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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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Objective To verify the performance of VITROS 5600 automatic biochemical analyzer.Methods According to laboratory accreditation criteria and performance verification documents of American CLIA'88,the precision,accuracy,liner range,clinical reportable range and biological reference interval were verified for the test of 17 conventional biochemical indicators performed on VITROS 5600 automatic biochemical analyzer.Results The precision、accuracy、liner range、clinical reportable range and biological reference interval of VITROS 5600 automatic biochemical analyzer were all acceptable.Conclusion VITROS 5600 automatic biochemical analyzer could fully meet the requirements in clinical application.
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Objective According to the comparison and deviation assessment of the part item test results between the OLYMPUS AU640 and BECKMAN AU5821 automatic biochemical analyzer in the laboratory,explore whether the test results between the 2 biochemical analyzers is comparable or not.Methods Reference EPg-A2 file requirements of the American Clinical Laboratory Standardization Committee(NCCLS),test the fresh clinical mixed serum and quality control serum in the 2 equipments respectively,the OLYMPUS AU640 is the reference equipment,the BECKMAN AU5821 is alignment equipment,using regression analysis and paired t test to compare the test results and deviation assessment of the same item,the standard is 1/2 of the total error which the American clinical laboratory improvement amendment (CLIA' 88)allowed,evaluate test results whether is comparable or not.Results Most test results showed good consistency between the 2 biochemical analyzers.Conclusion Through the comparison and deviation assessment in the different biochemical analyzers,the correlation of the same test results can be validated,it is useful to evaluate and correct the equipment,and meet the needs of the clinical.
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Objective:To design a new automatic cap opening device consists of holding mechanism, open mechanism, improve mechanism, rotating mechanism and recycling mechanism in order to resolve the poor adaptability, complex structure and lower liability problem for specimen container in the biological specimen pretreatment system.Methods: This paper designed a automatic equipment to remove the rubber cap and screw cap. This equipment is compatible with the different specification specimen containers and the container cap, and the specimen container cap was stepped up and rotated with same power component.Results: The application of equipment has reduced the manufacturing cost and maintenance cost for specimen container, improved the system reliability, solved the current technical problems of the equipment, such as poor adaptability and lower liability. Conclusion: The design of equipment mainly adapts to CS-6400 series of automatic biochemical analyzer, and it can improve the detection efficiency of biological specimen, reduce the cross contamination and satisfy the practice necessity for clinical detection.
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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 compare the impact on the results tested with arterial blood gas analysis and peripheral blood with glucose meter for critical patients in ICU in different temperature states. Methods The samples of venous biochemical test, blood arterial blood gas analysis and peripheral blood of 196 cases of critical patients in ICU were collected synchronously, and measure the D-value, correlation and bias adjustment factor of glucose blood tested with a synchronous fasting blood glucose test and venous/biochemical analyzer in different temperature states and different blood glucose groups, and the results of blood glucose test were analyzed. Results In normal temperature state, hypoglycemia simultaneous rapid intravenous glucose monitoring blood glucose level results compared with the lowest positive rate 3.31%(5/151), while the pairwise comparison showed there was both statistical signifcance between hypoglycemia group and target group (χ2=38.469), hyperglycemia group and target group (χ2=15.504) when choosing a synchronous fasting blood glucose test and intravenous blood glucose test (P<0.01). In high temperatures state, hypoglycemia simultaneous rapid intravenous glucose monitoring blood glucose level results compared with the lowest positive rate 0. There was both statistical significance between hypoglycemia group and target group (χ2=18.187), hypoglycemia group and hyperglycemia group (χ2=12.857) when choose a synchronous fasting blood glucose test and intravenous blood glucose test (P<0.01). Conclusions In high temperatures state, a synchronous fasting blood glucose test can not reflect the true value of blood glucose for critical patients.
