1.Development and Validation of a Lectin-independent Liquid Chromatography–Tandem Mass Spectrometry Method for Serum Glycosylated Alpha-fetoprotein Analysis and Comparison with a Liquid-phase Binding Assay
Hyojin KIM ; Juri PARK ; Hanseul SUH ; Saeyoung LEE ; Yoonha PARK ; Won Suk YANG ; Dohsik MINN ; Soon Sun KIM ; Jae Youn CHEONG ; Je-Hyun BAEK
Annals of Laboratory Medicine 2026;46(1):62-71
Background:
Alpha-fetoprotein (AFP) and its isoform AFP-L3 are well-established serum biomarkers for hepatocellular carcinoma (HCC), a common malignancy and a leading cause of cancer-related mortality worldwide. Current methods for measuring these biomarkers are primarily lectin-based assays including the liquid-phase binding assay (LiBA) and liquid chromatography–tandem mass spectrometry (LC-MS/MS), both of which have limitations in diagnostic sensitivity and clinical utility for samples with low AFP concentrations. We aimed to develop a lectin-independent LC-MS/MS method for quantifying fucosylated AFP proteins (AFP-Fuc%).
Methods:
We conducted analytical validation, including method comparisons, over 2 months. The analytical sensitivity and diagnostic performance of this method were evaluated using 525 human serum samples—235 from HCC patients and 290 from non-HCC individuals—and compared with those of LiBA, which measured AFP-L3 levels.
Results:
The LC-MS/MS method demonstrated acceptable within-laboratory imprecision (CVs < 17.1%) without detectable bias, carryover, or matrix effects. Our method exhibited a broader linear dynamic range (spanning five orders of magnitude) and 10-fold higher analytical sensitivity than LiBA. The diagnostic performance of our method was significantly superior to that of LiBA, particularly in patients with low AFP concentrations ( < 7 ng/mL, P < 0.001), with improved accuracy, sensitivity, and precision at a specificity of 96.2%.
Conclusions
The validated LC-MS/MS method demonstrated robust analytical performance and superior diagnostic accuracy over LiBA for HCC diagnosis while avoiding the inherent limitations of lectin-based assays. Our LC-MS/MS assay shows promise for early HCC detection and may contribute to enhanced patient care.
2.Profiling of Anti-Signal-Recognition Particle Antibodies and Clinical Characteristics in South Korean Patients With Immune-Mediated Necrotizing Myopathy
Soo-Hyun KIM ; Yunjung CHOI ; Eun Kyoung OH ; Ichizo NISHINO ; Shigeaki SUZUKI ; Bum Chun SUH ; Ha Young SHIN ; Seung Woo KIM ; Byeol-A YOON ; Seong-il OH ; Yoo Hwan KIM ; Hyunjin KIM ; Young-Min LIM ; Seol-Hee BAEK ; Je-Young SHIN ; Hung Youl SEOK ; Seung-Ah LEE ; Young-Chul CHOI ; Hyung Jun PARK
Journal of Clinical Neurology 2025;21(1):31-39
Background:
and Purpose This study evaluated the diagnostic utility of an anti-signal-recognition particle 54 (anti-SRP54) antibody-based enzyme-linked immunosorbent assay (ELISA) as well as the clinical, serological, and pathological characteristics of patients with SRP immune-mediated necrotizing myopathy (IMNM).
Methods:
We evaluated 87 patients with idiopathic inflammatory myopathy and 107 healthy participants between January 2002 and December 2023. The sensitivity and specificity of the ELISA for anti-SRP54 antibodies were assessed, and the clinical profiles of patients with antiSRP54 antibodies were determined.
Results:
The ELISA for anti-SRP54 antibodies had a sensitivity and specificity of 88% and 99%, respectively, along with a test–retest reliability of 0.92 (p<0.001). The 32 patients diagnosed with anti-SRP IMNM using a line-blot immunoassay included 28 (88%) who tested positive for anti-SRP54 antibodies using the ELISA, comprising 12 (43%) males and 16 (57%) females whose median ages at symptom onset and diagnosis were 43.0 years and 43.5 years, respectively. Symptoms included proximal muscle weakness in all 28 (100%) patients, neck weakness in 9 (32%), myalgia in 15 (54%), dysphagia in 5 (18%), dyspnea in 4 (14%), dysarthria in 2 (7%), interstitial lung disease in 2 (7%), and myocarditis in 2 (7%). The median serum creatine kinase (CK) level was 7,261 U/L (interquartile range: 5,086–10,007 U/L), and the median anti-SRP54 antibody level was 2.0 U/mL (interquartile range: 1.0–5.6 U/mL). The serum CK level was significantly higher in patients with coexisting anti-Ro-52 antibodies.
