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Background@#Mass spectrometry methods exhibit higher accuracy and lower variability than immunoassays at low testosterone concentrations. We developed and validated an ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) assay for quantifying serum total testosterone. @*Methods@#We used an ExionLC UPLC (Sciex, Framingham, MA, USA) system and a Sciex Triple Quad 6500+ (Sciex) MS/MS system in electrospray ionization and positive ion modes with multiple reaction monitoring transitions to evaluate precision, accuracy, linearity, lower limit of quantitation (LLOQ), carryover, ion suppression, stability, and reference intervals. For method comparison, we measured serum testosterone concentrations using this method in 40 subjects whose testosterone concentrations ranged from 0.14 to 55.48 nmol/L as determined using the Architect i2000 immunoassay (Abbott Diagnostics, Abbott Park, IL, USA) and in an additional 160 sera with testosterone concentrations <1.67 nmol/L. @*Results@#The intra- and inter-run precision CVs were <2.81%, and the accuracy bias values were <3.85%, which were all acceptable. The verified linear interval was 0.03–180.84 nmol/L; the LLOQ was 0.03 nmol/L. No significant carryover and ion suppression were observed. The testosterone in serum was stable at 4°C, at –20°C, and after three freeze-thaw cycles. The reference intervals were successfully verified. The correlation was good at testosterone concentrations of 0.14–55.48 nmol/L; however, the Architect assay showed positive percent bias at concentrations <1.67 nmol/L. @*Conclusions@#The UPLC-MS/MS assay shows acceptable performance, with a lower LLOQ than the immunoassay. This method will enable the quantitation of low testosterone concentrations.
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While numerous studies have evaluated humoral responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, data on the cellular responses to these vaccines remain sparse. We evaluated T cell responses to ChAdOx1-nCoV-19 and BNT162b2 vaccinations using an interferon gamma (IFN-γ) release assay (IGRA). ChAdOx1-nCoV-19- and BNT162b2-vaccinated participants initially showed stronger T cell responses than unvaccinated controls. The T cell response decreased over time and increased substantially after the administration of a BNT162b2 booster dose. Changes in the T cell response were less significant than those in the anti-receptor-binding domain IgG antibody titer. The study results can serve as baseline data for T cell responses after SARS-CoV-2 vaccination and suggest that the IGRA can be useful in monitoring immunogenicity.
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Background@#To ensure valid results of big data research in the medical field, the input laboratory results need to be of high quality. We aimed to establish a strategy for evaluating the quality of laboratory results suitable for big data research. @*Methods@#We used Korean Association of External Quality Assessment Service (KEQAS) data to retrospectively review multicenter data. Seven measurands were analyzed using commutable materials: HbA1c, creatinine (Cr), total cholesterol (TC), triglyceride (TG), alpha-fetoprotein (AFP), prostate-specific antigen (PSA), and cardiac troponin I (cTnI). These were classified into three groups based on their standardization or harmonization status. HbA1c, Cr, TC, TG, and AFP were analyzed with respect to peer group values. PSA and cTnI were analyzed in separate peer groups according to the calibrator type and manufacturer, respectively. The acceptance rate and absolute percentage bias at the medical decision level were calculated based on biological variation criteria. @*Results@#The acceptance rate (22.5%–100%) varied greatly among the test items, and the mean percentage biases were 0.6%–5.6%, 1.0%–9.6%, and 1.6%–11.3% for all items that satisfied optimum, desirable, and minimum criteria, respectively. @*Conclusions@#The acceptance rate of participants and their external quality assessment (EQA) results exhibited statistically significant differences according to the quality grade for each criterion. Even when they passed the EQA standards, the test results did not guarantee the quality requirements for big data. We suggest that the KEQAS classification can serve as a guide for building big data.
