Assessment of Bone Marrow Involvement in B-Cell non-Hodgkin Lymphoma Using Immunoglobulin Gene Rearrangement Analysis with Next-Generation Sequencing.

BACKGROUND: Assessment of bone marrow involvement (BMI) in non-Hodgkin lymphoma (NHL) is crucial for determining patient prognosis and treatment strategy. We assessed the prognostic value of next-generation sequencing (NGS)-based immunoglobulin (Ig) gene clonality analysis as an ancillary test for BMI evaluation in NHL. METHODS: A retrospective cohort of 124 patients newly diagnosed with B-cell NHL between 2019 and 2022 was included. NGS-based Ig clonality analysis was conducted using LymphoTrak IGH FR1 Assay and IGK Assay (Invivoscribe Technologies, San Diego, CA, USA) on BM aspirate samples, and the results were compared with those of histopathological BMI (hBMI). RESULTS: Among the 124 patients, hBMI was detected in 16.9% (n = 21). The overall agreement of BMI between Ig clonality analyses and histopathological analysis for IGH, IGK, and either IGH or IGK was 86.3%, 92.7%, and 90.3%. The highest positive percent agreement was observed with clonal rearrangements of either IGH or IGK gene (90.5%), while the highest negative percent agreement was observed with clonal rearrangement of IGK gene (96.1%). For the prediction of hBMI, positive prediction value ranged between 59.1% and 80.0% and the negative prediction value ranged between 91.3% and 97.9%. CONCLUSION: NGS-based clonality analysis is an analytic platform with a substantial overall agreement with histopathological analysis. Assessment of both IGH and IGK genes for the clonal rearrangement analysis could be considered for the optimal diagnostic performance of BMI detection in B-cell NHL.

Identification of a Complex Karyotype Signature with Clinical Implications in AML and MDS-EB Using Gene Expression Profiling.

Complex karyotype (CK) is associated with a poor prognosis in both acute myeloid leukemia (AML) and myelodysplastic syndrome with excess blasts (MDS-EB). Transcriptomic analyses have improved our understanding of the disease and risk stratification of myeloid neoplasms; however, CK-specific gene expression signatures have been rarely investigated. In this study, we developed and validated a CK-specific gene expression signature. Differential gene expression analysis between the CK and non-CK groups using data from 348 patients with AML and MDS-EB from four cohorts revealed enrichment of the downregulated genes localized on chromosome 5q or 7q, suggesting that haploinsufficiency due to the deletion of these chromosomes possibly underlies CK pathogenesis. We built a robust transcriptional model for CK prediction using LASSO regression for gene subset selection and validated it using the leave-one-out cross-validation method for fitting the logistic regression model. We established a 10-gene CK signature (CKS) predictive of CK with high predictive accuracy (accuracy 94.22%; AUC 0.977). CKS was significantly associated with shorter overall survival in three independent cohorts, and was comparable to that of previously established risk stratification models for AML. Furthermore, we explored of therapeutic targets among the genes comprising CKS and identified the dysregulated expression of superoxide dismutase 1 (SOD1) gene, which is potentially amenable to SOD1 inhibitors.

Rapid Detection of Mycobacterium Tuberculosis Using a Novel Point-of-Care BZ TB/NTM NALF Assay: Integrating LAMP and LFIA Technologies.

Tuberculosis (TB) is one of the leading causes of infectious mortality from a single infectious agent, Mycobacterium tuberculosis (MTB). This study evaluated the performance of the newly developed BZ TB/NTM NALF assay, which integrated loop-mediated isothermal amplification and lateral flow immunochromatographic assay technologies, for the detection of MTB. A total of 80 MTB-positive samples and 115 MTB-negative samples were collected, all of which were confirmed by TB real-time PCR (RT-PCR) using either AdvanSureTM TB/NTM RT-PCR Kit or Xpert® MTB/RIF Assay. The performance of the BZ TB/NTM NALF assay was evaluated by calculating its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in comparison to those of the RT-PCR methods. Compared to the RT-PCR, the sensitivity, specificity, PPV, and NPV of BZ TB/NTM NALF assay were 98.7%, 99.1%, 98.7%, and 99.1%, respectively. The concordance rate between BZ TB/NTM NALF and RT-PCR was 99.0%. Rapid and simple detection of MTB is essential for global case detection and further elimination of TB. The performance of the BZ TB/NTM NALF Assay is acceptable with a high concordance with RT-PCR, indicating that it is reliable for use in a low-resource environment.

