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.Prevalence and prognostic value of PD-L1 expression and tumor mutational burden in persistent, recurrent, or metastatic cervical cancer
Min-Hyun BAEK ; Lei CHEN ; Cumhur TEKIN ; Razvan CRISTESCU ; Xiao Yang JIN ; Changxia SHAO ; Soo Yeon IHM ; Petar JELINIC ; Jeong-Yeol PARK
Journal of Gynecologic Oncology 2024;35(6):e105-
Objective:
To evaluate the prevalence and prognostic role of programmed death ligand 1 (PDL1) expression and tumor mutational burden (TMB) in patients with non-immunotherapytreated advanced cervical cancer.
Methods:
Clinical data were retrospectively collected from medical records between January 1, 2008, and December 31, 2016, at Asan Medical Center (Korea); archived tumor samples were assessed for PD-L1 expression (combined positive score [CPS] ≥1) and TMB (≥175 mutations/exome). Overall survival (OS) was defined as time from advanced diagnosis or initiation of first-line or second-line systemic therapy until death/last follow-up. The association of OS with PD-L1 expression and TMB were analyzed using the log-rank test and Cox proportional hazards model adjusted for covariates.
Results:
Of 267 patients, 76.0% had squamous cell carcinoma (SCC), 24.0% had adenocarcinoma (AC)/adenosquamous carcinoma (ASC), 64.4% had PD-L1 CPS ≥1, and 32.6% had TMB ≥175 mutations/exome. PD-L1 CPS ≥1 and TMB ≥175 mutations/exome were more prevalent in SCC than in AC/ASC (73.9% and 37.2% vs. 34.4% and 17.7%). There was no association between OS and PD-L1 expression (CPS ≥1 vs. <1: adjusted hazard ratio [HR]=1.14; 95% confidence interval [CI]=0.84–1.53 from advanced diagnosis); OS trended shorter for the subgroup with TMB ≥175 versus <175 mutations/exome (adjusted HR=1.29;95% CI=0.95–1.75).
Conclusion
Retrospective analysis of non-immunotherapy-treated patients with advanced cervical cancer demonstrated a higher prevalence of PD-L1 CPS ≥1 and TMB ≥175 mutations/ exome in SCC versus AC/ASC. PD-L1 CPS ≥1 was not associated with OS; TMB ≥175 mutations/exome showed a trend toward shorter OS. Additional studies are needed to confirm these findings.
5.Prevalence and prognostic value of PD-L1 expression and tumor mutational burden in persistent, recurrent, or metastatic cervical cancer
Min-Hyun BAEK ; Lei CHEN ; Cumhur TEKIN ; Razvan CRISTESCU ; Xiao Yang JIN ; Changxia SHAO ; Soo Yeon IHM ; Petar JELINIC ; Jeong-Yeol PARK
Journal of Gynecologic Oncology 2024;35(6):e105-
Objective:
To evaluate the prevalence and prognostic role of programmed death ligand 1 (PDL1) expression and tumor mutational burden (TMB) in patients with non-immunotherapytreated advanced cervical cancer.
Methods:
Clinical data were retrospectively collected from medical records between January 1, 2008, and December 31, 2016, at Asan Medical Center (Korea); archived tumor samples were assessed for PD-L1 expression (combined positive score [CPS] ≥1) and TMB (≥175 mutations/exome). Overall survival (OS) was defined as time from advanced diagnosis or initiation of first-line or second-line systemic therapy until death/last follow-up. The association of OS with PD-L1 expression and TMB were analyzed using the log-rank test and Cox proportional hazards model adjusted for covariates.
