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1,114 result(s) for "Yoon, Hee Jun"
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Analytical and Clinical Validation of the ConfiSign HIV Self-Test for Blood-Based HIV Screening
Background/Objectives: Since the World Health Organization (WHO) recommended HIV self-testing as an alternative to traditional facility-based testing in 2016, it has been increasingly adopted worldwide. This study aimed to evaluate the performance of the ConfiSign HIV Self-Test (GenBody Inc., Republic of Korea), a newly developed blood-based immunochromatographic assay for the qualitative detection of total antibodies (IgG and IgM) against HIV-1/HIV-2. Methods: The evaluation included four components: (1) retrospective analysis of 1400 archived serum samples (400 HIV-positive and 1000 HIV-negative samples), (2) prospective self-testing by 335 participants (112 HIV-positive participants and 223 individuals with an unknown HIV status, including healthy volunteers), (3) assessment using seroconversion panels and diverse HIV subtypes, and (4) analytical specificity testing for cross-reactivity and interference. The Elecsys HIV combi PT and Alinity I HIV Ag/Ab Combo assays were used as reference assays. Results: In retrospective testing, the ConfiSign HIV Self-Test achieved a positive percent agreement (PPA) of 100%, a negative percent agreement (NPA) of 99.2%, and a Cohen’s kappa value of 0.986, showing excellent agreement with the reference assays. In the prospective study, the test showed 100% sensitivity and specificity, with a low invalid result rate of 1.8%. All HIV-positive samples, including those with low signal-to-cutoff (S/Co) values in the Alinity I assay, were correctly identified. The test also reliably detected early seroconversion samples and accurately identified a broad range of HIV-1 subtypes (A, B, C, D, F, G, CRF01_AE, CRF02_AG, and group O) as well as HIV-2. No cross-reactivity or interference was observed with samples that were positive for hepatitis viruses, cytomegalovirus, Epstein–Barr virus, varicella zoster virus, influenza, HTLV-1, HTLV-2, or malaria. Conclusions: The ConfiSign HIV Self-Test demonstrated excellent sensitivity, specificity, and robustness across diverse clinical samples, supporting its reliability and practicality as a self-testing option for HIV-1/2 antibody detection.
Development of a robust DNA quality and quantity assessment qPCR assay for targeted next-generation sequencing library preparation
Next-generation sequencing (NGS) is becoming a standard for genetic analyses of clinical samples. DNAs retrieved from formalin-fixed, paraffin-embedded (FFPE) tissue specimens are commonly degraded, and specimens such as core biopsies are sometimes too small to obtain enough DNA for NGS applications. Thus, it is important to measure both the DNA quantity and quality accurately from clinical samples. However, there is no standard method for DNA quantity and quality analyses for NGS library preparation. We tested four different methods (PicoGreen, Qubit® fluorometry, TaqMan and SYBR-Green-based qPCR assay) and compared each to RNase P TaqMan as a reference control. We found that SYBR-Green-based qPCR assay provides a consistent and accurate DNA quantification while keeping its cost relatively low and the throughput high. We designed a dual-probe SYBR-Green qPCR assay for DNA quantity and quality assessment for targeted NGS library preparation. This assay provides a Dscore (degradation score) of the interrogated DNA by analyzing two different sizes of amplicons. We show an example of a clinical sample with a very high Dscore (high degradation). With a regular DNA quantification, without considering the degradation status, no correct NGS libraries were obtained. However, after optimizing the library condition by considering its poor DNA quality, a reasonably good library and sequencing results were obtained. In summary, we developed and presented a new DNA quantity and quality analysis qPCR assay for the targeted NGS library preparation. This assay may be mostly efficient for the clinical samples with high degradation and poor DNA quality.
Mobile Genome Express (MGE): A comprehensive automatic genetic analyses pipeline with a mobile device
The development of next-generation sequencing (NGS) technology allows to sequence whole exomes or genome. However, data analysis is still the biggest bottleneck for its wide implementation. Most laboratories still depend on manual procedures for data handling and analyses, which translates into a delay and decreased efficiency in the delivery of NGS results to doctors and patients. Thus, there is high demand for developing an automatic and an easy-to-use NGS data analyses system. We developed comprehensive, automatic genetic analyses controller named Mobile Genome Express (MGE) that works in smartphones or other mobile devices. MGE can handle all the steps for genetic analyses, such as: sample information submission, sequencing run quality check from the sequencer, secured data transfer and results review. We sequenced an Actrometrix control DNA containing multiple proven human mutations using a targeted sequencing panel, and the whole analysis was managed by MGE, and its data reviewing program called ELECTRO. All steps were processed automatically except for the final sequencing review procedure with ELECTRO to confirm mutations. The data analysis process was completed within several hours. We confirmed the mutations that we have identified were consistent with our previous results obtained by using multi-step, manual pipelines.
