Brief Communication2021-09-01
Diagnostic Hematology
Ari Ahn 
, M.D., Chan-Jeoung Park , M.D., Ph.D., Min-sun Kim , M.D., Young-Uk Cho , M.D., Ph.D., Seongsoo Jang , M.D., Ph.D., Mi Hyun Bae , M.D., Ph.D., Jung-Hee Lee , M.D., Ph.D., Je-Hwan Lee , M.D., Ph.D., Kyung-Nam Koh , M.D., Ph.D., and Ho Joon Im , M.D., Ph.D.
Abstract : Myeloid-derived suppressor cells (MDSCs) represent phenotypically heterogeneous populations that suppress tumor-specific T-cell responses. MDSCs are produced from myeloid precursors in emergent states and are increased in several hematologic malignancies. We evaluated the differences in the levels and prognostic significance of MDSCs according to the clinical status of chronic myeloid leukemia (CML). The percentages and numbers of granulocytic (g)MDSCs and monocytic (m)MDSCs in peripheral blood (PB) and bone marrow (BM) aspirates were determined by five-color flow cytometry (HLA-DR/CD11b/CD15/CD33/CD14). The median BM-gMDSC% and PB-gMDSC% of the CML group were lower than those of the complete hematologic response (CHR) and control groups (P
Guideline2022-07-01
Clinical Microbiology
Ki Ho Hong , M.D., Gab Jung Kim , Ph.D., Kyoung Ho Roh , M.D., Heungsup Sung , M.D., Jaehyeon Lee , M.D., So Yeon Kim , M.D., Taek Soo Kim , M.D., Jae-Sun Park , Ph.D., Hee Jae Huh , M.D., Younhee Park , M.D., Jae-Seok Kim , M.D., Hyun Soo Kim , M.D., Moon-Woo Seong , M.D., Nam Hee Ryoo , M.D., Sang Hoon Song , M.D., Hyukmin Lee , M.D., Gye Cheol Kwon , M.D., and Cheon Kwon Yoo , Ph.D.
Abstract : Korean Society for Laboratory Medicine and the Korea Disease Prevention and Control Agency have announced guidelines for diagnosing coronavirus disease (COVID-19) in clinical laboratories in Korea. With the ongoing pandemic, we propose an update of the previous guidelines based on new scientific data. This update includes recommendations for tests that were not included in the previous guidelines, including the rapid molecular test, antigen test, antibody test, and self-collected specimens, and a revision of the previous recommendations. This update will aid clinical laboratories in performing laboratory tests for diagnosing COVID-19.
Original Article2021-01-01
Ahram Yi , M.D., Chang-Hoon Lee , M.D., Ph.D., Yeo-Min Yun , M.D., Ph.D., Hanah Kim , M.D., Ph.D., Hee-Won Moon , M.D., Ph.D., and Mina Hur , M.D., Ph.D.
Abstract : 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.
Original Article2021-05-01
Se Young Jang , M.D., Won Young Tak , M.D., Soo Young Park , M.D., Young-Oh Kweon , M.D., Yu Rim Lee , M.D., Gyeonghwa Kim , Ph.D., Keun Hur , Ph.D., Man-Hoon Han , M.D., and Won Kee Lee , Ph.D.
Abstract : Background: Mac-2 binding protein glycosylation isomer (M2BPGi) has been established as a non-invasive biomarker for liver fibrosis. We evaluated the diagnostic efficacy of M2BPGi compared with those of other liver fibrosis markers in liver fibrosis in non-alcoholic fatty liver disease (NAFLD). Methods: We analyzed serum M2BPGi levels in 113 NAFLD patients. A pathologist graded liver fibrosis histopathologically. The diagnostic efficacies of serum M2BPGi and other liver fibrosis markers (aspartate aminotransferase to platelet ratio index, fibrosis index based on four factors, and NAFLD fibrosis score [NFS]) were evaluated using correlation, area under the ROC curve (AUC), logistic regression, and C-statistics. Results: Serum M2BPGi level and other liver fibrosis markers showed a moderate correlation with fibrosis grade. The AUC values of M2BPGi were 0.761, 0.819, 0.866, and 0.900 for diagnosing fibrosis (F)>0, F>1, F>2, and F>3, respectively. Logistic regression analysis showed M2BPGi as the only independent factor associated with F>2 and F>3. Although C-statistics showed that NFS was the best diagnostic factor for F>2 and F>3, M2BPGi with NFS had an increased C-statistics value, indicating that it is a better diagnostic model. Conclusions: The serum M2BPGi level increased with liver fibrosis severity and could be a good biomarker for diagnosing advanced fibrosis and cirrhosis in NAFLD patients. A well-controlled, prospective study with a larger sample size is needed to validate the diagnostic power of M2BPGi and other fibrosis markers in NAFLD.
