本文選題：酶聯(lián)免疫吸附測(cè)定(ELISA)　切入點(diǎn)：Meta分析　出處：《江蘇省血吸蟲病防治研究所》2017年碩士論文

【摘要】：目前,日本血吸蟲病主要流行于我國(guó)湖區(qū)5省(安徽、湖北、湖南、江蘇、江西)和山區(qū)2省(四川、云南),血清學(xué)診斷在防治工作中發(fā)揮了重要的作用。關(guān)于血清學(xué)診斷方法檢測(cè)效能方面的研究開展的比較多,研究顯示血清學(xué)診斷方法在不同流行類型、流行程度、年齡及性別之間的檢測(cè)效能存在較大差異。隨著血吸蟲病防治工作的開展,人群感染率顯著下降,糞便檢查方法的低靈敏度問題日益突出。因此,探索一種能準(zhǔn)確估算人群血吸蟲感染率的統(tǒng)計(jì)學(xué)方法,對(duì)于評(píng)估當(dāng)前血吸蟲病疫情變化,協(xié)助制定防治策略十分重要。本研究首先根據(jù)Meta分析獲得的檢驗(yàn)效能篩選出較優(yōu)的檢測(cè)方法,然后采用貝葉斯分級(jí)模型,納入不同性別組和年齡組靈敏度與特異度等先驗(yàn)信息,構(gòu)建優(yōu)化后的血吸蟲病血清學(xué)貝葉斯模型,隨后利用構(gòu)建的模型對(duì)鎮(zhèn)江市丹徒區(qū)連續(xù)5年的血清庫(kù)數(shù)據(jù)進(jìn)行統(tǒng)計(jì)分析,分析人群估算血吸蟲感染率變化趨勢(shì),評(píng)估其防治效果。首先,通過對(duì)診斷實(shí)驗(yàn)結(jié)果進(jìn)行Meta分析,綜合評(píng)價(jià)不同流行程度下間接血凝實(shí)驗(yàn)(indirect hemagglutination test,IHA)、酶聯(lián)免疫吸附測(cè)定(enzyme-linked immunosorbent assay,ELISA)和膠體染料試紙條法(dipstick dye method,DDIA)的日本血吸蟲病診斷效果。IHA、ELISA與DDIA的加權(quán)合并靈敏度分別為0.83、0.87和0.90;加權(quán)合并特異度為0.69、0.60和0.62。IHA、ELISA和DDIA的總體SROC曲線下面積分別為0.89、0.96和0.92。ELISA曲線下面積大于IHA和DDIA,提示ELISA的診斷效能較高。然后對(duì)江西、安徽及湖北3省7個(gè)調(diào)查點(diǎn)的8248個(gè)樣本人群,同時(shí)開展Kato-Katz法(一糞三檢)病原學(xué)檢測(cè)與ELISA法血清學(xué)檢測(cè)。其中ELISA法在男性6~、10~、20~、30~、40~、50~和60~年齡組的靈敏度分別為0.7500、0.9500、1.0000、1.0000、0.9667、0.9512、1.0000和特異度分別為0.8898、0.6958、0.5105、0.4118、0.3549、0.3059、0.3180;ELISA法在女性6~、10~、20~、30~、40~、50~和60~年齡組的靈敏度分別為0.5000、0.8889、0.0000、0.9048、1.0000、0.9615、1.0000和特異度分別為0.8960、0.8193、0.6995、0.4930、0.4631、0.5086、0.5505。不同年齡組的靈敏度(t=16.231,P0.01)與特異度(t=7.727,P0.01)均有統(tǒng)計(jì)學(xué)差異。隨著年齡增加,男性與女性的靈敏度在6~30歲間呈上升趨勢(shì)后,趨于穩(wěn)定;其特異度均呈下降趨勢(shì),男性的特異度低于同年齡段的女性。第二,基于第一部分研究獲得的先驗(yàn)信息,利用威爾遜區(qū)間算法,得到不同年齡組、性別組的靈敏度與特異度95%可信區(qū)間。采用分層抽樣方法進(jìn)行樣本數(shù)據(jù)調(diào)查,年齡嵌套于性別、性別嵌套于村的巢式(nested)結(jié)構(gòu),同時(shí)納入了年齡組、性別靈敏度與特異度的先驗(yàn)分布信息,利用貝葉斯分級(jí)模型,從而構(gòu)建血吸蟲病血清學(xué)貝葉斯模型,并根據(jù)調(diào)查結(jié)果,驗(yàn)證模型;改變靈敏度、特異度等參數(shù)的先驗(yàn)分布范圍,開展模型敏感性分析。結(jié)果顯示不同樣本村莊(P=0.068,P0.05)、性別(男性:P=0.096,P0.05;女性:P=0.09,P0.05)和年齡組(P=0.266,P0.05)的模型估算感染率和真實(shí)感染率差異均無(wú)統(tǒng)計(jì)學(xué)意義,提示本研究構(gòu)建模型可以估算人群血吸蟲病感染率,不但解決了樣本數(shù)據(jù)相互嵌套的問題,而且可以提供樣本總體、性別及年齡組的估算血吸蟲病感染率。隨后,用ELISA法檢測(cè)江蘇省鎮(zhèn)江市丹徒區(qū)血吸蟲病國(guó)家監(jiān)測(cè)點(diǎn)連續(xù)5年的血清庫(kù)樣本(2011-2015年),開展血清ELISA法檢測(cè),并利用已經(jīng)構(gòu)建日本血吸蟲病血清學(xué)貝葉斯模型,推算人群血吸蟲病感染率變化趨勢(shì)。對(duì)血清庫(kù)的2180份血清樣本進(jìn)行檢測(cè),2012年血清學(xué)陽(yáng)性率最高為37.38%,2015年的最低為7.36%,2012年以后血清陽(yáng)性率通過趨勢(shì)分析呈逐年下降趨勢(shì),血清學(xué)檢測(cè)陽(yáng)性率存在統(tǒng)計(jì)學(xué)差異(P=0.0001,P0.05)。5年的估算人群感染率分別為1.288%、1.456%、1.032%、1.485%和1.358%,不同年份估算人群感染率差異無(wú)統(tǒng)計(jì)學(xué)差異(P=0.998,P0.05),提示2011-2015年此地區(qū)血吸蟲病傳播風(fēng)險(xiǎn)因素可能依然存在,需要繼續(xù)加強(qiáng)血吸蟲病風(fēng)險(xiǎn)監(jiān)測(cè),防治工作需要進(jìn)一步加強(qiáng)�？傊�,ELISA檢測(cè)方法具有較高的診斷效能;不同年齡組及性別組之間的靈敏度與特異度存在顯著差異;血吸蟲病血清學(xué)貝葉斯模型可以有效估算人群血吸蟲病感染率,用于血吸蟲病疫情評(píng)估。
[Abstract]:At present, schistosomiasis mainly popular in China's 5 provinces (Anhui, Hubei, Hunan, Jiangsu, Jiangxi) and 2 (Sichuan, Yunnan Province mountain), serological diagnosis plays an important role in the prevention and control work. Research on the serological diagnosis methods of the detection performance to carry out more research shows serological diagnostic method in different types of popular, popularity, there is a big difference between the detection performance of age and gender. With schistosomiasis prevention and control work, the infection rate decreased significantly, low stool examination method sensitivity problem has become increasingly prominent. Therefore, to explore a statistical method to estimate the schistosome infection rate, to evaluate the changes of schistosomiasis assist, the prevention and control strategy is very important. In this study, according to the analysis of Meta test efficiency can be