Conclusions
This study has confirmed the reliability of the ELISA for anti-SRP54 antibodies and provided insights into the clinical, serological, and pathological characteristics of South Korean patients with anti-SRP IMNM.
3.Profiling of Anti-Signal-Recognition Particle Antibodies and Clinical Characteristics in South Korean Patients With Immune-Mediated Necrotizing Myopathy
Soo-Hyun KIM ; Yunjung CHOI ; Eun Kyoung OH ; Ichizo NISHINO ; Shigeaki SUZUKI ; Bum Chun SUH ; Ha Young SHIN ; Seung Woo KIM ; Byeol-A YOON ; Seong-il OH ; Yoo Hwan KIM ; Hyunjin KIM ; Young-Min LIM ; Seol-Hee BAEK ; Je-Young SHIN ; Hung Youl SEOK ; Seung-Ah LEE ; Young-Chul CHOI ; Hyung Jun PARK
Journal of Clinical Neurology 2025;21(1):31-39
Background:
and Purpose This study evaluated the diagnostic utility of an anti-signal-recognition particle 54 (anti-SRP54) antibody-based enzyme-linked immunosorbent assay (ELISA) as well as the clinical, serological, and pathological characteristics of patients with SRP immune-mediated necrotizing myopathy (IMNM).
Methods:
We evaluated 87 patients with idiopathic inflammatory myopathy and 107 healthy participants between January 2002 and December 2023. The sensitivity and specificity of the ELISA for anti-SRP54 antibodies were assessed, and the clinical profiles of patients with antiSRP54 antibodies were determined.
Results:
The ELISA for anti-SRP54 antibodies had a sensitivity and specificity of 88% and 99%, respectively, along with a test–retest reliability of 0.92 (p<0.001). The 32 patients diagnosed with anti-SRP IMNM using a line-blot immunoassay included 28 (88%) who tested positive for anti-SRP54 antibodies using the ELISA, comprising 12 (43%) males and 16 (57%) females whose median ages at symptom onset and diagnosis were 43.0 years and 43.5 years, respectively. Symptoms included proximal muscle weakness in all 28 (100%) patients, neck weakness in 9 (32%), myalgia in 15 (54%), dysphagia in 5 (18%), dyspnea in 4 (14%), dysarthria in 2 (7%), interstitial lung disease in 2 (7%), and myocarditis in 2 (7%). The median serum creatine kinase (CK) level was 7,261 U/L (interquartile range: 5,086–10,007 U/L), and the median anti-SRP54 antibody level was 2.0 U/mL (interquartile range: 1.0–5.6 U/mL). The serum CK level was significantly higher in patients with coexisting anti-Ro-52 antibodies.
Conclusions
This study has confirmed the reliability of the ELISA for anti-SRP54 antibodies and provided insights into the clinical, serological, and pathological characteristics of South Korean patients with anti-SRP IMNM.
4.Profiling of Anti-Signal-Recognition Particle Antibodies and Clinical Characteristics in South Korean Patients With Immune-Mediated Necrotizing Myopathy
Soo-Hyun KIM ; Yunjung CHOI ; Eun Kyoung OH ; Ichizo NISHINO ; Shigeaki SUZUKI ; Bum Chun SUH ; Ha Young SHIN ; Seung Woo KIM ; Byeol-A YOON ; Seong-il OH ; Yoo Hwan KIM ; Hyunjin KIM ; Young-Min LIM ; Seol-Hee BAEK ; Je-Young SHIN ; Hung Youl SEOK ; Seung-Ah LEE ; Young-Chul CHOI ; Hyung Jun PARK
Journal of Clinical Neurology 2025;21(1):31-39
Background:
and Purpose This study evaluated the diagnostic utility of an anti-signal-recognition particle 54 (anti-SRP54) antibody-based enzyme-linked immunosorbent assay (ELISA) as well as the clinical, serological, and pathological characteristics of patients with SRP immune-mediated necrotizing myopathy (IMNM).
Methods:
We evaluated 87 patients with idiopathic inflammatory myopathy and 107 healthy participants between January 2002 and December 2023. The sensitivity and specificity of the ELISA for anti-SRP54 antibodies were assessed, and the clinical profiles of patients with antiSRP54 antibodies were determined.
