Determination of urinary iodine by catalytic spectrophotometry using discrete chemical analyzer / 中华地方病学杂志

Objective To establish a method for quantitative detection of urine iodine by catalytic spectrophotometry using discrete chemical analyzer.Methods After digestion of urine samples,discrete chemical analyzer was used to control the reaction temperature and time,determine the iodine content,which replaced the urine iodine arsenic cerium catalytic spectrophotometry (standard method) after sample digestion in the testing process,and the linear range,detection limit,precision and accuracy of the method were tested.The method was used to detect the urine iodine and the results were compared with the standard method.Results The urinary iodine was in a linear range of 0-1 000 μg/L,correlation coefficient r =-0.999 7.The detection limit of the method was 4.5 μg/L.Precision:the relative standard deviation (RSD) of urine iodine samples with high,medium,and low concentrations were all ＜ 5％.Accuracy:the contents of urinary iodine in reference materials at high,medium,and low concentrations were within their respective given value ranges.No statistical significant was found in the urinary iodine content detected either by this method or the standard method (t =0.643 8,P ＞ 0.05).Conclusion Catalytic spectrophotometry using discrete chemical analyzer is succeessfully established,this method is simple,rapid,accurate and easy to operate.

Combination of urine sediment quantitative analyzer and urine dry chemistry analyzer in detection of urine cell / 国际检验医学杂志

Objective To evaluate the efficacy of IQ200 urine sediment quantitative analyzer(IQ200) and Mejer700 urine dry chemistry analyzer(Mejer700) in detecting urine erythrocyte(RBC)and leukocyte(WBC) .Methods The WBC and RBC in 1 000 u‐rine specimens were detected by using IQ200 ,Mejer700 and sediment microscopy respectively .Taking sediment microscopy as the golden standard ,the sensitivity ,specificity and accuracy of IQ200 and Mejer700 in detecting urine RBC and WBC were analysed .Re‐sults No statistically significant differences of positive rates of RBC and WBC detected by using the three methods were found (P>0 .05) .When IQ200 and Mejer700 were combined ,the sensitivities of detection of RBC and WBC test were improved .Conclu‐sion The sensitivities of RBC and WBC detection by using IQ200 and Mejer700 are high .Combing the two methods the sensitivity and accuracy is higher ,which could improve work efficiency .Combination of the three methods should be recommended ,in order to improve the quality of urine analysis .

Study on consistency of urinary sediment analyzer,urine dry chemistry analyzer and optical microscope in detecting urine erythrocyte / 国际检验医学杂志

Objective To analyze the consistency of the SYSMEX UF1000i automatic urinary sediment analyzer,Arkray AX-4030 urine dry chemistry analyzer and optical microscope in detecting urine erythrocyte.Methods The fresh urine specimens from 427 patients were randomly extracted and tested by the SYSMEX UF1000i automatic urinary sediment analyzer,urine dry chemistry analyzer and OLUMPUS Arkray AX-4030 optical microscope.Then the consistency of the results for detecting urine erythrocyte was compared among three kinds of detection method.Results With the microscopic examination as control,the sensitivity and spe-cificity of the SYSMEX UF1000i automatic urinary sediment analyzer for detecting urine erythrocyte were 82.84% and 86.35% re-spectively,which of the Arkray AX-4030 urine dry chemistry analyzer were 89.55% and 83.96% respectively.There was a high consistency between the SYSMEX UF1000i automatic urinary sediment analyzer and the optical microscope for detecting urine e-rythrocyte and the Kappa value was 0.580.There was also a high consistency between the Arkray AX-4030 urine dry chemistry analyzer and the optical microscope for detecting urine erythrocyte and the Kappa value was 0.625,while the consistency between the SYSMEX UF1000i automatic urinary sediment analyzer and the Arkray AX-4030 urine dry chemistry analyzer was weaker and the Kappa value was 0.324.Conclusion With the detection by the SYSMEX UF1000i automatic urinary sediment analyzer and the Arkray AX-4030 urine dry chemistry analyzer as a screening test,it should need to combine with the optical microscopy to conduct recheck for providing the effective and reliable test results quickly and accurately.