Molecular characterization of human respiratory syncytial virus in Seoul, South Korea, during 10 consecutive years, 2010-2019.

Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections and hospitalization in infants and young children. Here, we analyzed the genetic diversity of RSV using partial G gene sequences in 84 RSV-A and 78 RSV- B positive samples collected in Seoul, South Korea, for 10 consecutive years, from 2010 to 2019. Our phylogenetic analysis revealed that RSV-A strains were classified into either the ON1 (80.9%) or NA1 (19.0%) genotypes. On the other hand, RSV-B strains demonstrated diversified clusters within the BA genotype. Notably, some sequences designated as BA-SE, BA-SE1, and BA-DIS did not cluster with previously identified BA genotypes in the phylogenetic trees. Despite this, they did not meet the criteria for the assignment of a new genotype based on recent classification methods. Selection pressure analysis identified three positive selection sites (amino acid positions 273, 274, and 298) in RSV-A, and one possible positive selection site (amino acid position 296) in RSV-B, respectively. The mean evolutionary rates of Korean RSV-A from 1999 to 2019 and RSV-B strains from 1991 and 2019 were estimated at 3.51 × 10-3 nucleotides (nt) substitutions/site/year and 3.32 × 10-3 nt substitutions/site/year, respectively. The population dynamics in the Bayesian skyline plot revealed fluctuations corresponding to the emergence of dominant strains, including a switch of the dominant genotype from NA1 to ON1. Our study on time-scaled cumulative evolutionary analysis contributes to a better understanding of RSV epidemiology at the local level in South Korea.

Implications of the 5th Edition of the World Health Organization Classification and International Consensus Classification of Myeloid Neoplasm in Myelodysplastic Syndrome With Excess Blasts and Acute Myeloid Leukemia.

The fifth edition of the WHO classification (2022 WHO) and the International Consensus Classification (2022 ICC) of myeloid neoplasms have been recently published. We reviewed the changes in the diagnosis distribution in patients with MDS with excess blasts (MDS-EB) or AML using both classifications. Forty-seven patients previously diagnosed as having AML or MDS-EB with available mutation analysis data, including targeted next-generation and RNA-sequencing data, were included. We reclassified 15 (31.9%) and 27 (57.4%) patients based on the 2022 WHO and 2022 ICC, respectively. One patient was reclassified as having a translocation categorized as a rare recurring translocation in both classifications. Reclassification was mostly due to the addition of mutation-based diagnostic criteria (i.e., AML, myelodysplasia-related) or a new entity associated with TP53 mutation. In both classifications, MDS diagnosis required the confirmation of multi-hit TP53 alterations. Among 14 patients with TP53 mutations, 11 harbored multi-hit TP53 alterations, including four with TP53 mutations and loss of heterozygosity. Adverse prognosis was associated with multi-hit TP53 alterations (P=0.009) in patients with MDS-EB, emphasizing the importance of detecting the mutations at diagnosis. The implementation of these classifications may lead to the identification of different subtypes from previously heterogeneous diagnostic categories based on genetic characteristics.

Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies.

The accurate detection of anti-neutralizing SARS-CoV-2 antibodies can aid in the understanding of the development of protective immunity against COVID-19. This study evaluated the diagnostic performance of the RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test. Using the 90% plaque reduction neutralization test (PRNT90) as a reference, 200 serum samples collected from 78 COVID-19-positive and 122 COVID-19-negative patients were divided into 76 PRNT90-positive and 124 PRNT90-negative groups. The ability of the RapiSure test to detect antibodies was compared to that of the STANDARD Q COVID-19 IgM/IgG Plus test and that of PRNT90. The positive, negative, and overall percent agreement between the RapiSure and STANDARD Q test was 95.7%, 89.3%, and 91.5%, respectively, with a Cohen's kappa of 0.82. The RapiSure neutralizing antibody test results revealed a sensitivity of 93.4% and a specificity of 100% compared to the PRNT results, with an overall percent agreement of 97.5% and Cohen's kappa of 0.95. The diagnostic performance of the RapiSure test was in good agreement with the STANDARD Q COVID-19 IgM/IgG Plus test and comparable to that of the PRNT. The RapiSure S1 RBD IgG/Neutralizing Ab Test was found to be convenient and reliable and, thus, can provide valuable information for rapid clinical decisions during the COVID-19 pandemic.

