Annals of Laboratory Medicine最新文献

{"title":"Automated Post-Analytical Workflow for Newborn Screening Using a Hybrid Rule-Based and Retrieval-Augmented Large Language Model System.","authors":"Se-Eun Koo, Soo-Ho Yu, Hyun-Woo Lee, Gyujin Lim, Hyung-Doo Park, Soo-Youn Lee","doi":"10.3343/alm.2026.0262","DOIUrl":"https://doi.org/10.3343/alm.2026.0262","url":null,"abstract":"<p><p>Newborn screening using tandem mass spectrometry requires complex post-analytical workflows, including QC review, patient report generation, and cutoff reassessment, which are repetitive, time-consuming, and error-prone. We developed a Python-based clinical decision support system with a graphical user interface, integrating four functionalities: QC and patient result evaluation with deterministic flagging, report drafting using hybrid rule-based and retrieval-augmented generation-enabled large language models, cutoff analysis, and a source-attributed reference chatbot. All artificial intelligence (AI)-generated outputs required mandatory specialist review before release. Implementation reduced the mean per-batch post-analytical processing time from 50.5±14.8 min to 24.3±8.8 min and the cutoff evaluation time from 9.2±1.9 hr to 63.6±13.6 min. Across 20 synthetic cases representing 10 disorders, five specialists identified no major errors affecting clinical interpretation. Repeated generation from identical inputs (50 drafts) produced stable diagnostic conclusions, and all source-attributed statements cited correct sources, with 56 of 60 fully covered by the cited excerpt. Deterministic QC flagging, patient result flagging, and cutoff calculations were fully concordant with manual review. This human-in-the-loop system demonstrates the feasibility and efficiency of controlled AI integration into clinical laboratory workflows, whereas diagnostic performance requires further validation using confirmed-positive specimens and human-comparator benchmarks.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital Morphology Analyzer-Based White Blood Cell Differentials: Practical Considerations for External Quality Assessment.","authors":"Hongkyung Kim, Oh Joo Kweon, Sumi Yoon, Yong Kwan Lim, Bohyun Kim","doi":"10.3343/alm.2026.0097","DOIUrl":"https://doi.org/10.3343/alm.2026.0097","url":null,"abstract":"<p><strong>Background: </strong>Digital morphology (DM) analyzers are increasingly used for white blood cell (WBC) differential counting in routine hematology laboratories, necessitating tailored external quality assessment (EQA) schemes. We evaluated EQA-relevant practical considerations for DM analyzer-based WBC differentials.</p><p><strong>Methods: </strong>Fifteen clinical laboratories participated in a multicenter EQA simulation using five centrally prepared, unstained peripheral blood smear samples. Institution-level post-classification results were analyzed as the primary outcomes. Exploratory analyses were performed using pre-classification and manual microscopic differentials. Examiner-level variability within institutions was evaluated, along with the distributions of WBC-classified and unclassified images following examiner verification.</p><p><strong>Results: </strong>Most participating laboratories used DM analyzers primarily for screening WBC differentials, with predefined criteria for manual microscopic reviews, particularly when abnormal cell populations were noted. Inter-institutional and examiner-level variability were most pronounced for morphologically similar cell classes. Post-classification results were generally comparable with those of manual differentials across most cell classes. The proportion of unclassified images (including artifacts) increased, suggesting that operational and sample-related factors influenced the interpretation of the EQA results.</p><p><strong>Conclusions: </strong>We identified key practical considerations for the EQA of DM analyzer-based WBC differential counting. An appropriate EQA design should incorporate clinically relevant abnormal cell populations and challenging sample types; data interpretation should extend beyond standard deviation index-based metrics to address abnormal cell detection. The overall concordance between post-classification results and manual differentials supports the importance of periodic verification, and slide quality should be considered when implementing DM analyzer-based EQA programs.