BACKGROUND: Red blood cell (RBC) sorbitol has been implicated in the pathogenesis of organic complications of diabetes mellitus. W8 investigated RBC sorbitol level as an indicator of glucose control or diabetic complications, and also evaluated whether RBC sorbitol/plasma glucose ratio is an indicator of diabetic complications. METHODS: RBC sorbitol levels were measured in 43 healthy persons and 133 diabetes mellitus (DM) patients by enzymatic method. We also tested linearity, inter- and intra- assay precisions. Plasma glucose and Hb Alc were measured by hexokinase method and HPLC, respectively. Hospital records were reviewed. RESULTS: The intra- and inter-assay coefficients of variation of RBC sorbitol test are 8.7% and 28.5%, respectively. Linearity is good. The RBC sorbitol level(3.60+/-1.00 ug/mL) and RBC sorbitol/plasma glucose ratio (2.37+/-0.98%) in diabetic patients are significantly higher than those in normal control (1.69+/-0.43 ug/mL, 1.85+/-0.49 per mill), respectively(p<0.0001). We can't observe correlation between RBC sorbitol and Hb Alc in BM patients, but observe that in non-treatment DM patients. We also observed correlation between Hb Alc and glucose and reverse correlation between RBC sorbitol ratio and Hb Alc. We can't find significant relation between diabetic complications and RBC sorbitol or RBC sorbitol/plasma glucose. CONCLUSIONS: We suggest that the reference range of normal RBC sorbitol level and RBC sorbitol/plasma glucose ratio by enzymatic method are 1.69+/-0.86 ug/mL and 1.85+/- 0.98%,. These Ire significantly different from DM patients and may be useful in diagnosis of DM.
Blood Glucose ; Chromatography, High Pressure Liquid ; Diabetes Complications ; Diabetes Mellitus* ; Diagnosis ; Erythrocytes ; Glucose ; Hexokinase ; Hospital Records ; Humans ; Reference Values ; Sorbitol*

BACKGROUND: Red blood cell (RBC) sorbitol has been implicated in the pathogenesis of organic complications of diabetes mellitus. W8 investigated RBC sorbitol level as an indicator of glucose control or diabetic complications, and also evaluated whether RBC sorbitol/plasma glucose ratio is an indicator of diabetic complications. METHODS: RBC sorbitol levels were measured in 43 healthy persons and 133 diabetes mellitus (DM) patients by enzymatic method. We also tested linearity, inter- and intra- assay precisions. Plasma glucose and Hb Alc were measured by hexokinase method and HPLC, respectively. Hospital records were reviewed. RESULTS: The intra- and inter-assay coefficients of variation of RBC sorbitol test are 8.7% and 28.5%, respectively. Linearity is good. The RBC sorbitol level(3.60+/-1.00 ug/mL) and RBC sorbitol/plasma glucose ratio (2.37+/-0.98%) in diabetic patients are significantly higher than those in normal control (1.69+/-0.43 ug/mL, 1.85+/-0.49 per mill), respectively(p<0.0001). We can't observe correlation between RBC sorbitol and Hb Alc in BM patients, but observe that in non-treatment DM patients. We also observed correlation between Hb Alc and glucose and reverse correlation between RBC sorbitol ratio and Hb Alc. We can't find significant relation between diabetic complications and RBC sorbitol or RBC sorbitol/plasma glucose. CONCLUSIONS: We suggest that the reference range of normal RBC sorbitol level and RBC sorbitol/plasma glucose ratio by enzymatic method are 1.69+/-0.86 ug/mL and 1.85+/- 0.98%,. These Ire significantly different from DM patients and may be useful in diagnosis of DM.
Blood Glucose ; Chromatography, High Pressure Liquid ; Diabetes Complications ; Diabetes Mellitus* ; Diagnosis ; Erythrocytes ; Glucose ; Hexokinase ; Hospital Records ; Humans ; Reference Values ; Sorbitol*