Performance evaluation and clinical impact of the Oncomine Myeloid Research Assay for gene expression analysis in myeloid haematologic malignancies.

AIM: Gene expression analysis facilitates the detection of diagnostic and prognostic biomarkers for myeloid haematological malignancies. The Oncomine Myeloid Research Assay (OMA; Thermo Fisher Scientific, Massachusetts, USA) provides a comprehensive analysis of gene expression of five target genes, along with gene alteration and fusion. Here, we present the performance of the OMA for gene expression analysis. METHODS: In total, 53 RNA samples from patients diagnosed with acute myeloid leukaemia (AML) or myelodysplastic syndrome were included. Of these 53 samples, 3 were evaluated for reproducibility and 50 were evaluated for comparison with RNA-sequencing (RNA-seq). The prognostic impact of the gene expression profile produced by both OMA and RNA-seq in AML was investigated using follow-up data from 33 patients with AML. RESULTS: The OMA showed good intrarun and interrun reproducibility. Compared with the RNA-seq results, high correlations were found in BAALC, MECOM and WT1 (all r>0.9), with moderate correlations in MYC (r=0.75, p<0.001) and SMC1A (r=0.42, p=0.002). The agreement between OMA and RNA-seq in classifying the dysregulated expression group was almost perfect, except for SMC1A (κ=0.175). Among these five genes, only BAALC showed a significant clinical impact in patients with AML. Patients with high BAALC expression showed significantly shorter overall survival based on both OMA (p=0.037) and RNA-seq (p=0.003). CONCLUSIONS: OMA gene expression analysis offers reproducible and accurate gene expression data for most targeted genes and demonstrates the utility of BAALC expression as a prognostic marker in AML.

Application of the theory of planned behavior to understand physical activity intentions and behavior among Korean breast cancer survivors.

PURPOSE: The purpose of this study was to apply the theory of planned behavior (TPB) to understand physical activity intentions and behaviors among Korean breast cancer survivors. METHODS: A total of 286 Korean breast cancer survivors (Mage52.3 ± 8.3) completed a self-reported survey administered face to face by a trained interviewer. The survey assessed the physical activity frequency and intensity in a typical week after breast cancer diagnosis, demographic factors, and theory of planned behavior variables including attitude, subjective norm, perceived behavioral control (PBC), planning, and intentions to participate in physical activity. We used structural equation modeling to examine the direct and indirect effects of the TPB variables on physical activity intentions and behavior. Covariates included age, cancer stage, and clinical treatment. RESULTS: Confirmatory factor analyses indicated a satisfactory model fit. We observed direct effects for instrumental attitude (ß = 0.34, p < 0.001), subjective norm (ß = 0.12, p < 0.05), and PBC (ß = 0.57, p < 0.001) on physical activity intentions. PBC (ß = .17, p < 0.01) and physical activity intentions (ß = 0.46, p < 0.01) had direct effects on planning. PBC (ß = 0.28, p < 0.01) and planning (ß = 0.22, p < 0.01) had direct effects on physical activity behavior. CONCLUSION: The TPB was a useful model for understanding Korean breast cancer survivors' physical activity intentions and behavior. Interventions that can enhance attitudes, subjective norm, PBC, intention, and planning may facilitate physical activity intentions and behaviors in this population.

Phylogenetic analysis of human parainfluenza type 3 virus strains responsible for the outbreak during the COVID-19 pandemic in Seoul, South Korea.

