1.Can Reference Materials Prepared Following CLSI C37-A Be Utilized Without Commutability Assessment?Perspectives Based on Lipid Measurements
Jong Do SEO ; Gye Cheol KWON ; Jeong-Ho KIM ; Sang-Guk LEE ; Junghan SONG ; Pil-Whan PARK ; Dongheui AN ; Qute CHOI ; Chan-Ik CHO ; Sollip KIM ; Yeo-Min YUN
Annals of Laboratory Medicine 2025;45(6):562-573
Background:
Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols.
Methods:
We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention AgencyLaboratory Standardization Project (per CLSI C37-A), using six routine measurement procedures (MPs). Regression equations and 95% prediction intervals derived from single-donor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differences in inter-MP biases between RM and clinical samples. The effect of the TG concentration on commutability was evaluated by analyzing biases between MP results and reference procedure-assigned values.
Results:
RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from assigned values were observed for RMs with higher TG levels.
Conclusions
RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to standardize laboratory tests.
2.In Vitro Diagnostics Certification for Creatinine Assays in Korea over 7 Years: Achievements and Future Outlook
Eun-Jung CHO ; Joonsang YU ; Jeayeon RYU ; Jiwoo SEO ; Hyunae LEE ; Chan-Ik CHO ; Tae-Dong JEONG ; Sollip KIM ; Woochang LEE ; Sail CHUN ; Won-Ki MIN
Annals of Laboratory Medicine 2025;45(5):493-502
Background:
An international reference measurement laboratory network for creatinine (Cr) is lacking; therefore, Korea developed an independent evaluation and certification system. The in vitro diagnostics (IVD) certification program, launched in 2017, formed part of a broader Cr standardization initiative intended to enhance accuracy at the manufacturing stage.
Methods:
The program was designed to evaluate analytical systems, including all reagent lots, calibrators, and instrument models, twice annually. Bias, imprecision, total error (TE), and linearity were evaluated based on established acceptance criteria. A post-certification process allows submission for a second challenge and validation of corrective actions.
Results:
Between 2017 and 2023, 489 analytical systems were evaluated. Average acceptance rates for bias, imprecision, TE, and linearity were 70.8%, 95.9%, 87.7%, and 87.8%, respectively. The lowest acceptance rate for bias evaluation was 8.7% for the kinetic Jaffe method without compensation in 2018. Over the 7-year period, the mean absolute percentage bias (absBias%), coefficient of variation (CV), and TE were 4.62%, 1.37%,and 7.29%, respectively. The highest absBias% (7.94%) was observed in the 0.0 ≤ Cr < 1.0target value range. Since 2019, a consistent reduction in absBias% has been observed.
Conclusions
This program is a pioneering response to the absence of a global certification program for Cr assays. It offers significant advantages, including comprehensive evaluations, fee-free participation, and a robust post-certification process. Continuous participation and improvement efforts by manufacturers have contributed to enhanced accuracy in Cr assays.
3.Comparative analysis of ERK and CREB activity in normal and cryptorchid testes of bulls
Changjin YUN ; Sohee JEONG ; Yongbin CHO ; Sang-Ik PARK ; In Sik SHIN ; Jun-Gyu PARK ; Changjong MOON ; Sohi KANG ; Joong-Sun KIM
Journal of Veterinary Science 2025;26(6):e83-
Objective:
This study aimed to examine morphological changes and changes in the extracellular signal-regulated kinase (ERK) and cyclic AMP response element-binding protein (CREB) activity in the testes of bulls with cryptorchidism.
Methods:
Testes from the 18-month-old unilateral cryptorchid bulls, including the descended (normal) and undescended (cryptorchid) testes from each animal, were analyzed through gross examination, histology, immunohistochemistry (Ki-67, phosphorylated p-ERK, p-CREB), and Western blotting.
Results:
Cryptorchid testes were smaller and exhibited reduced epithelial thickness, although seminiferous tubule area remained unchanged. Expression of Ki-67, p-ERK, and p-CREB was significantly decreased, indicating impaired cell proliferation and signaling.Total ERK and CREB protein levels were unchanged, but phosphorylation levels were notably reduced in cryptorchid samples.
Conclusions
and Relevance: Our findings demonstrate that cryptorchidism alters testicular morphology and disrupts key signaling pathways, particularly those involved in cell growth and function. Such alterations may contribute to infertility and highlight the importance of early diagnosis and intervention in the context of reproductive management in livestock.