BACKGROUNDS: Korean "in-vitro diagnostics (IVD)" market experienced rapid growth of almost 1800 folds in 20 years from 1970's to 1990's. Until recent financial crisis of Asia, the business showed very brisk annual growth rates; more than 20% for immunoserologic tests and 10-15% for other tests. Around 80-85% of all laboratory goods are imported and 15-20% are local products. MATERIALS AND METHODS: Market analyses of the world and Korean IVD business were done with interviews and written quesionnaires. Other data used were "List of trading in medical and pharmaceutical materials" by Korea Pharmaceutical Trader's Association and "List of production in medical and pharmaceutical materials" by the Korea Phamaceutical Manufacturers Association. RESULTS: In 1996, the Korean IVD was 151.64 million US Dollars (USD). Local products were responsible for 15-20% of market and imports for 80-85%. With recent financial crisis, importance of local IVD business and its R/D activity are getting keen attention. Market share by sectors, revenue analysis of local products, revenue according to product categories, export and import figures, comparison of import and local IVD product by sectors and manufacurers by their products were done and listed. CONCLUSIONS: Market analyses would be used by laboratorians to have a better knowledge and understanding of laboratory business and by the industry to view the Korea as a emerging and stabilizng market and by researchers to focus their resources into more feasible areas.
Asia ; Commerce ; Indicators and Reagents ; Korea

Non-O1 V. cholerae usually causes endemic disease. Common clinical manifestations of this infection involve gastroenteritis, sepsis, and wound infection. In Korea, six cases of infection with this pathogen have been reported. From 1995 to 1996, non-O1 V. cholerae was isolated from blood of three patients of sepsis in this hospital. Two of them had liver cirrhosis as an underlying disease. One patient died of progressive sepsis and another two patients recovered. The isolates were identified by API 20E(API system, BioMerieux, France) and their biochemical properties were characterized. The serotypes of two isolates were determined to be O2 and O24. These cases, with the previous reports, suggest that non-O1 V. cholera should be considered as a pathogen causing septicemia in patients who have underlying disease of liver cirrhosis during summer.
Cholera ; Endemic Diseases ; Gastroenteritis ; Humans ; Korea ; Liver Cirrhosis ; Sepsis* ; Vibrio cholerae* ; Vibrio* ; Wound Infection

BACKGROUND: We evaluated the analytical performance of LC-175CRP TM (Horiba Ltd., Kyoto, Japan), an automated blood cell counter and C-reactive protein (CRP) measuring instrument, and its clinical usefulness. METHODS: LC-175CRP was evaluated for linearity, precision, and comparison using patient specimens and quality control material. Usefulness of simultaneous measurement of WBC count and CRP was analyzed using results from 114 patients with infectious or inflammatory diseases. RESULTS: LC-175CRP showed a good linearity (R(2) > or =0.98, P<0.001) and within-run and total-run CVs within 8% for all items analysed. Good correlations were found for all analyzed parameters (r > or = 0.94, P<0.001) except monocyte proportion (r=0.35, P=0.02). Among the 55 patients who showed abnormal results of either WBC or CRP, 48 patients (87.3%) showed CRP elevation alone. CONCLUSIONS: LC-175CRP is a small instrument and easy to operate, offers simultaneous, rapid measurement of blood cell count and CRP, and shows an excellent performance. It can be very useful at the emergency room or physician's office for patients suspected to have acute infections or inflammations.
Blood Cell Count* ; C-Reactive Protein* ; Emergency Service, Hospital ; Humans ; Inflammation ; Leukocyte Count ; Monocytes ; Physicians' Offices ; Quality Control

