Review Article2022-05-01 General Laboratory Medicine

Promotion to Top-Tier Journal and Development Strategy of the Annals of Laboratory Medicine for Strengthening its Leadership in the Medical Laboratory Technology Category: A Bibliometric Study

Sun Huh , M.D., Ph.D.

Ann Lab Med 2022; 42(3): 321-330

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Abstract : Background: A bibliometric analysis of the Annals of Laboratory Medicine (ALM) was performed to understand its position in the medical laboratory technology category and to suggest a developmental strategy. Methods: Journal metrics, including the number of articles by publication type, country of authors, total citations, 2-year impact factor, country of cited authors, journals citing ALM, and Hirsch-index, were obtained from the Journal Citation Report and Web of Science Core Collection. Target data included ALM content in the Web of Science from January 1, 2012, to October 5, 2021. Bibliometric analysis was performed using Biblioshiny. Results: The impact factor increased from 1.481 in 2013 to 3.464 in 2020. Authors belonging to the USA, China, and Korea cited ALM articles the most. Plos One, Scientific Reports, and Frontiers in Microbiology most frequently cited ALM, besides ALM itself. The Hirsch-index was 34. The co-occurrence network of Keyword Plus indicated four clusters: diagnosis, identification, prevalence, and risk. The conceptual structure map of Keyword Plus based on multiple correspondence analysis showed two clusters: bacterial susceptibility at the bench and clinical courses. The co-citation network showed that ALM was in the cluster of the New England Journal of Medicine, The Lancet, JAMA, and the Annals of Internal Medicine. The collaboration network showed that Korean authors collaborated mainly with authors from the USA, Germany, and Italy. Conclusions: The journal’s promotion to an international top-tier journal has been successful. “Principles of transparency and best practice in scholarly publishing” and a preprint policy are yet to be added.

Original Article2022-03-01 Diagnostic Immunology

Comparison of Non-Invasive Clinical Algorithms for Liver Fibrosis in Patients With Chronic Hepatitis B to Reduce the Need for Liver Biopsy: Application of Enhanced Liver Fibrosis and Mac-2 Binding Protein Glycosylation Isomer

Mina Hur , M.D., Ph.D., Mikyoung Park , M.D., Ph.D., Hee-Won Moon , M.D., Ph.D., Won Hyeok Choe , M.D., Ph.D., and Chae Hoon Lee , M.D., Ph.D.

Ann Lab Med 2022; 42(2): 249-257

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Abstract : Background: Non-invasive clinical algorithms for the detection of liver fibrosis (LF) can reduce the need for liver biopsy (LB). We explored the implementation of two serum biomarkers, enhanced liver fibrosis (ELF) and Mac-2 binding protein glycosylation isomer (M2BPGi), in clinical algorithms for LF in chronic hepatitis B (CHB) patients. Methods: Two clinical algorithms were applied to 152 CHB patients: (1) transient elastography (TE) followed by biomarkers (TE/ELF and TE/M2GPGi); (2) biomarker test followed by TE (ELF/TE and M2BPGi/TE). Using the cut-off value or index for the detection of advanced LF (TE≥F3; 9.8 in ELF and 3.0 in M2BPGi), LB was expected to be performed in cases with discordant TE and biomarker results. Results: In both algorithms, the expected number of LBs was lower when using M2BPGi than when using ELF (TE/ELF or ELF/TE, 13.2% [N=20]; TE/M2BPGi or M2BPGi/TE, 9.9% [N=15]), although there was no statistical difference (P=0.398). In the TE low-risk group (TE≤F2), the discordance rate was significantly lower in the TE/M2BPGi approach than in the TE/ELF approach (1.5% [2/136] vs. 11.0% [15/136], P=0.002). In the biomarker low-risk group, there was no significant difference between the ELF/TE and M2BPGi/TE approaches (3.9% [5/126] vs. 8.8% [13/147], P=0.118). Conclusions: Both ELF and M2BPGi can be implemented in non-invasive clinical algorithms for assessing LF in CHB patients. Given the lowest possibility of losing advanced LF cases in the low-risk group when using the TE/M2BPGi approach, this combination seems useful in clinical practice.

