No abstract available.
Antibodies* ; Hepacivirus* ; Hepatitis C* ; Hepatitis* ; Humans ; Prevalence* ; Renal Dialysis*

Diagnostic hematology subcommitee of The Korean Association of Quality Assurance for Clinical Laboratory performed laboratory proficiency testing for blood cell count, cell morphology and coagulation tests in 2013. Four trials for blood cell count and cell morphology and 2 trials for coagulation tests were executed. Average 1,308, 494, and 558 laboratories participated in the surveys of blood cell count, cell morphology and coagulation tests, respectively. The overall reply rates were 95.78%, 97.75%, and 97.38%, respectively. The homogeneity of external quality materials was stable (less than 3%) and status of use of the instrument and reagents was similar to those of the previous year. The CVs in white blood cell count, red blood cell count, platelet count, hemoglobin, and hematocrit were 3.15%, 2.00%, 5.10%, 1.81%, and 2.71%, respectively. For cell morphology, most showed concordant rate >80%. CVs of coagulation tests showed difference depending on instruments or reagent groups. An educational workshop on hands-on experience in diagnostic hematology was held in July. In 2013, the number of participating laboratories is more increased and the performance of surveys of hematology tests is similar performance compared to previous year. In addition, the revision in the way of evaluation of coagulation tests is needed.
Blood Cell Count ; Education ; Erythrocyte Count ; Hematocrit ; Hematology* ; Indicators and Reagents ; Korea ; Laboratory Proficiency Testing ; Leukocyte Count ; Partial Thromboplastin Time ; Platelet Count ; Prothrombin Time

During 2015, the Diagnostic Hematology Subcommittee of Korean Association of External Quality Assessment Service performed laboratory proficiency testing for blood cell count, cell morphology, and coagulation tests. Four trials for blood cell count and cell morphology tests each and two trials for coagulation tests were performed. The trials for blood cell counts had a reply rate of 97.2% among 1,352 laboratories, compared to 99.0% among 503 laboratories for cell morphology and 98.6% among 574 laboratories for coagulation tests. The homogeneity of the external quality materials was stable (<3%), and the use of instruments and reagents was similar to that observed during the previous year. The coefficients of variation (CVs) for white blood cell counts, red blood cell counts, platelet counts, hemoglobin tests, and hematocrit tests were 4.13%, 1.89%, 1.92%, 5.02%, and 8.10%, respectively. For cell morphology tests, concordant rates were >80% for most of the participating laboratories. The CVs for the coagulation tests varied according to the specific instruments or reagents that were used. An educational workshop was held in November to provide hands-on experience in diagnostic hematology. During 2015, the number of participating laboratories increased, while the performance of hematology tests was similar to that observed in the previous year.
Blood Cell Count ; Education ; Erythrocyte Count ; Hematocrit ; Hematology* ; Indicators and Reagents ; Korea* ; Laboratory Proficiency Testing ; Leukocyte Count ; Partial Thromboplastin Time ; Platelet Count ; Prothrombin Time

During 2014, the Diagnostic Hematology Subcommittee of the Korean Association of Quality Assurance for Clinical Laboratories performed laboratory proficiency testing for blood cell count, cell morphology, and coagulation tests. Four trials for blood cell count and cell morphology tests and 2 trials for coagulation tests were performed. The trials for blood cell counts had a reply rate of 96.8% among 1,343 laboratories, compared to 99.3% among 489 laboratories for cell morphology and 98.6% among 565 laboratories for coagulation tests. The homogeneity of the external quality materials was stable (<3%), and the use of instruments and reagents was similar to that observed during the previous year. The CVs for white blood cell counts, red blood cell counts, platelet counts, hemoglobin tests, and hematocrit tests were 4.46%, 2.12%, 2.21%, 5.08%, and 8.31%, respectively. For cell morphology tests, concordant rates were >80% for most of the participating laboratories. The CVs for the coagulation tests varied according to the specific instruments or reagents that were used. An educational workshop was held in July to provide hands-on experience in diagnostic hematology. During 2014, the number of participating laboratories was increased, while the performance of hematology tests was similar to that observed in the previous year.
Blood Cell Count ; Education ; Erythrocyte Count ; Hematocrit ; Hematology* ; Indicators and Reagents ; Korea ; Laboratory Proficiency Testing ; Leukocyte Count ; Partial Thromboplastin Time ; Platelet Count ; Prothrombin Time