4.A nationwide study of regional preference and graft survival of kidney transplantation in South Korea: patterns of centralization in the capital area
Jeong-Ik PARK ; Youngjin JANG ; Hojong PARK ; Sungchoul PYUN ; Hong Rae CHO ; Sang Jun PARK
Annals of Surgical Treatment and Research 2024;106(1):11-18
Purpose:
This study aims to investigate regional patterns and graft survival rates in kidney transplantation (KT) within South Korea using the National Health Insurance Service database.
Methods:
By analyzing KT data from 2002 to 2017, including patient residency, KT location, and post-KT dialysis information, graft survival was assessed through post-KT dialysis and validated against Ulsan University Hospital and the Korean Organ Transplantation Registry’s 2017 report.
Results:
Among the 20,978 KTs, 60.5% occurred in the Korean capital, Seoul, whereas 39.5% occurred outside. The overall graft survival rate was 81.5% with a median survival duration of 57 months. Patient survival was 83.8%, with a median survival duration of 61 months. For KTs from 2002 to 2007, the 10-year graft and patient survival rates were 89.1% and 90.3%, respectively. The KT recipients living outside Seoul who underwent the KT within their residential regions had a graft survival rate of 88.3%, and those receiving KTs outside their original region had a graft survival rate of 88.0%. Among Seoul residents who underwent KTs in the city, the graft survival rate was 90.5%. Importantly, hospital location did not significantly affect graft survival rates (P = 0.136).
Conclusion
This study revealed a regional preference for KT in South Korea, particularly in the capital city, likely because of nonresidents. Nevertheless, the graft and patient survival rates showed no significant regional disparities. These findings emphasize the necessity for equitable KT service access across regions in order to optimize patient outcomes.
5.Novel Deep Learning-Based Vocal Biomarkers for Stress Detection in Koreans
Junghyun NAMKUNG ; Seok Min KIM ; Won Ik CHO ; So Young YOO ; Beomjun MIN ; Sang Yool LEE ; Ji-Hye LEE ; Heyeon PARK ; Soyoung BAIK ; Je-Yeon YUN ; Nam Soo KIM ; Jeong-Hyun KIM
Psychiatry Investigation 2024;21(11):1228-1237
Objective:
The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions.
Methods:
We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores.
Results:
The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks.
Conclusion
The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.
6.Novel Deep Learning-Based Vocal Biomarkers for Stress Detection in Koreans
Junghyun NAMKUNG ; Seok Min KIM ; Won Ik CHO ; So Young YOO ; Beomjun MIN ; Sang Yool LEE ; Ji-Hye LEE ; Heyeon PARK ; Soyoung BAIK ; Je-Yeon YUN ; Nam Soo KIM ; Jeong-Hyun KIM
Psychiatry Investigation 2024;21(11):1228-1237
Objective:
The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions.
Methods:
We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores.
Results:
The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks.
Conclusion
The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.
7.Major clinical research advances in gynecologic cancer in 2023:a tumultuous year for endometrial cancer
Seung-Hyuk SHIM ; Jung-Yun LEE ; Yoo-Young LEE ; Jeong-Yeol PARK ; Yong Jae LEE ; Se Ik KIM ; Gwan Hee HAN ; Eun Jung YANG ; Joseph J NOH ; Ga Won YIM ; Joo-Hyuk SON ; Nam Kyeong KIM ; Tae-Hyun KIM ; Tae-Wook KONG ; Youn Jin CHOI ; Angela CHO ; Hyunji LIM ; Eun Bi JANG ; Hyun Woong CHO ; Dong Hoon SUH
Journal of Gynecologic Oncology 2024;35(2):e66-
In the 2023 series, we summarized the major clinical research advances in gynecologic oncology based on communications at the conference of Asian Society of Gynecologic Oncology Review Course. The review consisted of 1) Endometrial cancer: immune checkpoint inhibitor, antibody drug conjugates (ADCs), selective inhibitor of nuclear export, CDK4/6 inhibitors WEE1 inhibitor, poly (ADP-ribose) polymerase (PARP) inhibitors. 2) Cervical cancer: surgery in low-risk early-stage cervical cancer, therapy for locally advanced stage and advanced, metastatic, or recurrent setting; and 3) Ovarian cancer: immunotherapy, triplet therapies using immune checkpoint inhibitors along with antiangiogenic agents and PARP inhibitors, and ADCs. In 2023, the field of endometrial cancer treatment witnessed a landmark year, marked by several practice-changing outcomes with immune checkpoint inhibitors and the reliable efficacy of PARP inhibitors and ADCs.
