1.Analytical Performance of INNOVANCE Free Protein S Antigen on Sysmex CS-5100.
Sholhui PARK ; Sanghee PARK ; Jungsoo LEE ; Jungwon HUH
Laboratory Medicine Online 2019;9(1):1-5
BACKGROUND: Protein S deficiency is a common cause of thrombophilia. Free protein S has been suggested as one of the best screening tests for this deficiency. We evaluated an immunoturbidimetric free protein S reagent, INNOVANCE Free Protein S Antigen (Free PS Ag; Siemens Healthcare Diagnostics, Germany), using a CS-5100 coagulation analyzer (Sysmex, Japan). METHODS: The performance of INNOVANCE Free PS Ag was evaluated according to the CLSI guidelines. Precision, linearity, and verification of reference intervals were examined. The INNOVANCE Free PS Ag was also compared by the STA-Liatest Free Protein S immunoturbidimetric assay (Diagnostica Stago, France). RESULTS: The repeatability and within-laboratory imprecision of INNOVANCE Free PS Ag were 0.8% CV and 2.0% CV at the normal level, and 1.3% CV and 2.3% CV at the abnormally low level, respectively. This assay showed linearity from 4.0% to 151.9% (correlation coefficient r=1, P < 0.0001). Reference intervals for males and females were verified as acceptable. INNOVANCE Free PS Ag was comparable with STA-Liatest Free Protein S with a very high correlation (r=0.935, P < 0.0001). The results for the INNOVANCE antigen were higher. CONCLUSIONS: The INNOVANCE Free PS Ag on a Sysmex CS-5100 coagulation analyzer has excellent analytical performance and is comparable with the STA-Liatest Free Protein S assay.
Delivery of Health Care
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Female
;
Humans
;
Male
;
Mass Screening
;
Protein S Deficiency
;
Protein S*
;
Thrombophilia
2.Evaluation of the Performance of a New Chromatographic Assay BD Veritor System for Rapid Detection of Influenza A & B.
Sholhui PARK ; Miae LEE ; Hae Sun CHUNG
Annals of Clinical Microbiology 2015;18(1):27-32
BACKGROUND: For early diagnosis and treatment of influenza, rapid influenza diagnostic tests are commonly used. We evaluated the performance of the BD Veritor System for Rapid Detection of Flu A+B (BD Veritor System; BD Diagnostics, USA) compared to multiplex real-time RT-PCR. METHODS: A total of 3,213 nasal and nasopharyngeal swab specimens in transport media from patients with influenza-like symptoms were tested with the BD Veritor System from December 2013 to April 2014. The sensitivity and specificity of 127 specimens were determined simultaneously using multiplex real-time RT- PCR with the AdvanSure RV real-time PCR (AdvanSure PCR; LG Life Sciences, Korea). RESULTS: Influenza viruses were detected in 41.3% (1,327/3,213) of all specimens tested using the BD Veritor System. Of the 127 specimens, 27 influenza A and 17 influenza B viruses were identified by the AvanSure PCR. The sensitivity and specificity of the BD Veritor System relative to the AdvanSure PCR was 85.2% and 99.0% for influenza A, and 58.8% and 99.1% for influenza B. Of the 190 specimens that tested negative using the BD Veritor System, the AdvanSure PCR detected influenza A and influenza B in 19 and 13 specimens, respectively. The mean threshold cycle (Ct) values of the antigen positive specimens were lower than those of the antigen negative specimens. CONCLUSION: The BD Veritor System showed excellent specificity for both influenza types and good sensitivity for influenza A. However, the system was less sensitive for influenza B compared to multiplex real-time RT-PCR. For accurate diagnosis of false negative specimens, a molecular diagnostic test should be performed. The BD Veritor system could be a useful tool for screening and early diagnosis of influenza.