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Background@#Neutrophil gelatinase-associated lipocalin (NGAL) is a useful biomarker for acute kidney injury (AKI) prediction. However, studies on whether using both plasma NGAL (PNGAL) and urine NGAL (UNGAL) can improve AKI prediction are limited. We investigated the best approach to predict AKI in high-risk patients when using PNGAL and UNGAL together. @*Methods@#We enrolled 151 AKI suspected patients with one or more AKI risk factors. We assessed the diagnostic performance of PNGAL and UNGAL for predicting AKI according to chronic kidney disease (CKD) status by determining the areas under the receiver operating curve (AuROC). Independent predictors of AKI were assessed using univariate and multivariate logistic regression analyses. @*Results@#In the multivariate logistic regression analysis for all patients (N = 151), Model 2 and 3, including PNGAL (P = 0.012) with initial serum creatinine (S-Cr), showed a better AKI prediction power (R2 = 0.435, both) than Model 0, including S-Cr only (R2 = 0.390). In the non-CKD group (N = 135), the AuROC of PNGAL for AKI prediction was larger than that of UNGAL (0.79 vs 0.66, P = 0.010), whereas in the CKD group (N = 16), the opposite was true (0.94 vs 0.76, P = 0.049). @*Conclusions@#PNGAL may serve as a useful biomarker for AKI prediction in high-risk patients. However, UNGAL predicted AKI better than PNGAL in CKD patients. Our findings provide guidance for selecting appropriate specimens for NGAL testing according to the presence of CKD in AKI high-risk patients.
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Background@#Accurate serum creatinine (Cr) concentration measurement is essential for evaluating kidney function. In 2011, the Korean Association of External Quality Assessment Service (KEQAS) launched an accuracy-based Cr proficiency testing (ABCr PT) survey. We analyzed long-term data of the KEQAS ABCr PT survey collected between 2011 and 2019 to assess recent trends in Cr assays in Korea. @*Methods@#The ABCr PT survey including three commutable fresh-frozen serum samples was performed twice a year. The target Cr concentration was assigned using isotope-dilution mass spectrometry. We analyzed data obtained from the participating laboratories, calculated the yearly bias, and evaluated bias trends for the major reagents and instruments. Outliers were excluded from all analysis. @*Results@#The mean percentage bias based on the total data of all participating laboratories was 10.8% in the 2011-A survey and 0.2% in 2019-B survey. Bias for the major reagents and instruments differed depending on the manufacturer. Enzymatic assays generally showed desirable bias ranging from –3.9% to 3.2% at all Cr concentrations and lower interlaboratory variability than non-enzymatic assays (enzymatic vs. non-enzymatic, 3.3%– 7.2% vs. 6.3%–9.1%). @*Conclusions@#Although the mean percentage bias of Cr assays tends to decrease over time, it is necessary to continuously strive to improve Cr assay accuracy, especially at low concentrations.
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Background@#Liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) is increasingly used for immunosuppressive drug tests. However, most LC-MS/MS tests are laboratory-developed and their agreement is unknown in different Korean laboratories.This interlaboratory comparison study evaluated test reproducibility and identified potential error sources. @*Methods@#Test samples containing three concentrations of tacrolimus, sirolimus, everolimus, cyclosporine, and mycophenolic acid were prepared by pooling surplus samples from patients undergoing routine therapeutic drug monitoring and tested in duplicate in the participating 10 clinical laboratories. Reconstitution and storage experiments were conducted for the commonly used commercial calibrator set. The robust estimators of reproducibility parameters were calculated. Spearman’s rank correlation coefficient (rho, ρ) was used to evaluate the correlation between drugs. Multiple linear regression was used to determine whether the experimental conditions alter the calibration curves. @*Results@#The reproducibility coefficient of variation exceeded 10% only for sirolimus concentrations 1 and 2 (10.8% and 12.5%, respectively) and everolimus concentrations 1 and 2 (12.3% and 11.4%, respectively). The percent difference values showed weak correlations between sirolimus and everolimus (ρ = 0.334, P = 0.175). The everolimus calibration curve slope was significantly altered after reconstitution following prolonged 5°C storage (P = 0.015 for 14 days; P = 0.025 for 28 days); the expected differences at 6 ng/mL were 0.598% for 14 days and 0.384% for 28 days. @*Conclusions@#LC-MS/MS test reproducibility for immunosuppressive drugs seems to be good in the Korean clinical laboratories. Continuous efforts are required to achieve test standardization and harmonization, especially for sirolimus and everolimus.
