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*

In 2018, external quality assessment trials for urinalysis and fecal occult blood (FOB) were performed using 1,590 participants. Urine chemistry tests were performed thrice while urine sediment and FOB tests twice. Urine chemistry tests comprised of pH, protein, glucose, ketone body, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity analyses. The results of urine chemistry and specific gravity tests showed accuracy rates >95%, except for the pH test. The accuracy rate of urine sediments was low, especially for atypical calcium oxalate crystal and red blood cell cast. In the FOB quality test, reagents showed accuracy rates >90%, except for SD and GC Genedia FOB reagents. In the FOB quantitative test, Alfresa NS-Plus C instrument showed falsely high values in the FOB negative specimens.
Bilirubin ; Calcium Oxalate ; Chemistry ; Erythrocytes ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Leukocytes ; Occult Blood ; Quality Control ; Specific Gravity ; Urinalysis ; Urobilinogen

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

In 2017, external quality assessment trials for urinalysis and fecal occult blood (FOB) were performed with 1,544 participants. Urine chemistry tests were performed three times and urine sediment and FOB tests were evaluated 2 times. Urine chemistry tests consisted of pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity analyses. The results of the urine chemistry and specific gravity tests showed accuracy rates >95%. The accuracy rate of urine sediments was low, especially for fat droplets and atypical uric acid crystals. In the FOB quality test, all reagents showed accuracy rates >82%, which suggested the persistent improvement of false-positive reactions. In the FOB quantitative test, discrepant results depending on the instrument used were observed. To compensate for the result differences caused by the amounts of stool samples, the results should be reported using another unit (µg/g of stool).
Bilirubin ; Chemistry ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Korea* ; Leukocytes ; Occult Blood* ; Quality Control ; Specific Gravity ; Uric Acid ; Urinalysis* ; Urobilinogen

BACKGROUND: To understand causes of abnormal reaction for the urinalysis, we analyze the interfering substances of clinical urine samples. We focused the effect of urinary vitamin C and fluorescein sodium to the urine chemistry especially glucose, hemoglobin, and leukocyte esterase. METHODS: Incidence of urinary vitamin C was determined for patients and people underwent a medical check–up. We decided dipstick results of glucose, hemoglobin, and leukocyte esterase as false negative based on urine sediment and serum glucose results. Dipstick urinalysis was tested by URiSCAN Pro III with URiSCAN 11 strip (YD Diagnostics, Korea). Urine sediments tests were performed by manual microscopic analysis or Sysmex UF–1000i (Sysmex Co., Japan). RESULTS: The incidence of vitamin C was 20.4% for all subjects. The positive rate of the medical check-up group (34.6%) was higher than others. When vitamin C was detected in clinical urine samples, 42.3%, 10.6%, and 8.2% were defined as false negative for glucose, hemoglobin, and leukocyte esterase dipstick tests, respectively. Fluorescein sodium also interfered on the results of hemoglobin and leukocyte esterase of the dipstick reagents. CONCLUSIONS: Vitamin C was frequently found in the clinical urine samples, and its incidence was higher in the people who underwent medical check-up. The urinary vitamin C and fluorescein sodium can cause interferences in urine dipstick results. Thus, it is expected that present study will give useful information to predict false negative rates of urine dipstick tests by vitamin C and fluorescein sodium.
Ascorbic Acid ; Blood Glucose ; Chemistry ; Fluorescein ; Glucose ; Humans ; Incidence ; Indicators and Reagents ; Leukocytes ; Urinalysis*

BACKGROUND: JEOL BioMajesty JCA-BM6010/C (JCA-BM6010/C, JEOL Ltd., Japan) is a recently developed ultra-compact automated clinical chemistry analyzer with a throughput of 1,200 tests per hour. Here, we present the first performance evaluation of JCA-BM6010/C. METHODS: We evaluated the precision, linearity, correlation, accuracy, and carryover of 11 analytes (ALP, ALT, AST, calcium, creatinine, GGT, glucose, LDH, total bilirubin, total protein, and uric acid) using the JEOL closed reagent (JEOL Ltd.) according to the guidelines of the Clinical Laboratory Standards Institute. Linearity was further evaluated for ALT, AST, and GGT using open reagents by Sekisui (Japan). The performance of JCA-BM6010/C was compared to that of the Roche-Hitachi Cobas 8000 c702 chemistry autoanalyzer (Cobas 8000, Roche Diagnostics, Switzerland). Its performance using open reagents from Denka Seiken (Japan), Roche, and Sekisui was also evaluated. RESULTS: The total coefficients of variation (CV) for all analytes were 1.0–2.7%. Linearity was observed for all analytes over the entire tested analytical range (R²≥0.99). The results of JCA-BM6010/C strongly correlated (r≥0.988) with those of Cobas 8000 for all evaluated analytes except LDH (r=0.963), as well as for all open reagents. Recovery rates for creatinine, glucose, calcium, and uric acid were 96.6–101.5% and 98.7–109.3% with the JEOL exclusive and open reagents, respectively. Sample carryover was less than 0.34%. CONCLUSIONS: JCA-BM6010/C showed acceptable performance in the precision, linearity, correlation, accuracy, and sample carryover analyses and in the method comparison. Therefore, it could be a useful routine laboratory medical analyzer.
Bilirubin ; Calcium ; Chemistry ; Chemistry, Clinical* ; Creatinine ; Glucose ; Indicators and Reagents ; Methods ; Uric Acid