Biological Science Disciplines
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Diagnosis
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Diagnostic Tests, Routine
;
Early Diagnosis
;
Humans
;
Influenza B virus
;
Influenza, Human*
;
Mass Screening
;
Orthomyxoviridae
;
Pathology, Molecular
;
Polymerase Chain Reaction
;
Real-Time Polymerase Chain Reaction
;
Sensitivity and Specificity
3.Estimated Glomerular Filtration Rates Show Minor but Significant Differences Between the Single and Subgroup Creatinine-Based Chronic Kidney Disease Epidemiology Collaboration Equations
Annals of Laboratory Medicine 2019;39(2):205-208
The creatinine-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation can be calculated according to race, sex, and creatinine concentration (subgroup equation) or in the form expressed by one equation (single equation). Minor differences in the constants used in the CKD-EPI equations (subgroup vs single equations) could result in a significant difference in the estimated glomerular filtration rate (eGFR). We evaluated the impact of this difference in 79,709 Korean patients. The eGFR was calculated as an integer using the single and subgroup CKD-EPI equations. The differences in eGFR and GFR categories between the equations were analyzed. eGFR was higher in the subgroup equation than the single equation by 1 mL/min/1.73 m² for 12,476 (27.4%) Korean females. The GFR category based on the subgroup equation was reclassified using the single equation for 352 (0.77%) females. Based on the results, the constant of the single equation was optimized. There was no difference in eGFR values between equations using a multiplier of 1.0213 instead of 1.018 for the “white or other” females constant in the single CKD-EPI equation. Clinicians should carefully apply the CKD-EPI equation because eGFR values may differ by 1 mL/min/1.73 m² depending on the manner of calculation. To minimize these differences, the constants of the single equation should be revised.
Continental Population Groups
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Cooperative Behavior
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Creatinine
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Epidemiology
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Female
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Glomerular Filtration Rate
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Humans
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Renal Insufficiency, Chronic
4.Emergence of Monosomy 7 in Philadelphia-Negative Cells during MDS Development and not CML Diagnosis Proved by Serial Droplet Digital PCR
Sholhui PARK ; Yeung Chul MUN ; Chu-Myong SEONG ; Jungwon HUH
Laboratory Medicine Online 2020;10(4):321-325
Emergence of new clonal chromosomal abnormality (CCA) has been reported in Philadelphia-negative cells in patients with chronic myeloid leukemia (CML) undergoing the tyrosine kinase inhibitor (TKI) treatment. However, the time of emergence and clinical significance of CCA remains to be elucidated. In this study, we report a CML patient undergoing TKI treatment who developed myelodysplastic syndrome (MDS) after 206 months since the diagnosis of CML. Results of droplet digital PCR performed with serial bone marrow samples revealed that monosomy 7 in Philadelphia-negative cells appeared at the time of MDS development that did not exist initially at the time of CML diagnosis.
5.Emergence of Monosomy 7 in Philadelphia-Negative Cells during MDS Development and not CML Diagnosis Proved by Serial Droplet Digital PCR
Sholhui PARK ; Yeung Chul MUN ; Chu-Myong SEONG ; Jungwon HUH
Laboratory Medicine Online 2020;10(4):321-325
Emergence of new clonal chromosomal abnormality (CCA) has been reported in Philadelphia-negative cells in patients with chronic myeloid leukemia (CML) undergoing the tyrosine kinase inhibitor (TKI) treatment. However, the time of emergence and clinical significance of CCA remains to be elucidated. In this study, we report a CML patient undergoing TKI treatment who developed myelodysplastic syndrome (MDS) after 206 months since the diagnosis of CML. Results of droplet digital PCR performed with serial bone marrow samples revealed that monosomy 7 in Philadelphia-negative cells appeared at the time of MDS development that did not exist initially at the time of CML diagnosis.
6.Clinical and Microbiological Characteristics of Six Staphylococcus pettenkoferi Isolates From Blood Samples.
Sholhui PARK ; Hae Sun CHUNG ; Miae LEE
Annals of Laboratory Medicine 2015;35(2):250-253
Coagulase-negative staphylococci (CoNS) are reported to be the leading cause of nosocomial bloodstream infections. Staphylococcus pettenkoferi is a novel member of CoNS that was first isolated from the human blood and bursitis wound in 2002. We have reported cases of 6 S. pettenkoferi strains isolated from blood specimens, including one pathogen and 5 contaminants and catheter colonizers. Brucker Biotyper (Brucker Daltonics, Bremen, Germany) and molecular typing with 16S rRNA gene sequencing confirmed the 6 isolates as S. pettenkoferi. The conventional phenotypic identification of these isolates is not reliable owing to their inconsistent biochemical characteristics. Five of the 6 isolates were found to be resistant to oxacillin, and all isolates showed susceptibility to vancomycin and linezolid. For accurate identification of this novel species, advanced methods by using Brucker Biotyper or molecular methods such as 16S rRNA gene sequencing are required.