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Healthcare workers (HCWs) may be at high risk for exposure to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) because of their frequent contact with patients or the direct handling of respiratory samples. We investigated the seroprevalence of SARS-CoV-2 IgG in HCWs in Seoul compared to those in coronavirus disease (COVID-19) patients and community-based individuals to evaluate the antibody response. A total of 358 samples from 348 individuals (155 HCWs, 7 COVID-19 patients, and 186 community-based individuals) were collected from April to November 2020. SARS-CoV-2 IgG was detected in 1 of 155 HCWs (1 of 46 HCWs with direct contact), 7 of 7 COVID-19 patients, and none of the 186 communitybased individuals (95% CI: 0.6%, 0.1 - 3.6%; 100%, 64.5 - 100%; 0.0%, 0.0 - 2.0%, respectively).The single HCW with a positive result showed 2.32 signal-to-cutoff (S/C) and 2.31 S/C at a 3-week interval. Therefore, it was assumed to be a false positive due to autoantibody or medication. The positive samples from 7 patients had a median of 3.79 S/C (range 1.72 - 6.54). The seroprevalence of SARS-CoV-2 IgG in HCWs was very low. The current infection control standard seems to be effective in protecting HCWs from COVID-19.
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Healthcare workers (HCWs) may be at high risk for exposure to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) because of their frequent contact with patients or the direct handling of respiratory samples. We investigated the seroprevalence of SARS-CoV-2 IgG in HCWs in Seoul compared to those in coronavirus disease (COVID-19) patients and community-based individuals to evaluate the antibody response. A total of 358 samples from 348 individuals (155 HCWs, 7 COVID-19 patients, and 186 community-based individuals) were collected from April to November 2020. SARS-CoV-2 IgG was detected in 1 of 155 HCWs (1 of 46 HCWs with direct contact), 7 of 7 COVID-19 patients, and none of the 186 communitybased individuals (95% CI: 0.6%, 0.1 - 3.6%; 100%, 64.5 - 100%; 0.0%, 0.0 - 2.0%, respectively).The single HCW with a positive result showed 2.32 signal-to-cutoff (S/C) and 2.31 S/C at a 3-week interval. Therefore, it was assumed to be a false positive due to autoantibody or medication. The positive samples from 7 patients had a median of 3.79 S/C (range 1.72 - 6.54). The seroprevalence of SARS-CoV-2 IgG in HCWs was very low. The current infection control standard seems to be effective in protecting HCWs from COVID-19.
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A new diagnosis-related group (DRG) based payment system has been implemented in most public hospitals in Korea. We investigated the effects of the new DRG system and its incentive policy on the utilization rate of diagnostic laboratory tests. Three groups were categorized; 36 hospitals under the new DRG system (participant group), 72 hospitals (control-1) matching with 36 participants according to the number of beds, and 42 tertiary hospitals (control-2). The patients of acute myocardial infarction, cerebral infarction, type 2 diabetes mellitus, and gonarthrosis receiving total arthroplasty were included. We analyzed the mean length of stay and the number of diagnostic laboratory tests conducted during hospitalization of the three groups according to the new DRG system and the incentive policy rates under the new DRG system. Before participating in the new DRG system, the number of diagnostic laboratory tests in the participant group was less than that in the two control groups for all four diseases. However, although the participant group’s length of stay decreased under the new DRG system, the number of diagnostic laboratory tests increased as the maximum incentive policy rate increased. The increment of the number of diagnostic laboratory tests was prominent in the period of a maximum of 35% incentive policy rates. Finally, the number of diagnostic laboratory tests of the participant group was similar to or exceeded that of the control-2 group. The new DRG system’s incentive policy rates played a driving force on the increased utilization rate of the diagnostic laboratory test. For preparing in advance for the change in incentive policy rates, monitoring and guidelines for the utilization of diagnostic laboratory tests are necessary.
