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.

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.

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.

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.

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.

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.

BACKGROUND: We examined the feasibility of a full-length gene analysis for the drug resistance-related genes inhA, katG, rpoB, pncA, rpsL, embB, eis, and gyrA using ion semiconductor next-generation sequencing (NGS) and compared the results with those obtained from conventional phenotypic drug susceptibility testing (DST) in multidrug-resistant Mycobacterium tuberculosis (MDR-TB) isolates. METHODS: We extracted genomic DNA from 30 pure MDR-TB isolates with antibiotic susceptibility profiles confirmed by phenotypic DST for isoniazid (INH), rifampin (RIF), ethambutol (EMB), pyrazinamide (PZA), amikacin (AMK), kanamycin (KM), streptomycin (SM), and fluoroquinolones (FQs) including ofloxacin, moxifloxacin, and levofloxacin. Enriched ion spheres were loaded onto Ion PI Chip v3, with 30 samples on a chip per sequencing run, and Ion Torrent sequencing was conducted using the Ion AmpliSeq TB panel (Life Technologies, USA). RESULTS: The genotypic DST results revealed good agreement with the phenotypic DST results for EMB (Kappa 0.8), PZA (0.734), SM (0.769), and FQ (0.783). Agreements for INH, RIF, and AMK+KM were not estimated because all isolates were phenotypically resistant to INH and RIF, and all isolates were phenotypically and genotypically susceptible to AMK+KM. Moreover, 17 novel variants were identified: six (p.Gly169Ser, p.Ala256Thr, p.Ser383Pro, p.Gln439Arg, p.Tyr597Cys, p.Thr625Ala) in katG, one (p.Tyr113Phe) in inhA, five (p.Val170Phe, p.Thr400Ala, p.Met434Val, p.Glu812Gly, p.Phe971Leu) in rpoB, two (p.Tyr319Asp and p.His1002Arg) in embB, and three (p.Cys14Gly, p.Asp63Ala, p.Gly162Ser) in pncA. CONCLUSIONS: Ion semiconductor NGS could detect reported and novel amino acid changes in full coding regions of eight drug resistance-related genes. However, genotypic DST should be complemented and validated by phenotypic DSTs.
Amikacin ; Clinical Coding ; Complement System Proteins ; DNA ; Drug Resistance* ; Ethambutol ; Fluoroquinolones ; Isoniazid ; Kanamycin ; Levofloxacin ; Mycobacterium tuberculosis* ; Mycobacterium* ; Ofloxacin ; Pyrazinamide ; Rifampin ; Semiconductors* ; Streptomycin

The main goal of transfusion medicine is safe and appropriate blood transfusion in all situations. To accomplish this, it is essential to have a high level quality management system for the entire process from blood donation to transfusion. Regulations regarding blood management have been adopted and strictly managed in Korea since 2007. Blood center's blood management tasks should establish appropriate quality management systems to ensure the safe supply of blood, as well as the basic resources of personnel, facilities and equipment in accordance with laws and regulations governed by the Ministry of Health and Welfare in Korea. The purpose of this review is to examine the contents and processes for quality control of clinical chemistry tests in Korean blood centers.
Blood Donors ; Blood Transfusion ; Chemistry, Clinical* ; Clinical Chemistry Tests* ; Humans ; Jurisprudence ; Korea ; Quality Control ; Social Control, Formal ; Transfusion Medicine

No abstract available.