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VISION-C全自動(dòng)血沉儀的臨床應(yīng)用研究

發(fā)布時(shí)間:2018-09-10 17:24
【摘要】:目的:本研究基于Westergren法測(cè)量的基礎(chǔ)上,對(duì)VISION-C全自動(dòng)血沉儀的主要性能進(jìn)行評(píng)價(jià),確定其ESR值測(cè)量的可靠性,探討VISION-C全自動(dòng)血沉儀測(cè)量ESR的影響因素,并初步建立VISION-C全自動(dòng)血沉儀的參考區(qū)間,為實(shí)驗(yàn)室VISION-C全自動(dòng)血沉儀臨床應(yīng)用提供參考價(jià)值。方法:1.方法學(xué)評(píng)價(jià)1.1重復(fù)性評(píng)價(jià):選取12例EDTA抗凝全血標(biāo)本,其中包括ESR正常值、中值、高值標(biāo)本各4例,分別用VISION-C全自動(dòng)血沉儀重復(fù)檢測(cè)21次,去掉第一次的測(cè)定結(jié)果,分析它們的變異系數(shù)(CV)值。1.2批間精密度評(píng)價(jià):使用美國(guó)伯樂(lè)公司提供的正常值和高值兩個(gè)水平的質(zhì)控品,連續(xù)檢測(cè)20天,初步評(píng)估VISION-C全自動(dòng)血沉儀批間精密度。1.3穩(wěn)定性評(píng)價(jià):隨機(jī)選取32例EDTA抗凝全血標(biāo)本,使用VISION-C全自動(dòng)血沉儀進(jìn)行檢測(cè),檢測(cè)時(shí)間段為:標(biāo)本采集后,室溫30分鐘之內(nèi)、室溫放置2小時(shí)、4小時(shí)、8小時(shí)、12小時(shí)、24小時(shí),以及4-8℃放置24小時(shí),所得的檢測(cè)結(jié)果與30分鐘之內(nèi)的檢測(cè)結(jié)果相比較,評(píng)價(jià)VISION-C全自動(dòng)血沉儀的穩(wěn)定性。1.4靈敏度和特異度評(píng)價(jià):隨機(jī)選取1038例患者血液標(biāo)本,用VISION-C全自動(dòng)血沉儀測(cè)量其ESR值,以廠家提供的參考范圍(男性0~15mm/h,女性0~20mm/h)判斷陰性數(shù)和陽(yáng)性數(shù),以Westergren法為參考方法,計(jì)算VISION-C全自動(dòng)血沉儀靈敏度和特異度。采用卡方檢驗(yàn),判斷Westergren法和VISION法的靈敏度、特異度有無(wú)差異。1.5相關(guān)性分析:隨機(jī)選取于2016年6月至2016年12月在吉林大學(xué)中日聯(lián)誼醫(yī)院門(mén)診及住院患者1038例,對(duì)收集1038例患者血液標(biāo)本用Westergren法和VISION-C全自動(dòng)血沉儀分別進(jìn)行實(shí)驗(yàn)室ESR值檢測(cè)。兩組數(shù)據(jù)差值進(jìn)行正態(tài)性分布檢驗(yàn),對(duì)于符合正態(tài)分布資料采用配對(duì)t檢驗(yàn),不符合正態(tài)分布資料采用Wilcoxon符號(hào)秩檢驗(yàn),采用線性回歸進(jìn)行相關(guān)性分析。2.評(píng)估紅細(xì)胞壓積(HCT)對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)值的影響對(duì)隨機(jī)選取1038例患者血液標(biāo)本測(cè)定其HCT值。其中低值HCT(0.4),Westergren法檢測(cè)結(jié)果使用“Ordway-Singer圖”貧血患者血沉值校正法校正,得出ESR真實(shí)數(shù)值,與VISION-C全自動(dòng)血沉儀檢測(cè)的ESR值做比較,評(píng)價(jià)HCT對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)值的影響。3.評(píng)估血漿蛋白質(zhì)對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)值的影響在1038例患者血液標(biāo)本中,隨機(jī)選取323例(HCT≥0.4)標(biāo)本用全自動(dòng)特種蛋白分析儀測(cè)定其C反應(yīng)蛋白,用VISION法和Westergren法分別測(cè)定ESR值,評(píng)價(jià)CRP對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)血沉值的影響;隨機(jī)選取67例(HCT≥0.4)標(biāo)本用全自動(dòng)出凝血分析儀測(cè)定其纖維蛋白原(FIB),用兩種方法分別測(cè)定ESR值,評(píng)價(jià)FIB對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)血沉值的影響;隨機(jī)選取708例(HCT≥0.4)標(biāo)本用全自動(dòng)生化分析儀測(cè)定其白蛋白(ALB)、球蛋白(GLB)和總蛋白(TP),用兩種方法分別測(cè)定ESR值,評(píng)價(jià)ALB、GLB和TP對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)血沉值的影響;隨機(jī)選取579例(HCT≥0.4)標(biāo)本用全自動(dòng)特種蛋白分析儀測(cè)定其免疫球蛋白Ig