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The combination of biochemistry analyzer and medical expert system was proposed in this report. Biochemistry analyzer is one of the most important analytical instrument used in clinical detection. It could take immunological examination and biochemical analysis for blood, urine, pleural effusion and cerebrospinal fluid and other body fluids. Medical expert system is an intelligent program system with knowledge and experience of a large number of medical specialists. It could use the knowledge and method of medical experts to solve and deal with problems in the field. This system mainly includes human interface, inference engine, interpreter, knowledge acquisition procedures, integrated database and knowledge base. Some parts of system design, such as the expression and design, and interpretation mechanism of the knowledge base, have been interpreted in details. It adopts production as an expression of knowledge. Generally, knowledge was expressed as if the conditions, then the conclusion form. Interpretation mechanism use the error counter propagation of neural network to train the algorithm (BP algorithm for short).The combination could automatically conduct comprehensive analysis of various data generated by the instruments, and then obtain the science theoretical foundation and the most reasonable specialist conclusions. This report provides an overview of the system design of medical expert system.
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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 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 investigate the method and application of measurement uncertainty in clinical biochemical tests .Meth-ods The synthetic uncertainty and expanding uncertainty of 13 emergency biochemical tests items were compared between Hitachi 7600 and Beckman DXC800 automatic biochemical analyzer by usingmodel method.The test items included aspartate aminotrans-ferase ,total protein ,albumin ,glucose ,urea ,creatinine ,creatine kinase ,lactate dehydrogenase ,amylase ,potassium ,sodium ,calcium and chloride .Results Measurement uncertainty of aspartate aminotransferase and lactate dehydrogenase were 3 .66% and 3 .51%respectively ,which were the top two on Hitachi 7600 analyzer ;measurement uncertainty of calcium and creatinine were 4 .00% and 3 .90% respectively ,which were the top two on Beckman DXC800 .Compared between the two analyzers ,the test item with the lar-gest difference of measurement uncertainty was sodium(2 .62% ) ,and the second was creatinine(2 .40% ) .The difference of meas-urement uncertainty of the 13 emergency biochemical test items between the two analyzers were relatively small .Conclusion The two analyzer both have good performance ,Model methodis suitable for the evaluation of regular test items′measurement uncer-tainty in clinical biochemical laboratory .
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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 verify the performance of Hitachi 7600 automatic biochemical analyzer .Methods According to labora‐tory accreditation criteria and the performance verification documents of American CLIA′88 ,the precision ,accuracy ,reference inter‐val ,linear range and clinical reportable range were verified for the tests of 19 conventional biochemical indicators performed on Hita‐chi 7600 biochemical analyzer most often .Results The precision ,accuracy ,reference interval ,linear range and clinical reportable range were all acceptable .Conclusion Hitachi 7600 automatic biochemical analyzer could fully meet the reqirements in clinical ap‐plication .
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Objective:To detect differences in results of routine biochemical indexesand serum anticoagulant heparin, explore the feasibility of plasma heparin in the emergency biochemical test in.Methods: Two hundred cases of patients in the emergency department of our hospital as the research object, peripheral venous blood samples, were installed on the ordinary drying tube and a heparin plasma in vitro, determination of 10 emergency patients in serum and plasma biochemical items using biochemical analyzer, comparative analysis of the effect of heparin plasmabiochemical test results, and to compare the two groups report time.Results: The difference of serum group and Mg2+ group, Cl-, plasma Ca2+, Cr, BUN, UA, ALT, GLU and other data is not obvious, no statistical significance, The plasma concentration of K+ group was significantly lower than serum group, serum concentration of Na+ was higher than group difference was significant, with statistical significance(t=8.167,t=4.361;P<0.05). Plasma group reported significantly less than the serum group(t=22.94,P<0.05).Conclusion: heparin sodium does not dissolve in the blood, with a strong ability for anticoagulation, emergency biochemical test can avoid the effect of blood coagulation test results, and shorten the time for patients toreport, to win the precious time, attention is needed to correct potassium ionconcentration difference test.