Brief Communication2022-01-01 Clinical Microbiology

Prevalence of a Single-Nucleotide Variant of SARS-CoV-2 in Korea and Its Impact on the Diagnostic Sensitivity of the Xpert Xpress SARS-CoV-2 Assay

Ki Ho Hong , M.D., Ji Won In , M.D., Jaehyeon Lee , M.D., So Yeon Kim , M.D., Kyoung Ah Lee , M.T., Seunghyun Kim , M.T., Yeoungim An , M.T., Donggeun Lee , M.T., Heungsup Sung , M.D., Jae-Seok Kim , M.D., and Hyukmin Lee , M.D.

Ann Lab Med 2022; 42(1): 96-99

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Abstract : The sensitivity of molecular diagnostics could be affected by nucleotide variants in pathogen genes, and the sites affected by such variants should be monitored. We report a single-nucleotide variant (SNV) in the nucleocapsid (N) gene of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), i.e., G29179T, which impairs the diagnostic sensitivity of the Xpert Xpress SARS-CoV-2 assay (Cepheid, Sunnyvale, CA, USA). We observed significant differences between the threshold cycle (Ct) values for envelope (E) and N genes and confirmed the SNV as the cause of the differences using Sanger sequencing. This SNV, G29179T, is the most prevalent in Korea and is associated with the B.1.497 virus lineage, which is dominant in Korea. Clinical laboratories should be aware of the various SNVs in the SARS-CoV-2 genome and consider their potential effects on the diagnosis of coronavirus disease 2019.

Review Article2022-05-01 Diagnostic Genetics

Current Issues, Challenges, and Future Perspectives of Genetic Counseling in Korea

Namhee Kim , M.D., Sun-Young Kong , M.D., Ph.D., Jongha Yoo , M.D., Ph.D., Do-Hoon Kim , M.D., Ph.D., Soo Hyun Seo , M.D., and Jieun Kim , M.D., Ph.D.

Ann Lab Med 2022; 42(3): 314-320

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Abstract : Genetic testing has become increasingly integrated into all areas of healthcare, and complex genetic testing usage continues to grow; thus, the demand for genetic counseling (GC) is likely to increase. However, it is unclear whether the current clinical GC capacity is sufficient for meeting the existing demand. This review describes the current issues, challenges, and future perspectives of GC in Korea based on a professional survey conducted among laboratory physicians. In view of the growing GC demand in the clinical setting, participants expressed a concern about the lack of support from the national healthcare insurance policy and legal requirements, such as certification, for GC practice. The implementation of genetic testing in the overall healthcare system in Korea is in an early phase. Proper implementation can be achieved through education and training of specialists, collaboration among healthcare personnel, proper regulatory oversight, genomic policies, and public awareness. Understanding the current GC capacity, issues, and challenges is a prerequisite for effective strategic planning by healthcare systems considering the expected growth in the demand for clinical genetic services over the next few decades.

Original Article2023-01-01 Clinical Microbiology

Serotype Distribution and Antimicrobial Resistance of Streptococcus pneumoniae Causing Invasive Pneumococcal Disease in Korea Between 2017 and 2019 After Introduction of the 13-Valent Pneumococcal Conjugate Vaccine

Gyu Ri Kim , Ph.D., Eun-Young Kim , Ph.D., Si Hyun Kim , Ph.D., Hae Kyung Lee , M.D., Jaehyeon Lee , M.D., Jong Hee Shin , M.D., Young Ree Kim , M.D., Sae Am Song , M.D., Joseph Jeong , M.D., Young Uh , M.D., Yu Kyung Kim , M.D., Dongeun Yong , M.D., Hyun Soo Kim , M.D., Sunjoo Kim , M.D., Young Ah Kim , M.D., Kyeong Seob Shin , M.D., Seok Hoon Jeong , M.D., Namhee Ryoo , M.D., and Jeong Hwan Shin , M.D.

