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Objective To verify the analytical performance of Hitachi 7600-210automatic biochemical analyzer detection system.Methods The precision, accuracy, linearity and clinical reportable range, limit of quantitative detection and anti-interference capability were validated according to Clinical and Laboratory Standards Institute (CLSI) documents (EP15-A3and EP17-A2) and Clinical Laboratory Improvement Amendment 1988 (CLIA′88) standards.Results The within precisions of high and low two concentrations were both less than1/4CLIA′88TEa (laboratory permissible total error), the day precisions were less than 1/3CLIA′88TEa, the pass rates of three external quality assessments in 2017 were all not less than 80％and range from 0.02mmol/L to 401.80mmol/L.The clinical reportable was ranged from 0.02to 401.80mmol/L with a linear relationship.The LoB, LoD and LoQ of glucose (GLU) detection were 0.01 mmol/L, 0.03 mmol/L and 0.08mmol/L respectively.The anti-interference capability to hemoglobin (Hb), vitamin C (VitC), bilirubin (BIL) and triglyceride (TG) in the detection system to GLU measurement were in accordance with the manufacturer′s statement.Conclusion Performance verification of Hitachi 7600-210automatic biochemical analyzer detection system to GLU detection is consistent with the manufacturer statement also in accordance with CLIA′88standards, which can meet the expectant use of clinical test.
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Objective To evaluate the automatic biochemical analyzer when used to detect urinary vanilmandelic acid (VMA), and to compare it with manual method. Methods The automatic biochemical analyzer using homogenous enzyme immunoassay technology was compared with the manual method on accuracy, precision, linear range, recovery rate, anti-interference capability and etc when used to detect VMA.The comparison was also carried out on positive rate and etc when the two methods were used to test the urine specimens of the healthy subjects and suspected patients of hypertension, hyperthyroidism and hypothyroidism. Results The two methods both had the results on accuracy, precision, linear range, recovery rate, anti-interference capability meet the requirements described in the instruction of reagent kit, while the analyzer gained advantages over the manual method.The positive rates by the two methods for testing urine specimens were similar,while the analyzer behaved better in diagnosing the patient with critical value.Conclusion The analyzer proves better than the manual method when used to detect VMA,and thus is worthy promoting in clinical trial.
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Objective To compare GM260 portable blood glucose meter and AU5821 automatic biochemical analyzer in order to prove the accuracy of GM260 and its applicability for clinical use.Methods Totally 20 pieces of EDTA-K2 anticoagulative specimens and 23 GM260 meters were numbered,and each specimen underwent examinations by both GM260 and AU5821,then the bias between the two kinds of devices was calculated.Results The maximal bias between GM260 and AU5821 was 0.47 mmol/L and all the meters had the bias between-0.83 and 0.83 mmol/L in case of 5 specimens with the glucose concentration less than 4.2 mmol/L;the maximal bias between GM260 and AU5821 was 18.07％ and all the meters had the bias between-20％ and 20％ in case of 15 specimens with the glucose concentration not less than 4.2 mmol/L;the examination results by GM260 all accorded with industrial standard.The results by GM260 were lower than those by AU5821,and the maximal negative deviation was-13.43％.Conclusion Portable blood glucose meter can only be used for screening,and automatic biochemical analyzer is the preferred device for diabetes diagnosis.
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Objetive To analyze the standard of training and evaluation on semi-automatic biochemical analyzer to improve grass-root medical unit in training on the analyzer.Methods The standard was analyzed and expounded from the aspects of scope of application,requirements,subjects setting,key links as well as the demands of evaluation scoring scale.Results The main points of the standard included elementary knowledge of biochemical analysis as well as the structure,principle,installation,operation,application,maintenance and etc of the semi-automatic biochemical analyzer.The integration of personnel and instrument contributed to accurate and rapid output of test report.Conclusion It is necessary to grasp accurately the connotation of the standard to improve the quality of medical equipment training.