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Mucormycosis is a fungal infection, which is difficult to treat due to its rapid dissemination and low susceptibility to anti-fungal agents. Peritonitis preceded by gastrointestinal mucormycosis is very rare, and only a few cases have been reported. We present a case of peritonitis and disseminated mucormycosis caused by Mucor circinelloides in an immunocompromised patient. A 59-year-old man, diagnosed with nodal marginal zone B-cell lymphoma, was diagnosed with liver failure due to severe septic shock. A white, woolly cotton-like growth, which was consistent with that of Mucor species, was isolated from ascites and sputum specimens. Targeted DNA sequencing confirmed the isolate as M. circinelloides with 100% identity. Despite anti-fungal treatment, the patient died after four days. This is a rare case of peritonitis and disseminated mucormycosis that was probably preceded by gastrointestinal mucormycosis caused by M. circinelloides, as determined by molecular methods. Accurate and rapid identification of mold using molecular methods might be necessary for early treatment in critical cases, and more cases should be clinically evaluated further.
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Accurate detection of BCR-ABL fusion transcripts at and below molecular response (MR) 4 (0.01% International Scale [IS]) is required for disease monitoring in patients with chronic myeloid leukemia (CML). We evaluated the analytical performance of the QXDx BCR-ABL %IS (Bio-Rad, Hercules, CA, USA) droplet digital PCR (ddPCR) assay, which is the first commercially available ddPCR-based in vitro diagnostics product. In precision analysis, the %CV was 9.3% and 3.0%, with mean values of 0.031% IS and 9.4% IS, respectively. The assay was linear in the first order, ranging from 0.032% IS to 20% IS. The manufacturer-claimed limit of blank, limit of detection, and limit of quantification were verified successfully. There was a very strong correlation between the results of the QXDx BCR-ABL %IS ddPCR assay and the ipsogen BCR-ABL1 Mbcr IS-MMR (Qiagen, Hilden, Germany) real-time quantitative PCR assay (r=0.996). In conclusion, the QXDx BCR-ABL %IS ddPCR assay can provide reliable results for CML patients.
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Background@#A rise and/or fall in cardiac troponin value with at least one value above the 99th percentile upper reference limit is essential for acute myocardial infarction (AMI) diagnosis. We evaluated the clinical usefulness of serial high-sensitivity cardiac troponin I (hs-cTnI) measurements in AMI diagnosis, in terms of the predictability of absolute and relative changes. @*Methods@#For this retrospective, forward observational study, we enrolled 281 patients older than 18 years who presented with chest pain at the emergency department (ED) between August 2015 and December 2016. The patients were grouped as AMI and nonAMI, and 73 (26%) were diagnosed as having AMI. Hs-cTnI (Abbott Diagnostics, Abbott Park, IL, USA) was measured at presentation and 3 hours later. We assessed the diagnostic performance of the absolute and relative changes in hs-cTnI. @*Results@#The cut-off values to predict AMI were 16.2 ng/L and 42.1% for the absolute and relative hs-cTnI changes, respectively. The area under the curve of hs-cTnI for AMI diagnosis was larger for absolute changes than for relative changes [0.96 (95% confidence interval [CI], 0.92–0.98) vs 0.89 (95% CI, 0.85–0.93)] (P = 0.014). @*Conclusions@#The absolute hs-cTnI change at 3 hours after presentation was superior to the relative change, and a rise and/or fall in hs-cTnI of > 16.2 ng/L at 3 hours after presentation was useful to identify AMI in patients presenting at the ED.
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Background@#Current methods for diagnosing Clostridioides difficile infections (CDIs) fail to provide information on their severity. Fecal neutrophil gelatinase-associated lipocalin (NGAL) and calprotectin are candidate biomarkers for evaluating the severity of intestinal inflammation. We assessed fecal NGAL and calprotectin levels in patients with CDI and compared these values between subgroups of patients. We also evaluated their utility in predicting CDI clinical outcomes. @*Methods@#A total of 147 leftover fecal samples were obtained; 97 samples were from patients with CDI and 50 were from routine healthcare checkups. Fecal calprotectin and NGAL levels were measured using a Quantitative Fecal NGAL ELISA Kit and Quantitative Fecal Calprotectin ELISA Kit (Epitope Diagnostics, USA). @*Results@#Significant differences in fecal NGAL and calprotectin levels were observed between CDI patients and healthy controls (P<0.0001 for both). Significant differences in fecal NGAL and calprotectin levels were also seen between patients with high and low tcdB gene load (P=0.005 and 0.006, respectively). Fecal calprotectin levels were lower in patients with leukopenia (P=0.002), and high calprotectin levels were associated with severe CDI and treatment failure (P=0.021 and 0.033, respectively). @*Conclusions@#Fecal NGAL and calprotectin levels were higher in patients with CDI than in healthy controls and correlated with high tcdB gene loads. Leukopenia patients with CDI had significantly lower levels of calprotectin and the assessment should be regarded with caution. High fecal calprotectin levels were also associated with severe CDI and treatment failure. This warrants future studies with more patients and in-depth analyses.