Performance Evaluation of Beckman Coulter AU5822 Automated Clinical Chemistry Analyzer

BACKGROUND: AU5822 Automated Clinical Chemistry Analyzer (Beckman Coulter, USA) is a fully automated analytical platform designed for the analysis of general chemistry, specific serologic proteins, therapeutic drug monitoring, and drug abuse testing. AU5822 is a high-throughput system that can process up to 5,800 tests per hour and is easy to maintain. In this study, we evaluated the performance of AU5822 on 31 analytes. METHODS: The precision, linearity, correlation, and sample carryover of 31 analytes were evaluated in accordance with the guidelines of the Clinical Laboratory Standards Institute (CLSI). Lyphochek (Bio-Rad Laboratories Inc., USA), Liquichek (Bio-Rad Laboratories Inc.), Validate (Marine Standard Company, USA), and patient sera were used in the analysis. For the correlation study, we carried out a comparison of AU5822 and Cobas 8000 Modular Analyzer (Roche, Switzerland). RESULTS: The coefficients of variation of all samples showed values below 5%. The coefficient of determination (R2) was > or =0.99, with linearity in the clinically important range. The comparison with Cobas 8000 showed a good correlation, with a correlation coefficient of >0.975 for all of the analytes, excluding sodium that had a correlation coefficient of 0.9641. The test values of percentage sample carryover were less than 0.89%. CONCLUSIONS: AU5822 performed well in terms of precision, linearity, comparison, and sample carryover in the established assays for 31 analytes. Therefore, Beckman Coulter AU5822 Automated Clinical Chemistry Analyzer is expected to be useful for routine chemistry analysis in hospitals with large test volumes.

Evaluation of the CS-6400 Automated Chemistry Analyzer / 임상검사와정도관리

BACKGROUND: Analyzing large numbers of specimens in a short time and generating accurate results while minimizing costs are critical to laboratory tests. The CS-6400 (Dong-A Dirui, China), an automated chemistry analyzer, has been recently developed in China in collaboration with domestic corporations. To assess the performance and usability of the analyzer, we evaluated its analytical performance and clinical usefulness including accuracy and linearity of electrolytes and chemistry tests using HiSens reagent (HBI Co., Korea) with protocols provided by the Clinical and Laboratory Standards Institute, and compared these results with those of the formerly used DXC800 (Beckman Coulter, USA), and Vista500 (Siemens, Germany). METHODS: The accuracy, linearity, recovery factor, and sample carryover of the CS-6400 using HiSens reagent were determined for 29 tests-aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), gamma glutamyl transferase, glucose, total cholesterol, triglyceride (TG), amylase, lipase, creatine kinase (CK), blood urea nitrogen, creatinine, uric acid, total protein, albumin, total bilirubin (TB), direct bilirubin (DB), calcium, inorganic phosphorus, magnesium (MG), HDL cholesterol, rheumatoid factor (RF), LDL cholesterol, C-reactive protein, anti-streptolysin O, sodium, potassium, and chloride and the results were compared with the values obtained from the DXC800 and Vista500 to set reference intervals for each test. Serum samples obtained from 128 healthy adults were used for the reference intervals. and values obtained from DXC800 and Vista500 were used to make comparison on and to set reference intervals for each routine. Serum specimens obtained from a total of 128 healthy adults were used for the reference intervals. RESULTS: The coefficient of variation showed excellent values of or =5%). The coefficient of determination (R2) was > or =0.993 with linearity between 0.928 and 1.078 within the useful clinical span. In addition, the recovery factor values of the tests were 84% to 108%, and correlation comparisons were 0.975 except for albumin (0.9516), RF (0.7617), and LDL cholesterol (0.9709). We evaluated whether the CS-6400 contributed to the attempt to minimize the test's cost and running time. Developed in China, the CS-6400 has been approved by the Food and Drug Administration and uses indirect ion selective electrodes for electrolytes and colorimetry and turbidimetry for general and specific chemistry items. The tests showed excellent linearity of > or =0.993 using commercial certified linearity material. The recovery factor values of the tests were 93% to 108%, except for LDL cholesterol (84%). Except for the minimum values, percentage sample carryover values for CK and LDH were < or =1% (0.00% and 0.07%, respectively), suggesting that the results of the tests were not affected by sample carryover, and reference interval was present based on sex. CONCLUSIONS: The CS-6400 with HiSens showed excellent analytical performance (precision, linearity, and accuracy). Furthermore, results from the CS-6400 were highly correlated with those obtained from similar tests performed on DXC800 and Vista500. Therefore, the CS-6400 is appropriate for tertiary care hospitals where large volumes of test samples must be processed within a short period with minimal cost.

