Preparation And Preliminary Application Of Reference Materials Of Major Formed Element In Urine

A reference material is a substance or material that has one or more characteristic values that are sufficiently uniform.Urine formation is a general term for substances formed from the urinary tract and exuded,discharged,shed,and concentrated crystals in a visible form.It mainly includes red blood cells(RBC),white blood cells(WBC)and casts.Urine formed red blood cell and white blood cell test is an important indicator for clinical evaluation of kidney disease and urinary system disease.Because domestic and foreign urine formed reference measurement procedures are not unique,there is a lack of unified standard substance calibration automated analyzer,test data Lack of reliability and comparability.Therefore,the development of urine with fine red blood cells and the development of white blood cell reference materials has become an urgent need.In this paper,red blood cells and commercially available white blood cells obtained by centrifugation in pig blood were used as raw materials as two simulated particles of standard substances.By optimizing the preparation process of fixation,dispersion and packaging technology,different concentrations of red blood cells and white blood cell reference materials were prepared,and the sample appearance,p H value,electrical conductivity,osmotic concentration,specific gravity,refractive index,cell deformation rate,and dispersion rate were respectively prepared nature inspection.The Z2 full-automatic cell analysis counter was used to establish a reference material electrical impedance determination method,which was verified using a microscope count method,and compared with a commercially available reference material.The reference materials prepared in this paper were tested by automatic cell urine formation analyzers in many hospitals,and the expected results were obtained.The experimental results show that the appearance of the reference material sample is a cloudy suspension,the p H value is between 7.08 and 7.12,and the conductivity is15.00 ± 0.50 m S / cm.The osmotic concentration is 275 ± 10 mmol / L,the specific gravity and refractive index are 1.005 ± 0.003 and 1.3350 ± 0.0100,respectively,and the cell deformation rate is ≤40% and the dispersion rate is ≥95%.Statistical method analysis and evaluation showed that the homogeneity of the reference material is good,and it can be stably stored for 180 days under the conditions of 2-8 ℃ in the dark;the characteristic values of the reference material are: RBC-1: 955.7 ± 87.45;RBC-2:519.4 ± 58.87;RBC-3: 238.5 ± 37.02;WBC-1: 1044.6 ± 86.97;WBC-2: 554.9 ±55.96;WBC-3: 226.7 ± 26.83(pcs / μL,k = 2).There was no significant difference between the microscopic test results and the fixed values.The comparison of the two methods shows that the electrical impedance method is superior to the microscope method in all aspects.FUS2000,UF500i(two)and UF1000 i were used to detect thethree commonly used urine constituent analyzers.The results show that the three instruments have a recognition rate of standard substances above 85%.Therefore,the reference material prepared in this paper can be uniformly applied to the calibration of three instruments as a common reference range.