Results:
Of 267 patients, 76.0% had squamous cell carcinoma (SCC), 24.0% had adenocarcinoma (AC)/adenosquamous carcinoma (ASC), 64.4% had PD-L1 CPS ≥1, and 32.6% had TMB ≥175 mutations/exome. PD-L1 CPS ≥1 and TMB ≥175 mutations/exome were more prevalent in SCC than in AC/ASC (73.9% and 37.2% vs. 34.4% and 17.7%). There was no association between OS and PD-L1 expression (CPS ≥1 vs. <1: adjusted hazard ratio [HR]=1.14; 95% confidence interval [CI]=0.84–1.53 from advanced diagnosis); OS trended shorter for the subgroup with TMB ≥175 versus <175 mutations/exome (adjusted HR=1.29;95% CI=0.95–1.75).
Conclusion
Retrospective analysis of non-immunotherapy-treated patients with advanced cervical cancer demonstrated a higher prevalence of PD-L1 CPS ≥1 and TMB ≥175 mutations/ exome in SCC versus AC/ASC. PD-L1 CPS ≥1 was not associated with OS; TMB ≥175 mutations/exome showed a trend toward shorter OS. Additional studies are needed to confirm these findings.
6.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.
7.Prevalence and prognostic value of PD-L1 expression and tumor mutational burden in persistent, recurrent, or metastatic cervical cancer
Min-Hyun BAEK ; Lei CHEN ; Cumhur TEKIN ; Razvan CRISTESCU ; Xiao Yang JIN ; Changxia SHAO ; Soo Yeon IHM ; Petar JELINIC ; Jeong-Yeol PARK
Journal of Gynecologic Oncology 2024;35(6):e105-
Objective:
To evaluate the prevalence and prognostic role of programmed death ligand 1 (PDL1) expression and tumor mutational burden (TMB) in patients with non-immunotherapytreated advanced cervical cancer.
Methods:
Clinical data were retrospectively collected from medical records between January 1, 2008, and December 31, 2016, at Asan Medical Center (Korea); archived tumor samples were assessed for PD-L1 expression (combined positive score [CPS] ≥1) and TMB (≥175 mutations/exome). Overall survival (OS) was defined as time from advanced diagnosis or initiation of first-line or second-line systemic therapy until death/last follow-up. The association of OS with PD-L1 expression and TMB were analyzed using the log-rank test and Cox proportional hazards model adjusted for covariates.
Results:
Of 267 patients, 76.0% had squamous cell carcinoma (SCC), 24.0% had adenocarcinoma (AC)/adenosquamous carcinoma (ASC), 64.4% had PD-L1 CPS ≥1, and 32.6% had TMB ≥175 mutations/exome. PD-L1 CPS ≥1 and TMB ≥175 mutations/exome were more prevalent in SCC than in AC/ASC (73.9% and 37.2% vs. 34.4% and 17.7%). There was no association between OS and PD-L1 expression (CPS ≥1 vs. <1: adjusted hazard ratio [HR]=1.14; 95% confidence interval [CI]=0.84–1.53 from advanced diagnosis); OS trended shorter for the subgroup with TMB ≥175 versus <175 mutations/exome (adjusted HR=1.29;95% CI=0.95–1.75).
Conclusion
Retrospective analysis of non-immunotherapy-treated patients with advanced cervical cancer demonstrated a higher prevalence of PD-L1 CPS ≥1 and TMB ≥175 mutations/ exome in SCC versus AC/ASC. PD-L1 CPS ≥1 was not associated with OS; TMB ≥175 mutations/exome showed a trend toward shorter OS. Additional studies are needed to confirm these findings.
8.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.
9.Developing a Data Visualization Program for Transfusion Appropriateness Management
Myoung-Schook YOOU ; Sangah HAN ; Eunkyung PARK ; Jihun JEONG ; Inchul JUNG ; Yeunsu KIM ; Chunhwa IHM
Korean Journal of Blood Transfusion 2024;35(2):93-105
Background:
Transfusion appropriateness is extremely important due to the growing concerns about the decrease in the supply of blood products and the increase in demand. Considerable time and effort are required to effectively collect and analyze large volumes of data. Therefore, we aimed to develop a transfusion appropriateness management program using the Tableau visual analytics platform, which allows intuitive visualization through various visualization options and interactive features and can quickly process large volumes of data.