Evaluation of the Dimension Vista 1500 Chemical Autoanalyzer / 임상검사와정도관리

BACKGROUND: Laboratory tasks involve the analysis of a large number of specimens and generation of accurate results in a short period of time. The Dimension Vista 1500 (Siemens, Germany), an automated chemistry analyzer, has been introduced in our hospital to improve the efficiency of laboratory analysis. In order to assess the performance and usability of the analyzer, we evaluated its analytical performance and clinical usefulness, and compared these factors to those of the formerly used Modular DP analyzer (Roche Diagnostics, USA), Vitros 5.1 FS analyzer (Ortho Clinical Diagnostics, USA), and ADVIA Centaur analyzer (Siemens). METHODS: The accuracy, linearity, recovery factor, and sample carryover of the Dimension Vista 1500 analyzer were determined for 19 routine, immunochemistry, and cardiac marker tests (blood urea nitrogen, creatinine, glucose, calcium, phosphorus, total protein, albumin, AST, ALT, gamma-glutamyl transferase, creatine kinase [CK], lactate dehydrogenase, alkaline phosphatase, total bilirubin, high-sensitivity C-reactive protein, CK-MB, cardiac troponin I [cTnI], myoglobin, B-type natriuretic peptide), and values obtained for Modular DP, ADVIA centaur, and Vitros 5.1 FS analyzers were used to make comparisons. RESULTS: The coefficient of variation (CV) showed excellent values of or =0.996 with excellent linearity between 0.99 and 1.02. In addition, the recovery factor values of the tests were 88-107%, and percentage sample carryover values of the tests were or =0.96, except for cTnI (0.935), and showed good correlation (P<0.001). CONCLUSIONS: The Dimension Vista 1500 analyzer showed good analytical performance (linearity, precision, and accuracy) for 15 routine chemistry and 4 cardiac marker tests. Furthermore, results from the tests performed on the Dimension Vista 1500 analyzer correlated well with those obtained from similar tests performed on the Modular DP, ADVIA centaur, and Vitros 5.1 FS analyzers. Therefore, the Dimension Vista 1500 analyzer is appropriate for a tertiary care hospital where large volumes of tests have to be processed within a short period of time.

Performance Evaluation of HbA1c Test on the Toshiba 200FR NEO Using AutoLab HbA1c Reagent / 임상검사와정도관리