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Application of Circulating Tumor DNA in Surgically Treated Esophageal Squamous Cell Carcinoma.","authors":"Hanmil Jang, Seung Jung Han, Seong Yong Park, Dongju Won, Saeam Shin, Jong Rak Choi, Seung-Joo Yoo, Zisun Choi, Seung-Tae Lee, Dae Joon Kim","doi":"10.3343/alm.2025.0546","DOIUrl":"https://doi.org/10.3343/alm.2025.0546","url":null,"abstract":"<p><strong>Background: </strong>Esophageal squamous cell carcinoma (ESCC) is associated with a high recurrence rate and is one of the most aggressive malignancies. Recurrence is mainly detected via imaging modalities; however, postoperative imaging surveillance has disadvantages, including reduced sensitivity in postoperative or irradiated tissues, high cost, and repeated radiation exposure. Research elucidating the diagnostic utility of circulating tumor DNA (ctDNA) in ESCC remains limited. In this prospective study, we evaluated the clinical value of ctDNA as a biomarker for ESCC diagnosis and longitudinal monitoring.</p><p><strong>Methods: </strong>Eighty-four patients with pathologically confirmed ESCC who underwent curative resection were prospectively enrolled (mean age, 63.7±8.3 yrs; men, 92.9%; pathological stage 0-I, 41.7%; II, 31.0%; III-IV, 26.2%; neoadjuvant therapy, 10.7%). In total, 334 samples (84 at initial diagnosis and 250 during follow-up at 4-month intervals with computed tomography) were analyzed. Ultra-high-depth sequencing (mean effective depth, >30,000×) was performed using a customized panel targeting 27 ESCC-related genes. Matched leukocyte DNA was used to exclude germline and clonal hematopoiesis variants; variants with allele frequencies ≥ 0.25% were interpreted according to the AMP/ASCO/CAP tiers.</p><p><strong>Results: </strong>At initial diagnosis, oncogenic tier I/II variants (e.g., <i>TP53, FAT1, KMT2D</i>) were detected in 31 patients (36.9%). Detection rates were higher in advanced stages (63.6%) than in early-stage cancers (28.3%). While the initial ctDNA detection rate correlated with pTNM stages, no significant association was found with other pathological features. Follow-up assessments revealed that 18 of 24 patients with recurrence (75%) harbored detectable ctDNA variants. Notably, in three cases, ctDNA positivity preceded radiological recurrence by 3-6 months.</p><p><strong>Conclusions: </strong>The ctDNA detection rate using a customized gene panel correlated with tumor burden. Accordingly, ctDNA may be helpful for monitoring recurrence in patients with ESCC.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identification of Clinically Relevant Hb Variants During HbA1c Testing Using the ARKRAY HA-8180V in Fast Mode: Reliable HbE Detection Based on Retention Time.","authors":"Monthon Mayoon, Sitthichai Panyasai","doi":"10.3343/alm.2026.0183","DOIUrl":"https://doi.org/10.3343/alm.2026.0183","url":null,"abstract":"<p><strong>Background: </strong>Hb variants are often incidentally detected during HbA1c testing and can cause interference. We evaluated the ability of the ARKRAY HA-8180V HPLC system operating in fast mode (FM) to identify Hb variants, particularly HbE, in samples submitted for HbA1c testing based on characteristic retention times (RTs).</p><p><strong>Methods: </strong>Chromatograms of samples tested for HbA1c were analyzed; those showing predefined abnormal chromatographic patterns suggestive of Hb variants were further evaluated using capillary electrophoresis (CE) and β- and α-globin gene sequencing. RTs were recorded.</p><p><strong>Results: </strong>Of 4,888 chromatograms analyzed, 588 (12.0%) were abnormal. Among these, 564 (95.9%) showed an abnormal peak at an RT of 23-25 s and were confirmed to contain HbE via CE. Identified Hb phenotypes included EA (N=526), compound heterozygotes [Constant Spring (CS) EA, N=2; CSEE, N=1], EE (N=27), EFA (N=3), and EF (N=5). Other variants included Hb CSA₂ABart'sH, A₂FA, A₂FABart's, and A₂F. Rare variants, Hb Hope (N=12) and Hb Korle-Bu (N=1), and two uncharacterized variants were also detected. Hb Hope interfered with HbA1c measurements, and all CSA₂ABart'sH samples produced falsely low HbA1c values. Artificially decreased HbA1c was detected in 21/27 (77.8%) HbEE samples. ARKRAY HA-8180V FM analysis yielded reproducible RTs for HbE, achieving 100% sensitivity, specificity, and accuracy in the validation cohort.