From the perspective of technical review, this paper made statistics on the supplement contents of
Chemistry, Clinical/standards* ; China ; Indicators and Reagents ; Reagent Kits, Diagnostic/standards*

Clinical and Laboratory Standard Institute's guidelines. Test results from clinical samples were compared between Tosoh G11 and the routine testing systems, Tosoh G8 and Capillarys 2 Flex Piercing.RESULTS: With respect to the precision of Tosoh G11, the test results for low- and high-concentration controls showed a coefficient of variation of less than 1.1%. Furthermore, the new device exhibited good linearity for HbA(1c) values ranging from 3.4% to 18.8%, and carry-over was not observed. HbA(1c) results for Tosoh G11 (N=143) correlated well with those for Tosoh G8 (r=0.9971) and Capillarys 2 Flex Piercing (r=0.9918).CONCLUSIONS: Tosoh G11 demonstrated reliable analytical performance with good precision and linearity, and no carry-over results. In addition, its results were comparable to those of the existing instruments. Thus, the results of this evaluation suggest that Tosoh G11 is suitable for the routine diagnostic testing of HbA(1c) levels in clinical chemistry laboratories.]]>
Chemistry, Clinical ; Diagnostic Tests, Routine ; Hemoglobin A, Glycosylated ; Humans

No abstract available.
Chemistry, Clinical ; Clinical Chemistry Tests ; Methods

The Clinical Mass Spectrometry Research Committee (CMSRC), in affiliation with the Korean Society of Clinical Chemistry (KSCC), conducted a questionnaire survey on opinions about the general status of clinical mass spectrometric analysis in Korea. As a result, we understand that this field has passed through the introductory stage and is settled as a field of clinical laboratory testing in Korea, with the number of new laboratories performing mass spectrometric analysis being low. In spite of the many difficulties in introducing and operating clinical mass spectrometric analysis, there is a strong interest in this field, and even though further expansion is expected, there are still many issues to be resolved. In the future, it will be necessary to make concrete and thorough efforts to further develop the laboratory tests using clinical mass spectrometric analysis in Korea, centering on the CMSRC affiliated with the KSCC.
Chemistry, Clinical ; Korea ; Mass Spectrometry

An observational study was conducted at the Section of Clinical Chemistry, Department of Pathology and Laboratory Medicine, to assess the iodine status using the World Health Organization (WHO), United Nations International Children's Emergency Fund (UNICEF), and the International Council for Control of Iodine Deficiency Disorders (ICCIDD) consensus criteria, which state that >3% prevalence of serum thyroid stimulating hormone (TSH) ≥10 mIU/L in the population is an indicator of iodine deficiency. Serum neonatal TSH was analyzed from January to December 2013. In a period of one year, a total of 11,597 neonates with the mean (25 percentile, 75 percentile value) age of 2.0 days (0.5–3.5) were tested for serum TSH. The overall mean TSH level was 3.38 mIU/L (5.63–1.96), with optimal levels (1–39 mIU/L) in 93%, <1 mIU/L in 6.3%, and ≥40 mIU/L in 0.3% neonates. Of all the neonates, 7.9% (N=916) showed TSH ≥10 mIU/L which is higher than the recommended WHO/UNICEF/ICCIDD criteria for mild endemicity for iodine deficiency in the population. These results suggest that iodine deficiency is still prevalent in our population, indicating a need for effective intervention programs and increasing awareness regarding the use of iodized salt and supplementation in all reproductive-aged women to prevent iodine deficiency in neonates.
Chemistry, Clinical ; Congenital Hypothyroidism ; Consensus ; Emergencies ; Female ; Financial Management ; Humans ; Infant, Newborn ; Iodine ; Observational Study ; Pathology ; Prevalence ; Thyrotropin ; United Nations ; World Health Organization

BACKGROUND: Although the same equipment and reagents can be employed for inspecting identical samples, the setting and verification methods for the corresponding reference intervals differ from each other, and such methods are not well established. To address the issues associated with establishing and validating reference intervals, a Web-based application is proposed for collaboratively setting reference intervals. METHODS: A Web application was designed for automatically providing the statistical results associated with a reference interval upon receiving the corresponding test results from participating institutions and incorporating the cumulative data. RESULTS: By employing the proposed Web-based application (www.referencerange.org), reference intervals can be collaboratively set based on objective and statistical analyses incorporating clinical chemistry results obtained from Korea Healthcare Association in the years 2016 and 2017. Cumulative data obtained from the existing input peer group associated with an inspection are updated in real time, and the current set reference interval is displayed in real time. CONCLUSIONS: In this study, a Web-based application is designed for collaboratively setting reference intervals whereby all Korean laboratories can easily participate, collectively set reference intervals, and apply the set reference intervals. Hence, the proposed application can aid in providing basic data associated with health information.
Chemistry, Clinical ; Delivery of Health Care ; Indicators and Reagents ; Korea ; Peer Group