BACKGROUND: Hemoglobin A1c (HbA1c) is widely used for the monitoring of glycemic control in diabetes mellitus patients. Various methods are applied for the determination of HbA1c levels. Recently, a novel National Glycohemoglobin Standardization Program (NGSP)-certificated reagent (AutoLab HbA1c, IVD-LAB, Korea) was introduced for use in an automated chemistry analyzer. We evaluated the analytical performance of this immunoturbidimetry reagent and compared it with the ion-exchange high performance liquid chromatography (Variant II Turbo, Bio-Rad Laboratories, Inc., USA) and immunoassay (Cobas Integra 800, Roche Diagnostics, Germany) methods. METHODS: Toshiba 200FR NEO (Toshiba Medical Systems Co., Japan) with the AutoLab reagent was evaluated for precision, linearity, carryover and compared with Cobas Integra and Variant II Turbo. RESULTS: Coefficients of variation (CVs) of within-run imprecision for low and high level were 1.8% and 0.7%, respectively. CVs of within-laboratory imprecision for low and high level were 2.4% and 1.0%, respectively. The linearity was excellent with R2 = 0.99 in the range of 3.05-15.50%. It was well correlated with Variant II Turbo (R=0.9904) and Cobas Integra 800 (R=0.9992). The carryover rate was 0.4%. CONCLUSIONS: The Toshiba 200FR NEO with the AutoLab reagent showed excellent precision and linearity and minimal carryover rate. It was well correlated with the other widely used methodological instruments. It may be used for the diagnosis and the treatment monitoring of diabetes.

he Performance of the Newly Released Automated Chemistry Analyzer Rx Imola / 임상검사와정도관리

BACKGROUND: The Rx Imola (Randox, UK) is newly released bench top - fully automated analyzer based on Window XP software with high-throughput (640 tests per hour with ISE) and continuous random access. We evaluated the performance of Rx Imola for the routine chemistry. METHODS: Repeatability (within-day precision), between-day precision, within-device precision, linearity, recovery rates and correlation were evaluated for 19 items including AST, ALT, ALP, GGT, total bilirubin, calcium, phosphorus, albumin, total protein, BUN, creatinine, glucose, amylase, total cholesterol, triglyceride, HDL, LDH, CK and uric acid. Commercialized quality control materials and patient's sera were used. For correlation study, 747-100 (HITACHI, Japan) and VITROS 950 (Ortho-Clinical Diagnostics, USA) were used as comparative analyzers. RESULTS: Coefficients of variation (CVs) of all items in repeatability and between-day precision study were below 5%. The linearities were statistically acceptable (R2>0.99) for all items. The recovery rates ranged from 95.7 to 105.3%. The comparison study showed high correlation between Rx Imola and 747-100 or VITROS 950. Correlation coefficients of all items were above 0.99 except HDL and albumin. CONCLUSIONS: This study showed satisfactory results in precision, linearity, recovery rates and comparison studies of Rx Imola. It was expected to be useful for routine chemistry analysis and back up, because of high performance, easy handling and small size.

Evaluation of Kanto Cica Liquid Reagents for Chemistry Analyzer / 임상검사와정도관리

BACKGROUND: Many reagents have been developed along with advances in chemistry auto analyzer. Deciding on an appropriate reagent is required for an accurate test, diagnosis and efficient laboratory management. We evaluated Cica Liquid reagent produced by Kanto chemical corporation (Tokyo, Japan) for checking reagent ability. METHODS: Twelve chemistry reagents (AST, ALT, ALP, glucose, BUN, creatinine, total bilirubin, direct bilirubin, cholesterol, triglyceride, iron, magnesium) were tested on precision, linearity, interference, and correlation. We have evaluated using Hitachi 7600 (Hitachi High Technologies co., Japan) chemistry auto analyzer in accordance with the CLSI guidelines EP5-A, EP6-A, EP7-A, EP9-A2. EP_Suite (Marchem Associates Inc., USA) and SPSS ver. 11.0 (SPSS Inc., USA) were used for statistics. RESULTS: Precision results were satisfactory to CLIA '88 in all of the analytes except for ALP and magnesium. The linearity was satisfactory in measurement ranges as all analytes showed linearity in polynomial regression result or relative nonlinearity of less than 2.5%. Coefficients of correlation were above 0.985 in all analytes except for direct bilirubin and magnesium. When interference test results were compared with criteria of CLIA '88, low level of AST was positively interfered by hemoglobin and magnesium was negatively interfered by bilirubin. CONCLUSIONS: In conclusion, the Kanto Cica Liquid reagents are valuable in clinical laboratory, since they showed good precision, linearity, and correlation with other reagents.