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No abstract available.
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Sustitución de Aminoácidos , Corea (Geográfico) , Proteínas de Unión a las Penicilinas , Penicilinas , StreptococcusRESUMEN
The Clinical Mass Spectrometry Research Committee (CMSRC), in affiliation with the Korean Society of Clinical Chemistry (KSCC), conducted a questionnaire survey on opinions about the general status of clinical mass spectrometric analysis in Korea. As a result, we understand that this field has passed through the introductory stage and is settled as a field of clinical laboratory testing in Korea, with the number of new laboratories performing mass spectrometric analysis being low. In spite of the many difficulties in introducing and operating clinical mass spectrometric analysis, there is a strong interest in this field, and even though further expansion is expected, there are still many issues to be resolved. In the future, it will be necessary to make concrete and thorough efforts to further develop the laboratory tests using clinical mass spectrometric analysis in Korea, centering on the CMSRC affiliated with the KSCC.
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Química Clínica , Corea (Geográfico) , Espectrometría de MasasRESUMEN
BACKGROUND: Standardization of creatinine assay is consistently performed and much effort has been put into improving the accuracy of the results. We aimed to analyze the results of accuracy-based proficiency testing of creatinine assays performed by the Korea Association of External Quality Assessment Service from 2011 to 2017 to assess the current state of creatinine assays in Korea. METHODS: From 2011 to 2017, the accuracy-based proficiency testing of creatinine was performed twice a year. We analyzed the results obtained from the participating laboratories and calculated the year-wise bias. The acceptable limit of bias was as follows: ±11.4% for creatinine concentration >1.0 mg/dL, and 0.114 mg/dL for creatinine concentration ≤1.0 mg/dL. The trend of bias with the major instruments and reagent manufacturers were analyzed. RESULTS: The number of participating laboratories was 54 in 2011, which gradually increased to 146–178 after 2015. For each of the three samples used in the survey, the percentage of laboratories whose biases in the results were within the acceptable limits was 33.3% for the first time in 2011, which gradually increased to 74.7%–85.0% after 2014. The mean biases in all the results of the participating laboratories were 11.1% in 2011 (1st trial) and 2.4% in 2017 (2nd trial). The biases in the results with the major instruments and reagents differed according to the manufacturers. CONCLUSIONS: The mean bias in the results obtained from the participating laboratories in the accuracy-based proficiency testing of creatinine surveys showed a decreasing trend.
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Sesgo , Creatinina , Indicadores y Reactivos , Corea (Geográfico)RESUMEN
The accuracy-based lipid (ABL) proficiency testing (PT) program was started in 2016 by the Korean External Quality Assessment Service to minimize the matrix effect. We analyzed 3 years of the program. We made or purchased six kinds of commutable frozen sera based on the Clinical and Laboratory Standards Institute 37A guideline and distributed it in two rounds per year from 2016 to 2018. We obtained reference values for levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC), total glycerides, and triglycerides in each fresh frozen pool at the reference-measurement laboratories. We evaluated the average percent bias of the participating laboratories based on the National Cholesterol Education Program (NCEP) bias limit. The number of participating laboratories evaluating TC, HDLC, LDLC, total glycerides, and triglycerides increased from 164 to 223, 163 to 223, 158 to 214, 98 to 139, and 61 to 82, respectively. The average percent bias of all participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was +0.14%, −0.54%, +2.9%, −1.08%, and −1.32%, respectively. The average percent bias exceeded the NCEP bias limit only once or twice for TC, HDLC, and total glycerides but frequently for LDLC (eight out of 18 pools). The manufacturer-specific bias estimation report seemed useful for traceability. Although the average percent bias of participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was mostly within the bias limit provided by NCEP, cases of bias limit exceeding the NCEP bias limit occurred occasionally, especially for LDLC during the 3 years of the ABL PT program in Korea, suggesting that ABL PT can be used to keep maintaining traceability.