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: Diagnosing albuminuria by measuring the urinary albumin-creatinine ratios (UACR) is important for the early detection of kidney diseases in patients with diabetes or hypertension. Currently, a few point-of-care testing (POCT) systems exist for estimating the UACR. Here, we evaluated the performance characteristics of two semi-quantitative UACR POCT assays. METHODS: Albumin and creatinine levels were quantified for 219 randomly acquired urine samples with the Toshiba TBA-200FR NEO analyzer, and the UACR were calculated. The results were compared to UACR measured using the CLINITEK Microalbumin 2 Strip (Siemens, USA) and URiSCAN 2 ACR Strip (YD diagnostics, Korea) POCT assays. RESULTS: Semi-quantitative results from the CLINITEK and URiSCAN UACR assays showed that the sensitivity and specificity of each test were, respectively, 96.7% and 62.7%, and 45.9% and 84.8%. Positive and negative predictive values of the CLINITEK and URiSCAN tests were, respectively, 50.0% and 98.0%, and 53.8% and 80.2%. The rate of agreement between URiSCAN test and CLINITEK test was 91.1% in the normal UACR range (<30 mg/g), but it was as low as 36.4% in the abnormal UACR range (> or =30 mg/g). CONCLUSIONS: The URiSCAN test showed higher specificity than did the CLINITEK test owing to the lower false positive results. However, the high rate of false negatives for the URiSCAN test significantly lowered its sensitivity and negative predictive values. Therefore, the sensitivity of the URiSCAN device in detecting urine albumin needs to be improved before its adoption as a reliable rule-out testing system.
Albuminuria ; Creatinine ; Humans ; Hypertension ; Kidney Diseases ; Sensitivity and Specificity

BACKGROUND: Methotrexate (MTX) is an antifolate antagonist that is widely used for treating various malignancies and non-malignant diseases. MTX levels should be monitored when used in high concentration to determine when to start leucovorin rescue. In this study, we evaluated the analytical performance of the EMIT Methotrexate Assay on a 200FR NEO Chemistry Analyzer (Toshiba Medical System Co., Japan) and compared it with Viva-E Drug Testing System (Siemens Healthcare, Germany). METHODS: According to the Clinical Laboratory and Standards Institute (CLSI) Evaluation Protocol (EP) 5-A2, three concentrations of the Liquichek Therapeutic Drug Monitoring Control (Bio-Rad Laboratories, USA) were analyzed twice a day for 20 days to monitor assay precision. The 200FR NEO and Viva-E instruments were compared using 40 patients' sera, according to CLSI EP9-A2. The linearity and carry-over rate were also evaluated. RESULTS: Between-run CVs for low-, medium-, and high-level controls were 4.9%, 0.9%, and 2.0%, respectively, whereas between-day CVs for low-, medium-, and high-level controls were 8.1%, 1.3%, and 3.5%, respectively. In the linearity test, the coefficient of determination (R2) was 0.98 (0.06-1.92 micromol/L). In the comparison study, R2 was 0.955, showing good correlation between the 200FR NEO and Viva-E instruments. The carry-over rate was 0.9%. CONCLUSIONS: The EMIT assay showed good precision, linearity, and carry-over rate on the Toshiba 200FR. An excellent correlation was observed when comparing results obtained using the Toshiba and Viva-E instruments. In conclusion, the Syva EMIT MTX assay can be readily used for MTX monitoring on the Toshiba 200FR NEO.
Chemistry ; Delivery of Health Care ; Drug Monitoring ; Leucovorin ; Methotrexate*