Examining SEB skills’ incremental validity over personality traits in predicting academic achievement
Personality traits and social, emotional, and behavioral (SEB) skills share the same behavioral referents, but whereas traits refer to a person’s typical or average performance, skills refer to their capacity or maximal performance. Given their shared behavioral foundations, an important question to address is whether personality traits and SEB skills independently predict important outcomes. In this study (N = 642), we examined whether subscales of the Behavioral, Emotional, and Social Skills Inventory (BESSI), a measure of SEB skills, provided incremental validity in the prediction of the ACT composite score, an important academic outcome for American adolescents, over the Big Five personality traits. Consistent with our expectations, on average, SEB skills showed stronger associations with ACT achievement scores than personality traits. Moreover, SEB skills added incremental validity over and above personality traits in predicting ACT achievement scores. The findings reinforce the importance of conceptually distinguishing and measuring traits and skills.
Direct effectiveness of pneumococcal polysaccharide vaccine against invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia in elderly population in the era of pneumococcal conjugate vaccine: A case-control study
•National immunization program for PPV23 for the elderly was implemented in Korea.•PPV23 was effective against IPD and NBPP for young elderly patients aged 65–74.•Effectiveness of PPV23 against IPD was higher for PPV23 unique serotypes.•PPV23 was non-protective against IPD caused by PCV13 serotypes. While herd effects and serotype replacement by childhood pneumococcal protein conjugated vaccines (PCVs) continues to accumulate worldwide, direct effectiveness of 23-valent pneumococcal polysaccharide vaccine (PPV23) against pneumococcal diseases in the elderly has been challenged. We estimated the direct effectiveness of PPV23 in the elderly population. For a hospital-based case-control study, cases of invasive pneumococcal disease (IPD) and non-bacteremic pneumococcal pneumonia (NBPP) (adults ≥ 65 years) were identified in 14 hospitals participated in the pneumococcal surveillance program from March 2013 to October 2015, following implementation of PPV23 national immunization program (NIP) for the elderly in the Republic of Korea. Controls matched by age, sex, and hospital were selected at ratios of 1:2 (IPD) or 1:1 (NBPP). Clinical data and vaccination records were collected. Vaccine effectiveness was calculated as (1-adjusted odds ratio) × 100. We enrolled 148 IPD and 557 NBPP cases, and 295 IPD and 557 NBPP controls for analyses. Overall effectiveness of PPV23 against IPD was 28.5% [95% confidence interval (CI) −5.8%–51.6%] and against NBPP was 10.2% (-15.1-30.6) in all patients ≥ 65 years. However, in subgroup analysis of patients aged 65–74 years, PPV23 was protective against IPD [effectiveness 57.4% (19.4–77.5)] and against NBPP [effectiveness 35.0% (2.3–56.7)]. Furthermore, serotype-specific effectiveness of PPV23 against IPD was 90.6% (27.6–98.8) for PPV23-unique serotypes and 81.3% (38.6–94.3) for PPV23 serotypes excluding serotype 3. This study indicates that PPV23 with broad serotype coverage might be beneficial in preventing IPD and NBPP due to non-PCV13 serotypes in the young-elderly, with potentially increasing effectiveness in the setting of childhood PCV NIP.
Effect of characteristics on the clinical course at the initiation of treatment for human immunodeficiency virus infection using dimensionality reduction
The beginning of human immunodeficiency virus (HIV) infection treatment depends on various factors, which are significantly correlated with the initial CD4 cell number. However, a covariate correlation between these factors may not reflect the correct outcome variable. Thus, we evaluated the effects of a combination of fixed factors (reduced dimensions), which determine when to start treatment for the first time, on short-term outcome, long-term outcome, and survival, considering correlations between factors. Multiple correspondence analysis was performed on variables obtained from 925 patients who participated in a Korean HIV/acquired immunodeficiency syndrome cohort study (2006–2017). Five reduced dimension groups were derived according to clinical data, viral load, CD4 cell count at diagnosis, initial antiretroviral therapy, and others. The dimension group with high initial viral loads (55,000 copies/mL) and low CD4 cell counts (< 200 cells/mm 3 ) should start treatment promptly after diagnosis. Groups with high initial CD4 cell counts (> 350 cells/mm 3 ) that did not require immediate treatment according to previous guidelines had a higher failure rate for long-term relative CD4 recovery. Our results highlight the importance of early diagnosis and treatment to positively influence long-term disease outcomes, even if the initial immune status is poor, given the patient’s combination of early diagnostic symptoms.