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Objective:To study the influence of hematocrit on the consistency between blood glucose meters and automatic biochemical analyzer for testing blood glucose of peripheral blood and venous blood.Methods: 200 cases of diabetic and non-diabetic patients were selected in our hospital from January 2013 to September 2015, in which 124 cases were diabetics and 76 cases were non-diabetics. All the selected patients were treated with venous blood and peripheral blood glucose testing by the SIEMENS ADVIA1800 full automatic biochemical analyzer and three brand of blood glucose meters (Reiter GM300, Arkray GT-1920, Johnson & Johnson One Touch), comparing their consistency.Results: The hematocrit range was 35.1~51.6%, accounted for 91.0%(182), 25.0~35.0% of patients accounted for 9.0%(18), and average hematocrit was (42.3±4.2). When hematocrit was 35.1~51.6%, the correlation of automatic biochemical analyzer and Reiter GM300 blood glucose meter was high and stable, followed by Arkray GT-1920 and Johnson &Johnson One Touch. When hematocrit was 25.0~35.0%, the correlation of automatic biochemical analyzer and three blood glucose meters were high than hematocrit was 35.1~51.6%. There was no significant difference between SIEMENS ADVIA1800 automatic biochemical analyzer and Reiter GM300 about monitoring the blood glucose results, but there were significant differences between Johnson and Johnson One Touch and Arkray GT-1920.Conclusion: The automatic biochemical analyzer and three blood glucose meters have good correlation. When hematocrit is greater than 35%, the correlation is lower; when hematocrit is less than 35%, the correlation increases.
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Objective To establish a method for determination of urinary iodine by an automatic biochemical analyzer,and to analysis the applicability on the detetion of iodine deficiency disorders.Methods An automatic biochemical analyzer was used to determine urinary iodine content.Linear range,detection limit,precision,recovery and so on were studied.Results The linear range was 0-300 μg/L;the detection limit was 1.57 μg/L (600 μl sample);the relative standard deviations (RSD) were 1.30％,0.83％ and 1.05％ when measuring urine samples with iodine concentrations of (84.8±1.1),(156.5 ± 1.3) and (227.7 ± 2.4)μg/L,respectively;the average recovery was 98.0％,100.1％ and 98.6％,and the total average recovery was 98.9％,when measuring urine samples containing three different iodine concentrations.The test results of standard material were all within the required ranges.The difference of measuring 24 urine samptes in the field by this method and the standard method was not statistically significant by paired t test (t =0.35,P ＞ 0.05).Compared with standard method,the amount usage of arsenic trioxide was reduced to 2％ (0.50 to 25.00 mg per sample).Conclusions The method has theadvantages of simple operation,low requirement for environment,and the linear rang of detection is reasonable.Using this method,the usage of highly toxic reagent can be greatly reduced,as well as the risk of harm to personnel health and the level of environment pollution.The standard solution and reagents can be prepared by ourselves,which greatly reduces the costs.With short reaction time,high detection speed and measuring automatically for large numbers of samples,this method for determination of urinary iodine by an automatic biochemical analyzer can be applied in monitoring of iodine deficiency disorders.
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Objective To explore the clinical application value of fast blood glucose meter in the emergency test of blood glu‐cose .Methods 186 critical patients in or hospital from August 2013 to August 2014 were selected for conducting the clinical re‐search .The average blood sugar was detected in all the research subjects by using the fast blood glucose meter and the fully auto‐matic biochemical analyzer .Results The consistency rate of detection results by the two kinds of detection method reached 22 .04% ,the difference of data was relatively small .In addition ,the detection time for the fast blood glucose meter was significantly shorter than that of the fully automatic biochemical analyzer ,the difference showed the statistical significance (P< 0 .05) .Conclu‐sion The detection results of the fast blood glucose meter have no too large difference with those of fully automatic biochemical an‐alyzer and have the same guidance significance to the diagnosis and treatment .The fast blood glucose meter has the advantages of quickness and convenience ,short time‐consuming and can be used in emergency .