</p><p><strong>Conclusions: </strong>HbE and thalassemia variants can interfere with HbA1c quantification. ARKRAY HA-8180V FM chromatogram review allows reliable detection of HbE and prevents misinterpretation of HbA1c results.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148711243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implications of Incorporating Myelodysplasia-Related Gene Variant Data on Acute Myeloid Leukemia Reclassification According to WHO-HAEM5 and ICC: A Large Multicenter Korean Cohort Study.","authors":"Yu Jeong Choi, Jee-Soo Lee, Saeam Shin, In-Suk Kim, Hyun-Young Kim, Boram Kim, Hee-Jin Kim, Eunhui Ji, Hyerin Kim, Hyerim Kim, Byunggyu Bae, Yonggoo Kim, Jong-Mi Lee, Yoon Hwan Chang, Hyun Kyung Kim, Ja Young Lee, Shinae Yu, Miyoung Kim, Young-Uk Cho, Seongsoo Jang, Myungshin Kim","doi":"10.3343/alm.2026.0043","DOIUrl":"https://doi.org/10.3343/alm.2026.0043","url":null,"abstract":"<p><strong>Background: </strong>In the 5th edition of the WHO Classification of Hematopoietic Neoplasms (WHO-HAEM5) and the International Consensus Classification (ICC), acute myeloid leukemia (AML) diagnostic criteria were revised to incorporate genetic abnormalities, such as variants in myelodysplasia-related (MR) genes. As the implications of these changes on AML reclassification in Korean patients had not yet been fully evaluated, we comprehensively investigated them in this large-scale, multicenter study.</p><p><strong>Methods: </strong>We retrospectively analyzed data from 2,668 patients with AML aged ≥ 18 yrs from seven institutions who were originally diagnosed according to WHO-HAEM4R criteria. Clinical, cytogenetic, and targeted next-generation sequencing data (including MR genes and <i>TP53</i> variants) were collected and analyzed. All cases were reassessed according to both WHO-HAEM5 and ICC criteria.</p><p><strong>Results: </strong>Overall, 28.5% of patients harbored at least one MR gene variant. Among the MR genes, variants in <i>RUNX1</i> and <i>ASXL1</i> were most frequently detected. Compared with the original diagnoses, 20.3% and 29.9% of patients were reclassified to different categories according to the WHO-HAEM5 and ICC criteria, respectively. Discordance between WHO-HAEM5 and ICC classifications was 13.2%, which is largely attributed to the inclusion of \"AMLs with <i>TP53</i>\" variants in the ICC. AML-MR was associated with older age, male predominance, and poorer survival compared with AML, not otherwise specified. Patients with recurrent fusion genes largely retained their original classification.</p><p><strong>Conclusions: </strong>Incorporating MR gene variant data and <i>TP53</i>-variant status in diagnosis influenced AML classification and risk stratification in our cohort, highlighting the potential importance of comprehensive molecular profiling in AML characterization.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148700726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analytical Performance Specifications Derived from External Quality Assessment Data: Comparison with Biological Variation-Based Models for Intermediate Precision Assessment.","authors":"Claudio Ilardo, Emmanuel Reynaud, Nathalie Benaily","doi":"10.3343/alm.2026.0092","DOIUrl":"https://doi.org/10.3343/alm.2026.0092","url":null,"abstract":"<p><strong>Background: </strong>Analytical performance specifications (APSs) are essential for quality management in medical laboratories. Considering the discrepancies between laboratory performance and existing guidelines, lack of consideration of concentration-dependent variability, and absence of recommendations for certain parameters, we aimed to define APSs for internal use in biochemistry, hemostasis, and hematology based on external quality assessment (EQA) peer group data and evaluate their suitability for intermediate precision assessment versus biological variation (BV)-based APSs.