Background: Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols. Methods: We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention AgencyLaboratory Standardization Project (per CLSI C37-A), using six routine measurement procedures (MPs). Regression equations and 95% prediction intervals derived from single-donor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differences in inter-MP biases between RM and clinical samples. The effect of the TG concentration on commutability was evaluated by analyzing biases between MP results and reference procedure-assigned values. Results: RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from assigned values were observed for RMs with higher TG levels. Conclusions RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to standardize laboratory tests.

Serologic ABO typing might be hampered in some patients with hematologic malignancies.We performed ABO genotyping using next-generation sequencing as part of a routine hematologic malignancy gene panel to determine the ABO blood type of patients with hematologic malignancies. Targeted sequencing of seven ABO gene exons was performed within a hematologic malignancy gene panel for 520 patients diagnosed with various hematologic malignancies. The distribution of predicted ABO blood phenotypes determined through genotyping was as follows: 33.3% A, 27.3% B, 26.7% O, and 12.7% AB. No significant associations were identified between ABO allele distributions and specific hematologic malignancy diagnoses. We compared the phenotypes predicted using ABO genotyping with serological ABO testing results in 502 samples where serological data were available. All genotyping-based phenotypes were accurate, with 99.8% (501/502) of initial serological results aligning with the true phenotypes. Unusual serological results were observed in 21 samples (4.2%). The percentages of recipient cells containing ABO allele variants indicated chimerism in relapsed patients who had undergone ABO-mismatched transplantation. Thus, incorporating ABO genotyping into the hematology gene panel provides valuable information offering a cost-effective approach to address challenges in blood typing and post-transplant care.

In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, an online laboratory surveillance system was established to monitor severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) real-time reverse transcription-PCR (rRT-PCR) testing capacities and results. SARS-CoV-2 rRT-PCR testing data were collected from 97 clinical laboratories, including 84 medical institutions and 13 independent clinical laboratories in Korea. We assessed the testing capacities to utilize SARS-CoV-2 rRT-PCR based on surveillance data obtained from February 7th to June 4th, 2020 and evaluated positive result characteristics according to the reagents used and sample types. A total of 1,890,319 SARS-CoV-2 rRT-PCR testing were performed, 2.3% of which were positive. Strong correlations were observed between the envelope (E ) gene and RNA-dependent RNA polymerase (RdRp )ucleocapsid (N ) genes threshold cycle (Ct) values for each reagent. No statistically significant differences in gene Ct values were observed between the paired upper and lower respiratory tract samples, except in the N gene for nasopharyngeal swab and sputum samples. Our study showed that clinical laboratories in Korea have rapidly expanded their testing capacities in response to the COVID-19 outbreak, with a peak daily capacity of 34,193 tests. Rapid expansion in testing capacity is a critical component of the national response to the ongoing pandemic.

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.

Background: Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. Methods: The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. Results: The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. Conclusion South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.

Background: Nurses play a central role in the process of blood transfusion because they have the closest interactions with patients. Providing nurses with the appropriate knowledge and competency through education can help ensure transfusion safety. This study investigated the effectiveness of the first nationwide transfusion-related education for nurses by analyzing questionnaires for a self-assessment of competency on transfusion-related knowledge before and after the education and general evaluation for the educational program. Methods: The education program was composed of four lectures and was conducted in seven regions in South Korea. One hundred and ninety-two nurses participated, and the questionnaires for 170 nurses were analyzed. Results: The participants consisted of 90 nurses (53.0%) from tertiary hospitals, 23 (13.5%) from general hospitals, and 57 (33.5%) from other hospitals. The majority of the participants (103/170, 60.6%) were from hospitals with ≥500 beds, and 69.4% had a work period of ≥10 years. The scores for pre-/post-education self-assessment of competency were as follows: blood components, 3.03/3.73; pretransfusion testing, 2.86/3.64; management of transfusion, 3.18/3.84; and transfusion reactions, 3.11/3.78. In all categories, there was a significant increase in the score after the education program. The majority of participants (99.4%) provided a positive response regarding the necessity of a transfusion-related education program. Conclusion South Korea’s first attempt at transfusion-related education for nurses showed a strong positive effect by improving participants’ transfusion-related competency. Considering the important role of nurses in blood transfusion, the educational program should continue and be expanded in the future.