Ann Lab Med 2023; 43(1): 45-54

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Abstract : Background: Streptococcus pneumoniae is a serious pathogen causing various infections in humans. We evaluated the serotype distribution and antimicrobial resistance of S. pneumoniae causing invasive pneumococcal disease (IPD) after introduction of pneumococcal conjugate vaccine (PCV)13 in Korea and investigated the epidemiological characteristics of multidrug-resistant (MDR) isolates. Methods: S. pneumoniae isolates causing IPD were collected from 16 hospitals in Korea between 2017 and 2019. Serotyping was performed using modified sequential multiplex PCR and the Quellung reaction. Antimicrobial susceptibility tests were performed using the broth microdilution method. Multilocus sequence typing was performed on MDR isolates for epidemiological investigations. Results: Among the 411 S. pneumoniae isolates analyzed, the most prevalent serotype was 3 (12.2%), followed by 10A (9.5%), 34 (7.3%), 19A (6.8%), 23A (6.3%), 22F (6.1%), 35B (5.8%), 11A (5.1%), and others (40.9%). The coverage rates of PCV7, PCV10, PCV13, and pneumococcal polysaccharide vaccine (PPSV)23 were 7.8%, 7.8%, 28.7%, and 59.4%, respectively. Resistance rates to penicillin, ceftriaxone, erythromycin, and levofloxacin were 13.1%, 9.2%, 80.3%, and 4.1%, respectively. MDR isolates accounted for 23.4% of all isolates. Serotypes 23A, 11A, 19A, and 15B accounted for the highest proportions of total isolates at 18.8%, 16.7%, 14.6%, and 8.3%, respectively. Sequence type (ST)166 (43.8%) and ST320 (12.5%) were common among MDR isolates. Conclusions: Non-PCV13 serotypes are increasing among invasive S. pneumoniae strains causing IPD. Differences in antimicrobial resistance were found according to the specific serotype. Continuous monitoring of serotypes and antimicrobial resistance is necessary for the appropriate management of S. pneumoniae infections.

Original Article2022-03-01 Clinical Chemistry

Impact of Individualized Hemolysis Management Based on Biological Variation Cut-offs in a Clinical Laboratory

Fernando Marques-Garcia , Ph.D., David Hansoe Heredero Jung , M.D., and Sandra Elena Pérez, B.D.

Ann Lab Med 2022; 42(2): 169-177

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Abstract : Background: Hemolysis is the most common type of preanalytical interference. Cut-offs based on the hemolysis index level can be established using different approaches. The Working Group for Preanalytical Phase of the European Federation of Laboratory Medicine has developed a protocol for hemolysis management based on cut-offs estimated from biological variation (BV) and the use of interpretative comments. We developed and assessed the implementation of the protocol in our laboratory. Methods: Hemolysates from whole blood were prepared following the Meites method, and pooled serum samples with known Hb concentrations were prepared. For each analyte (42 ), interferograms were generated and used to establish cut-offs: desirable analytical quality specification and reference change value. This protocol was assessed, both pre- and post-implementation, according to expert rules in the Laboratory Information System. Results: Among the analytes evaluated, we selected those that showed the highest degree of hemolysis interference: lactate dehydrogenase (LDH), aspartate aminotransferase, direct bilirubin, potassium, and folic acid. The cut-offs for LDH and direct bilirubin were the lowest. Only 28.16% of all LDH values were adequately reported in the pre-implantation retrospective study, but this percentage improved in the post-implementation stage. Conclusions: The development and implementation of a harmonized protocol for hemolysis management based on BV cut-offs and result reporting significantly improve hemolysis detection and lead to a decrease in the number of hemolyzed samples over time.

Original Article2022-03-01 Clinical Chemistry

Diagnostic Characteristics of Urinary Red Blood Cell Distribution Incorporated in UF-5000 for Differentiation of Glomerular and Non-Glomerular Hematuria

Hanwool Cho , M.D., Jaeeun Yoo , M.D., Hyunjung Kim , M.D., Hyunsik Jang , M.T., Yonggoo Kim , M.D., and Hyojin Chae , M.D.