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Objective:To me affiliated hospitals are currently using Shimadzu CL8000 Hitachi 7180 automatic biochemical analyzer comparison study on Shimadzu CL8000 Hitachi 7180 automatic biochemical analyzer cleaning effect for clinical obtain accurate test results provide a reliable basis. Methods:Patients with the same blood samples TG, TBA testing, using different instruments, different sequence of tests in order to determine Hitachi 7180 automatic biochemical analyzer and Shimadzu CL8000 automatic biochemical analyzer test results whether they carry the previous reagents, according to the detection results to determine two kinds of automatic biochemical analyzer after cleaning effect. Results:A group of TBA measurements were significantly higher than in group B, C group, D group(x2=4.091, P<0.05), comparing the results with statistical significance;B group, C group, D group compared TBA measurements no significant difference, the difference was not statistically significant. Conclusion:Shimadzu CL8000 automatic biochemical analyzer cleaning better than Hitachi 7180 automatic biochemical analyzer, its stable performance, excellent cleaning effect, clinicians can provide accurate diagnosis and treatment basis, improve patient outcomes, quality of life and protect their life safety, may be of clinical use.
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Objective To perform the comparative analysis on the blood glucose results detected by the portable glucose meter and the Olympus AU2700 biochemical analyzer.Methods 20 fresh whole blood samples with sodium fluoride and potassium oxalate anticoagulation were the Olympus AU2700 biochemical analyzer biochemical analyzer.Results In these 27 portable glucose meters, the comparison results in only 1 portable glucose meter was unqualified,which in the other 26 portable glucose meters were passed, the passing rate was 96.3%,which in 2 glucose meters were clinically acceptable and which in the other 24 glucose meters were completely acceptable and the clinical completely acceptable rate was 88.9%.Conclusion There are some biases of blood glucose results detected by the portable glucose meter and the fully automatic biochemical analyzer,but the overall correlation is well.The comparison and calibration of the blood glucose meters should be performed at the regular intervals for improving the consistency and accuracy of blood glucose detection results.
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Objective To study The influence and preventive measures for the test results of total bile acid about blood Lipid testing reagent. Methods In Mindray BS -300 automatic biochemical analyzer, we detected total bile acid of the fresh mixed serum separately, then we tested the same samples after the test items of cholesterol, triglycerides, high -density lipoprotein, low - density lipoprotein. Then using fresh serum mixed with normal saline and blood lipid reagent according to 1: 1 dilution ,we measured TBA. We did cross - contamination corrected test (by the anti - cross - contamination to repeat the first step after the test) and recorded all results and had statistics analysis. Results This experiment found that reagents Ⅰ of TC, TG and the reagent Ⅱ of HDL - C , LDL - C had significant positive interference in determination of TBA results. After being corrected by anti - cross - contamination, the results returned to normal. Conclusion When using the automatic biochemical analyzer, we not only acquired the worker fououed of the equipment, and reagents, determined principle, but also pay attention to cross - contamination among reagents, and then in accordance with the equipment work characteristics to establish the appropriate measures to eliminate them, so made sure the reliability of the experimental data to provide clinic with the true objective and actual diagnosis evidence fundamentally.
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Objective To investigate the detection and treatment of carry-over of automatic biochemistry analyzer. Methods We detected the sample carry-over by determining one high level quality control serum and three zero levels serum continuously in five days. We used mixed patients serum to detect the carry-over come from reagent probe, muddler and cuvette by arranging test sequence of different item, combination and the times of rerun. We also used different methods such as immersion, cleaning probe, extended priming to handle the reagent carry-over.Results The sample carry-over was -0.37%～0.48% on new analyzer and 0.51～1.17% on old analyzer, respectively. The carry-over of CHO, TG, HDL on reagent probe and muddler of TBA was 86.9%～208.7% and 86.0%～256.5% on old analyzer, respectively. There was no reagent carry-over among other items on old analyzer. There was no carry-over on reagent probe on new analyzer, the carry-over of different items on cuvette of TBA was -0.9%～1.7%. After immersion, cleaning and extended priming, the carry-over of CHD, TG, HDL on TBA reagent probe fell to -1.1%～2.7% and -0.07%～0.09%, respectively.Conclusions The methods which have been mentioned above can detect the sample and reagent carry-over. The carry-over can be reduced by immersion, cleaning, extended priming and testing in different unit.