An In-depth Review of Conscientiousness and Educational Issues
Why does conscientiousness matter for education? How is conscientiousness conceptualized in the field of research on education? How do socio-emotional (SE) skills relate to conscientiousness? In an effort to help answer these questions, we review the current research on conscientiousness in education. Specifically, we examine (1) how conscientiousness is defined, (2) the assessment of conscientiousness, (3) the relation between conscientiousness and educational outcomes, (4) whether too much conscientiousness may be a bad thing, (5) the relation between conscientiousness and conceptually related educational constructs, (6) the changeability of conscientiousness and the importance of that fact to education, and (7) the challenges of assessing conscientiousness across cultures.
Comprehensive evaluation and validation of targeted next-generation sequencing performance in two clinical laboratories
Next-generation sequencing (NGS) has led to breakthroughs for genetic and genomic analyses and personalized medicine approaches for many diseases. More and more clinical laboratories are using NGS as a genetic screening tool for providing mutation information that is used to select the best treatment regimens for cancer patients. However, several obstacles prevent the routine implementation of NGS technology into the clinical molecular diagnosis setting: the sophisticated sample preparation process, high cost, time-consuming data analyses, as well as the reproducibility and accuracy of interpretation. To systematically evaluate the performance and quality of targeted NGS cancer panel analyses in clinical laboratories, we performed three different tests: i) laboratory-to-laboratory accuracy test, ii) intra-laboratory precision validation, and iii) limit of detection test, using formalin-fixed, paraffin-embedded cancer tissue specimens, cell lines and mutation positive DNA. A laboratory-to-laboratory accuracy test performed using 51 samples showed 100% sensitivity and 99.97% specificity. For the intra-laboratory precision test, 100% reproducibility was observed. For the limit of detection test, KRAS mutations from samples diluted from 70 to 2% of mutant allele frequencies were detected correctly. We believe that the present study demonstrated the feasibility of clinical implementation of a targeted NGS cancer panel analysis for personalized medicine.
Comparative Evaluation of Standard E TB-Feron ELISA and QuantiFERON-TB Gold Plus Assays in Patients with Tuberculosis and Healthcare Workers
Recently, the American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention advised against performing the interferon-γ-release assay (IGRA) test for individuals with a low risk of TB, and also recommended retesting low-risk individuals with an initial positive IGRA result. However, to evaluate both sensitivity and specificity of available tests, we compared the performance of the Standard E TB-Feron (TBF) and QuantiFERON-TB Gold Plus (QFT-Plus) assays in healthcare workers (HCWs) and tuberculosis (TB) patients. We also retrospectively investigated diabetes mellitus (DM) comorbidity among the enrolled TB patients. We prospectively collected samples from 177 HCWs and 48 TB patients. The TBF and QFT-Plus tests were performed and analyzed according to the manufacturers’ instructions. We also defined IGRA results between 0.2 and 0.7 IU/mL as ‘borderline’. The agreement rate between TBF and QFT-Plus was 92.0% (207/225) with a Cohen’s kappa value of 0.77 (95% CI, 0.68–0.87). While the majority (26/31, 83.9%) of borderline TBF results were in HCWs, the majority (14/19, 73.7%) of borderline QFT-Plus results were in TB patients. Discordant results were found in 18 samples, with TBF-positive/QFT-Plus-negative or indeterminate results in 11 HCWs and seven TB patients. After resampling from 10 HCWs (seven borderline-positive and three positive results, all <1.0), six reverted to negative. The prevalence of DM comorbidity was very high (35.4%). In summary, TBF showed substantial agreement with the QFT-Plus assay but had a higher positivity rate in both HCWs and TB patients. The negative conversion rate was high (60%) among HCWs whose initial (TB Ag-nil) result was <1.0.
Design of an Efficient Unified Storage System for Large-Scale Science Experimental Data Services
Large-scale science experimental services based on high-performance infrastructure, such as a large ion collider experiment (ALICE), compact muon solenoid (CMS), and next-generation sequencing (NGS), requires extremely high-performance and scalability to store and manipulate a set of scientific experimental data from advanced research equipment. To handle the massive and growing amount of file-based data, infrastructure requires efficient, highly scalable, and high-performance storage systems. The current large unified storage comprises multiple storage types (e.g. TAPE, HDD, SSD, Cloud) that are merged into a large single storage via unification file systems. However, previously reported file systems that use a union mount, such as UnionFS and AUFS lack an efficient write policy with regard to heterogeneous storage types. In this work, we propose an efficient unified storage system for large-scale data farms. The proposed system provides scalable storage and rapid I/O performance through a new write policy for the unification file system. Applying the proposed write policy to AuFS which has presented one of the well-known unification file systems, we show its advantages in terms of data write performance for high-performance-computer (HPC)-based science experimental services