Although various studies on predictive markers in the use of PD-1/PD-L1 inhibitors are in progress, only PD-L1 expression levels in tumor tissues are currently used. In the present study, we investigated whether baseline serum levels of IL-6 can predict the treatment response of patients with advanced non-small cell lung cancer (NSCLC) treated with PD-1/PD-L1 inhibitors. In our cohort of 125 NSCLC patients, the objective response rate (ORR) and disease control rate (DCR) were significantly higher in those with low IL-6 (<13.1 pg/ml) than those with high IL-6 (ORR 33.9% vs. 11.1%, p=0.003; DCR 80.6% vs. 34.9%, p<0.001). The median progression-free survival was 6.3 months (95% confidence interval [CI], 3.9–8.7) in the low IL-6 group, significantly longer than in the high IL-6 group (1.9 months, 95% CI, 1.6–2.2, p<0.001). The median overall survival in the low IL-6 group was significantly longer than in the high IL-6 group (not reached vs. 7.4 months, 95% CI, 4.8–10.0). Thus, baseline serum IL-6 levels could be a potential biomarker for predicting the efficacy and survival benefit of PD-1/PD-L1 inhibitors in NSCLC.

BACKGROUND: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. METHODS: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. RESULTS: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. CONCLUSIONS: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.
Bias (Epidemiology) ; Creatinine* ; Delivery of Health Care ; Diagnosis ; Indicators and Reagents ; Kidney Diseases ; Methods ; Quality Control ; Risk Assessment

BACKGROUND: Automated systems are used widely for pre-transfusion tests in blood banks, in an attempt to reduce effort and human error. We evaluated the clinical performance of an automated blood bank system, ORTHO VISION (Ortho-Clinical Diagnostics, Switzerland), for blood cross-matching. METHODS: Saline cross-matching was performed for 93 tests using 56 samples. Coombs cross-matching was performed for 400 tests using 166 samples. Saline cross-matching was compared for the automated ORTHO VISION and manual tube methods. Coombs cross-matching was compared for the automated ORTHO VISION and manual column agglutination technique (CAT) methods. The evaluation of 32 antibody-positive samples using the automated ORTHO VISION and manual CAT methods was compared by performing 97 cross-matching tests. Additionally, the ORTHO VISION efficiency and carryover were evaluated. RESULTS: The concordance rate of the saline cross-matching results between the manual method and automated ORTHO VISION was 100%. The concordance rate of coombs cross-matching results between manual CAT and automated ORTHO VISION was 97.9%. The concordance rate of cross-matching for antibody positive samples between manual CAT and the automated ORTHO VISION was 97.9%. Coombs cross-matching was efficient using ORTHO VISION, whereas saline cross-matching was efficient using the tube manual method. CONCLUSIONS: ORTHO VISION showed reliable results for cross-matching and was more efficient than manual CAT for coombs cross-matching. Thus, ORTHO VISION can be used for pre-transfusion tests in blood banks.
Agglutination ; Animals ; Automation ; Blood Banks ; Cats ; Humans ; Methods

BACKGROUND: Analysis of body fluids provides important information for assessing various medical conditions. We aimed to validate the analytical and diagnostic performance of the Sysmex UF-5000 (Sysmex, Japan) system for the analysis of different body fluids. METHODS: Eighty body fluid samples were analyzed using the UF-5000 system in the body fluid mode and light microscopy. Body fluids included ascitic, pleural, and cerebrospinal fluid (CSF), as well as other fluid samples. RESULTS: A comparison between the UF-5000 system and manual counting demonstrated good correlations with regard to red (r=0.6555) and white blood cell (r=0.9666) counts. The UF-5000 system also demonstrated good performance for differential cell counting (r=0.9028). CSF particularly showed a good correlation. CONCLUSIONS: The use of the UF-5000 system for cell counting and differential analysis of body fluid samples might be an effective and automated alternative to chamber counting in laboratory routine analysis, thereby enhancing laboratory workflow and clinical effectiveness.
Automation ; Body Fluids ; Cell Count ; Cerebrospinal Fluid ; Erythrocytes ; Leukocytes ; Methods ; Microscopy ; Treatment Outcome