Results:
The ELISA for anti-SRP54 antibodies had a sensitivity and specificity of 88% and 99%, respectively, along with a test–retest reliability of 0.92 (p<0.001). The 32 patients diagnosed with anti-SRP IMNM using a line-blot immunoassay included 28 (88%) who tested positive for anti-SRP54 antibodies using the ELISA, comprising 12 (43%) males and 16 (57%) females whose median ages at symptom onset and diagnosis were 43.0 years and 43.5 years, respectively. Symptoms included proximal muscle weakness in all 28 (100%) patients, neck weakness in 9 (32%), myalgia in 15 (54%), dysphagia in 5 (18%), dyspnea in 4 (14%), dysarthria in 2 (7%), interstitial lung disease in 2 (7%), and myocarditis in 2 (7%). The median serum creatine kinase (CK) level was 7,261 U/L (interquartile range: 5,086–10,007 U/L), and the median anti-SRP54 antibody level was 2.0 U/mL (interquartile range: 1.0–5.6 U/mL). The serum CK level was significantly higher in patients with coexisting anti-Ro-52 antibodies.
Conclusions
This study has confirmed the reliability of the ELISA for anti-SRP54 antibodies and provided insights into the clinical, serological, and pathological characteristics of South Korean patients with anti-SRP IMNM.
5.Chromosomal Rearrangements in 1,787 Cases of Acute Leukemia in Korea over 15 Years
DongGeun SON ; Ho Cheol JANG ; Young Eun LEE ; Yong Jun CHOI ; Joo Heon PARK ; Ha Jin LIM ; Hyun-Jung CHOI ; Hee Jo BAEK ; Hoon KOOK ; Mihee KIM ; Ga-Young SONG ; Seo-Yeon AHN ; Sung-Hoon JUNG ; Deok-Hwan YANG ; Je-Jung LEE ; Hyeonug-Joon KIM ; Jae-Sook AHN ; Myung-Geun SHIN
Annals of Laboratory Medicine 2025;45(4):391-398
Background:
Chromosomal alterations serve as diagnostic and prognostic markers in acute leukemia. Given the evolving landscape of chromosomal abnormalities in acute leukemia, we previously studied these over two periods. In this study, we investigated the frequency of these abnormalities and clinical trends in acute leukemia in Korea across three time periods.
Methods:
We retrospectively analyzed data from 1,787 patients with acute leukemia (319 children and 1,468 adults) diagnosed between 2006 and 2020. Conventional cytogenetics, FISH, and multiplex quantitative PCR were used for analysis. The patient groups were divided according to the following three study periods: 2006–2009 (I), 2010–2015 (II), and 2016–2020 (III).
Results:
Chromosomal aberrations were detected in 92% of patients. The PML::RARA translocation was the most frequent. Over the 15-yr period, chromosomal aberrations showed minimal changes, with specific fusion transcripts being common among patients.ALL was more prevalent in children than in adults and correlated significantly with the ETV6::RUNX1 and RUNX1::RUNX1T1 aberrations. The incidence of ALL increased during the three periods, with PML::RARA remaining common.
Conclusions
The frequency of chromosomal abnormalities in acute leukemia has changed subtly over time. Notably, the age of onset of adult AML has continuously increased. Our results may help in establishing diagnoses and clinical treatment strategies and developing various molecular diagnostic platforms.
6.Human dermal allograft patch cushioning augmentation in large rotator cuff repair
Eugene BAEK ; Eugene BAEK ; Hyun Gon KIM ; Hyun Gon KIM ; Jong Hyun LEE ; Jong Hyun LEE ; Seung Jin YOO ; Seung Jin YOO ; Je Hyeong JO ; Je Hyeong JO ; Su Cheol KIM ; Su Cheol KIM ; Jae Chul YOO ; Jae Chul YOO
Clinics in Shoulder and Elbow 2025;28(4):489-494
In large posterosuperior rotator cuff tears, retear is more likely due to factors such as poor tendon quality, tendon loss, incomplete footprint coverage, and incomplete repair. To reduce the retear rate and promote healing, various strategies have been explored, including augmentation using a human acellular dermal matrix (HADM) allograft patch. However, the traditional patch augmentation with a suture-bridge configuration is complicated and time consuming. Another method to alleviate impingement between the repaired tendon and acromion, similar to the ballooning effect in the subacromial space, is the acromiograft technique. However, a thin acromion may lead to fractures, and such a graft is less likely to incorporate with the repaired tendon. To address these concerns, we developed a new technique that enhances healing through direct contact with the repaired tendon, alleviates impingement with a spacer effect, and simplifies the procedure while ensuring adequate medial coverage including the musculotendinous junction. This article describes our “patch cushioning technique” using an HADM allograft. The present report provides a purely technical description of the procedure.
