{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:52:59Z","timestamp":1792788779332,"version":"4.5.0"},"reference-count":31,"publisher":"Walter de Gruyter GmbH","funder":[{"name":"The National Natural Science Foundation of China","award":["82300104"],"award-info":[{"award-number":["82300104"]}],"id":[{"id":"https:\/\/ror.org\/01h0zpd94","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2026-1012_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Interlaboratory variability in HEp-2 indirect immunofluorescence assay (IFA) interpretation remains a major challenge. Conventional agreement metrics quantify disagreement but do not distinguish discrepancies by diagnostic relevance. We aimed to develop a likelihood ratio (LR)-based framework for clinically informed assessment of interpretation variability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-1012_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Pattern-specific positive LRs were derived from 33,690 routine HEp-2 IFA records and used to classify patterns into four risk tiers. A pattern discrepancy score (PDS) was developed to quantify discrepancies according to risk-tier displacement. Interlaboratory variability was assessed using a standardized 200-specimen panel tested by 18 laboratories, and diagnostic performance was explored in six laboratories.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-1012_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Pattern disagreement rates ranged from 17.5 to 50.0\u202f%. PDS strongly correlated with disagreement rate (Spearman\u2019s \u03c1=0.936, p&lt;0.001), but laboratories with similar disagreement rates differed in cross-tier discrepancy distribution. Most discrepancies remained within the same risk tier; among discordant interpretations involving high-risk reference patterns, 20.4\u202f% crossed into another tier. Pattern concordance varied markedly, while titer agreement was moderate to almost perfect (weighted \u03ba, 0.569\u20130.821). Across six laboratories, diagnostic performance varied (Youden Index, 0.391\u20130.617), but was not significantly associated with interpretation consistency.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-1012_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>HEp-2 IFA interpretation variability differs in both frequency and potential diagnostic relevance. The LR-based framework and PDS complement conventional agreement measures by identifying discrepancies that alter diagnostic risk classification, potentially supporting risk-oriented proficiency assessment and targeted quality improvement.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2026-1012","type":"journal-article","created":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T21:01:32Z","timestamp":1790715692000},"source":"Crossref","is-referenced-by-count":0,"title":["An LR-based risk stratification framework for assessing interlaboratory variability in HEp-2 IFA pattern interpretation"],"prefix":"10.1515","author":[{"given":"Chaochao","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine , Renji Hospital, Shanghai Jiao Tong University School of Medicine , Shanghai , China"},{"name":"Department of Laboratory Medicine , SK WuXi Hospital , Wuxi , Jiangsu Province , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingxin","family":"Dai","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Renji Hospital, Shanghai Jiao Tong University School of Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Shanghai Public Health Clinical Center , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rong","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory , Shanghai Children\u2019s Medical Center, School of Medicine, Shanghai Jiao Tong University , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyuan","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifan","family":"Gong","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Eye and ENT Hospital of Fudan University , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anni","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Medicine , Shanghai Skin Disease Hospital, School of Medicine, Tongji University , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaowei","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Ningbo Hangzhou Bay Hospital , Ningbo , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aiping","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Huashan Hospital, Fudan University , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiantian","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Longhua Hospital, Shanghai University of Traditional Chinese Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ce","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenjuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongkun","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Shanghai Changzheng Hospital, Naval Medical University , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Zhongshan Hospital, Fudan University , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiwen","family":"Yao","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Shanghai Tongji Hospital, Tongji University School of Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Shanghai Tenth People\u2019s Hospital, Tongji University School of Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Obstetrics & Gynecology Hospital of Fudan University, Shanghai Key Lab of Reproduction and Development, Shanghai Key Lab of Female Reproductive Endocrine Related Diseases , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haiyin","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaimin","family":"Mao","sequence":"additional","affiliation":[{"name":"Department of Critical Care Medicine , Renji Hospital, Shanghai Jiao Tong University 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