VISION-C全自动血沉仪的临床应用研究
[Abstract]:Objective: Based on Westergren method, the main performance of VISION-C automatic ESR analyzer was evaluated, and the reliability of ESR measurement was determined. The influencing factors of ESR measurement by VISION-C automatic ESR analyzer were discussed, and the reference range of VISION-C automatic ESR analyzer was preliminarily established, which could be used as the laboratory VISION-C automatic ESR analyzer. Methods: 1. Methodological evaluation 1.1 Repetitive evaluation: 12 EDTA anticoagulant whole blood samples, including 4 normal, median and high ESR samples, were detected by VISION-C automatic ESR analyzer 21 times, the first results were removed, and their CV values were analyzed. Evaluation: Using two levels of quality control products, normal value and high value provided by Bole Company of the United States, continuous testing for 20 days, preliminary evaluation of inter-batch precision of VISION-C automatic ESR. 1.3 stability evaluation: 32 cases of EDTA anticoagulant whole blood samples were randomly selected and tested by VISION-C automatic ESR. The detection time period was: after sample collection, room. The stability of VISION-C automatic ESR was evaluated by comparing the results of two hours, four hours, eight hours, twelve hours, 24 hours and four to eight degrees centigrade at room temperature within 30 minutes. ESR values were measured by ESR, negative and positive numbers were judged by reference range (male 0-15mm/h, female 0-20mm/h). The sensitivity and specificity of VISION-C automatic ESR were calculated by Westergren method. Chi-square test was used to determine the sensitivity and specificity of Westergren method and VISION method. Analysis: 1038 outpatients and inpatients in Jilin University Sino-Japanese Friendship Hospital from June 2016 to December 2016 were randomly selected. The ESR values of 1038 blood samples were measured by Westergren method and VISION-C automatic ESR analyzer. The difference between the two groups was tested by normal distribution, and the data were collected by normal distribution. Wilcoxon symbolic rank test and linear regression were used to analyze the correlation. 2. To evaluate the influence of hematocrit (HCT) on the value of VISION-C automatic ESR, 1038 blood samples were randomly selected to determine the HCT value. "Ordway-Singer diagram" of anemia patients with ESR correction method, obtained the true ESR value, and VISION-C automatic ESR meter test ESR value for comparison, to evaluate the impact of HCT on the VISION-C automatic ESR meter test value. 3. Assess the plasma protein on the VISION-C automatic ESR meter test value in 1038 patients with blood samples, with A total of 323 specimens (HCT < 0.4) were selected to measure their C-reactive protein (CRP) by automatic special protein analyzer, and ESR values were measured by VISION and Westergren methods respectively to evaluate the effect of CRP on ESR values measured by VISION-C automatic ESR analyzer. Methods ESR values were measured to evaluate the effect of FIB on ESR values measured by VISION-C automatic ESR analyzer, and 708 samples (HCT < 0.4) were randomly selected to determine their albumin (ALB), globulin (GLB) and total protein (TP) by automatic biochemical analyzer. ESR values were measured by two methods, and the effects of ALB, GLB and TP on VISION-C automatic ESR were evaluated. To evaluate the effect of IgG on ESR by VISION-C automatic ESR analyzer. 4. To evaluate the influence of lipid and blood on the value of VISION-C automatic ESR analyzer in 1 038 blood samples of patients. Total cholesterol (CHOL) and triglyceride (TG) were measured by automatic biochemical analyzer. ESR values were measured by VISION-C automatic erythrocyte sedimentation meter and Westergren method respectively. The effects of blood lipids on ESR values were evaluated by VISION-C automatic erythrocyte sedimentation meter. 5. 319 Cases of Jilin University Sino-Japanese Friendship Hospital were selected. EDTA anticoagulant specimens were collected from patients with autoimmune diseases and evaluated by VISION-C automatic ESR. 6. 