Study On Clinical Application Of VISION-C Automatic ESR Analyzer

Objective:Based on the Westergren method,this paper evaluates the main performance of VISION-C automatic ESR analyzer and determines the reliability of ESR measurement.It discusses the influencing factors of ESR measurement by VISION-C automatic ESR analyzer,and initially established of VISION-C automatic ESR analyzer test reference interval,which provided reference value for the clinical application of VISION-C automatic erythrocyte in laboratory.Methods:1.Methodological evaluation1.1 Reproducibility evaluation: 12 samples of EDTA anticoagulated whole blood samples,including ESR normal,median,high-value specimens of 4 cases,respectively,with VISION-C automatic ESR analyzer test instrument repeated detection 21 times,remove the first The results were analyzed and their coefficient of variation(CV)was analyzed.1.2 batch precision evaluation: the use of the United States Bole Corporation to provide the normal value and high value of the two levels of quality control,continuous testing for 20 days,the initial assessment of VISION-C automatic ESR analyzer inter-assay precision.1.3 stability evaluation: random selection of 32 cases of EDTA anticoagulant,the use of VISION-C automatic ESR analyzer test instrument to detect the detection period: the specimen collection,room temperature within 30 minutes,room temperature for 2 hours,4 hours,8 hours,12 hours,24 hours,and 4-8 ℃for 24 hours.The results obtained were compared with the results of 30 minutes to evaluate the stability of the VISION-C automatic blood test.1.4 Sensitivity and specificity evaluation: 1038 patients were randomly selected samples,with VISION-C automatic ESR analyzer to measure its ESR value to the manufacturer to provide the reference range(male 0 ~ 15 mm / h,women 0 ~ 20 mm /h)to determine Negative number and Positive number,the Westergren method as a reference method to calculate the sensitivity and specificity of VISION-C automatic ESR analyzer.The sensitivity and specificity of Westergren method and VISION method were determined by chi-square test.1.5 Correlation analysis: randomly selected from June 2016 to December 2016 in China-Japan Union Hospital of Jilin University outpatient and hospitalized patients in 1038 cases,the collection of 1038 cases of blood samples with Westergren method and VISION-C automatic ESR analyzer test Perform laboratory ESR value detection.The data were analyzed by the Wilcoxon sign test,and the linear regression was used to analyze the correlation analysis.2.To evaluate the effect of HCT on VISION-C automatic ESR analyzer testPatients were randomly selected from 1038 patients with blood samples to determine their HCT values.The low value of HCT(<0.4),Westergren test results using "Ordway-Singer anemia in patients with ESR correction" correction,obtained ESR true value,and VISION-C automatic ESR analyzer ESR value of the ESR value of the comparison,evaluation Effect of HCT on the detection of VISION-C automatic ESR analyzer3.To evaluate the effect of plasma protein on the VISION-C automatic ESR analyzer testIn 1038 patients with blood samples,323 samples(HCT≥0.4)were randomly selected.The CRP value was measured by automatic special protein analyzer.ESR was measured by VISION-C automatic ESR analyzer test and Westergren method respectively.The VISION-C automatic ESR analyzer test To detect the effect of ESR;67 samples(HCT≥0.4)were randomly selected and their FIB values were measured by automatic coagulation analyzer.ESR values were measured by two methods respectively.To evaluate the effect of FIB on the detection of ESR in VISION-C automatic ESR analyzer test;708 samples(HCT≥0.4)were randomly selected and their ALB、GLB and TP values were measured by automatic biochemical analyzer.ESR values were measured by two methods respectively.To evaluate the effect ofALB、GLB and TP on the detection of ESR in VISION-C automatic ESR analyzer test;579 samples(HCT≥0.4)were randomly selected and their Ig G values were measured by automatic special protein analyzer.ESR values were measured by two methods respectively.To evaluate the effect of Ig G on the detection of ESR in VISION-C automatic ESR analyzer test.4.To evaluate the effect of blood lipid on VISION-C automatic ESR analyzer testIn 1038 patients with blood samples,470 samples(HCT≥0.4)were randomly selected.The CHOL and TG were measured by automatic biochemical analyzer.The ESR values were measured by VISION-C automatic ESR analyzer test and Westergren method respectively.To evaluate the effect of blood lipid on VISION-C automatic ESR analyzer test.5.A total of 319 patients with autoimmune diseases who had been diagnosed as autoimmune diseases were enrolled in the Department of Rheumatology,China-Japan Union Hospital of Jilin University,and EDTA anticoagulant specimens were collected to evaluate the VISION-C automatic ESR analyzer test in clinical disease diagnosis.6.Set VISION-C automatic ESR analyzer biometric reference intervalA total of 645 healthy people in the physical examination center of the China-Japan Union Hospital of Jilin University were selected.The EDTA anticoagulant specimens were collected(abnormal samples such as hemolytic and chylous blood)were collected.The ESR values were measured by VISION-C automatic ESR analyzer test.ESR measurements of different sex and age groups were tested by normality and normalized distribution.The reference interval of ESR was set by ““(?)