8.Chemotherapy response score no longer predicts survival outcomes in high-grade serous ovarian cancer patients with BRCA mutation and/or maintenance therapy
Young Joo LEE ; Yoon Kyung SHIN ; Nae Ry KIM ; Se Ik KIM ; Yoo-Young LEE ; Jeong-Yeol PARK ; Jae-Weon KIM ; Hyun-Woong CHO ; Jung-Yun LEE
Journal of Gynecologic Oncology 2024;35(6):e73-
Objective:
We aimed to revalidate the chemotherapy response score (CRS) system as a prognostic factor for ovarian cancer patients with breast cancer gene (BRCA) mutations or those receiving frontline poly-ADP ribose polymerase (PARP) inhibitors or bevacizumab as maintenance therapy.
Methods:
A retrospective analysis was performed using medical records of patients with high-grade serous carcinoma who received neoadjuvant chemotherapy followed by interval debulking surgery between January 2007 and December 2021 at 5 tertiary medical institutions in South Korea. At each hospital, pathologists independently assessed each slide of omental tissues obtained from surgery using the CRS system. Progression-free survival (PFS) and overall survival (OS) values were obtained using Kaplan-Meier analysis to evaluate the effect of BRCA mutation, maintenance therapy, and CRS on survival time.
Results:
Of 466 patients, BRCA mutations were detected in 156 (33.5%) and 131 (28.1%) were treated with maintenance therapy; 98 (21.0%) and 42 (9.0%) were treated with PARP inhibitors or bevacizumab, respectively. Patients with CRS3 had significantly longer PFS than those with CRS1 or 2 (24.7 vs. 16.8 months, p<0.001). However, there was no significant difference in PFS improvement between CRS3 patients and those with CRS1 or 2 with BRCA mutation (22.0 vs. 19.3 months, p=0.193). Moreover, no significant PFS prolongation was observed in CRS3 patients compared to CRS1 or 2 patients treated with PARP inhibitors or bevacizumab (24.3 vs. 22.4 months, p=0.851; 27.5 vs. 15.7 months, p=0.347, respectively).
Conclusion
CRS may not be a prognostic factor in patients with BRCA mutations and those receiving frontline maintenance therapy.
9.Novel Deep Learning-Based Vocal Biomarkers for Stress Detection in Koreans
Junghyun NAMKUNG ; Seok Min KIM ; Won Ik CHO ; So Young YOO ; Beomjun MIN ; Sang Yool LEE ; Ji-Hye LEE ; Heyeon PARK ; Soyoung BAIK ; Je-Yeon YUN ; Nam Soo KIM ; Jeong-Hyun KIM
Psychiatry Investigation 2024;21(11):1228-1237
Objective:
The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions.
Methods:
We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores.
Results:
The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks.
Conclusion
The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.
10.Major clinical research advances in gynecologic cancer in 2023:a tumultuous year for endometrial cancer
Seung-Hyuk SHIM ; Jung-Yun LEE ; Yoo-Young LEE ; Jeong-Yeol PARK ; Yong Jae LEE ; Se Ik KIM ; Gwan Hee HAN ; Eun Jung YANG ; Joseph J NOH ; Ga Won YIM ; Joo-Hyuk SON ; Nam Kyeong KIM ; Tae-Hyun KIM ; Tae-Wook KONG ; Youn Jin CHOI ; Angela CHO ; Hyunji LIM ; Eun Bi JANG ; Hyun Woong CHO ; Dong Hoon SUH
Journal of Gynecologic Oncology 2024;35(2):e66-
In the 2023 series, we summarized the major clinical research advances in gynecologic oncology based on communications at the conference of Asian Society of Gynecologic Oncology Review Course. The review consisted of 1) Endometrial cancer: immune checkpoint inhibitor, antibody drug conjugates (ADCs), selective inhibitor of nuclear export, CDK4/6 inhibitors WEE1 inhibitor, poly (ADP-ribose) polymerase (PARP) inhibitors. 2) Cervical cancer: surgery in low-risk early-stage cervical cancer, therapy for locally advanced stage and advanced, metastatic, or recurrent setting; and 3) Ovarian cancer: immunotherapy, triplet therapies using immune checkpoint inhibitors along with antiangiogenic agents and PARP inhibitors, and ADCs. In 2023, the field of endometrial cancer treatment witnessed a landmark year, marked by several practice-changing outcomes with immune checkpoint inhibitors and the reliable efficacy of PARP inhibitors and ADCs.

Result Analysis
Print
Save
E-mail