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Objective To study the reference range of the urine analyzer and the target value of the common quality control object.Methods The reference ranges of urine analyzer test items from different mnanufacturers were investigated,and laboratory bias proportion was used as an indicator of the evaluation of the target value scheme.EQA raw data of Guangxi clinical examination center in 2014 were analyzed.Results The target value ranges of pH,specific gravity,bilirubin and nitrite were found reliable,while the ones for WBC,URO,RBC,ketone body,glucose and protein needed improving.Conclusion The target values and evaluation indexes of EQA have to be reselected for mutual recognition of the results.
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Objective To validate the performance parameters of DIRUI FUS-2000 automated urine analyzer declared by the manufacturer.Methods The fresh urine samples were diluted with special diluent to different concentration of suspension according to experimental requirements,then such parameters were validated as the precision,carrying pollution rate,detection limit and reportable range.At the same time,the coincidence rate of red blood cells and white blood cells was also verified in urine samples tested by FUS-2000 according to the result of manual inspection.Results RBC had the low and median values for within-run precision being 7.74％ and 6.13％ respectively,and WBC had the low and median values for within-run precision being 14.35％ and 2.45％ respectively.The negative and positive quality control materials had the between-run precision being 0％ and 3.43％ respectively.The carrying pollution rate was 0.08％ for RBC and 0.57％ for WBC,and the detection limits for RBC and WBC were both 10 ones per Liter.The reportable range was from 10 to 38 754 p/μl for RBC and from 10 to 32 202 p/μl for WBC.The coincidence rate with artificial microscopy was 90.83％ for RBC and 95.83％ for WBC.Conclusion FUS-2000's performance parameters are in line with the requirement,and it can be used for the clinical urine detection.The review criteria of FUS-2000 should be established to improve distinguishing sensitivity and specificity of RBC and WBC in urine.
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Objective To validate the performance parameters of DIRUI FUS-2000 automated urine analyzer declared by the manufacturer.Methods The fresh urine samples were diluted with special diluent to different concentration of suspension according to experimental requirements,then such parameters were validated as the precision,carrying pollution rate,detection limit and reportable range.At the same time,the coincidence rate of red blood cells and white blood cells was also verified in urine samples tested by FUS-2000 according to the result of manual inspection.Results RBC had the low and median values for within-run precision being 7.74％ and 6.13％ respectively,and WBC had the low and median values for within-run precision being 14.35％ and 2.45％ respectively.The negative and positive quality control materials had the between-run precision being 0％ and 3.43％ respectively.The carrying pollution rate was 0.08％ for RBC and 0.57％ for WBC,and the detection limits for RBC and WBC were both 10 ones per Liter.The reportable range was from 10 to 38 754 p/μl for RBC and from 10 to 32 202 p/μl for WBC.The coincidence rate with artificial microscopy was 90.83％ for RBC and 95.83％ for WBC.Conclusion FUS-2000's performance parameters are in line with the requirement,and it can be used for the clinical urine detection.The review criteria of FUS-2000 should be established to improve distinguishing sensitivity and specificity of RBC and WBC in urine.
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Objective To analyze the training and evaluation standards on urine analyzers in the grass-roots medical unit.Methods The applicability,requirements,subject setup and items of the standards as well as the requirements of evaluation scoring chart were expounded in detail,and the related elementary knowledge was analyzed including the structure,working principle,installation and adjustment,operation,application,maintenance and etc of the analyzer.Combined personnel with the equipment was suggested to ensure the accuracy and high efficiency of the test result.Results The interpretation of the standards contributed to enhancing the quality of medical equipment training and the ability of practical support,and facilitated the examiner to perform annual evaluation with the scoring chart.Conclusion It is necessary to grasp accurately the connotation of the standards,to improve the quality of medical equipment training and to enhance combat support capability for the grass-roots medical unit and examiner.