Aged
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Aged, 80 and over
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Anti-Bacterial Agents/pharmacology/therapeutic use
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DNA, Bacterial/chemistry/metabolism
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Drug Resistance, Bacterial/drug effects
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Female
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Humans
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Linezolid/pharmacology
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Male
;
Microbial Sensitivity Tests
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Middle Aged
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Oxacillin/pharmacology
;
Phenotype
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RNA, Ribosomal, 16S/chemistry/genetics/metabolism
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Sequence Analysis, DNA
;
Staphylococcal Infections/drug therapy/*microbiology/pathology
;
Staphylococcus/drug effects/*genetics/isolation & purification
;
Vancomycin/pharmacology
7.Diagnostic Utility of Serum Glycated Albumin for Diabetes Mellitus and Its Correlation With Hyperlipidemia.
Sholhui PARK ; Wookeun LEE ; Hae Sun CHUNG ; Ki Sook HONG
Annals of Laboratory Medicine 2016;36(4):306-312
BACKGROUND: Glycated albumin (GA) is a better marker of short-term glycemic control than glycated hemoglobin (A1c). Dyslipidemia is the main cause of cardiovascular complications in diabetes mellitus (DM). Studies on the correlation of GA with lipid indices are sparse. We investigated the diagnostic utility of GA for DM and its relationship with serum lipid profiles compared with that of A1c. METHODS: The GA enzymatic method was used to determine the diagnostic utility of GA for DM by using samples from 163 normal subjects (group 1) and 102 patients newly diagnosed with type 2 DM (T2DM; group 2). To analyze the lipid profiles, 263 patients with T2DM receiving treatment (group 3) were recruited. RESULTS: GA correlated with A1c (r=0.934, P<0.0001). Linear regression analysis indicated that GA levels were about 2.48 folds those of A1c. In the ROC analysis for GA to diagnose DM, the areas under the curve (0.988, 95% confidence interval 0.972-1.004) was excellent. HDL levels were significantly lower in groups 2 and 3. In group 1, positive correlations were observed between A1c and triglyceride (TG), total cholesterol (TC), LDL, TG/HDL, TC/HDL, and LDL/HDL levels. A negative correlation was observed between HDL and A1c levels. In group 3, HDL levels (P=0.0124 and P=0.0141, respectively) were significantly higher and LDL levels tended to be lower, not statistically significant, in the well-controlled group categorized using the A1c and GA cut-off values. CONCLUSIONS: GA is a potential diagnostic tool for DM. Compared with A1c, GA seems less relevant to dyslipidemia.
Adult
;
Area Under Curve
;
Blood Glucose/analysis
;
Cholesterol, HDL/blood
;
Cholesterol, LDL/blood
;
Chromatography, High Pressure Liquid
;
Diabetes Mellitus, Type 2/complications/*diagnosis/drug therapy
;
Female
;
Humans
;
Hyperlipidemias/complications/*diagnosis
;
Hypoglycemic Agents/therapeutic use
;
Linear Models
;
Lipids/blood
;
Male
;
Middle Aged
;
ROC Curve
;
Serum Albumin/*analysis
8.Neutrophilic Leukemoid Reaction Associated with Malignancy Initially Suspected as Chronic Neutrophilic Leukemia.