Ann Lab Med 2022; 42(2): 160-168

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Abstract : Background: Automated urine sediment analysis has been developed to address the limitations of microscopic examination of dysmorphic red blood cells (RBCs). We evaluated the urinary RBC distribution (URD) parameter of a recently launched automated urinary flow cytometry analyzer, UF-5000 (Sysmex, Kobe, Japan), to differentiate glomerular hematuria (GH) from non-GH (NGH). Methods: Samples submitted for urine sediment analysis from patients with hematuria (>20 RBCs/μL) were divided into derivation (N=156; 101 GH, 55 NGH) and validation cohorts (N=107; 60 GH, 47 NGH). The clinical diagnosis of GH or NGH was established based on clinical data review. Differences in UF-5000 parameters (URD, small RBC, lysed RBC, RBC-P70FSC, RBC-SF-FSC-W, mean forward-scattered light, and mean side-scattered light) between GH and NGH, and areas under the ROC curves (AUC) were analyzed in the derivation cohort. The derived ideal cut-off value was evaluated in the validation cohort. We applied the Kitasato criteria to compare the diagnostic performance. Results: URD (%), differed significantly between GH and NGH (P20.1%, the sensitivity was 99.0%/89.4% and the specificity was 50.9%/63.3% in the derivation/validation cohort. When the Kitasato criteria were applied, the sensitivity and specificity were 80.2% and 52.7%, respectively. Conclusions: URD is a rapid, objective, and quantitative measure that can be used to differentiate GH and NGH.

Original Article2022-07-01 Clinical Chemistry

Prognostic Utility of Procalcitonin, Presepsin, and the VACO Index for Predicting 30-day Mortality in Hospitalized COVID-19 Patients

Mikyoung Park , M.D., Ph.D, Mina Hur , M.D., Ph.D, Hanah Kim , M.D., Ph.D, Chae Hoon Lee , M.D., Ph.D, Jong Ho Lee , M.D., Hyung Woo Kim , M.D., and Minjeong Nam , M.D., Ph.D.

Ann Lab Med 2022; 42(4): 406-414

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Abstract : Background: Biomarkers and clinical indices have been investigated for predicting mortality in patients with coronavirus disease (COVID-19). We explored the prognostic utility of procalcitonin (PCT), presepsin, and the Veterans Health Administration COVID-19 (VACO) index for predicting 30-day-mortality in COVID-19 patients. Methods: In total, 54 hospitalized COVID-19 patients were enrolled. PCT and presepsin levels were measured using the Elecsys BRAHMS PCT assay (Roche Diagnostics GmbH, Mannheim, Germany) and HISCL Presepsin assay (Sysmex, Kobe, Japan), respectively. The VACO index was calculated based on age, sex, and comorbidities. PCT and presepsin levels and the VACO index were compared using ROC curve, Kaplan–Meier method, and reclassification analysis for the 30-day mortality. Results: ROC curve analysis was used to measure PCT and presepsin levels and the VACO index to predict 30-day mortality; the optimal cut-off values were 0.138 ng/mL for PCT, 717 pg/mL for presepsin, and 12.1% for the VACO index. On Kaplan–Meier survival analysis, hazard ratios (95% confidence interval) were 15.9 (4.1-61.3) for PCT, 26.3 (6.4-108.0) for presepsin, and 6.0 (1.7-21.1) for the VACO index. On reclassification analysis, PCT and presepsin in addition to the VACO index significantly improved the prognostic value of the index. Conclusions: This study demonstrated the prognostic utility of measuring PCT and presepsin levels and the VACO index in COVID-19 patients. The biomarkers in addition to the clinical index were more useful than the index alone for predicting clinical outcomes in COVID-19 patients.