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Objective To explore the division XL automatic urine analyzer reagent strips placed time impact on nitrite (NIT) test results,to ensure that provide accurate and reliable experimental data for clinical,and improve clinical diagnostic rate. Methods Used a new load reagent storehouse article in the new reagents respectively in <5,30 min;1,2,3,3.5,4,4.5,5, 5.5,6,6.5,7 and 8 h,in different period,16 0.9 g/dl saline NIT in the false positive rate,and carried on the comparison to different times NIT false-positive rate analysis.Results <3.5 h NIT false positive rate was 0% (0/16),4~4.5 h false pos-itive rate was 18.8% (3/16),5~5.5 h false positive rate was 43.8% (7/16),6~6.5 h was 62.5% (10/16),7~8 h was 87.5% (14/16).More than 4 h each time comparison between NIT false positive rate,differences were statistically signifi-cant (χ2 =11.7~59.2,all P <0.01).Conclusion Division XL automatic urine analyzer reagent strips placed after 4 h,NIT false-positive rate started to rise,NIT false-positive rate was significantly increased after 5 h.Therefore,strengthen the divi-sion XL automatic urine analyzer reagent strips placed reasonable time management,should be in the < 3.5 h advisable,it helps reduce the NIT false positive rate.
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Objective To compare the value of UF‐1000i urinary sediment analyzer and phase‐contrast microscopy in identify source of hematuria .Methods A total of 98 patients diagnosed as hematuresis from December 2013 to May 2014 in the Affiliated Hospital of Putian Institute were enrolled in this study .Both the urinary sediment examination and phase‐contrast microscopy ex‐amination were conducted on the patients .According to clinical diagnosis results ,the sensitivity and specificity of the two methods were calculated and compared .Results The sensitivity of UF‐1000i urinary sediment analyzer (95 .3% ) was higher than that of the phase contrast microscope (81 .9% ) ,the difference was significant (P < 0 .05) ,while the specificity of phase contrast microscope (92 .3% ) was higher than that of UF‐1000i urinary sediment analyzer(89 .2% ) ,the difference was significant(P < 0 .05) .Conclu‐sion Combining application of UF‐1000i urinary sediment analyzer and phase contrast microscope has great clinical significance .
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Objective To perform Quality comparative study of urine visible components tests by using Sysmex UF-1000i auto-mated urine analyzer (Sysmex UF-1000i) ,AX-4030 automated urine chemistry analyzer (AX-4030) ,and three kinds of manual opti-cal microscope instrument .Methods Applying the above three kinds of instrumental methods respectively to 2 086 case of RBC , WBC and the CAST test and their positive rate and sensitivity difference were analyzed .Results SysmexUF-1000i ,AX-4030 and microscopic three kinds of instrument detection RBC ,WBC ,CAST positive rates were as follows ,Sysmex UF-1000i:20 .4% 、20 .8% 、6 .4% ;AX-4030 :23 .6% 、16 .5% (no CAST );microscope:15 .2% 、18 .6% 、2 .4% .Among the 3 kinds of tests ,RBC ,CAST detection rate were significantly different (P0 .05) .Conclusion Sysmex UF-1000i and AX-4030 can not completely replace the gold standard manual microscopic examination of urine sediment should be three kinds of methods used in combination to ensure the accuracy of the urine analysis results .
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To introduce composition,the testing principle of the urine analyzer,To reduce the failure rate, extend the service life of the instrument and improve the accuracy of diagnosis. Make the maintenance system ,according to the system of equipment maintenance maintain the urine analyzer daily and monthly. The maintenance plays an important role in reducing the failure rate, extending equipment life and improving the accuracy of diagnosis.