β-Glucosidase activity assays constitute an important indicator for the early diagnosis of neonatal necrotizing enterocolitis and qualitative changes in medicinal plants. The drawbacks of the existing methods are high consumption of both time and reagents, complexity in operation, and requirement of expensive instruments and highly trained personnel. The present study provides a simplified, highly selective, and miniaturized glucometer-based strategy for the detection of β-glucosidase activity. Single-factor experiments showed that optimum β-glucosidase activity was exhibited at 50 °C and pH 5.0 in a citric acid-sodium citrate buffer when reacting with 0.03 g/mL salicin for 30 min. The procedure for detection was simplified without the need of a chromogenic reaction. Validation of the analytical method demonstrated that the accuracy, precision, repeatability, stability, and durability were good. The linear ranges of β-glucosidase in a buffer solution and rat serum were 0.0873-1.5498 U/mL and 0.4076-2.9019 U/mL, respectively. The proposed method was free from interference from β-dextranase, snailase, β-galactosidase, hemicellulase, and glucuronic acid released by baicalin. This demonstrated that the proposed assay had a higher selectivity than the conventional dinitrosalicylic acid (DNS) assay because of the specificity for salicin and unique recognition of glucose by a personal glucose meter. Miniaturization of the method resulted in a microassay for β-glucosidase activity. The easy-to-operate method was successfully used to detect a series of β-glucosidases extracted from bitter almonds and cultured by Aspergillus niger. In addition, the simplified and miniaturized glucometer-based assay has potential application in the point-of-care testing of β-glucosidase in many fields, including medical diagnostics, food safety, and environmental monitoring.
Animals ; Aspergillus niger ; Calibration ; Cellulase/analysis* ; Chemistry, Clinical/methods* ; Dextranase/analysis* ; Enterocolitis, Necrotizing/diagnosis* ; Equipment Design ; Flavonoids/analysis* ; Glucose/analysis* ; Glucuronic Acid/analysis* ; Glucuronidase/analysis* ; Glycoside Hydrolases/analysis* ; Hydrogen-Ion Concentration ; Linear Models ; Multienzyme Complexes/analysis* ; Plants, Medicinal ; Polygalacturonase/analysis* ; Rats ; Reproducibility of Results ; beta-Galactosidase/analysis* ; beta-Glucosidase/analysis*

A fixed-dose combination tablet of benazepril and pimobendan (Fortekor Plus; Elanco Animal Health) was tested in dogs with congestive heart failure (CHF) caused by myxomatous mitral valve disease (MMVD) in a three-arm, masked, randomized, non-inferiority clinical trial in Japan. The test group (n = 34) received Fortekor Plus twice daily. Two control groups received registered formulations of benazepril (Fortekor; Elanco Animal Health) and pimobendan (Vetmedin; Boehringer Ingelheim Vetmedica) with administration of Vetmedin twice daily and Fortekor twice (Control I, n = 14) or once (Control II, n = 19) daily. Diuretics were used in 22 dogs (32.8%). Global clinical scores decreased significantly from baseline in all groups; there were no significant differences between groups, and non-inferiority of Fortekor Plus compared to Control I, Control II, and combined Control I + II groups was demonstrated. There were no significant differences between groups for relevant clinical chemistry and hematology variables or frequency of all adverse events. Frequency of emesis was significantly (p = 0.0042) lower in the Fortekor Plus (8.8%) group than in the Control I + II (39.4%) group. In conclusion, Fortekor Plus had non-inferior efficacy and was associated with significantly less emesis compared to Fortekor and Vetmedin in dogs with CHF caused by MMVD.
Animals ; Chemistry, Clinical ; Diuretics ; Dogs ; Estrogens, Conjugated (USP) ; Heart Failure ; Hematology ; Japan ; Masks ; Mitral Valve ; Vomiting

High oxygen-affinity hemoglobin (Hb) variants and a 2,3-diphosphoglycerate (2,3-DPG) deficiency could cause congenital (familial) erythrocytosis. High oxygen-affinity Hb variants and a 2,3-DPG deficiency might result in low tissue oxygen tension left-shifted oxygen dissociation curves and reduction in the standard P₅₀ value (P(50,std), oxygen tension at which haemoglobin is 50% saturated). Hence, the P(50,std) value is considered while formulating diagnostic strategies for erythrocytosis. In this study, we established a reference range for P(50,std) using an International Federation of Clinical Chemistry and Laboratory Medicine-approved equation (Hill's equation) for individual single venous/arterial blood samples. Blood gas analysis results of 243 samples with oxygen saturation ranging from 40%–90% (Hb < 16 mg/dL) were selected. The reference range of P(50,std) was in the 2.5th–97.5th percentile, and was 25.9–27.3 mm Hg. Hill's equation is a simple approved method for evaluating the P(50,std) values. Only a single sample of venous or arterial blood and a blood gas analyser are required to obtain the P(50,std). Our study provides a useful tool for the diagnostic work-up of patients with erythrocytosis.
2,3-Diphosphoglycerate ; Blood Gas Analysis ; Chemistry, Clinical ; Humans ; Methods ; Oxygen ; Polycythemia* ; Reference Values

In 2017, the clinical chemistry proficiency testing program consisted of 24 programs with the addition of the urine chemistry program in the Korean Association of External Quality Assessment Service. The routine chemistry program consisted of 32 test items, including osmolality, total CO2, and estimated glomerular filtration rate tests, and the urine chemistry program consisted of 12 test items, including the albumin test. Based on the information and results of each test item entered by each institution, statistical analysis data according to test method, instrument, and reagent were reported. The statistics included the number of participating institutions, mean, standard deviation, coefficient of variation, median, minimum, and maximum values for each group. Each report was composed of a table, histogram, Levy-Jennings chart, and standard deviation index showing statistics by each test item. A total of 14 items, including albumin, were evaluated by more than 1,000 institutions, and the number of participating institutions is continuously increasing. The coefficient of variation tended to increase, as the concentration of the control material was lower for each test item. Most of them showed a coefficient of variation within 10%. Alkaline phosphatase and lactate dehydrogenase were found to have high coefficients of variation due to differences in measurement values between measurement methods. The distribution of measurement methods in general chemistry test items was not significantly different from that of previous years, and the distribution of measurement methods for albumin, glucose, phosphorus, and protein among the urine chemistry program was different from that of the routine chemistry program.
Alkaline Phosphatase ; Chemistry* ; Chemistry, Clinical ; Glomerular Filtration Rate ; Glucose ; Korea* ; L-Lactate Dehydrogenase ; Methods ; Osmolar Concentration ; Phosphorus