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VISION-C全自动血沉仪的临床应用研究

发布时间:2018-09-10 17:24
【摘要】:目的:本研究基于Westergren法测量的基础上,对VISION-C全自动血沉仪的主要性能进行评价,确定其ESR值测量的可靠性,探讨VISION-C全自动血沉仪测量ESR的影响因素,并初步建立VISION-C全自动血沉仪的参考区间,为实验室VISION-C全自动血沉仪临床应用提供参考价值。方法:1.方法学评价1.1重复性评价:选取12例EDTA抗凝全血标本,其中包括ESR正常值、中值、高值标本各4例,分别用VISION-C全自动血沉仪重复检测21次,去掉第一次的测定结果,分析它们的变异系数(CV)值。1.2批间精密度评价:使用美国伯乐公司提供的正常值和高值两个水平的质控品,连续检测20天,初步评估VISION-C全自动血沉仪批间精密度。1.3稳定性评价:随机选取32例EDTA抗凝全血标本,使用VISION-C全自动血沉仪进行检测,检测时间段为:标本采集后,室温30分钟之内、室温放置2小时、4小时、8小时、12小时、24小时,以及4-8℃放置24小时,所得的检测结果与30分钟之内的检测结果相比较,评价VISION-C全自动血沉仪的稳定性。1.4灵敏度和特异度评价:随机选取1038例患者血液标本,用VISION-C全自动血沉仪测量其ESR值,以厂家提供的参考范围(男性0~15mm/h,女性0~20mm/h)判断阴性数和阳性数,以Westergren法为参考方法,计算VISION-C全自动血沉仪灵敏度和特异度。采用卡方检验,判断Westergren法和VISION法的灵敏度、特异度有无差异。1.5相关性分析:随机选取于2016年6月至2016年12月在吉林大学中日联谊医院门诊及住院患者1038例,对收集1038例患者血液标本用Westergren法和VISION-C全自动血沉仪分别进行实验室ESR值检测。两组数据差值进行正态性分布检验,对于符合正态分布资料采用配对t检验,不符合正态分布资料采用Wilcoxon符号秩检验,采用线性回归进行相关性分析。2.评估红细胞压积(HCT)对VISION-C全自动血沉仪检测值的影响对随机选取1038例患者血液标本测定其HCT值。其中低值HCT(0.4),Westergren法检测结果使用“Ordway-Singer图”贫血患者血沉值校正法校正,得出ESR真实数值,与VISION-C全自动血沉仪检测的ESR值做比较,评价HCT对VISION-C全自动血沉仪检测值的影响。3.评估血浆蛋白质对VISION-C全自动血沉仪检测值的影响在1038例患者血液标本中,随机选取323例(HCT≥0.4)标本用全自动特种蛋白分析仪测定其C反应蛋白,用VISION法和Westergren法分别测定ESR值,评价CRP对VISION-C全自动血沉仪检测血沉值的影响;随机选取67例(HCT≥0.4)标本用全自动出凝血分析仪测定其纤维蛋白原(FIB),用两种方法分别测定ESR值,评价FIB对VISION-C全自动血沉仪检测血沉值的影响;随机选取708例(HCT≥0.4)标本用全自动生化分析仪测定其白蛋白(ALB)、球蛋白(GLB)和总蛋白(TP),用两种方法分别测定ESR值,评价ALB、GLB和TP对VISION-C全自动血沉仪检测血沉值的影响;随机选取579例(HCT≥0.4)标本用全自动特种蛋白分析仪测定其免疫球蛋白Ig G,用两种方法分别测定ESR值,评价IgG对VISION-C全自动血沉仪检测血沉值的影响。4.评估脂血对VISION-C全自动血沉仪检测值的影响在1038例患者血液标本中,随机选取470例(HCT≥0.4)标本用全自动生化分析仪测定其总胆固醇(CHOL)和甘油三酯(TG),用VISION-C全自动血沉仪和Westergren法分别测定ESR值,评价血脂对VISION-C全自动血沉仪检测血沉值的影响。5.选取319例吉林大学中日联谊医院风湿免疫科已确诊为自身免疫性疾病的患者,采集EDTA抗凝血标本,评估临床疾病诊断中VISION-C全自动血沉仪检测值。6.设定VISION-C全自动血沉仪生物参考区间选取吉林大学中日联谊医院体检中心体检健康人群645例,常规采集EDTA抗凝血标本(排除溶血、乳糜血等外观不正常样本),用VISION-C全自动血沉仪测定其ESR值。不同性别和年龄分组的ESR测量结果经正态性检验,符合正态分布采用“(?)+1.65S”设定血沉值的参考区间,呈非正态分布采用百分位数“P95”设定血沉值的参考区间,初步设定VISION-C全自动血沉仪生物参考区间并验证。调查资料使用Epidata3.1双录入,应用SPSS17.0软件对数据进行统计分析,两组数据差值进行正态性分布检验,对于符合正态分布资料采用配对t检验,不符合正态分布资料采用Wilcoxon符号秩检验,组间两两比较采用LSD检验,采用线性回归进行相关性分析。