BACKGROUND: Smoking has been suggested to invoke many health problems. Nicotine, one of the effective major components of tobacco smoke, has a half-life less than 2 hours and is oxidized to its major metabolite, cotinine. This study was conducted to establish the measurement system of nicotine and cotinine by high performance liquid chromatographic method (HPLC) and to set reference range in Korean population. METHODS: Fifteen nonsmokers (25-66 years old, 37.9 average) and 30 smokers (22-63 years old, 27.9 average) were investigated. We modified the methods from Kyerenmaten, et al. and from Hariharan, et al. Urine and heparinized plasma samples were pretreated. Pretreated samples were injected into Waters u-Bondapak C18 reverse column (3.9 mm 30 cm) of Waters HPLC system unit with flow rate of 2 mL/min. Absorbance was monitored at 254 nm of wavelength. RESULTS: The retention times of the NNX (nicotine-1'-N-oxide), cotinine, and nicotine peaks were 2.9, 3.7, 5.1 min, respectively, and readily delayed with increase of pH in the mobile phase. Nicotine and cotinine levels in plasma and urine samples by a modified HPLC method showed high linearity from 0 to 1000 ng/mL for both compounds. Intra- and inter-assay coefficients of variation were 7.49% and 6.54%, respectively for nicotine assay and 5.71% and 14.20%, respectively for cotinine assay. The averages and standard deviations for plasma cotinine, nicotine, urine cotinine, and nicotine in nonsmokers (N=15) were 277.8+/-313.9, 0.7+/-2.4, 382.0+/-273.7, and 17.2+/-27.5 ng/mL, respectively, and in smokers (N=30) were 312.9+/-267.1, 26.3+/-50.1, 1,049.2+/-556.2, and 555.7+/-895.1 ng/mL, respectively (P=0.351, 0.009, 0.0026, 0.000004). CONCLUSIONS: A modified HPLC method for nicotine and cotinine measurement showed a high precision and accuracy. Nicotine and cotinine levels in plasma and urine samples of smokers were significantly higher than those of non-smokers, except for plasma cotinine in passive smokers of nonsmoker group. And this method can be used as a routine test for detection of passive smoking and managing of smoking habit. Reference values of nicotine and cotinine measured in Korean nonsmokers and smokers were suggested.
Chromatography, High Pressure Liquid ; Cotinine ; Half-Life ; Heparin ; Hydrogen-Ion Concentration ; Nicotine* ; Plasma* ; Reference Values ; Smoke ; Smoking ; Tobacco Smoke Pollution ; Tobacco*

Despite efforts to control the spread of malaria, the disease persists in certain parts of the world. Moreover, there has been a resurgence of the disease recently. Another protozoan disease, babesiosis is a disease of animals; Humans are infected only incidentally, and when they are infected, they develop a nonspecific febrile illness. Babesia organism enters red blood cells and resembles malaria parasites, thus posing a problem in the differential diagnosis. We encountered an imported case of mixed infection of malaria and babesia. The patient was a 20-year old Korean male who had been in Saong-dume near Gabon for 3 months. We treated him with chloroquine with the diagnosis of Plasmodium malariae infection, but fever recurred after 2 weeks of the treatment. The second peripheral blood smear findings revealed specific ring forms of Babesia spp, so we changed to quinine and clindamycin. The treatment was successful and the patient was well after 4 months of follow-up period.
Animals ; Babesia* ; Babesiosis ; Chloroquine ; Clindamycin ; Coinfection* ; Diagnosis ; Diagnosis, Differential ; Erythrocytes ; Fever ; Follow-Up Studies ; Gabon ; Humans ; Malaria* ; Male ; Parasites ; Plasmodium malariae ; Quinine ; Young Adult

BACKGROUND/AIMS: In multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods. METHODS: We chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laboratories. Twenty serum samples for each analyte were prepared, sent frozen, and analyzed by each participating laboratory. RESULTS: All methods used by participating laboratories for the six analytes had traceability by reference materials and methods. When the results from the nine laboratories were compared with those from GC Labs, the mean CVs for total cholesterol, HDL-C, LDL-C, and glucose analyzed using the same method were 1.7%, 3.7%, 4.3%, and 1.7%, respectively; and those for triglycerides and creatinine analyzed using two different methods were 4.5% and 4.48%, respectively. After adjusting data using Deming regression, the mean CV were 0.7%, 1.4%, 1.8%, 1.4%, 1.6%, and 0.8% for total cholesterol, HDL-C, LDL-C, triglyceride, creatinine, and glucose, respectively. CONCLUSIONS: We found that more comparable results can be produced by laboratory data harmonization using commutable samples. Therefore, harmonization efforts should be undertaken in multicenter trials for accurate data analysis (CRIS number; KCT0001235).
Cholesterol ; Cholesterol, HDL ; Cholesterol, LDL ; Creatinine ; Glucose ; Humans ; Methods ; Multicenter Studies as Topic ; Research Design* ; Statistics as Topic ; Triglycerides