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Sesgo , Colesterol , Educación , Glicéridos , Corea (Geográfico) , Ensayos de Aptitud de Laboratorios , Lipoproteínas , Valores de Referencia , TriglicéridosRESUMEN
BACKGROUND/AIMS: In countries with a higher risk of gastric atrophic gastritis, noninvasive tests are helpful for a more reliable diagnosis of Helicobacter pylori infection. The aim of this study was to evaluate the characteristics of seropositive subjects according to their stool H. pylori antigen test, serum pepsinogen (PG) assay, and endoscopic findings. METHODS: Consecutive subjects who visited Konkuk University Medical Center for upper gastrointestinal endoscopy for a regular check-up were included in a prospective setting if the serum anti-H. pylori immunoglobulin G assay was positive. A H. pylori antigen stool test was measured using a stool H. pylori antigen enzyme-linked immunosorbent assay kit on the same day as a serum PG assay and endoscopy. RESULTS: Of 318 seropositive subjects, 256 (80.5%) showed positive stool test findings. Subjects with a negative stool test result showed lower serum PG I (p < 0.001) and PG II (p < 0.001) levels and higher PG I/II ratio (p < 0.001) than those with a positive stool test. Chronic atrophic gastritis was more common in the positive stool test group than the negative stool test group on endoscopic finding (p = 0.009). A higher serum PG I level (p = 0.001) and a lower serum PG I/II ratio (p = 0.001) were independent risk factors for the presence of H. pylori antigen in stool. CONCLUSIONS: A high serum PG level denotes an ongoing current H. pylori infection with positive stool H. pylori antigen test findings. Seropositive subjects with increased gastric secreting ability tend to have H. pylori in their fecal material as reflected by a positive stool H. pylori antigen test finding.
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Centros Médicos Académicos , Diagnóstico , Endoscopía , Endoscopía Gastrointestinal , Ensayo de Inmunoadsorción Enzimática , Gastritis Atrófica , Helicobacter pylori , Helicobacter , Inmunoglobulina G , Pepsinógeno A , Estudios Prospectivos , Factores de RiesgoRESUMEN
BACKGROUND: Liver biopsies have been partially replaced by noninvasive methods for assessing liver fibrosis. We explored the usefulness of four novel biomarkers, enhanced liver fibrosis (ELF), glycosylation isomer of Mac-2 binding protein (M2BPGi), galectin-3, and soluble suppression of tumorigenicity 2 (sST2), in association with liver fibrosis. METHODS: ELF, M2BPGi, galectin-3, and sST2 were assayed in 173 patients with chronic liver diseases. The results were analyzed according to fibrosis grade (F0/1, F2, and F3/4) by transient elastography (TE). RESULTS: ELF, M2BPGi, galectin-3, and sST2 values differed significantly according to TE grade; ELF and M2BPGi values were higher in F2 and F3/4 than in F0/1 (P≤0.001, all), sST2 values were higher in F3/4 than in F0/1 and F2 (P < 0.05), and galectin-3 values were higher in F3/4 than in F0/1 (P=0.0036). ELF and M2BPGi showed good TE fibrosis detection performance (area under the curves [AUC], 0.841 and 0.833 for ≥F2; and 0.837 and 0.808 for ≥F3). The sensitivity and specificity for predicting TE grade F≥2 were 84.1% and 76.7% for ELF and 63.6% and 91.5% for M2BPGi. CONCLUSIONS: This is the first study to compare the liver fibrosis assessment of four novel biomarkers: ELF, M2BPGi, galectin-3, and sST2. The biomarkers varied significantly according to TE grade, and each biomarker showed a different trend. ELF and M2BPGi seem to have comparable good performance for detecting liver fibrosis.
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Humanos , Biomarcadores , Biopsia , Proteínas Portadoras , Diagnóstico por Imagen de Elasticidad , Fibrosis , Galectina 3 , Glicosilación , Cirrosis Hepática , Hepatopatías , Hígado , Sensibilidad y EspecificidadRESUMEN
Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.