1.Clinical Performance Evaluation of the Ag Test for Detecting SARS-CoV-2 and Influenza A/B Viruses Using Nasopharyngeal Swabs
Myoung-Schook YOOU ; Ji Hun JEONG ; Eun-Hye CHOI ; Yuri KIM ; Chunhwa IHM
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):208-213
Background:
Rapid antigen tests (RATs) are widely used in clinical settings, aiding in the prevention of infectious diseases. However, there is a lack of research on the performance of RATs that can simultaneously diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Influenza A/B viruses. In this study, we aimed to evaluate the performance of a newly developed RAT that can detect all three pathogens at once, to assess its potential for clinical application.
Methods:
Clinical performance testing was conducted using 436 nasopharyngeal swab samples collected from patients with suspected respiratory infections. The newly developed RAT was compared with realtime reverse transcription-polymerase chain reaction (rRT-PCR) results to evaluate clinical sensitivity and specificity. Additionally, concordance with two previously approved products was assessed.
Results:
For patients who tested positive with rRT-PCR, the detection sensitivity of the newly developed INCLIX TRF COVID-19 & Flu A/B Ag test was 90.91% for SARS-CoV-2, 97.75% for Influenza A, and 93.00% for Influenza B, with a specificity of 100% for all three pathogens. In the concordance assessment with the existing RATs, the agreement was 99.76% (κ=0.9922) for SARS-CoV-2, 99.76% (κ=0.9927) for Influenza A, and 99.76% (κ=0.9930) for Influenza B. Compared to the existing RATs, all showed a concordance with κ >0.8.
Conclusions
The INCLIX TRF COVID-19 & Flu A/B Ag test efficiently detected antigens of SARS-CoV-2 and Influenza A/B viruses simultaneously within a short testing time of 15 minutes. Therefore, this test method, with its high sensitivity and specificity, will be highly useful for diagnosing viral infections in clinical settings.
2.Clinical Performance Evaluation of the Ag Test for Detecting SARS-CoV-2 and Influenza A/B Viruses Using Nasopharyngeal Swabs
Myoung-Schook YOOU ; Ji Hun JEONG ; Eun-Hye CHOI ; Yuri KIM ; Chunhwa IHM
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):208-213
Background:
Rapid antigen tests (RATs) are widely used in clinical settings, aiding in the prevention of infectious diseases. However, there is a lack of research on the performance of RATs that can simultaneously diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Influenza A/B viruses. In this study, we aimed to evaluate the performance of a newly developed RAT that can detect all three pathogens at once, to assess its potential for clinical application.
Methods:
Clinical performance testing was conducted using 436 nasopharyngeal swab samples collected from patients with suspected respiratory infections. The newly developed RAT was compared with realtime reverse transcription-polymerase chain reaction (rRT-PCR) results to evaluate clinical sensitivity and specificity. Additionally, concordance with two previously approved products was assessed.
Results:
For patients who tested positive with rRT-PCR, the detection sensitivity of the newly developed INCLIX TRF COVID-19 & Flu A/B Ag test was 90.91% for SARS-CoV-2, 97.75% for Influenza A, and 93.00% for Influenza B, with a specificity of 100% for all three pathogens. In the concordance assessment with the existing RATs, the agreement was 99.76% (κ=0.9922) for SARS-CoV-2, 99.76% (κ=0.9927) for Influenza A, and 99.76% (κ=0.9930) for Influenza B. Compared to the existing RATs, all showed a concordance with κ >0.8.
Conclusions
The INCLIX TRF COVID-19 & Flu A/B Ag test efficiently detected antigens of SARS-CoV-2 and Influenza A/B viruses simultaneously within a short testing time of 15 minutes. Therefore, this test method, with its high sensitivity and specificity, will be highly useful for diagnosing viral infections in clinical settings.
3.Clinical Performance Evaluation of the Ag Test for Detecting SARS-CoV-2 and Influenza A/B Viruses Using Nasopharyngeal Swabs
Myoung-Schook YOOU ; Ji Hun JEONG ; Eun-Hye CHOI ; Yuri KIM ; Chunhwa IHM
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):208-213
Background:
Rapid antigen tests (RATs) are widely used in clinical settings, aiding in the prevention of infectious diseases. However, there is a lack of research on the performance of RATs that can simultaneously diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Influenza A/B viruses. In this study, we aimed to evaluate the performance of a newly developed RAT that can detect all three pathogens at once, to assess its potential for clinical application.
Methods:
Clinical performance testing was conducted using 436 nasopharyngeal swab samples collected from patients with suspected respiratory infections. The newly developed RAT was compared with realtime reverse transcription-polymerase chain reaction (rRT-PCR) results to evaluate clinical sensitivity and specificity. Additionally, concordance with two previously approved products was assessed.