Methods:
Using the transfusion prescription history and blood management and distribution history, we created a data mart comprising patient information, hospitalization history, inpatient/outpatient prescriptions, test results, records, and surgical information. Based on this we developed visualization analysis content for monitoring transfusion appropriateness.We automated the periodic aggregation of the data mart into an analysis database and connected it to Tableau.
Results:
We developed Transfusion Appropriateness Management (TAM), a program for managing transfusion appropriateness linked to Tableau, after analyzing transfusion-related data and metadata extracted from the Daejeon Eulji Medical Center's order communication system/electronic medical record (OCS/EMR) system. Detailed filters were applied to allow users to intuitively view the desired data according to their criteria. Data were visualized in various forms, such as bar graphs, heat maps, and box plots based on filtering criteria.
Conclusion
The development of the Transfusion Appropriateness Management program at the Daejeon Eulji Medical Center is expected to effectively reduce inappropriate transfusions in clinical settings and enhance patient safety within the hospital by swiftly and conveniently visualizing vast amounts of data.
10.Elevated On-Treatment Diastolic Blood Pressure and Cardiovascular Outcomes in the Presence of Achieved Systolic Blood Pressure Targets
Dae-Hee KIM ; In-Jeong CHO ; Woohyeun KIM ; Chan Joo LEE ; Hyeon-Chang KIM ; Jeong-Hun SHIN ; Si-Hyuck KANG ; Mi-Hyang JUNG ; Chang Hee KWON ; Ju-Hee LEE ; Hack Lyoung KIM ; Hyue Mee KIM ; Iksung CHO ; Dae Ryong KANG ; Hae-Young LEE ; Wook-Jin CHUNG ; Kwang Il KIM ; Eun Joo CHO ; Il-Suk SOHN ; Sungha PARK ; Jinho SHIN ; Sung Kee RYU ; Seok-Min KANG ; Wook Bum PYUN ; Myeong-Chan CHO ; Ju Han KIM ; Jun Hyeok LEE ; Sang-Hyun IHM ; Ki-Chul SUNG
Korean Circulation Journal 2022;52(6):460-474
Background and Objectives:
This study aimed to investigate the association between cardiovascular events and 2 different levels of elevated on-treatment diastolic blood pressures (DBP) in the presence of achieved systolic blood pressure targets (SBP).
Methods:
A nation-wide population-based cohort study comprised 237,592 patients with hypertension treated. The primary endpoint was a composite of cardiovascular death, myocardial infarction, and stroke. Elevated DBP was defined according to the Seventh Report of Joint National Committee (JNC7; SBP <140 mmHg, DBP ≥90 mmHg) or to the 2017 American College of Cardiology/American Heart Association (ACC/AHA) definitions (SBP <130 mmHg, DBP ≥80 mmHg).
Results:
During a median follow-up of 9 years, elevated on-treatment DBP by the JNC7 definition was associated with an increased risk of the occurrence of primary endpoint compared with achieved both SBP and DBP (adjusted hazard ratio [aHR], 1.14; 95% confidence interval [CI], 1.05–1.24) but not in those by the 2017 ACC/AHA definition. Elevated ontreatment DBP by the JNC7 definition was associated with a higher risk of cardiovascular mortality (aHR, 1.42; 95% CI, 1.18–1.70) and stroke (aHR, 1.19; 95% CI, 1.08–1.30). Elevated on-treatment DBP by the 2017 ACC/AHA definition was only associated with stroke (aHR, 1.10;95% CI, 1.04–1.16). Similar results were seen in the propensity-score-matched cohort.
Conclusion
Elevated on-treatment DBP by the JNC7 definition was associated a high risk of major cardiovascular events, while elevated DBP by the 2017 ACC/AHA definition was only associated with a higher risk of stroke. The result of study can provide evidence of DBP targets in subjects who achieved SBP targets.

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