Brief Communication2022-03-01 Clinical Microbiology

Serotype Distribution and Antimicrobial Resistance of Salmonella Isolates in Korea between 2016 and 2017

Si Hyun Kim , Ph.D., Gyung-Hye Sung , Ph.D., Eun Hee Park , Ph.D., In Yeong Hwang , Ph.D., Gyu Ri Kim , Ph.D., Sae Am Song , M.D., Hae Kyung Lee , M.D., Young Uh , M.D., Young Ah Kim , M.D., Seok Hoon Jeong , M.D., Jong Hee Shin , M.D., Kyeong Seob Shin , M.D., Jaehyeon Lee , M.D., Joseph Jeong , M.D., Young Ree Kim , M.D., Dongeun Yong , M.D., Miae Lee , M.D., Yu Kyung Kim , M.D., Nam Hee Ryoo , M.D., Seungok Lee , M.D., Jayoung Kim , M.D., Sunjoo Kim , M.D., Hyun Soo Kim , M.D., and Jeong Hwan Shin , M.D.

Ann Lab Med 2022; 42(2): 268-273

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Abstract : Salmonella is one of the major causes of food-borne infections. We investigated the serotype distribution and antimicrobial resistance of Salmonella isolates collected in Korea between January 2016 and December 2017. In total, 669 Salmonella isolates were collected from clinical specimens at 19 university hospitals. Serotyping was performed according to the Kauffmann–White scheme, and antimicrobial susceptibility was tested using Sensititre EUVSEC plates or disk diffusion. Among the strains, C (39.8%) and B (36.6%) were the most prevalent serogroups. In total, 51 serotypes were identified, and common serotypes were S. enterica serovar I 4,[5],12:i:- (16.7%), S. Enteritidis (16.1%), S. Bareilly (14.6%), S. Typhimurium (9.9%), and S. Infantis (6.9%). The resistance rates to ampicillin, chloramphenicol, and trimethoprim-sulfamethoxazole were 32.6%, 12.1%, and 8.4%, respectively. The resistance rates to cefotaxime and ciprofloxacin were 8.1% and 3.0%, respectively, while 5.4% were multidrug-resistant. S. enterica serovar I 4,[5],12:i:- and S. Enteritidis were highly prevalent, and there was an increase in rare serotypes. Multidrug resistance and ciprofloxacin resistance were highly prevalent. Periodic investigations of Salmonella serotypes and antimicrobial resistance are needed.

Guideline2022-09-01 Clinical Microbiology

Guidelines for Mobile Laboratories for Molecular Diagnostic Testing of COVID-19

Kyoung Ho Roh , M.D., Ki Ho Hong , M.D., Myung-Hyun Nam , M.D., Taek Soo Kim , M.D., Moon-Woo Seong , M.D., Jin Kyung Lee , M.D., Sookyoung Bae , M.D., Hee Jae Huh , M.D., Jeong-Yeal Ahn , M.D., Jinsook Lim , M.D., Gab Jung Kim , Ph.D., Jae Sun Park , Ph.D., Hyun Yeong Kim , Ph.D., Cheon Kwon Yoo , Ph.D., and Hyukmin Lee , M.D. on behalf of Korean Society for Laboratory Medicine, COVID-19 Task Force, and the Bureau of Infectious Disease Diagnosis Control, Korea Disease Control and Prevention Agency

Ann Lab Med 2022; 42(5): 507-514

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Abstract : With the rapid spread of the coronavirus disease (COVID-19), the need for rapid testing and diagnosis and consequently, the demand for mobile laboratories have increased. Despite this need, there are no clear guidelines for the operation, maintenance, or quality control of mobile laboratories. We provide guidelines for the operation, management, and quality control of mobile laboratories, and specifically for the implementation and execution of COVID-19 molecular diagnostic testing. These practical guidelines are primarily based on expert opinions and a laboratory accreditation inspection checklist. The scope of these guidelines includes the facility, preoperative evaluation, PCR testing, internal and external quality control, sample handling, reporting, laboratory personnel, biosafety level, and laboratory safety management. These guidelines are useful for the maintenance and operation of mobile laboratories not only in normal circumstances but also during public health crises and emergencies.