Original Article2021-09-01
Haeil Park , M.D., Ph.D. and Younsuk Ko , M.T.
Abstract : Background: Urine reagent strip test (URST) results are semi-quantitative; therefore, the precision of URSTs is evaluated as the proportion of categorical results from repeated measurements of a sample that are concordant with an expected result. However, URSTs have quantitative readout values before ordinal results challenging statistical monitoring for internal quality control (IQC) with control rules. This study aimed to determine the sigma metric of URSTs and derive appropriate control rules for IQC. Methods: The URiSCAN Super Plus fully automated urine analyzer (YD Diagnostics, Yongin, Korea) was used for URSTs. Change in reflectance rate (change %R) data from IQC for URSTs performed between November 2018 and May 2020 were analyzed. Red blood cells, bilirubin, urobilinogen, ketones, protein, glucose, leukocytes, and pH were measured from 2-3 levels of control materials. The total allowable error (TEa) for a grade was the difference in midpoints of a predefined change %R range between two adjacent grades. The sigma metric was calculated as TEa/SD. Sigma metric-based control rules were determined with Westgard EZ Rules 3 software (Westgard QC, Madison, WI, USA). Results: Seven out of the eight analytes had a sigma metric >4 in the control materials with a negative grade (-), which were closer to the cut-offs. Corresponding control rules ranged from 12.5s to 13.5s. Conclusions: Although the URST is a semi-quantitative test, statistical IQC can be performed using the readout values. According to the sigma metric, control rules recommended for URST IQC in routine clinical practice are 12.5s to 13.5s.
Review Article2022-03-01
Diagnostic Genetics
Saeam Shin , M.D., Ph.D., Hye In Woo , M.D., Ph.D., Jong-Won Kim , M.D., Ph.D., Yoonjung Kim M.D. , Ph.D., Kyung-A Lee , M.D., Ph.D.
Abstract : Standardization of cell-free DNA (cfDNA) testing processes is necessary to obtain clinically reliable results. The pre-analytical phase of cfDNA testing greatly influences the results because of the low proportion and stability of circulating tumor DNA (ctDNA). In this review, we provide evidence-based clinical practice guidelines for pre-analytical phase procedures of plasma epidermal growth factor receptor gene (EGFR) variant testing. Specific recommendations for pre-analytical procedures were proposed based on evidence from the literature and our experimental data. Standardization of pre-analytical procedures can improve the analytical performance of cfDNA testing.
Original Article2021-01-01
Seong Jun Park , M.D., Jung Yoon , M.D., Ph.D., Jung Ah Kwon , M.D., Ph.D., and Soo-Young Yoon , M.D., Ph.D.
Abstract : Background: The Advanced RBC Application of the CellaVision DM9600 system (CellaVision AB, Lund, Sweden) automatically characterizes and classifies red blood cells (RBCs) into 21 morphological categories based on their size, color, shape, and inclusions. We evaluated the diagnostic performance of the CellaVision Advanced RBC Application with respect to the classification and grading of RBC morphological abnormalities in accordance with the 2015 International Council for Standardization in Haematology (ICSH) guidelines. Methods: A total of 223 samples, including 123 with RBC morphological abnormalities and 100 from healthy controls, were included. Seven RBC morphological abnormalities and their grading obtained with CellaVision DM9600 pre- and post-classification were compared with the results obtained using manual microscopic examination. The grading cut-off percentages were determined in accordance with the 2015 ICSH guidelines. The sensitivity and specificity of the CellaVision DM9600 system were evaluated using the manual microscopic examination results as a true positive. Results: In pre-classification, >90% sensitivity was observed for target cells, tear drop cells, and schistocytes, while >90% specificity was observed for acanthocytes, spherocytes, target cells, and tear drop cells. In post-classification, the detection sensitivity and specificity of most RBC morphological abnormalities increased, except for schistocytes (sensitivity) and acanthocytes (specificity). The grade agreement rates ranged from 35.9% (echinocytes) to 89.7% (spherocytes) in pre-classification and from 46.2% (echinocytes) to 90.1% (spherocytes) in post-classification. The agreement rate of samples with within-one grade difference exceeded 90% in most categories, except for schistocytes and echinocytes. Conclusions: The Advanced RBC Application of CellaVision DM9600 is a valuable screening tool for detecting RBC morphological abnormalities.