BACKGROUND: Human parainfluenza virus 3 (HPIV3) is a major respiratory pathogen that causes acute respiratory infections in infants and children. Since September 2021, an out-of-season HPIV3 rebound has been noted in Korea. The objective of this study was to analyze the molecular characteristics of the HPIV3 strains responsible for the outbreak in Seoul, South Korea. METHODS: A total of 61 HPIV3-positive nasopharyngeal swab specimens were collected between October and November 2021. Using 33 HPIV3-positive specimens, partial nucleotide sequences of the HPIV3 hemagglutinin-neuraminidase (HN) gene were aligned with previously published HN gene sequences for phylogenetic and genetic distance (p-distance) analyses. RESULTS: Phylogenetic tree revealed that all Seoul HPIV3 strains grouped within the phylogenetic subcluster C3. However, these strains formed a unique cluster that branched separately from the C3a lineage. This cluster showed 99% bootstrap support with a p-distance < 0.001. Genetic distances within the other C3 lineages ranged from 0.013 (C3a) to 0.023 (C3c). Deduced amino acid sequences of the HN gene revealed four protein substitutions in Seoul HPIV3 strains that have rarely been observed in other reference strains: A22T, K31N, G387S, and E514K. CONCLUSIONS: Phylogenetic analysis of Seoul HPIV3 strains revealed that the strain belonged to a separate cluster within subcluster C3. Genetic distances among strains within subcluster C3 suggest the emergence of a new genetic lineage. The emergence of a new genetic lineage could pose a potential risk of a new epidemic. Further monitoring of the circulating HPIV3 strains is needed to understand the importance of newly discovered mutations.

Phylogenetic analysis of human parainfluenza type 3 virus strains responsible for the outbreak during the COVID-19 pandemic in Seoul, South Korea

BackgroundHuman parainfluenza virus 3 (HPIV3) is a major respiratory pathogen that causes acute respiratory infections in infants and children. Since September 2021, an out-of-season HPIV3 rebound has been noted in Korea. The objective of this study was to analyze the molecular characteristics of the HPIV3 strains responsible for the outbreak in Seoul, South Korea. MethodsA total of 61 HPIV3-positive nasopharyngeal swab specimens were collected between October and November 2021. Using 33 HPIV3-positive specimens, partial nucleotide sequences of the HPIV3 hemagglutinin-neuraminidase (HN) gene were aligned with previously published HN gene sequences for phylogenetic and genetic distance (p-distance) analyses. ResultsPhylogenetic tree revealed that all Seoul HPIV3 strains grouped within the phylogenetic subcluster C3. However, these strains formed a unique cluster that branched separately from the C3a lineage. This cluster showed 99% bootstrap support with a p-distance < 0.001. Genetic distances within the other C3 lineages ranged from 0.013 (C3a) to 0.023 (C3c). Deduced amino acid sequences of the HN gene revealed four protein substitutions in Seoul HPIV3 strains that have rarely been observed in other reference strains: A22T, K31N, G387S, and E514K. ConclusionsPhylogenetic analysis of Seoul HPIV3 strains revealed that the strain belonged to a separate cluster within subcluster C3. Genetic distances among strains within subcluster C3 suggest the emergence of a new genetic lineage. The emergence of a new genetic lineage could pose a potential risk of a new epidemic. Further monitoring of the circulating HPIV3 strains is needed to understand the importance of newly discovered mutations.

Comparison of three molecular diagnostic assays for SARS-CoV-2 detection: Evaluation of analytical sensitivity and clinical performance.

BACKGROUND: Currently, SARS-CoV-2 RNA detection using real-time reverse-transcription PCR (rRT-PCR) is the standard diagnostic test for COVID-19 infection. Various rRT-PCR assays are currently used worldwide, targeting different genes of the SARS-CoV-2. Here, we compared the analytical sensitivity and clinical performance (sensitivity and specificity) of Allplex SARS-CoV-2/FluA/FluB/RSV assay (Seegene), Standard M nCoV real-time detection kit (SD Biosensor), and U-TOP COVID-19 detection kit (Seasun Biomaterials) for SARS-CoV-2 detection. METHODS: Two hundred and forty-nine nasopharyngeal swab samples were evaluated to compare the clinical performance of the rRT-PCR assays. For the analytical performance evaluation, two RNA controls with known viral loads-SARS-CoV-2 RNA control and SARS-COV-2 B.1.351 RNA control-were used to investigate the potential impact of SARS-CoV-2 variants, particularly the B.1.351 lineage. RESULTS: Limits of detection ranged from 650 to 1300 copies/ml for rRT-PCR assays, and the mean differences in cycle threshold (Ct ) values of the two RNA controls were within 1.0 for each target in the rRT-PCR assays (0.05-0.73), without any prominent Ct value shift or dropouts in the SARS-COV-2 B.1.351 RNA control. Using the consensus criterion as the reference standard, 89 samples were positive, whereas 160 were negative. The overall clinical performance of rRT-PCR assays was comparable (sensitivity 98.88%-100%; specificity 99.38%-100%), whereas the sensitivities of each target gene were more variable. CONCLUSIONS: The three rRT-PCR assays showed comparable analytical sensitivity and clinical performance. The analytical and clinical sensitivities of each target gene were influenced more by the primer and probe design than the target gene itself.