645 healthy people were selected from the physical examination center of China-Japan Friendship Hospital of Jilin University for routine collection of EDTA anticoagulant specimens (excluded). ESR values were measured by VISION-C automatic ESR analyzer for abnormal appearance samples such as hemolysis and chylous blood. The ESR results of different sex and age groups were tested by normality. The reference interval of ESR values was set by (?) + 1.65S for normal distribution. The reference interval of ESR values was set by percentile P95 for non-normal distribution. The biological reference interval of VISION-C automatic ESR was initially set up and validated. The investigation data were input by Epidata 3.1 and analyzed by SPSS17.0 software. The difference between the two groups of data was tested by normal distribution, and the data conforming to normal distribution were tested by paired t test, and the data not conforming to normal distribution were analyzed by Wilcoxon symbolic rank. Results: 1. VISION-C automatic ESR was 7.91%, 5.63%, 4.52%, 3.88%, 3.78%, 3.72%, 3.67%, 3.56%, 3.53%, 2.89%, 2.72%, 2.61%, respectively, according to 12 specimens. The stability of 32 EDTA anticoagulant samples showed that there was no significant difference in ESR values between 2,4,6,12 hours and 30 minutes at room temperature (P 0.05), but the ESR values were significantly decreased after 24 hours at room temperature and 24 hours at 4-8 degrees Celsius (P 0.05). The sensitivity and specificity of VISION-C automatic ESR were 92.38% and 92.20%, respectively. There was no difference in sensitivity and specificity between the two methods by chi-square test, P 0.05.2. All 1038 patients in this study were from Jilin University. There were 762 female outpatients (73.4%) and 1038 inpatients (44.36 + 14.72) aged from 3 to 84. The correlation analysis between VISION method and Westergren method showed that there was a significant linear correlation between the two methods (Y = 0.95X-1.01, r = 0.886). The results showed that the ESR value increased with the decrease of HCT value. In 310 patients with low HCT value (53 males and 257 females), there was a significant difference between VISION method and Westergren method (P 0.05), but there was a significant difference between VISION method and Westergren method (P 0.05). There was no significant difference (P 0.05). 4. In 323 CRP specimens (HCT < 0.4), the ESR values measured by VISION and Westergren methods increased with the increase of CRP, but the ESR values measured by VISION method were faster than that by Westergren method. With the increase of FIB, there was no difference between the two methods (P 0.05). In 708 ALB specimens (HCT < 0.4), the ESR values measured by the two methods decreased with the increase of ALB, but the ESR values measured by VISION method decreased slightly, and there was no difference between the two methods (P 0.05). In TP group, the ESR values of low TP group were higher than those of normal group and high TP group, and there was no difference between the two methods (P 0.05); in 579 Ig G samples (HCT < 0.4), the ESR values of the two methods were higher than those of normal group and high TP group. The ESR values of both groups were higher than those of the normal group and the low group, and there was no difference between the two methods (P 0.05). In 470 CHOL and TG samples (HCT < 0.4), the ESR values of the two methods were higher than those of the normal group. There was no difference between the low group and the normal group (P 0.05). The results of the two methods were statistically significant (P 0.05). There was no significant difference in the ESR values between the two methods in the normal group (P 0.05). In the high group of TG, the results of the two methods were statistically significant (P 0.05). 5. In the clinical diagnosis of 319 inpatients and outpatients in the Department of Rheumatology and immunology, RA was predominant (42.3%). There was no significant difference between the two methods (P 0.05) in the results of RA, SLE, Sjogren's syndrome and ankylosing spondylitis, but there was significant difference between the two methods in the results of thyroiditis (P 0.05). 6. Men 2-60 years old: 0-10 mm/h, 60 years old: 0-24 mm/h; women 2-50 years old: 0-22 mm/h, 50 years old: 0-26 mm/h. Conclusion: 1. In this study, VISION-C automatic ESR measurement has good reproducibility, stability, sensitivity and specificity. Reference interval: 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. ESR value measured by VISION-C automatic ESR meter was positively correlated with C RP, FIB and GLB value, negatively correlated with ALB value, not affected by low value HCT samples, and could provide more accurate ESR value for clinical diagnosis. The influence of ESR value determined by automatic ESR analyzer needs to be further evaluated. 4. VISION-C automatic ESR analyzer can shorten the time of ESR detection, share a sample with blood routine to reduce blood collection, and detect in a closed environment, avoiding potential biological hazards.
【学位授予单位】:吉林大学
【学位级别】:硕士
【学位授予年份】:2017
【分类号】:R446.11
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