</p><p><strong>Methods: </strong>EQA-based allowable CV (CV<i>_allowable</i>) was estimated from pooled CVs derived from EQA peer group results. Allowable bias, expanded measurement uncertainty, and total allowable error were calculated. CV<i>_allowable</i> targets were assessed using intermediate precision data from different analytical systems within a laboratory group and compared with BV-based APSs. Concordance between theoretical specifications derived from mathematical models and observed analytical performance (AP) was evaluated using (i) the proportion of internal QC CVs meeting the predefined CV<i>_allowable</i> across laboratories and (ii) observed analytical imprecision expressed as a percentage of the allowable imprecision budget.</p><p><strong>Results: </strong>APSs were established for 110 biochemical analytes, 23 hemostasis parameters, and 28 hematology parameters across different concentration ranges. EQA-derived APSs agreed with observed intermediate precision for 102 biochemical, 14 hemostasis, and 24 hematology parameters. BV-based APSs showed agreement for only 49 biochemical, two hemostasis, and 11 hematology parameters, while overly restrictive goals or lack of agreement were observed for several analytes.</p><p><strong>Conclusions: </strong>APSs derived from pooled EQA peer group data provide realistic and technically achievable intermediate precision targets consistent with current AP and thus can complement BV-based specifications.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148683224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-Based Real-Time Quality Control for Semiquantitative Tests Based on Hierarchical Differences.","authors":"Yuanyuan Li, Xiaoling Chen, Ying Zhao","doi":"10.3343/alm.2026.0055","DOIUrl":"https://doi.org/10.3343/alm.2026.0055","url":null,"abstract":"<p><strong>Background: </strong>With developments in artificial intelligence, patient-based real-time quality control (PBRTQC) has advanced. However, its application to semiquantitative tests remains unreported. Taking urine protein (URP), a semiquantitative parameter in routine urinalysis, as an example, we explored the application of PBRTQC in semiquantitative tests.</p><p><strong>Methods: </strong>We assessed the correlation between URP and the quantitative parameter, urine total protein (UTP). Measurement results for both analytes were classified into five grades to calculate hierarchical differences (HDs). Three HD-based algorithms were established: the moving rate of inconsistency (MRI), moving average of HDs (MAHD), and moving average of absolute HDs (MAAD). Their performance was compared with that of the moving rate of positive results (MRP) using computer simulations to evaluate the detection of systematic errors (SEs) and random errors (REs). Anti-interference capability was evaluated by rearranging the sample sequence.</p><p><strong>Results: </strong>The MRP method detected SEs but failed to monitor REs. Compared with MRP, HD-based algorithms reduced the median number of patients affected before detection at critical errors by 83.1% for SEs and by 94.2% for REs. MRI, MAHD and MAAD showed significantly improved detection capabilities for SEs and, particularly, REs. Regarding anti-interference, rearranging the sample sequence significantly deteriorated MRP performance, whereas the HD-based algorithms remained unaffected and stable.</p><p><strong>Conclusions: </strong>The novel HD-based algorithms demonstrate superior error detection and anti-interference capabilities compared with MRP. This study provides an effective PBRTQC strategy for semiquantitative tests by leveraging related quantitative data.