Simultaneous point-of-care testing of blood lipid profile and glucose: Performance evaluation of the GCare Lipid Analyzer.

BACKGROUND: Point-of-care (POC) testing provides quick results and includes tests for blood glucose and lipid profiles. We evaluated the newly developed POC device, the GCare Lipid Analyzer, which is used to measure glucose, total cholesterol (TC), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C) levels. METHODS: Venous and capillary blood samples were collected from patients who visited Korea University Guro Hospital. The results obtained using the GCare Lipid Analyzer were compared with those obtained using the TBA 2000FR chemistry analyzer and YSI 2300 STAT Plus analyzer. The glucose system evaluation process was based on the International Organization for Standardization 15197:2013 guidelines. RESULTS: The correlation coefficients (R) for TC, TG, and HDL-C were 0.965, 0.969, and 0.943 in capillary blood and 0.969, 0.990, and 0.956 in venous blood, respectively. The total errors for TC, TG, and HDL-C of the lipid profile using venous blood were all acceptable at 6.6%, 9.3%, and 11.6%, respectively. For glucose concentrations <100 mg/dl, 96.1% of the measured glucose levels were within ±15 mg/dl in venous samples and 100% were within ±15 mg/dl in capillary samples. For glucose concentrations ≥100 mg/dl, 100% and 99.5% of the measured glucose levels were within 15% for venous and capillary blood, respectively. CONCLUSION: The performance of the GCare Lipid Analyzer is acceptable for both blood glucose and lipid profile testing, indicating that it is reliable for use in patients with diabetic dyslipidemia.

Comparative study of i-SENS glucometers in neonates using capillary blood samples.

OBJECTIVES: The accuracy of point-of-care blood glucometers in the detection and evaluation of neonatal hypoglycemia is a concern. This study compared the performance of three i-SENS glucometers with that of the YSI 2300 STAT Plus Analyzer, which was used as a reference. METHODS: The leftover neonatal capillary blood samples of 319 patients were used in this study. The evaluation process and accuracy performance criteria were based on the International Organization for Standardization 15197:2013 guidelines. The evaluation involved three i-SENS glucometers (BAROzen H Expert plus, CareSens PRO, and CareSens H Beat) and the ACCU-CHEK® Inform II glucometer. RESULTS: The accuracy evaluation yielded acceptable results as follows: a) 100 and 100% for BAROzen H Expert plus; 99.8 and 100% for CareSens PRO; 98.7%, and 97.2% for CareSens H Beat glucometers were within the range of ±0.8 mmol/L (15 mg/dL) and ±15% of the average reference values at glucose concentrations <5.55 mmol/L (100 mg/dL) and ≥5.55 mmol/L (100 mg/dL), respectively, and b) all estimated glucose values (100%) were within the zones A and B of Consensus Error Grid for all three i-SENS glucometers. There was good correlation between the glucose values estimated by the glucometers and the reference values (R>0.990). CONCLUSIONS: This study demonstrated that i-SENS glucometers exhibit acceptable performance and can be used as effective point-of-care devices in neonates.

Performance Evaluation of Alere i Influenza A&B in Detecting Influenza Viruses A and B.

OBJECTIVE: Alere i Influenza A&B is an isothermal nucleic acid amplification-based integrated system used for detecting and differentiating between influenza virus A and influenza virus B. We evaluated the clinical performances of Alere i Influenza A&B compared to that of real-time PCR, multiplex real-time PCR, and two rapid influenza diagnostic kits. METHODS: Nasopharyngeal aspiration specimens (n=315) from patients with signs of acute respiratory infection were collected between 2015 and 2016. Samples were tested using real-time PCR, the multiplex RT-PCR Anyplex II RV16 Detection kit, Alere i Influenza A&B, BD Veritor™ System Flu A+B, and the Sofia Influenza A+B Fluorescence Immunoassay. Positive influenza specimens detected by the Anyplex II RV16 Detection kit were tested by real-time PCR. RESULTS: Compared to that of multiplex RT-PCR (influenza A, n=88; influenza B, n=82; influenza-negative, n=145), the sensitivities of Alere i, Sofia, and Veritor for influenza A were 97.7%, 72.7%, and 71.6%, respectively, whereas for influenza B, the sensitivities were 96.3%, 80.4%, and 75.6%, respectively. The specificity of Alere i, Sofia, and Veritor was 100.0%. CONCLUSIONS: The clinical performance of Alere i Influenza A&B is satisfactory, with the advantage of a significantly shorter test time than other molecular assays. It is suitable for point-of-care testing and rapid influenza diagnostic tests because of its high sensitivity and specificity.