Letter to the Editor2021-09-01
Clinical Microbiology
Hee Sue Park , M.D., Ph.D., Pan Kee Bae , Ph.D., Hye Won Jeong , M.D., Ph.D., Bo Ra Son , M.D., Ph.D., and Kyeong Seob Shin , M.D., Ph.D.
Brief Communication2022-01-01
Transfusion Medicine
Yousun Chung , M.D., Dae-Hyun Ko , M.D., Ph.D., Jihyang Lim , M.D., Ph.D., Kyeong-Hee Kim , M.D., Ph.D., and Hyungsuk Kim , M.D.
Abstract : The number of ABO-incompatible solid organ transplantations (ABOi SOTs) has markedly increased worldwide since the early 2000s. We investigated the choice of ABO group for blood component transfusion in ABOi SOT. We conducted a survey by e-mailing a questionnaire to blood bank specialists at 77 major hospitals in Korea, among whom 34 responded to the survey. In major ABOi SOT, for red blood cells (RBCs), the recipient’s type (70.6%) was the most common choice, followed by group O (29.4%); for platelets, group AB (50.0%) was the most common choice, followed by the donor type (38.2%); for plasma, group AB (55.9%) was the most common choice, followed by the donor type (32.4%). In bidirectional ABOi SOT, for RBCs, the recipient’s type (55.9%) was the most common choice, followed by group O (44.1%); for platelets and plasma, group AB was the most common choice (94.1% and 97.1%, respectively). The policies for transfusion in ABOi SOT were diverse. We suggest a guideline on the choice of ABO group for transfusion in ABOi SOT to secure patient health and enable an efficient use of blood components.
Original Article2021-03-01
Ja Young Seo , M.D., Ph.D., Jeong-Yeal Ahn , M.D., Ph.D., Bhumsuk Keam , M.D., Ph.D., Miso Kim , M.D., Shinkyo Yoon , M.D., Ph.D., Jae Lyun Lee , M.D., Ph.D., Kwonoh Park , M.D., Ph.D., and Inkeun Park , M.D., Ph.D.
Abstract : Background: Hereditary leiomyomatosis and renal cell cancer (HLRCC) is an autosomal dominant cancer predisposition syndrome. HLRCC is characterized by the development of cutaneous leiomyomas, early-onset uterine leiomyomas, and HLRCC-associated renal cell cancer (RCC) and caused by germline fumarate hydratase (FH) deficiency. We investigated the genotypic and phenotypic characteristics of Korean patients with HLRCC. Methods: We performed direct sequencing analysis of FH in 13 patients with suspected HLRCC and their family members. A chromosomal microarray test was performed in female patients with negative sequencing results but highly suspected HLRCC. In addition, we analyzed the clinical characteristics and evaluated the genotype–phenotype correlations in Korean patients with HLRCC. Results: We identified six different pathogenic or likely pathogenic FH variants in six of the 13 patients (46.2%). The variants included two nonsense variants, two splicing variants, one frameshift variant, and one missense variant. Of the six variants, two (33.3%) were novel (c.132+1G>C, and c.243dup). RCC and early-onset uterine leiomyoma were frequently observed in families with HLRCC, while cutaneous leiomyoma was less common. No significant genotype–phenotype correlation was observed. Conclusions: We describe the genotypic and phenotypic spectrum in a small series of Korean patients with HLRCC. Our data reveal the unique characteristics of Korean patients with HLRCC and suggest a need for establishing an optimal diagnostic approach for them.
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