G,用兩種方法分別測(cè)定ESR值,評(píng)價(jià)IgG對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)血沉值的影響。4.評(píng)估脂血對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)值的影響在1038例患者血液標(biāo)本中,隨機(jī)選取470例(HCT≥0.4)標(biāo)本用全自動(dòng)生化分析儀測(cè)定其總膽固醇(CHOL)和甘油三酯(TG),用VISION-C全自動(dòng)血沉儀和Westergren法分別測(cè)定ESR值,評(píng)價(jià)血脂對(duì)VISION-C全自動(dòng)血沉儀檢測(cè)血沉值的影響。5.選取319例吉林大學(xué)中日聯(lián)誼醫(yī)院風(fēng)濕免疫科已確診為自身免疫性疾病的患者,采集EDTA抗凝血標(biāo)本,評(píng)估臨床疾病診斷中VISION-C全自動(dòng)血沉儀檢測(cè)值。6.設(shè)定VISION-C全自動(dòng)血沉儀生物參考區(qū)間選取吉林大學(xué)中日聯(lián)誼醫(yī)院體檢中心體檢健康人群645例,常規(guī)采集EDTA抗凝血標(biāo)本(排除溶血、乳糜血等外觀不正常樣本),用VISION-C全自動(dòng)血沉儀測(cè)定其ESR值。不同性別和年齡分組的ESR測(cè)量結(jié)果經(jīng)正態(tài)性檢驗(yàn),符合正態(tài)分布采用“(?)+1.65S”設(shè)定血沉值的參考區(qū)間,呈非正態(tài)分布采用百分位數(shù)“P95”設(shè)定血沉值的參考區(qū)間,初步設(shè)定VISION-C全自動(dòng)血沉儀生物參考區(qū)間并驗(yàn)證。調(diào)查資料使用Epidata3.1雙錄入,應(yīng)用SPSS17.0軟件對(duì)數(shù)據(jù)進(jìn)行統(tǒng)計(jì)分析,兩組數(shù)據(jù)差值進(jìn)行正態(tài)性分布檢驗(yàn),對(duì)于符合正態(tài)分布資料采用配對(duì)t檢驗(yàn),不符合正態(tài)分布資料采用Wilcoxon符號(hào)秩檢驗(yàn),組間兩兩比較采用LSD檢驗(yàn),采用線性回歸進(jìn)行相關(guān)性分析。檢驗(yàn)水準(zhǔn)為0.05,P0.05表示差異具有統(tǒng)計(jì)學(xué)意義。結(jié)果:1.VISION-C全自動(dòng)血沉儀按12例標(biāo)本ESR值由低到高,CV值依次為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%;正常值和高值兩個(gè)水平的質(zhì)控品批間精密度分別為11.63%、6.20%;32例EDTA抗凝血標(biāo)本穩(wěn)定性結(jié)果顯示:在室溫放置2、4、6、12小時(shí)與30分鐘內(nèi)的ESR值差異均無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),而在室溫放置24小時(shí)、4-8℃下放置24小時(shí)后ESR值明顯降低,與30分鐘內(nèi)的ESR值差異具有統(tǒng)計(jì)學(xué)意義(P0.05);1038例患者樣本ESR測(cè)量靈敏度和特異度結(jié)果顯示:VISION-C全自動(dòng)血沉儀靈敏度為92.38%,特異度為92.20%,經(jīng)卡方檢驗(yàn)兩種方法的靈敏度和特異度均無(wú)差異,P0.05。2.本研究中1038例患者中均來(lái)自吉林大學(xué)中日聯(lián)誼醫(yī)院的門(mén)診及住院患者,性別主要為女性762人(73.4%);年齡范圍為3~84歲,平均(44.36±14.72)歲。1038例患者,VISION法與Westergren法測(cè)量ESR相關(guān)性分析表明,兩種方法呈顯著線性正相關(guān)(Y=0.95X-1.01,r=0.886),兩種方法測(cè)定結(jié)果差異具有統(tǒng)計(jì)學(xué)意義(Z=2.521,P=0.012)。