Performance of ivisen IA-1400, a new point-of-care device with an internal centrifuge system, for the measurement of cardiac troponin I levels.

BACKGROUND: We present the analytical performance of the ivisen IA-1400, a new point-of-care device that features a characteristic built-in centrifuge system, to measure blood cardiac troponin I (cTnI) levels. METHODS: Whole blood and plasma samples obtained from patients who visited Korea University Guro Hospital were used to analyze measurement range, cross-reactivity, interference, and sensitivity and specificity. We performed a correlation analysis of the ivisen IA-1400 versus the Access AccuTnI+3 immunoassay using the UniCel™ DxI 800 platform and the PATHFAST™ hs-cTnI assay. RESULTS: Within-run precisions were classified as low, 9.8%; middle, 10.2%; and high, 8.5%. The limit of blank was 3.1 ng/L for plasma samples and 4.3 ng/L for whole blood samples. The limit of detection was 8.4 ng/L for plasma samples and 10.0 ng/L for whole blood samples, respectively. The limit of quantitation at a coefficient of variation of 20% and 10% was 19.5 ng/L and 45.5 ng/L for plasma samples, respectively. The comparative evaluation between the two other assays and ivisen IA-1400 showed excellent correlation, with Spearman's correlation coefficients (R) of 0.992 and 0.985. The sensitivity and specificity of ivisen IA-1400 using the optimum cut-off value of 235 ug/L were 94.6% and 98.2%, respectively. CONCLUSION: The ivisen IA-1400 showed acceptable and promising performance in cTnI measurements using whole blood and plasma samples, with limited information in the clinical performance. The flexibility for sample selection using the internal centrifugation system is the main advantage of this point-of-care device.

Comparison of a new enzymatic assay for serum homocysteine on Toshiba TBA-c16000 against an immunoassay on Abbott Architect.

Homocysteine, a risk factor for cardiovascular disease, is commonly analyzed using enzymatic measurements and immunoassays. We compared the results of a new enzymatic assay with those of an immunoassay, using new reagents for homocysteine. The 87 serum samples were analyzed using the Abbott Architect i2000sr (immunoassay) and Toshiba TBA-c16000 (enzymatic assay), and the results obtained from the two assays were compared for precision, correlation, linearity, sample carryover, and reference range verification according to the Clinical and Laboratory Standards Institute guidelines. Repeatability and total imprecision were within the desirable range (Westgard QC, 4.15%). Correlation analysis revealed a strong correlation with a slope ranging from 0.9887 to 1.052, a correlation coefficient (R 2) of 0.9886 [95% confidence interval (CI) of 0.9899-0.9968], and a y-intercept from -0.5741 to 0.6252. Linearity was acceptable (R 2 = 0.9993), and the recovery rate was within ±10% of the expected value. The enzymatic assay showed an acceptable carryover rate (-0.15%) and a shorter turnaround time (10-12 min) compared with that of the immunoassay (30 min). Our new enzymatic assay for the measurement of homocysteine showed an acceptable performance in terms of precision, correlation, linearity, carryover test, cost-effectiveness, and speed.

Performance of Norudia Glycated Albumin Assay on Multiple Analytical Platforms and Comparison to Lucica Assay.