检验水准为0.05,P0.05表示差异具有统计学意义。结果:1.VISION-C全自动血沉仪按12例标本ESR值由低到高,CV值依次为7.91%、5.63%、4.52%、3.88%、3.78%、3.72%、3.67%、3.56%、3.53%、2.89%、2.72%、2.61%,均低于10%;正常值和高值两个水平的质控品批间精密度分别为11.63%、6.20%;32例EDTA抗凝血标本稳定性结果显示:在室温放置2、4、6、12小时与30分钟内的ESR值差异均无统计学意义(P0.05),而在室温放置24小时、4-8℃下放置24小时后ESR值明显降低,与30分钟内的ESR值差异具有统计学意义(P0.05);1038例患者样本ESR测量灵敏度和特异度结果显示:VISION-C全自动血沉仪灵敏度为92.38%,特异度为92.20%,经卡方检验两种方法的灵敏度和特异度均无差异,P0.05。2.本研究中1038例患者中均来自吉林大学中日联谊医院的门诊及住院患者,性别主要为女性762人(73.4%);年龄范围为3~84岁,平均(44.36±14.72)岁。1038例患者,VISION法与Westergren法测量ESR相关性分析表明,两种方法呈显著线性正相关(Y=0.95X-1.01,r=0.886),两种方法测定结果差异具有统计学意义(Z=2.521,P=0.012)。3.在1038例患者标本中,HCT正常组居多(男性75%,女性65.6%)。结果显示,ESR值随着HCT值的降低而增加。在310例HCT低值(男性53例、女性257例)中,VISION法与Westergren法ESR值检测结果有显著性差异(P0.05),而与校正后的Westergren法ESR值检测结果无显著性差异(P0.05)。4.在323例(HCT≥0.4)CRP检测标本中,VISION法与Westergren法测量的ESR值随着CRP的升高而加快,VISION法加快较明显。各CRP分组中两种方法测定结果无差异(P0.05);在67例(HCT≥0.4)FIB检测标本中,两种方法测量的ESR值均随着FIB的升高而加快,各组中两种方法测定结果无差异(P0.05);在708例(HCT≥0.4)ALB检测标本中,两种方法测量的ESR值随着ALB的升高而减低,VISION法减低稍明显,各组中两种方法测定结果无差异(P0.05)。在GLB检测标本中,两种方法测量的ESR值随着GLB的升高而增加,各组中两种方法测定结果无差异(P0.05)。在TP分组中两种方法检测的ESR值,TP低组均比正常组和高组值高,各组中两种方法测定结果亦无差异(P0.05);在579例(HCT≥0.4)Ig G检测标本中,两种方法测定的ESR值在Ig G高组比正常组和低组值均高,Ig G正常组比低组ESR值均低,各组中两种方法测定结果无差异(P0.05);在470例(HCT≥0.4)CHOL和TG检测标本中,两种方法测定的ESR值在CHOL高组均比正常组值高。在CHOL低组和正常组中,两种方法测定结果无差异(P0.05),在CHOL高组中,两种方法测定结果差异有统计学意义(P0.05),同样两种方法测定的ESR值在TG正常组中结果无差异(P0.05),在TG高组中两种方法测定结果差异有统计学意义(P0.05)。5.在319例风湿免疫科的住院和门诊患者临床诊断中以RA居多(42.3%),不同病理情况下ESR值均高于正常水平。在RA、SLE、干燥综合征、强直性脊柱炎中两种方法测定结果无统计学意义(P0.05),而在甲状腺炎两种方法测定结果差异具有统计学意义(P0.05)。6.对645例健康人群建立VISION-C全自动血沉仪生物参考区间结果显示:男性2~60岁:0~10mm/h,60岁:0~24mm/h;女性2~50岁:0~22mm/h,50岁:0~26mm/h。结论:1.本研究中VISION-C全自动血沉仪测量ESR值具有较好的重复性、稳定性、灵敏度和特异度。2.VISION法与Westegren法测量ESR结果具有良好的相关性。本研究建立了该仪器在本实验室的参考区间:男性2~60岁:0-10mm/h,60岁:0-24mm/h;女性2~50岁:0-22 mm/h,50岁:0-26mm/h。3.VISION-C全自动血沉仪测量的ESR值与CRP、FIB和GLB值正相关、与ALB值负相关,不受低值HCT标本的影响,能为临床疾病诊断提供较准确的ESR测量值。高CHOL和TG对VISION-C全自动血沉仪测定ESR值的影响有待进一步评估。4.VISION-C全自动血沉仪缩短了血沉检测时间,可与血常规共用一个样本减少采血量,并在封闭环境下检测,避免了潜在的生物危害性。
[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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