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Objective To analyze the consistency of the detection results of glycosylated hemoglobin (HbA1c) by SMART POCT and Hitachi 7180 biochemical analyzers .Methods Firstly the accuracy of HbA1c detected by the SMART POCT and Hita‐chi 7180 biochemical analyzers were evaluated .And then 20 randomly selected samples were tested by both equipments .A relevance analysis between detected data from two equipments was conducted .Results There was a good correlation between the results of the HbA1c detected by two detecting systems ,with the correlation coefficient of r2 =0 .981 1 .Conclusion There is a good consis‐tency in detection results of glycosylated hemoglobin (HbA1c) detected by SM ART POCT and Hitachi 7180 biochemical analyzer .
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Objective To investigate the application of theoretical K value and the calibration K value on Hitachi 7600 Automatic Biochemical Analyzer .Methods Rate method was employed to detect alanine aminotransferase (ALT ) ,aspartate aminotransferase (AST) ,gamma-glutamyl transpeptidase(γ-GT) ,creatine kinase(CK) and lactate dehydrogenase(LDH) .The theoretical K value and K values calibrated by two kinds of calibration serum were recorded as K ,K1 ,K2 and the three kinds of calibration results of enzymes mentioned above were compared .Results The theoretical K values of ALT ,AST ,γ-GT ,CK and LDH were all less than their two kinds of actual K values .The results of the calibration K value were significantly superior to that of the theoretical K value .The calibration results R2 value of five kinds of enzymes were all greater than 0 .95 .Conclusion The theoretical K value is not suitable for clinical laboratories ,and the two kinds of calibration serum can meet the needs of quality control and clinical work .
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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 Using Hitachi 7170 external quality assessment return target value to evaluate the accuracy of 10 items after Regression calibration of the Vistros 350 dry-type Biochemical Analyzer.Methods The same quality control samples were separately tested on two instruments,and results were reported to the clinical National Center for Clinical Laborato-ries.Substituted the external quality assessment return target value result from the National Center for Clinical Laboratories by using Vitros350 into regression calibration equation,then the getting data were compared with the external quality assess-ment return target value obtained from Hitachi 7170,and the deviation analysis was processed.The total error range from the America Clinical Laboratory Amended Bill was used as the standard.For the results within the reference range,error less than 1/2CLIA’88 total error,taken as the comparable judging standard,as it satisfied the requirement.For the results out off the reference range,error less than CLIA’88 total error,those still satisfied the requirement.For those items not meet the requirements,it must to do the regression calibration for Vitros350,using Hitachi 7170 as the standard instrument.Results The deviations of 7 items were all less than 1/2CLIA’88 allowed total error,with LDH was 0.16~-9.89,CK 2.92~6.25, ALT -4.64~-8.07,TBIL 0.08~2.67,TP -0.37~4.41,ALB 2.74~4.77 and URIC 1.04~3.0 respectively,and did not need re-calibration.For GLU and CREA,only one out of the reference range sample,the error range was >1/2CLIA’ 88,but
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Objective To evaluate the performance of electrolyte module in OLYMPUS AU5421 Automatic Biochemical Analy-zer in K+ ,Na+ ,Cl- detection .Methods Electrolyte module in OLYMPUS AU5421 Automatic Biochemical Analyzer was employed to detect K+ ,Na+ ,Cl- ,and their precision ,accuracy ,linearity range ,cross-contamination and the test results of instruments were compared .The linear regression equation and regression coefficients were calculated according to the methods of Clinical and Labo-ratory Standards Institute(CLSI) EP6-A ,EP9-A2 documents .Results The within-run precisions of K + ,Na+ ,Cl- were 0 .328% , 0 .306% ,0 .343% ,respectively ,and their between-run precisions were 0 .780% ,1 .012% ,0 .985% ,respectively .Their regression coefficients of linear equation were all greater than 0 .999 ,and their cross-contamination rate were 1 .066% ,0 .812% and 0 .858% , respectively .Conclusion Electrolyte module in OLYMPUS AU5421 Automatic Biochemical Analyzer modules has advantages of good precision ,accuracy ,linear range ,and low cross-contamination rate .