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148676808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic Gaps as a Hidden Barrier to Hantavirus Vaccine Development.","authors":"Roshan Shaikh","doi":"10.3343/alm.2026.0292","DOIUrl":"https://doi.org/10.3343/alm.2026.0292","url":null,"abstract":"","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148668302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Validation of AurisC2-ID, a Fourier-Transform Infrared Spectroscopy Classifier for Differentiation of Clade II and Non-Clade II <i>Candida auris</i> Isolates.","authors":"Yong Jun Kwon, Jung-Ah Kim, Hyunseul Choi, Minhee Kang, Yukyung Jeon, Tae Yeul Kim, Eun Jeong Won","doi":"10.3343/alm.2026.0156","DOIUrl":"https://doi.org/10.3343/alm.2026.0156","url":null,"abstract":"<p><p><i>Candida auris</i> clade II isolates are generally more susceptible to antifungal agents and are less frequently associated with outbreaks than non-clade II isolates. We developed and validated a Fourier-transform infrared (FTIR) spectroscopy-based classifier (AurisC2-ID) to distinguish clade II from non-clade II <i>C. auris</i> isolates. In total, 106 <i>C. auris</i> isolates col-lected from 14 Korean hospitals, representing clades I and II, and 10 reference isolates from the Centers for Disease Control and Prevention and Food and Drug Administration Antimicrobial Resistance Isolate Bank, representing four clades (I-IV), were analyzed using FTIR spectroscopy (IR Biotyper; Bruker Daltonics, Bremen, Germany) as the training set for classifier development. The classifier was constructed using an artificial neural network al-gorithm following principal component analysis and was validated using 87 additional clini-cal isolates collected from nine Korean hospitals. The training set spectra showed clear separation between clade II and non-clade II isolates, with minor overlap between the two groups. During validation, all 31 clade II isolates were correctly classified as clade II, and the remaining 56 clade I isolates as non-clade II. These results demonstrate that AurisC2-ID can accurately distinguish clade II from non-clade II <i>C. auris</i> isolates and may serve as a useful tool for infection control in Korea.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148576326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance of the Line Blot Immunoassay for Detecting Myositis Autoantibodies in Real-Life Laboratory Settings: An Italian Multicenter Study.","authors":"Anna Ghirardello,Maria Infantino,Nicoletta Gallo,Francesca Buzzulini,Elisabetta Zanatta,Chiara Franco,Nicola Bizzaro,Danilo Villalta,Paola Migliorini,Roberta Ramonda,Luca Iaccarino, ","doi":"10.3343/alm.2026.0024","DOIUrl":"https://doi.org/10.3343/alm.2026.0024","url":null,"abstract":"BackgroundCommercial line immunoassays (LIAs) are used to detect myositis-specific and myositis-associated autoantibodies (MSAs/MAAs) in patients with suspected idiopathic inflammatory myopathy (IIM). However, performance consistency with LIAs remains challenging. We evaluated the appropriateness, clinical consistency, and diagnostic performance of MSA/MAA LIA testing in real-life clinical practice.MethodsBetween January and December 2024, eight Italian laboratories performed 1,127 MSA/MAA LIA determinations (Euroline Myopathies 16 Ags plus cN-1A). LIA appropriateness was defined as concordance between the clinical information provided and the MSA/MAA request; clinical consistency was defined as agreement between the IIM diagnosis and LIA results; and diagnostic performance was defined as the reliability of LIA in confirming an IIM diagnosis.ResultsMSA/MAA positivity was observed with 564/1,127 (50.1%) LIA requests. LIA appropriateness and consistency were 31.6% and 51.3%, respectively. Of the 1,127 LIA requests, 666 (59.1%) included a clinical diagnosis. The appropriateness and consistency of the 666 LIA reports were 53.4% and 86.8%, respectively. Among the 666 patients, 337 (50.6%) were diagnosed as having IIM, and 329 (49.4%) were diagnosed as having a non-IIM disease. In patients with IIM, 288/337 (85.4%) received true-positive MSA/MAA LIA results, whereas 105/329 (31.9%) of patients with non-IIM disease received false-positive results (P<0.001). Significant positive odds ratios were observed for anti-Jo-1, anti-MDA5, anti-PM-Scl-75/100, and MSA-associated anti-Ro52 antibodies (P<0.001).ConclusionsWith increasing MSA/MAA requests for suspected IIM, LIA testing can help identify certain antibodies in real-life scenarios. The appropriateness of the request and the clinical information provided mainly influence the LIA diagnostic performance.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"19 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148372793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}