BACKGROUND: Point-of-care testing (POCT) is designed to be used near the site where the clinical care is being delivered. The demand for POCT in the medical field is expanding significantly, given that rapid results can eventually lead to early diagnosis and immediate clinical management of diseases. Therefore, the aim of this study was to evaluate the performance of the i-STAT POC analyser (Abbott Diagnostics, USA) for testing 8 chemical analytes (viz., sodium, potassium, chloride, total carbon dioxide, blood urea nitrogen, creatinine, glucose, and ionised calcium) and 2 hematological analytes (hematocrit [HCT], hemoglobin [Hb]). METHODS: The precision and linearity of the 10 analytes were measured according to Clinical and Laboratory Standards Institute (CLSI) EP15-A3 and EP6-A guidelines. Comparisons with a central laboratory hematology analyser, Coulter LH 780 (Beckman Coulter Inc., USA), and a chemical analyser, UniCel DxC 880i (Beckman Coulter Inc.), were performed using 85 patient samples according to CLSI EP9-A3. RESULTS: The coefficient of variation values for the within-run precision and total precision at 3 levels of all analytes were within 5%, except those for low level creatinine. In the aspect of linearity, the correlation coefficient values of all analytes were over 0.975 in the clinically important concentration range. A very high correlation was observed in glucose, blood urea nitrogen and creatinine (R>0.975), high correlation was observed in sodium, potassium, Hct and Hb (R>0.9), and relatively good correlation was observed in chloride and total carbon dioxide (R>0.7) compared to the central laboratory analysers. CONCLUSIONS: i-STAT showed relatively high precision and linearity, and comparable data to that of routine hematology and chemistry analysers. This device was concluded to have potential for providing faster results and relatively acceptable values to clinicians in need of immediate results.
Blood Glucose ; Blood Urea Nitrogen ; Carbon Dioxide ; Chemistry ; Creatinine ; Early Diagnosis ; Glucose ; Hematology ; Humans ; Nitrogen ; Point-of-Care Systems* ; Point-of-Care Testing ; Potassium ; Sodium ; Urea

BACKGROUND: Diabetes mellitus (DM) is characterized by impaired glucose regulation and various complications. It is known that chronic inflammation and platelet activation play a role in development of insulin resistance or diabetic complications. This study investigated whether hematologic parameters are useful for monitoring blood glucose regulation or complications in DM patients. METHODS: Total 90 diabetic patients were divided into two groups according to their hemoglobin A1c (HbA1c) levels: 59 regulated DM patients with HbA1c levels<7% and 31 unregulated DM patients with HbA1c levels≥7%. RESULTS: White blood cell counts (P=0.021), neutrophil counts (P=0.005), monocyte counts (P=0.040), neutrophil % (P=0.042) and the neutrophil lymphocyte ratio (NLR) (P=0.032) were significantly higher in the unregulated DM group compared to that in the regulated DM group. There were no differences in lymphocyte counts, lymphocyte %, monocyte %, mean neutrophil volume, mean monocyte volume, platelet count, and mean platelet volume between groups. Neutrophil counts and NLR were higher in unregulated DM patients with complications than in the regulated DM group. A positive correlation was observed between HbA1c and white blood cell count (r=0.389, P<0.001) and neutrophil count (r=0.361, P<0.001). CONCLUSIONS: In DM patients, neutrophil counts and NLR were related to glycemic control and the presence of complications. Additionally, neutrophil counts showed a positive correlation with HbA1c. Therefore, neutrophil counts and NLR can be used as related markers for diabetic regulation and complications during the follow-up of diabetic patients.
Blood Glucose ; Diabetes Complications ; Diabetes Mellitus ; Follow-Up Studies ; Glucose ; Humans ; Inflammation ; Insulin Resistance ; Leukocyte Count ; Lymphocyte Count ; Lymphocytes ; Mean Platelet Volume ; Monocytes ; Neutrophils ; Platelet Activation ; Platelet Count

No abstract available.
*Aneuploidy ; Bone Marrow/pathology ; Chromosomes, Human, Pair 21 ; Down Syndrome/*complications ; Female ; Humans ; Hyperplasia/pathology ; In Situ Hybridization, Fluorescence ; Infant ; Isochromosomes/*genetics ; Karyotype ; Leukemia, Megakaryoblastic, Acute/complications/*diagnosis ; Megakaryocytes/pathology