Laboratory Evaluation of Bone Metabolism Index Using Elecsys 2010 / 대한진단검사의학회지

BACKGROUND: Bone markers can provide a prognostic information about the risk of osteoporotic fracture and are useful tools for monitoring the efficacy of antiresorptive therapy. We evaluated the analytical performance of the bone markers of Elecsys 2010 (Roche Diagnostics Corp., Indianapolis, USA). METHODS: We evaluated the analytical performance of the Elecsys 2010 for serum parathyroid hormone (PTH), osteocalcin, and serum bone-derived degradation products of type I collagen C-telopeptide (S-CTX) using control material and patients' specimens. For the comparison studies, an immunoradiometric assay was used for PTH and an ELISA for serum osteocalcin and serum bone-derived degradation products of type I collagen N-telopeptide (S-NTX). We established the reference intervals of S-CTX and serum osteocalcin by analyzing 4569 Korean healthy subjects according to sex and age. RESULTS: Within-run and total CV of most items were below 5% except S-CTX low level (5.42%). Elecsys 2010 showed a good linearity (r> or =0.99, P<0.01). Good correlations with other methods were found in osteolcalcin (r=0.95, P<0.01) and PTH (r=0.96, P<0.01). S-CTX showed a good correlation with S-NTX (r=0.76, P<0.01). Reference intervals of serum osteocalcin (ng/mL) and S-CTX (ng/mL) were 9.58-33.62 and 0.18-0.89, respectively, in adult male, 8.00-31.46 and 0.11-0.81 in 31-50 years old female, and 8.30-43.50 and 0.11-1.00 in 51-80 years old female. CONCLUSIONS: Elecsys 2010 bone markers showed a satisfactory precision, linearity, and a good correlation with other methods. With its 'one system-many capabilities' features, Elecsys 2010 would be a useful tool for measuring bone metabolism indices.

Evaluation of VITROS(R) 5,1 FS Automated Chemistry Analyzer / 임상검사와정도관리

BACKGROUND: VITROS(R) 5,1 FS (Ortho-Clinical Diagnostics, NY, USA) is a newly developed, fully automated analyzer that uses the dry slide type technology to process routine chemistry items, electrolytes, therapeutic drug monitoring and immunity items. We evaluated the usefulness of the VITROS(R) 5,1 FS in the aspect of precision, linearity, recovery rates and comparison. METHODS: We evaluated the analytical performance of the VITROS(R) 5,1 FS for sodium, potassium, chloride, total CO2, BUN, creatinine, glucose, amylase, total protein, albumin, ALT, AST, ALP, GGT, total bilirubin, unconjugated bilirubin, calcium and phosphorus. Commercialized quality control material, Performance Verifiers (Ortho-Clinical Diagnostics, NY, USA), chemTRAK(R).H (Medical Analysis Systems, California, USA) and patient' sera for evaluation of precision, linearity, recovery rates and comparison were used. MODULAR Systems (Roche Diagnostics, Switzerland) and CX3 (Beckman Coulter, California, USA) were used as a comparative analyzer to evaluate comparison study. RESULTS: Within-run and within-day coefficients of variation (CVs) of all items were below 5%. Between-day and total CVs were less than 5% in almost all items except of total CO2, amylase, ALT, AST, total bilirubin, unconjugated bilirubin and phosphorus. The linearities were statistically acceptable (R2>0.99) for all items (P<0.001). The recovery rates for all items were in the range of 96.20 to 111.45%. The comparison study indicated good correlation between VITROS(R) 5,1 FS and MODULAR Systems or CX3, and correlation coefficients of all items were above 0.975 except sodium (0.971) (P<0.01). CONCLUSIONS: VITROS(R) 5,1 FS showed satisfactory precision, linearity, recovery rates and comparison. Because it has features of one system with many capabilities, we recommend that VITROS(R) 5,1 FS would be used for the emergency laboratories in general hospitals with many examinations or in medium-sized laboratories with relatively small numbers of cases.