BACKGROUND: The sensitivity and specificity of tumor markers for detecting cancer could be significantly changed by the reference intervals of tumor markers. We established reference intervals of tumor markers in Korean adults and evaluated its importance, since the reference intervals recommended by the manufacturers were determined in the Caucasian population and have sometimes been adopted without verification. METHODS: We established the reference intervals of alpha fetoprotein (AFP), carcinoembryonic antigen (CEA), cancer antigen (CA)125, carbohydrate antigen (CA)19-9, total prostate specific antigen (TPSA), cytokeratin fragment (Cyfra)21-1, and neuron specific enolase (NSE) according to the CLSI guideline in a maximum number of 1,364 healthy adults aged 20-60 yrs who visited a health promotion center from January to February 2007. RESULTS: Reference intervals of all tumor markers except for AFP were not in agreement with those recommended by the manufacturers. Reference intervals of CEA, TPSA, CA19-9, CA125, and Cyfra21-1 were age dependent. The mean reference values of NSE, CA125, and CEA were statistically different according to gender (11.72 vs 10.78 ng/mL), menopause status (18.89 vs 12.62 U/mL), and smoking status (2.60 vs 2.12 vs 1.80 ng/mL for smokers, past smokers, and non-smokers, respectively),respectively. CONCLUSIONS: With the verification and establishment of reference intervals of tumor markers in a Korean local population, we found the reference intervals significantly different by either age, gender, smoking or menopause status.
Adult ; Age Factors ; Carcinoembryonic Antigen/analysis ; Female ; Humans ; Korea ; Male ; Menopause ; Middle Aged ; Phosphopyruvate Hydratase/analysis ; Prostate-Specific Antigen/analysis ; Questionnaires ; Reagent Kits, Diagnostic ; Reference Values ; Sex Factors ; Smoking ; Tumor Markers, Biological/*standards ; alpha-Fetoproteins/analysis

BACKGROUND: The use of point-of-care (POC) devices for evaluating HbA1c is increasing; accordingly, comparisons between these devices and central laboratory methods are important. In the present study, we evaluated the analytical performance of the cobas b 101 analyzer for POC HbA1c testing. METHODS: The analytical quality of the cobas b 101 system was assessed based on repeatability, within-laboratory precision, linearity, and lot-to-lot reproducibility. Two specimen types, i.e., EDTA whole blood and capillary blood, were examined using the cobas b 101 system and the Variant II Turbo instrument. RESULTS: The coefficient of variation for within laboratory precision was 5.22% for a normal HbA1c level and 2.56% for a higher HbA1c level. The method showed good linearity, with a coefficient of correlation of 0.990. In a comparison of two different HbA1c disk lots, a strong correlation (r=0.986) and a mean %difference of −2.9% were observed. The cobas b 101 results using EDTA whole blood were strongly correlated with the Variant II Turbo results (r=0.958), with a mean %difference of 0.8%; the cobas b 101 results using capillary blood were strongly correlated with the Variant II Turbo results, using EDTA whole blood (r=0.976), with a mean %difference of 2.0%. A comparison between HbA1c levels in EDTA whole blood and capillary blood obtained using the cobas b 101 showed a strong correlation (r=0.985) and a mean %difference of 1.3%. CONCLUSIONS: The cobas b 101 analyzer is convenient for the measurement of HbA1c levels for diabetes management.
Capillaries ; Edetic Acid ; Methods ; Point-of-Care Systems* ; Point-of-Care Testing*