Results:
For patients who tested positive with rRT-PCR, the detection sensitivity of the newly developed INCLIX TRF COVID-19 & Flu A/B Ag test was 90.91% for SARS-CoV-2, 97.75% for Influenza A, and 93.00% for Influenza B, with a specificity of 100% for all three pathogens. In the concordance assessment with the existing RATs, the agreement was 99.76% (κ=0.9922) for SARS-CoV-2, 99.76% (κ=0.9927) for Influenza A, and 99.76% (κ=0.9930) for Influenza B. Compared to the existing RATs, all showed a concordance with κ >0.8.
Conclusions
The INCLIX TRF COVID-19 & Flu A/B Ag test efficiently detected antigens of SARS-CoV-2 and Influenza A/B viruses simultaneously within a short testing time of 15 minutes. Therefore, this test method, with its high sensitivity and specificity, will be highly useful for diagnosing viral infections in clinical settings.
4.Clinical Performance Evaluation of the Ag Test for Detecting SARS-CoV-2 and Influenza A/B Viruses Using Nasopharyngeal Swabs
Myoung-Schook YOOU ; Ji Hun JEONG ; Eun-Hye CHOI ; Yuri KIM ; Chunhwa IHM
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):208-213
Background:
Rapid antigen tests (RATs) are widely used in clinical settings, aiding in the prevention of infectious diseases. However, there is a lack of research on the performance of RATs that can simultaneously diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Influenza A/B viruses. In this study, we aimed to evaluate the performance of a newly developed RAT that can detect all three pathogens at once, to assess its potential for clinical application.
Methods:
Clinical performance testing was conducted using 436 nasopharyngeal swab samples collected from patients with suspected respiratory infections. The newly developed RAT was compared with realtime reverse transcription-polymerase chain reaction (rRT-PCR) results to evaluate clinical sensitivity and specificity. Additionally, concordance with two previously approved products was assessed.
Results:
For patients who tested positive with rRT-PCR, the detection sensitivity of the newly developed INCLIX TRF COVID-19 & Flu A/B Ag test was 90.91% for SARS-CoV-2, 97.75% for Influenza A, and 93.00% for Influenza B, with a specificity of 100% for all three pathogens. In the concordance assessment with the existing RATs, the agreement was 99.76% (κ=0.9922) for SARS-CoV-2, 99.76% (κ=0.9927) for Influenza A, and 99.76% (κ=0.9930) for Influenza B. Compared to the existing RATs, all showed a concordance with κ >0.8.
Conclusions
The INCLIX TRF COVID-19 & Flu A/B Ag test efficiently detected antigens of SARS-CoV-2 and Influenza A/B viruses simultaneously within a short testing time of 15 minutes. Therefore, this test method, with its high sensitivity and specificity, will be highly useful for diagnosing viral infections in clinical settings.
5.Clinical Performance Evaluation of the Ag Test for Detecting SARS-CoV-2 and Influenza A/B Viruses Using Nasopharyngeal Swabs
Myoung-Schook YOOU ; Ji Hun JEONG ; Eun-Hye CHOI ; Yuri KIM ; Chunhwa IHM
Journal of Laboratory Medicine and Quality Assurance 2024;46(4):208-213
Background:
Rapid antigen tests (RATs) are widely used in clinical settings, aiding in the prevention of infectious diseases. However, there is a lack of research on the performance of RATs that can simultaneously diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Influenza A/B viruses. In this study, we aimed to evaluate the performance of a newly developed RAT that can detect all three pathogens at once, to assess its potential for clinical application.
Methods:
Clinical performance testing was conducted using 436 nasopharyngeal swab samples collected from patients with suspected respiratory infections. The newly developed RAT was compared with realtime reverse transcription-polymerase chain reaction (rRT-PCR) results to evaluate clinical sensitivity and specificity. Additionally, concordance with two previously approved products was assessed.
Results:
For patients who tested positive with rRT-PCR, the detection sensitivity of the newly developed INCLIX TRF COVID-19 & Flu A/B Ag test was 90.91% for SARS-CoV-2, 97.75% for Influenza A, and 93.00% for Influenza B, with a specificity of 100% for all three pathogens. In the concordance assessment with the existing RATs, the agreement was 99.76% (κ=0.9922) for SARS-CoV-2, 99.76% (κ=0.9927) for Influenza A, and 99.76% (κ=0.9930) for Influenza B. Compared to the existing RATs, all showed a concordance with κ >0.8.
Conclusions
The INCLIX TRF COVID-19 & Flu A/B Ag test efficiently detected antigens of SARS-CoV-2 and Influenza A/B viruses simultaneously within a short testing time of 15 minutes. Therefore, this test method, with its high sensitivity and specificity, will be highly useful for diagnosing viral infections in clinical settings.