BACKGROUND: The Norudia glycated albumin (GA) assay was evaluated for analytical performance and assay applicability on multiple analytical platforms. METHODS: The evaluation included precision, linearity, reference interval, and comparison with Lucica GA assay. A multicenter study was conducted to compare the results of Norudia GA assay on five kinds of widely used automated clinical chemistry analyzers. RESULTS: Within-laboratory imprecisions for GA% presented 1.3 - 3.3% and 0.8 - 2.6% for low- and high-level control materials, respectively, on different analyzers. GA assay was linear from 20.0 to 680.0 µmol/L of GA. The claimed reference range (12 - 16 GA%) was verified. Norudia GA showed a good GA% correlation with Lucica GA (correlation coefficient 0.999). GA% from each analyzer showed good correlation with the consensus mean of the results of five analyzers (correlation coefficient 0.997 - 0.999). CONCLUSIONS: The Norudia GA assay can successfully be implemented in all the tested platforms, with good GA% correlation.

Performance evaluation of three i-SENS glucometers using arterial blood samples compared with the YSI 2300 Glucose Analyzer.

BACKGROUND: Capillary blood is the most commonly used sample for point-of-care (POC) glucometers. However, in critically ill patients, the glucose levels measured from capillary blood may not be reliable. Thus, we aimed to evaluate and compare the accuracy of glucose levels measured with POC glucometers and the YSI 2300 glucose analyzer using leftover arterial blood samples. METHODS: In total, 100 leftover heparinized arterial blood samples were used to evaluate the performance of three i-SENS glucometers (BAROzen H Expert plus, CareSens PRO, and CareSens H Beat) and the ACCU-CHEK® Inform II glucometer. The reference value was obtained using the YSI 2300 glucose analyzer. The results were analyzed based on International Organization for Standardization 15197:2013 guidelines. RESULTS: More than 95% of results obtained using POC glucometers were within ±15 mg/dL of the reference value for glucose concentrations <100 mg/dL and within ±15% of the reference value for glucose concentrations ≥100 mg/dL. In the consensus error grid analysis, more than 99% of results were found to be within zones A and B. An excellent correlation was found between the values obtained using POC glucometers and the YSI 2300 glucose analyzer (R2  > .99). CONCLUSION: The i-SENS glucometers showed stable and accurate results when leftover arterial blood samples were used. Therefore, POC glucometers could be useful in critical care settings, such as intensive care units, where arterial samples are routinely used.

The unique expression profile of FAM19A1 in the mouse brain and its association with hyperactivity, long-term memory and fear acquisition.

Neurodevelopment and mature brain function are spatiotemporally regulated by various cytokines and chemokines. The chemokine-like neuropeptide FAM19A1 is a member of family with sequence similarity 19 (FAM19), which is predominantly expressed in the brain. Its highly conserved amino acid sequence among vertebrates suggests that FAM19A1 may play important physiological roles in neurodevelopment and brain function. Here we used a LacZ reporter gene system to map the expression pattern of the FAM19A1 gene in the mouse brain. The FAM19A1 expression was observed in several brain regions starting during embryonic brain development. As the brain matured, the FAM19A1 expression was detected in the pyramidal cells of cortical layers 2/3 and 5 and in several limbic areas, including the hippocampus and the amygdala. FAM19A1-deficient mice were used to evaluate the physiological contribution of FAM19A1 to various brain functions. In behavior analysis, FAM19A1-deficient mice exhibited several abnormal behaviors, including hyperactive locomotor behavior, long-term memory deficits and fear acquisition failure. These findings provide insight into the potential contributions of FAM19A1 to neurodevelopment and mature brain function.

Exercise Barriers and Facilitators After Transverse Rectus Abdominis Myocutaneous Flap Breast Reconstruction

Purpose@#The purpose of this study was to understand the experience of exercise participation among patients following transverse rectus abdominis myocutaneous (TRAM) flap breast reconstruction surgery. @*Methods@#A phenomenological method was used in this study. Exercise experiences for twelve patients, who had undergone TRAM flap breast reconstruction, were collected through focus group interviews. @*Results@#The factors that contributed to exercise barriers in the experience of TRAM flap breast reconstruction patient exercise participation were categorized into 3 groups: ‘fear of exercise after surgery’, ‘weakened emotional condition’, and ‘lack of exercise information’. Exercise facilitators after TRAM flap breast reconstruction were also categorized into 3 groups: ‘desire to improve appearance’, ‘feasiable exercise program’, and ‘exercise experience’. @*Conclusion@#The results of this study reveal the exercise barriers and facilitators for patients following TRAM flap breast reconstruction, which should be considered to develop effective exercise programs.