7.Identification of signature gene set as highly accurate determination of metabolic dysfunction-associated steatotic liver disease progression
Sumin OH ; Yang-Hyun BAEK ; Sungju JUNG ; Sumin YOON ; Byeonggeun KANG ; Su-hyang HAN ; Gaeul PARK ; Je Yeong KO ; Sang-Young HAN ; Jin-Sook JEONG ; Jin-Han CHO ; Young-Hoon ROH ; Sung-Wook LEE ; Gi-Bok CHOI ; Yong Sun LEE ; Won KIM ; Rho Hyun SEONG ; Jong Hoon PARK ; Yeon-Su LEE ; Kyung Hyun YOO
Clinical and Molecular Hepatology 2024;30(2):247-262
Background/Aims:
Metabolic dysfunction-associated steatotic liver disease (MASLD) is characterized by fat accumulation in the liver. MASLD encompasses both steatosis and MASH. Since MASH can lead to cirrhosis and liver cancer, steatosis and MASH must be distinguished during patient treatment. Here, we investigate the genomes, epigenomes, and transcriptomes of MASLD patients to identify signature gene set for more accurate tracking of MASLD progression.
Methods:
Biopsy-tissue and blood samples from patients with 134 MASLD, comprising 60 steatosis and 74 MASH patients were performed omics analysis. SVM learning algorithm were used to calculate most predictive features. Linear regression was applied to find signature gene set that distinguish the stage of MASLD and to validate their application into independent cohort of MASLD.
Results:
After performing WGS, WES, WGBS, and total RNA-seq on 134 biopsy samples from confirmed MASLD patients, we provided 1,955 MASLD-associated features, out of 3,176 somatic variant callings, 58 DMRs, and 1,393 DEGs that track MASLD progression. Then, we used a SVM learning algorithm to analyze the data and select the most predictive features. Using linear regression, we identified a signature gene set capable of differentiating the various stages of MASLD and verified it in different independent cohorts of MASLD and a liver cancer cohort.
Conclusions
We identified a signature gene set (i.e., CAPG, HYAL3, WIPI1, TREM2, SPP1, and RNASE6) with strong potential as a panel of diagnostic genes of MASLD-associated disease.
8.The impact of supraspinatus tear on subscapularis muscle atrophy and fatty infiltration
Su Cheol KIM ; Seung Jin YOO ; Je Hyeong JO ; Jong Hyun LEE ; Eugene BAEK ; Sang Min LEE ; Jae Chul YOO
Clinics in Shoulder and Elbow 2024;27(4):437-446
Background:
Aimed to report the prevalence and predisposing factors affecting subscapularis muscle atrophy and fatty infiltration (MAFI) in patients without a subscapularis tear, and to analyze the effect of this condition on surgical outcomes.
Methods:
Between 2020 and 2022, 153 patients (mean age 58.1 ± 10.2 years; 84 men and 69 women) who underwent repair of posterosuperior cuff tears, with no subscapularis tears identified during arthroscopy were retrospectively analyzed. Baseline characteristics, preoperative and follow-up (6 months) magnetic resonance imaging findings, arthroscopic findings, and clinical outcomes (>1 year) were recorded.
Results:
The prevalence of subscapularis MAFI (Goutallier grade 1 or 2) was 73.9% (113/153), of which the prevalence of Goutallier grade 2 was 23.5% (36/153). From multivariable logistic regression analysis, female sex (odds ratio [OR], 5.6; 95% CI, 1.7–18.6; P=0.005), older age (OR, 1.1; 95% CI, 1.0–1.1; P=0.052), advanced supraspinatus MAFI by Goutallier grade (OR, 3.2; 95% CI, 1.5–6.9; P=0.004), and synovitis (OR, 2.8; 95% CI, 1.1–7.9; P=0.030) were identified as independent predisposing factors for subscapularis MAFI. However, patients with preoperative subscapularis MAFI exhibited similar final range of motion, pain and function, and belly press strength compared to those without preoperative subscapularis MAFI.
Conclusions
Subscapularis MAFI is frequently observed conditions even in the absence of subscapularis tears, and this condition could be affected by supraspinatus MAFI, female sex, older age, and synovitis. However, because subscapularis MAFI does not affect the surgical outcome, surgeons need not be concerned about this condition when repairing posterosuperior rotator cuff tear.Level of evidence: IV.