Min Kyung SO ; Sholhui PARK ; Yeung Chul MUN ; Chu Myong SEONG ; Hee Jin HUH ; Jungwon HUH
Laboratory Medicine Online 2017;7(4):206-210
Although neutrophilia can manifest from various causes, it is important to be able to distinguish chronic neutrophilic leukemia (CNL) from neutrophilic leukemoid reactions (NLR). In this paper, we describe four cases of leukocytosis with neutrophilia, including one case of CNL with a T618I mutation in colony stimulating factor 3 receptor (CSF3R) and three cases of NLR associated with malignancy or sepsis, which were initially suspected as CNL. Of the three NLR cases, one was associated with ovarian cancer, one with monoclonal gammopathy of undetermined significance and one with multiple myeloma with sepsis. This study demonstrated that confirming the clonality of myeloid cells with CSF3R T618I could contribute to making an accurate differential diagnosis between CNL and NLR in patients with solid cancers or plasma cell neoplasms caused by paraneoplastic syndromes and/or infection.
Colony-Stimulating Factors
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Diagnosis, Differential
;
Humans
;
Leukemia, Neutrophilic, Chronic*
;
Leukemoid Reaction*
;
Leukocytosis
;
Monoclonal Gammopathy of Undetermined Significance
;
Multiple Myeloma
;
Myeloid Cells
;
Neoplasms, Plasma Cell
;
Neutrophils*
;
Ovarian Neoplasms
;
Paraneoplastic Syndromes
;
Sepsis
9.Two Cases of Medical Device-Related Corynebacterium striatum Infection: A Meningitis and A Sepsis.
Sholhui PARK ; Hae Sun CHUNG ; Eui Kyo SEO ; Yeung Chul MUN ; Miae LEE
Annals of Clinical Microbiology 2016;19(1):28-31
Corynebacterium striatum is a commonly isolated contaminant in the clinical microbiology. However, it can be an opportunistic pathogen in immunocompromised and even immunocompetent hosts. The increasing prevalence of C. striatum infection has been associated with immunosuppression and prosthetic devices. We report a case of meningitis with cerebrospinal fluid drainage and a case of catheter-related bloodstream infection caused by C. striatum. The isolates were identified as nondiphtherial Corynebacterium species by VITEK 2 (bioMérieux, France) anaerobe and Corynebacterium card. The final identification by 16S rRNA gene sequencing analysis was C. striatum with 99.7% identity and 99.6% identity with C. striatum ATCC 6940, respectively. Both strains were sensitive to vancomycin and gentamicin, but multidrug-resistant to ciprofloxacin, penicillin, erythromycin and imipenem.
Cerebrospinal Fluid
;
Ciprofloxacin
;
Corynebacterium*
;
Drainage
;
Erythromycin
;
Genes, rRNA
;
Gentamicins
;
Imipenem
;
Immunosuppression
;
Meningitis*
;
Penicillins
;
Prevalence
;
Sepsis*
;
Vancomycin
10.Anaplastic Large Cell Lymphoma with Massive Eosinophilia and Complex Karyotype Initially Misdiagnosed as Chronic Eosinophilic Leukemia.
Min Kyung SO ; Sholhui PARK ; Min Sun CHO ; Yeung Chul MUN ; Jungwon HUH
Laboratory Medicine Online 2018;8(2):56-61
We report a patient with massive eosinophilia and a complex karyotype that was initially misdiagnosed as chronic eosinophilic leukemia (CEL), but later diagnosed as anaplastic large cell lymphoma (ALCL) masked by massive eosinophilia. The complex karyotype observed at initial diagnosis remained unchanged later, after the evidence of bone marrow involvement of ALCL was obtained. At diagnosis, genetic aberrations corresponding to metaphase cytogenetics were not identified by interphase fluorescence in situ hybridization, although abnormal results were noted at follow-up. Together, these observations indicate that the complex karyotype at initial work-up has been derived from a low proportion of lymphoma cells with high mitotic ability that were not identified by microscopy, rather than from massive eosinophils. These findings suggest that our patient had ALCL with secondary eosinophilia rather than CEL since initial diagnosis.
Bone Marrow
;
Cytogenetics
;
Diagnosis
;
Eosinophilia*
;
Eosinophils*
;
Fluorescence
;
Follow-Up Studies
;
Humans
;
Hypereosinophilic Syndrome*
;
In Situ Hybridization
;
Interphase
;
Karyotype*
;
Lymphoma
;
Lymphoma, Large-Cell, Anaplastic*
;
Masks
;
Metaphase
;
Microscopy