6.Cervical Myelopathy Following Intervertebral Disc Herniation at the Surgical Site Post-Cervical Artificial Disc Replacement Surgery
In Bo KIM ; Yeong Hun KANG ; Sung Soo CHUNG ; Se Myoung JO
The Journal of the Korean Orthopaedic Association 2024;59(3):219-222
A 64-year-old male patient presented with hand numbness and gait disturbance. He had undergone cervical artificial disc replacement (C-ADR) at another hospital nine years earlier. Magnetic resonance imaging (MRI) revealed a protruded disc at the surgical level compressing the spinal cord. The implant and protruded disc were removed. Fusion was then performed. This case report highlights the importance of long-term follow-up of patients who have undergone C-ADR, and the need to be aware of the potential for late complications.In addition, it is important to ensure as complete a disk removal as possible during C-ADR.
7.A study on the pathway for severe emergency patients visiting emergency departments to establish regionalization of emergency medical services in Busan, Ulsan, and Gyeongsangnam-do regions
Myoung-Hwa LEE ; Kil-Hun KIM ; Hyun-Jun YUN ; Seok-Ran YEOM ; Ji-Ho RYU
Journal of the Korean Society of Emergency Medicine 2023;34(6):550-557
Objective:
This study assessed the characteristics of medical utilization by analyzing the pathway of severe emergency patients visiting emergency departments in the three regions.
Methods:
The study was conducted based on the National Emergency Department Information System, which collected information from 43 local governments from 2017 to 2019. Severe emergency patients were classified according to the Korean Triage and Acuity Scale level. A map was produced based on the results of connectivity centrality analysis, and groupings were performed using the R program. The relevance index was calculated to confirm medical utilization within and among regions.
Results:
Medical utilization within the region for severe emergency patients was concentrated in major cities. With the opening of local emergency medical agencies in underserved areas of emergency medical services, medical utilization within the region has increased compared to three years ago. Severe emergency patients in the western region of Gyeongsangnam-do mainly visit the emergency department in Jinju city. In contrast, in western county areas, they mainly visit the emergency department in Busan city. In Ulsan city, which belongs to Ulju county and Jung-gu, many patients frequently visit the emergency department in Yangsan city. Patients from Geochang, Changnyeong, Hamyang, and Hapcheon counties in Gyeongnam Province frequently visit the emergency department in Daegu city.
Conclusion
The intersection and cooperation of health resources within and between regions of the emergency medical system are no longer a task that can be postponed, and regionalization has been proposed as an alternative concept.
9.Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
Seo-Yeon AHN ; Sang Kyun SON ; Gyu Hyung LEE ; Inho KIM ; June-Won CHEONG ; Won Sik LEE ; Byung Soo KIM ; Deog-Yeon JO ; Chul Won JUNG ; Chu Myoung SEONG ; Jae Hoon LEE ; Young Jin YUH ; Min Kyoung KIM ; Hun-Mo RYOO ; Moo-Rim PARK ; Su-Hee CHO ; Hoon-Gu KIM ; Dae Young ZANG ; Jinny PARK ; Hawk KIM ; Seryeon LEE ; Sung-Hyun KIM ; Myung Hee CHANG ; Ho Sup LEE ; Chul Won CHOI ; Jihyun KWON ; Sung-Nam LIM ; Suk-Joong OH ; Inkyung JOO ; Dong-Wook KIM
Blood Research 2022;57(2):144-151
Background:
Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.
Methods:
An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.
Results:
During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).
Conclusion
This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.
10.Association of Insulin, Metformin, and Statin with Mortality in Breast Cancer Patients
Mihong CHOI ; Jiyeon HAN ; Bo Ram YANG ; Myoung-jin JANG ; Miso KIM ; Dae-Won LEE ; Tae-Yong KIM ; Seock-Ah IM ; Han-Byoel LEE ; Hyeong-Gon MOON ; Wonshik HAN ; Dong-Young NOH ; Kyung-Hun LEE
Cancer Research and Treatment 2021;53(1):65-76
Purpose:
This study investigated the association of insulin, metformin, and statin use with survival and whether the association was modified by the hormone receptor status of the tumor in patients with breast cancer.
Materials and Methods:
We studied 7,452 patients who had undergone surgery for breast cancer at Seoul National University Hospital from 2008 to 2015 using the nationwide claims database. Exposure was defined as a recorded prescription of each drug within 12 months before the diagnosis of breast cancer.
Results:
Patients with prior insulin or statin use were more likely to be older than 50 years at diagnosis and had a higher comorbidity index than those without it (p < 0.01 for both). The hazard ratio (HR) for death with insulin use was 5.7 (p < 0.01), and the effect was attenuated with both insulin and metformin exposure with an HR of 1.2 (p=0.60). In the subgroup analyses, a heightened risk of death with insulin was further prominent with an HR of 17.9 (p < 0.01) and was offset by co-administration of metformin with an HR of 1.3 (p=0.67) in patients with estrogen receptor (ER)–negative breast cancer. Statin use was associated with increased overall mortality only in patients with ER-positive breast cancer with HR for death of 1.5 (p=0.05).
Conclusion
Insulin or statin use before the diagnosis of breast cancer was associated with an increase in all-cause mortality. Subsequent analyses suggested that metformin or statin use may have been protective in patients with ER-negative disease, which warrants further studies.

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