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BACKGROUND: The ComboStick Reader 720(R)(DFI Co., Ltd. Korda) is a newly developed automated urine analyzer. The objective of this analysis was to evaluate the analytical performance of the Combostick Reader 720 and ComboStick 10 reagent strips and to compare the results using the Uriscan Pro II and Uriscan Gen 10 SGL strips (YD Diagnostics, Korea). METHODS: The Dipstick urinalyses were performed on a ComboStick Reader 720(R) using ComboStick 10 strips and on a Uriscan Pro II(R) using Uriscan 10 SGL strips. Precision was evaluated with commercial control materials. The sets of results were analyzed for concordance with weighted kappa values or intraclass correlation coefficients (ICCs). The microscopic urine analysis was carried out to confirm the results from both automated urine analyzers. Agreement between the dipstick methods and the microscopic method was evaluated by kappa values and the McNemar test. RESULTS: Within and between-run precisions of the ComboStick Reader 720(R) were 90.0% to 100%. A comparison of results from 1,700 urine samples using the ComboStick Reader 720(R) and Uriscan Pro II(R) revealed a very high concordance rate of > or = 91.0% on consideration of neighboring blocks for all analytes of the dipstick urinalysis. There was a good association between the microscopic method and the dipstick methods of the two automated urine analyzers. The ComboStick Reader 720(R) revealed a statistically higher degree of agreement for leukocytes. CONCLUSIONS: The ComboStick Reader 720(R) and ComboStick 10 strips showed good precisions and revealed a statistically significant agreement with the Uriscan Pro II(R) and Uriscan 10 SGL strips. For leukocytes, the ComboStick Reader 720(R) was superior to the Uriscan Pro II(R) in comparing the agreement between the microscopic and dipstick methods. The overall performance of the ComboStick Reader 720(R) and ComboStick 10 strips were satisfactory.
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Leukocytes , Reagent Strips , UrinalysisABSTRACT
OBJECTIVE To investigate the value of screening hospital urinary tract infection with UF-100 automated urine analyzer. METHODS It was to count the bacteria and white blood cells in 422 urine specimens with UF-100 as well as to culture the specimens quantitatively.Then the sensitivity and specificity of UF-100 counts and the correspondence of the two methods were evaluated with Yerushalmy mode. RESULTS Compared with the culture results,UF-100 showed a sensitivity of 81.5%,specificity of 63.9%,positive predictive value of 29.1%,negative predictive value of 95.0%,false positive rate of 30.5%,false negative rate of 2.8% and an accuracy of 67.2%. CONCLUSIONS The UF-100 is excellent in analyzing urine specimens,and its bacteria counts can be a valuable indicator in screening hospital urinary tract infection.
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Objective;Discussing clinical utilization of Automation Urine Analyszer in the testing Hydrothorax and Hydroperitonium. Methods:Testing 80 specimen got from our clinci and patient by using Uritest-200 equipemnt to get the results of PRO and SC, using UF - 100 to get the results of RBC,WBC,EC which can be compared with the results which got by handwork. Results:Comparison between Uritest-200 and handwork method, PRO and SG usex2 examination, the results have very siginficant differ( P
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Objective To evaluate the function of IRISiQ200 full automated urine analyzer and its clinical application of user re-classification function.Methods The reproducibility,linearity and mutual infection rate of IRISiQ200 were detected.116 fresh urine specimen were obtained from outpatient and inpatient at random.After the specimen were detected with IRISiQ200,the doubtful urine sediment images were discriminated repeatedly by user reclassification.The microscopic quantitation in uncentrifuged samples was used as reference.Results IRISiQ200 showed good reproducibility,linearity and lower mutual infection rate.The performances by using iQ-200 were: erythrocytes Y=0.596X+11.353,R2=0.834;leukocytes Y=0.468X+5.745,R2=0.708;epithelial cells Y=0.524X-2.649,R2=0.815.The performances after reclassification: erythrocytes Y=0.895X-3.328,R2=0.997;leukocytes Y=0.786X-1.880,R2=0.976;epithelial cells Y=0.911X-5.502,R2=0.992.Conclusion IRISiQ200 full automated urine analyzer shows excellent performance.There is fine correlation between iQ-200 and microscopic quantitation in uncentrifuged samples,and the urine sediment can be observed intuitively by using reclassification function.The doubtful urine sediment images can be discriminated.It can degrade the instrument error and increase the detection accuracy greatly.[Chinese Medical Equipment Journal,2008,29(2):82-83,85]