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

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

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

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: CEDIA is a newly developed method for therapeutic drug monitoring (TDM) and has some merits such as easy application to routine chemical analyzers, rapid and precise quantitation even in low concentrations and less cross reactivity. We evaluated the CEDIA(epsilon) (Microgenics Co., CA, USA) in measurement of theophyllin, valproic acid and phenytoin levels using 502X(epsilon) (A & T, Tokyo, Japan) and compared the results to those of the TDx(epsilon) (Abbott Laboratories, IL, USA) in order to assess the utility of the CEDIA(epsilon). METHODS: We evaluated the performance of 502X(epsilon) in the aspects of the within-runs and the between-runs precision, linearity, and carry-over. We compared the results of the CEDIA(epsilon) reagent with those of TDx(epsilon). The control materials (Bio-Rad TDM control level 1 and level 3; Bio-Rad laboratories, CA, USA) and clinical specimens were used for these studies. RESULTS: The coefficients of variation (CV) for the within-run and the between-run imprecision of 502X(epsilon) were 2.0-7.6% and 4.0-6.5%, respectively. The carry-over rate for theophyllin, valproic acid and phenytoin was 1.33%, 0.45% and 0.53%, respectively. The linearity (r(2)) of theophyllin, valproic acid and phenytoin was 0.9941, 0.9983 and 0.9947, respectively. The correlation coefficients (r) of theophyllin, valproic acid and phenytoin levels of CEDIA(epsilon), with those determined by the TDx(epsilon), were 0.9730, 0.9703 and 0.9695, respectively (P<0.001). CONCLUSIONS: The recentlydeveloped CEDIA(epsilon) proved to be highly precise and linear for quantitative analysis of theophyllin, phenytoin and valproic acid. Correlations with TDx(epsilon) were significantly high. CEDIA(epsilon) was thought to be clinically useful for TDM.
Drug Monitoring ; Phenytoin* ; Theophylline* ; Valproic Acid*

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

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: Fecal occult blood tests have been widely used as a means of gastrointestinal bleeding and colorectal cancer screening. HM-JACKarc (Kyowa Medex Co. Ltd, Japan) is a recently introduced automated fecal occult blood test analyser, which uses latex agglutination method. We evaluated the analytical performance of HM-JACKarc. METHODS: The linearity and precision for HM-JACKarc were evaluated according to the corresponding Clinical and Laboratory Standard Institute guidelines. The comparison study between HM-JACKarc and OC-SENSOR DIANA (Eiken Chemical Co. Ltd., Japan) was done with stool specimens. RESULTS: The linearity was good (R²=0.999) and the coefficients of variation of within-day precision and between-day precision were 5.2% and 4.9%, respectively, in low concentration and 2.7% each in high concentration. The concordance rate between HM-JACKarc and OCSENSOR DIANA was 99.0% (198 out of 200). CONCLUSIONS: HM-JACKarc showed excellent performance in linearity, precision, and comparison studies. Therefore, it appears to be a useful automated fecal occult blood test analyser.
Agglutination ; Colorectal Neoplasms ; Hemorrhage ; Latex ; Mass Screening ; Methods ; Occult Blood*