Evaluation of Dimension(R) RxL Automated Chemistry Analyzer / 임상검사와정도관리

BACKGROUND: The Dimension(R) RxL (Dade Behring Inc., Illinois) is a newly developed, high-throughput and versatile automated chemistry analyzer with continuous and random-access features for routine chemistry tests, enzymes, electrolytes, therapeutic drug monitoring, cardiac markers, and hormones. We evaluated the usefulness of Dimension(R) RxL in the aspect of precision, linearity, and comparison. METHODS: We evaluated the analytical performance of the Dimension(R) RxL for aspartate aminotransferase, alanine aminotransferase, high density lipoprotein cholesterol, blood urea nitrogen, creatinine, glucose, total bilirubin, total iron binding capacity, sodium, potassium, chloride, total CO2, digoxin, phenytoin, valporic acid, CK-MB, myoglobin and cardiac troponin-I. We used control materials for linearity and precision evaluation and random patients sera for comparison study with Hitachi 747 (Hitachi LTD., Tokyo, Japan), TDxFLx(TM) (Abbott Diagnotistics, Chicago) and ACS: Centaur(TM) (Bayer Diagnotistics, New York) according to NCCLS guidelines. RESULTS: In the precision study, within-run and total CVs of most items were below 5% except CK-MB and cardiac troponin-I. The linearities were maintained well in the range of medically significant levels and were statistically acceptable (P<0.001). The comparison study indicated good correlation with the central laboratory analyzer and correlation coefficients were above 0.975 (P<0.01). CONCLUSIONS: Dimension(R) RxL showed satisfactory precision, linearity, and good correlation compared with other analyzers. Because it has features of one system with many capabilities, we recommend that Dimension(R) RxL would be used for the routine chemistry setting or stat test settings at medium- to large-sized hospitals.

Analytical and Clinical Evaluation of Lana(TM), the Reagent Measuring 1,5-Anhydroglucitol / 대한임상병리학회지

BACKGROUND: There have been many reports that 1,5-Anhydroglucitol (1,5-AG) was a better marker than the hemoglobin A1c (HbA1c) or fructosamine for monitoring the control of glucose in patients with Diabetes Mellitus (DM). However, there was difficulty in performing the tests on the patient's samples in the hospital laboratory because the measurement was possible only with gas chromatog-raphy or high performance chromatography. Recently, a reagent that can measure 1,5-AG on the automatic chemistry analyzer was introduced. We evaluated the analytical and clinical characteris-tics of the reagent. METHODS: We measured the 1,5-AG with the Lana(TM) (Japan Chemistry Medicine, Tokyo, Japan) on the automatic chemistry analyzer, TBA-30FR (Toshiba, Otawara, Japan). We evaluated the pre-cision, the recovery rate, the lower detection limit, the reference value, and the correlation with other clinical markers for glucose control of the DM patient. RESULTS: The within-run precisions of abnormal and normal samples were 1.27% and 1.41%. The between-day precisions were 2.34% and 4.56%, respectively. The recovery rate was 100.1% and 100.7% in abnormal and normal samples, respectively. The lower detection limit was 0.05 mg/L. The reference value from the healthy people was from 12.7 to 50.9 mg/L. The correlation coefficients of the 1,5-AG with glucose and HbA1c were -0.45 and -0.63, respectively. CONCLUSIONS: The newly introduced reagent for 1,5-AG that could be applied with the automatic chemistry analyzer was enough to satisfy the analytical features and it showed better correlation with HbA1c than with the fasting blood glucose. We expect that the Lana(TM) can be used in hospital lab-oratories to monitor the blood glucose control of DM patients and more studies on the clinical value of the 1,5-AG can be done with the convenient reagent such as this.