , Ravishankar Sargur , Carol Stanley , Amina Bhayat-Cammack , Emirena Garrafa , Silvia Pancani , Mariangela Manfredi , Luis E.C. Andrade , Nicola Bizzaro

{"title":"Harmonization of anti-nuclear antibody testing (ANA) by indirect immunofluorescence assay: Results from ten years of UK NEQAS external quality assessment","authors":"Maria Infantino , Teresa Carbone , Dina Patel , Ravishankar Sargur , Carol Stanley , Amina Bhayat-Cammack , Emirena Garrafa , Silvia Pancani , Mariangela Manfredi , Luis E.C. Andrade , Nicola Bizzaro","doi":"10.1016/j.cca.2024.120088","DOIUrl":null,"url":null,"abstract":"<div><div>External quality assurance (EQA) programs play a pivotal role in monitoring laboratory practices, allowing each laboratory to evaluate the consistency of results across different methods as well the ability of individual laboratories to compare and improve over time their own performance.</div><div>The objective of our study was to analyze the UK NEQAS EQA reports for the “Antibodies to Nuclear and Related Antigens” program from 2013 to 2023, to assess the overall level of harmonization of the responses for anti-nuclear antibody (ANA) testing by indirect immunofluorescence (IIF), in terms of both pattern and titer consensus. As a second aim, we analyzed the impact of the introduction in UK NEQAS EQA reports of the International Consensus on ANA Patterns (ICAP) nomenclature and of digital image recognition on the harmonization of the ANA HEp-2 IIF test.</div><div>The percentage of consensus for positive/negative results was significantly higher (90.9 ± 1.4) in 2023 than in 2013 (64.0 ± 7.8, p < 0.001). Common to all years in the investigated period, consensus on pattern recognition was significantly lower for the homogenous pattern (70.5 ± 16.0) compared to the centromere (84.9 ± 14.9), the speckled (90.3 ± 12.3), and the negative (84.5 ± 18.6, p < 0.001) samples, while it was significantly higher for titers 1:80–1:320 than for titers > 1:320 (p < 0.001).</div><div>The difference between manual reading and digital reading was not significant (93.8 % <em>vs</em>. 92.4 %; p = 0.078), but it was significant between the pre- and post-use of the ICAP nomenclature (82.6 % <em>vs</em>. 93.8 %; p < 0.001).</div><div>This study shows that the variability in ANA recognition and reporting is pattern (homogeneous > speckled > centromere) and titer (high titer > low titer) dependent. While we did not find any difference between the use of manual reading compared to digital reading, the adoption of the ICAP nomenclature greatly improved the harmonization of ANA reporting.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"567 ","pages":"Article 120088"},"PeriodicalIF":3.2000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0009898124023416","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

External quality assurance (EQA) programs play a pivotal role in monitoring laboratory practices, allowing each laboratory to evaluate the consistency of results across different methods as well the ability of individual laboratories to compare and improve over time their own performance.

The objective of our study was to analyze the UK NEQAS EQA reports for the “Antibodies to Nuclear and Related Antigens” program from 2013 to 2023, to assess the overall level of harmonization of the responses for anti-nuclear antibody (ANA) testing by indirect immunofluorescence (IIF), in terms of both pattern and titer consensus. As a second aim, we analyzed the impact of the introduction in UK NEQAS EQA reports of the International Consensus on ANA Patterns (ICAP) nomenclature and of digital image recognition on the harmonization of the ANA HEp-2 IIF test.

The percentage of consensus for positive/negative results was significantly higher (90.9 ± 1.4) in 2023 than in 2013 (64.0 ± 7.8, p < 0.001). Common to all years in the investigated period, consensus on pattern recognition was significantly lower for the homogenous pattern (70.5 ± 16.0) compared to the centromere (84.9 ± 14.9), the speckled (90.3 ± 12.3), and the negative (84.5 ± 18.6, p < 0.001) samples, while it was significantly higher for titers 1:80–1:320 than for titers > 1:320 (p < 0.001).

The difference between manual reading and digital reading was not significant (93.8 % vs. 92.4 %; p = 0.078), but it was significant between the pre- and post-use of the ICAP nomenclature (82.6 % vs. 93.8 %; p < 0.001).

This study shows that the variability in ANA recognition and reporting is pattern (homogeneous > speckled > centromere) and titer (high titer > low titer) dependent. While we did not find any difference between the use of manual reading compared to digital reading, the adoption of the ICAP nomenclature greatly improved the harmonization of ANA reporting.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

间接免疫荧光法统一抗核抗体检测（ANA）：英国NEQAS 10年外部质量评价结果

外部质量保证（EQA）计划在监控实验室实践中发挥着关键作用，允许每个实验室评估不同方法结果的一致性，以及单个实验室比较和改进自身绩效的能力。本研究的目的是分析2013年至2023年英国NEQAS“核及相关抗原抗体”项目的EQA报告，以评估间接免疫荧光（IIF）检测抗核抗体（ANA）反应的总体协调水平，包括模式和滴度一致性。作为第二个目标，我们分析了在英国NEQAS EQA报告中引入国际ANA模式共识（ICAP）命名法和数字图像识别对ANA HEp-2 IIF测试统一的影响。共识正面/负面结果的比例明显高于(90.9 ±1.4 )2023年比2013年(64.0 ± 7.8,p  1:320 (p  斑点 > 着丝粒)和效价(高效价 > 低效价)相关的。虽然我们没有发现手工阅读与数字阅读之间的差异，但采用ICAP命名法大大提高了ANA报告的协调性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.