+1.65S””,and the non-normal distribution was given by the percentile “P95” ESR reference interval,the initial estimation of VISION-C automatic ESR analyzer bio-reference interval and verify.The data were analyzed by Epidata3.1,and SPSS17.0 software was used to analyze the data.The data of the two groups were tested by normal distribution.For the normal distribution data,the paired t test was used,which did not accord with the normal distribution data.Wilcoxon sign test,the LSD test was used to compare thetwo groups,the use of linear regression for correlation analysis,test level of 0.05,P <0.05 that the difference was statistically significant.Results:1.The CV value of the VISION-C automatic ESR analyzer test was 7.51%,5.63%,4.52%,3.88%,3.78%,3.72%,3.67%,3.56%,3.53%,2.89%,2.72% and 2.61%,respectively,which were 11.63% and 6.20%,respectively.The stability of the two samples of EDTA anticoagulant was stable at the two levels of normal and high The results showed that there was no significant difference in ESR values at room temperature for 2 hours,4 hours,6 hours,12 hours and 30 minutes(P> 0.05),and 24 hours at room temperature and 24 hours after 4~8℃.(P <0.05).The sensitivity and specificity of ESR in 1038 patients showed that the sensitivity and specificity of VISION-C automatic ESR analyzer test were 92.38% and the specificity was92.20%.The sensitivity and specificity of the two methods were no significant difference.(P> 0.05)2.In the study,1038 patients were outpatients and inpatients from China-Japan Union Hospital of Jilin University.The main sex was 762(73.4%).The age range was 3 to 84 years(mean,44.36 ± 14.72).1038 patients,VISION and Westergren method to measure ESR correlation analysis showed that the two methods showed a significant linear positive correlation(Y=0.95X-1.01,r=0.886).The difference between the two methods was statistically significant(Z = 2.521,P =0.012).3.In 1038 patients,the majority of HCT normal group(75% of men,65.6% of women).The results show that the ESR values increase with decreasing HCT values.In the 310 cases of low HCT(male 53 cases,female 257 cases),VISION method and the corrected Westergren method ESR value test results were significantly different(P <0.05),and corrected Westergren method ESR value test results There was no significant difference(P> 0.05).4.In the 323 cases(HCT≥0.4)CRP test specimens,VISION method and Westergren method measured ESR values with the increase in CRP accelerated,VISION method to speed up more obvious.The results of the two methods in each group were no significant difference(P> 0.05);In 67 FIB test specimens,the ESR values measured by both methods were accelerated with the increase of FIB.There was no significant difference between the two methods(P> 0.05);In 708 cases(HCT 0.4 or higher)propagated in the test specimen,two methods of measurement of the ESR value decreased with the rising of propagated,VISION method to reduce a little obvious,constituting the determination results of the two methods have no difference(P > 0.05).In GLB test specimens,two methods of measurement of the ESR value with increases with the rising of GLB,determination results between groups in the two methods have no difference(P > 0.05).In TP group of two kinds of methods to detect the ESR value,low TP group were higher than normal group and high value,the determination results of the two methods in each group had no difference(P > 0.05);In the 579 Ig G test specimens,the ESR values of the two methods were higher in the Ig G group than in the normal and low groups,and the ESR values in the Ig G normal group were lower than those in the low group.There was no significant difference between the two methods(P> 0.05);In 470 CHOL and TG samples,the ESR values measured in both methods were higher in the CHOL group than in the normal group.CHOL low group and normal group,the two methods did not measure the difference(P> 0.05).In the CHOL high group,the difference between the two methods was statistically significant(P <0.05).The same in the TG normal group,the ESR values of the two methods were not significantly different between the two methods(P> 0.05).There were significant differences between the two methods in TG high group(P <0.05).5.In the 319 cases of rheumatoid immunology inpatient and outpatient clinic patients with primary clinical diagnosis of RA(42.3%),different pathology ESR values were higher than normal levels.There was no statistically significant difference between RA,SLE,Sjogren’s syndrome,snkylosing spondylitis(P> 0.05),and the difference between the two methods of thyroiditis Statistically significant(P <0.05).6.The establishment of VISION-C automatic ESR analyzer bio-reference interval in 645 healthy people showed that male 2 ~ 60 years old: 0 ~ 10mm/h,> 60 years old: 0 ~ 24mm/h;female 2 ~ 50 years old: 0 ~ 22mm/h,> 50 years old: 0 ~26mm/h.Conclusions:1.In this study,VISION-C automatic ESR analyzer measurement ESR value has good repeatability,stability,sensitivity and specificity.2.The VISION method has a good correlation with the ESR results of the Westegren method.This study established the reference interval of the instrument in the laboratory: male 2 ~ 60 years old: 0 ~ 10 mm / h,> 60 years old: 0 ~ 24 mm / h;female 2 ~ 50 years old: 0 ~ 22 mm / h,> 50 years old: 0 ~ 26 mm / h.3.The ESR values measured by VISION-C automatic ESR analyzer test were positively correlated with CRP、FIB and GLB,which were negatively correlated with ALB and were not affected by low-grade HCT,and could provide more accurate ESR measurements for patients with clinical disease.The effect of high CHOL and TG on the determination of ESR values by VISION-C automatic ESR analyzer was to be further evaluated.4.VISION-C automatic ESR analyzer test to shorten the time of ESR,blood samples can be shared with a sample to reduce blood collection,and in a closed environment to detect,to avoid the potential biological hazards.