3.在1038例患者標(biāo)本中,HCT正常組居多(男性75%,女性65.6%)。結(jié)果顯示,ESR值隨著HCT值的降低而增加。在310例HCT低值(男性53例、女性257例)中,VISION法與Westergren法ESR值檢測(cè)結(jié)果有顯著性差異(P0.05),而與校正后的Westergren法ESR值檢測(cè)結(jié)果無(wú)顯著性差異(P0.05)。4.在323例(HCT≥0.4)CRP檢測(cè)標(biāo)本中,VISION法與Westergren法測(cè)量的ESR值隨著CRP的升高而加快,VISION法加快較明顯。各CRP分組中兩種方法測(cè)定結(jié)果無(wú)差異(P0.05);在67例(HCT≥0.4)FIB檢測(cè)標(biāo)本中,兩種方法測(cè)量的ESR值均隨著FIB的升高而加快,各組中兩種方法測(cè)定結(jié)果無(wú)差異(P0.05);在708例(HCT≥0.4)ALB檢測(cè)標(biāo)本中,兩種方法測(cè)量的ESR值隨著ALB的升高而減低,VISION法減低稍明顯,各組中兩種方法測(cè)定結(jié)果無(wú)差異(P0.05)。在GLB檢測(cè)標(biāo)本中,兩種方法測(cè)量的ESR值隨著GLB的升高而增加,各組中兩種方法測(cè)定結(jié)果無(wú)差異(P0.05)。在TP分組中兩種方法檢測(cè)的ESR值,TP低組均比正常組和高組值高,各組中兩種方法測(cè)定結(jié)果亦無(wú)差異(P0.05);在579例(HCT≥0.4)Ig G檢測(cè)標(biāo)本中,兩種方法測(cè)定的ESR值在Ig G高組比正常組和低組值均高,Ig G正常組比低組ESR值均低,各組中兩種方法測(cè)定結(jié)果無(wú)差異(P0.05);在470例(HCT≥0.4)CHOL和TG檢測(cè)標(biāo)本中,兩種方法測(cè)定的ESR值在CHOL高組均比正常組值高。在CHOL低組和正常組中,兩種方法測(cè)定結(jié)果無(wú)差異(P0.05),在CHOL高組中,兩種方法測(cè)定結(jié)果差異有統(tǒng)計(jì)學(xué)意義(P0.05),同樣兩種方法測(cè)定的ESR值在TG正常組中結(jié)果無(wú)差異(P0.05),在TG高組中兩種方法測(cè)定結(jié)果差異有統(tǒng)計(jì)學(xué)意義(P0.05)。5.在319例風(fēng)濕免疫科的住院和門(mén)診患者臨床診斷中以RA居多(42.3%),不同病理情況下ESR值均高于正常水平。在RA、SLE、干燥綜合征、強(qiáng)直性脊柱炎中兩種方法測(cè)定結(jié)果無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),而在甲狀腺炎兩種方法測(cè)定結(jié)果差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。6.對(duì)645例健康人群建立VISION-C全自動(dòng)血沉儀生物參考區(qū)間結(jié)果顯示:男性2~60歲:0~10mm/h,60歲:0~24mm/h;女性2~50歲:0~22mm/h,50歲:0~26mm/h。結(jié)論:1.本研究中VISION-C全自動(dòng)血沉儀測(cè)量ESR值具有較好的重復(fù)性、穩(wěn)定性、靈敏度和特異度。2.VISION法與Westegren法測(cè)量ESR結(jié)果具有良好的相關(guān)性。本研究建立了該儀器在本實(shí)驗(yàn)室的參考區(qū)間:男性2~60歲:0-10mm/h,60歲:0-24mm/h;女性2~50歲:0-22 mm/h,50歲:0-26mm/h。3.VISION-C全自動(dòng)血沉儀測(cè)量的ESR值與CRP、FIB和GLB值正相關(guān)、與ALB值負(fù)相關(guān),不受低值HCT標(biāo)本的影響,能為臨床疾病診斷提供較準(zhǔn)確的ESR測(cè)量值。高CHOL和TG對(duì)VISION-C全自動(dòng)血沉儀測(cè)定ESR值的影響有待進(jìn)一步評(píng)估。4.VISION-C全自動(dòng)血沉儀縮短了血沉檢測(cè)時(shí)間,可與血常規(guī)共用一個(gè)樣本減少采血量,并在封閉環(huán)境下檢測(cè),避免了潛在的生物危害性。
[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.
【學(xué)位授予單位】:吉林大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2017
【分類(lèi)號(hào)】:R446.11

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