9.The impact of supraspinatus tear on subscapularis muscle atrophy and fatty infiltration
Su Cheol KIM ; Seung Jin YOO ; Je Hyeong JO ; Jong Hyun LEE ; Eugene BAEK ; Sang Min LEE ; Jae Chul YOO
Clinics in Shoulder and Elbow 2024;27(4):437-446
Background:
Aimed to report the prevalence and predisposing factors affecting subscapularis muscle atrophy and fatty infiltration (MAFI) in patients without a subscapularis tear, and to analyze the effect of this condition on surgical outcomes.
Methods:
Between 2020 and 2022, 153 patients (mean age 58.1 ± 10.2 years; 84 men and 69 women) who underwent repair of posterosuperior cuff tears, with no subscapularis tears identified during arthroscopy were retrospectively analyzed. Baseline characteristics, preoperative and follow-up (6 months) magnetic resonance imaging findings, arthroscopic findings, and clinical outcomes (>1 year) were recorded.
Results:
The prevalence of subscapularis MAFI (Goutallier grade 1 or 2) was 73.9% (113/153), of which the prevalence of Goutallier grade 2 was 23.5% (36/153). From multivariable logistic regression analysis, female sex (odds ratio [OR], 5.6; 95% CI, 1.7–18.6; P=0.005), older age (OR, 1.1; 95% CI, 1.0–1.1; P=0.052), advanced supraspinatus MAFI by Goutallier grade (OR, 3.2; 95% CI, 1.5–6.9; P=0.004), and synovitis (OR, 2.8; 95% CI, 1.1–7.9; P=0.030) were identified as independent predisposing factors for subscapularis MAFI. However, patients with preoperative subscapularis MAFI exhibited similar final range of motion, pain and function, and belly press strength compared to those without preoperative subscapularis MAFI.
Conclusions
Subscapularis MAFI is frequently observed conditions even in the absence of subscapularis tears, and this condition could be affected by supraspinatus MAFI, female sex, older age, and synovitis. However, because subscapularis MAFI does not affect the surgical outcome, surgeons need not be concerned about this condition when repairing posterosuperior rotator cuff tear.Level of evidence: IV.
10.The impact of supraspinatus tear on subscapularis muscle atrophy and fatty infiltration
Su Cheol KIM ; Seung Jin YOO ; Je Hyeong JO ; Jong Hyun LEE ; Eugene BAEK ; Sang Min LEE ; Jae Chul YOO
Clinics in Shoulder and Elbow 2024;27(4):437-446
Background:
Aimed to report the prevalence and predisposing factors affecting subscapularis muscle atrophy and fatty infiltration (MAFI) in patients without a subscapularis tear, and to analyze the effect of this condition on surgical outcomes.
Methods:
Between 2020 and 2022, 153 patients (mean age 58.1 ± 10.2 years; 84 men and 69 women) who underwent repair of posterosuperior cuff tears, with no subscapularis tears identified during arthroscopy were retrospectively analyzed. Baseline characteristics, preoperative and follow-up (6 months) magnetic resonance imaging findings, arthroscopic findings, and clinical outcomes (>1 year) were recorded.
Results:
The prevalence of subscapularis MAFI (Goutallier grade 1 or 2) was 73.9% (113/153), of which the prevalence of Goutallier grade 2 was 23.5% (36/153). From multivariable logistic regression analysis, female sex (odds ratio [OR], 5.6; 95% CI, 1.7–18.6; P=0.005), older age (OR, 1.1; 95% CI, 1.0–1.1; P=0.052), advanced supraspinatus MAFI by Goutallier grade (OR, 3.2; 95% CI, 1.5–6.9; P=0.004), and synovitis (OR, 2.8; 95% CI, 1.1–7.9; P=0.030) were identified as independent predisposing factors for subscapularis MAFI. However, patients with preoperative subscapularis MAFI exhibited similar final range of motion, pain and function, and belly press strength compared to those without preoperative subscapularis MAFI.
Conclusions
Subscapularis MAFI is frequently observed conditions even in the absence of subscapularis tears, and this condition could be affected by supraspinatus MAFI, female sex, older age, and synovitis. However, because subscapularis MAFI does not affect the surgical outcome, surgeons need not be concerned about this condition when repairing posterosuperior rotator cuff tear.Level of evidence: IV.

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