In 2016, external quality assessment trials for urinalysis and faecal occult blood (FOB) were performed with 1,487 participants in Korea. Urine chemistry and FOB tests were performed three and two times, respectively, whereas urine sediment was evaluated once using photography. Urine chemistry tests consisted of pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, and nitrite levels; leukocyte count; specific gravity. The results of the urine chemistry and specific gravity tests showed accuracy rates of >95%. The accuracy rate of urine sediments was low, especially that for transitional epithelial cells and atypical crystals. In the FOB quality test, all reagents showed accuracy rates of >90%, which suggested the improvement of false-positive reaction. In the FOB quantitative test, discrepant results depending on the instrument used was observed. To compensate for the result differences caused by the stool samples, the results should be reported using another unit (µg/g of stool).
Bilirubin ; Chemistry ; Epithelial Cells ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Korea* ; Leukocyte Count ; Occult Blood* ; Photography ; Specific Gravity ; Urinalysis* ; Urobilinogen

In Korea, external quality assessment trials for urinalysis and faecal occult blood (FOB) were performed for 1,250 participants. Urine chemistry and FOB tests were evaluated three times, whereas urine sediment by photography was evaluated twice. Urine chemistry tests consisted those for pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity. The results of the urine chemistry and specific gravity tests showed accuracy rates >95%. In the FOB quality test, all reagents showed false-positive results. These reagents showed positive results in stool specimens containing >11 ng/mL haemoglobin. In the FOB quantitative test, the results were significantly different, based on the instrument used for the measurements. The average accuracy rate of urine sediments was 90.8%, whereas those for renal epithelial cells and cholesterol crystals were 83%.
Bilirubin ; Chemistry ; Cholesterol ; Epithelial Cells ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Korea* ; Leukocytes ; Occult Blood* ; Photography ; Specific Gravity ; Urinalysis* ; Urobilinogen

OBJECTIVETo compare the efficiency and cytotoxicity of different transfection reagents used in transfection of RIP140-siRNA into Kupffer cells to optimize the transfection conditions.

METHODSKupffer cells were transfected with RIP140-siRNA labeled with GFP as the reporter gene using lipofectamine 2000, Roche reagent (X-treme GENE siRNA Transfection Reagent) and puro screening lentivirus (1.0×10(8) TU/mL) as the transfection reagents. The transfection effect was observed under a fluorescent inverted microscope, and laser scanning confocal microscopy was used to analyze RIP140 expression in trasnfected Kupffer cells. Flow cytometry was performed to detect cell apoptosis, and CCK-8 test was used to evaluate the cell proliferation inhibition. RT-RCR and Western blotting were performed to detect the expressions of RIP140 mRNA and protein in the trasnfected cells.

RESULTSPuro screening lentivirus yielded the highest cell transfection efficiency, which exceeded 90%, followed by Roche reagent and then by lipofectamine 2000. Flow cytometry and CCK-8 test showed that the cytotoxicity was the mildest with Roche reagent, moderate with lentivirus, and severe with lipofectamine 2000. The cells trasnfected with lentivirus showed a significantly lower RIP140 expression than cells trasnfected with lipofectamine 2000 and Roche reagent (P<0.05).

CONCLUSIONIn Kupffer cells, lentivirus-mediated transfection, as compared with the other two trasnfection reagents, can achieve good transfection efficiency with a relativelty low cytotoxicity, and allows for better controllability and stability of the trasnfectiion conditions.

Adaptor Proteins, Signal Transducing ; genetics ; Apoptosis ; Cell Proliferation ; Flow Cytometry ; Humans ; Indicators and Reagents ; chemistry ; Kupffer Cells ; drug effects ; Lentivirus ; Lipids ; chemistry ; Nuclear Proteins ; genetics ; RNA, Messenger ; RNA, Small Interfering ; genetics ; Transfection

OBJECTIVETo develop a simple, rapid and sensitive colorimetric reverse-transcription loop-mediated isothermal amplification (RT-LAMP) for rapid detection of coxsackievirus A6 (CV-A6) based on the colour chang of hydroxy naphthol blue (HNB).

METHODSThe method employed a set of six primers that recognized sequences of VP1 gene for amplification of nucleic acid under isothermal conditions at 63 °C for 50 min. The products were detected through visual inspection of color change by the pre-addition of HNB dye. The specificity was validated by detecting a collection of different human enteroviruses. The sensitivity of this assay was evaluated by serial dilutions of RNA molecules from in vitro transcription of CV-A6 VP1 gene, and compared with real-time RT-PCR (rRT-PCR) in parallel. This assay was evaluated with 92 clinical specimens from patients with hand-foot-mouth disease.

RESULTSA positive color (sky blue) was only observed in the preparation of CV-A6, whereas none of the other 23 kinds of human enteroviruses showed a color change. The HNB based RT-LAMP showed a sensitivity of 100 copies/reaction, which was at the same level as that of the rRT-PCR. The result of RT-LAMP in analysis of 92 clinical specimens was consistent with that of the rRT-PCR. The kappa correlation between the two methods was 1 and both of the sensitivity and specificity of the RT-LAMP assay were 100%.

CONCLUSIONThe established RT-LAMP assay had good specificity and sensitivity and thus demonstrated to be a promising screening tool for CV-A6 infection. It also has the potential to be used in resource-limited clinical sites and field study.

Colorimetry ; Coloring Agents ; chemistry ; DNA Primers ; Enterovirus ; isolation & purification ; Hand, Foot and Mouth Disease ; virology ; Humans ; Indicators and Reagents ; chemistry ; Naphthalenesulfonates ; chemistry ; Nucleic Acid Amplification Techniques ; Real-Time Polymerase Chain Reaction ; Reverse Transcription ; Sensitivity and Specificity