obtained by selecting the optimum detection method, and then the Bias classification model, different gender and age groups included in the sensitivity and specificity of the prior information, the construction of the model after optimization of schistosomiasis serological Bias, then the Dantu District of Zhenjiang City, 5 consecutive years of data for statistical analysis using serum bank model, analysis of population estimate schistosome infection rate trends, evaluate the control effect. First of all, through the Meta analysis of diagnostic test results, comprehensive evaluation of different epidemic under the indirect hemagglutination test (indirect hemagglutination, test, IHA), enzyme-linked immunosorbent assay (enzyme-linked immunosorbent, assay, ELISA) and dipstick dye immunoassay (dipstick dye method, DDIA) in the diagnosis of schistosomiasis japonica.IHA, weighted sensitivity ELISA and DDIA were 0.83,0.87 and 0.90 respectively; the weighted specificity of 0.69,0.60 and 0.62.IHA, the overall SROC curve and DDIA under ELISA The area was 0.89,0.96 and the area under the 0.92.ELISA curve is greater than IHA and DDIA, suggesting that high diagnostic efficiency of ELISA. And then to Jiangxi, a sample of 8248 people in Anhui and Hubei 3 provinces in 7 survey, carried out at the same time Kato-Katz method (a fecal seized three) pathogen detection and serological detection method ELISA ELISA method in which. Male 6~, 10~, 20~, 30~, 40~, 50~ and 60~ groups were 0.7500,0.9500,1.0000,1.0000,0.9667,0.9512,1.0000 sensitivity and specificity for 0.8898,0.6958,0.5105,0.4118,0.3549,0.3059,0.3180; ELISA in 10~, 20~, female 6~, 30~, 40~, 50~ and 60~ age groups respectively. The sensitivity of 0.5000,0.8889,0.0000,0.9048,1.0000,0.9615,1.0000 sensitivity and specificity were of different age groups (0.8960,0.8193,0.6995,0.4930,0.4631,0.5086,0.5505. t=16.231, P0.01) and specificity (t=7.727, P0.01) were statistically significant with age. Increase the sensitivity of male and female increased among 6~30 years, tends to be stable; the specificity decreased, male specificity was lower than women the same age. Second, the first part of the study was based on a priori information, the use of Wilson interval algorithm, to different age groups, gender sensitivity group with a specificity of 95% confidence intervals. Using stratified sampling method to sample survey data, age nested in gender, gender in the village of nested nested (nested) structure, included in the same age group, gender sensitivity and specificity of the prior distribution of information, using the Bias classification model, so as to construct the schistosomiasis serological Bias model, and according to the survey the results validate the model; change the sensitivity, specificity and other parameters of the prior distribution range, carry out model sensitivity analysis. The results showed that different sample villages (P=0.068, P0.05), gender (male : P=0.096, P0.05; P=0.09, P0.05): women and age groups (P=0.266, P0.05) model to estimate the infection rate and the infection rate of real differences were not statistically significant, suggesting that this research model can estimate the schistosomiasis infection rate, not only solves the problem of mutual nested sample data, and can provide the overall sample. The estimation of schistosomiasis infection rate of sex and age groups. Then, ELISA was used to detect the Zhenjiang province Jiangsu city Dantu district national schistosomiasis monitoring points for 5 consecutive years, the serum sample library (2011-2015 years), to carry out the method of serum ELISA detection, and using the constructed schistosomiasis serological Bayesian model, population projections schistosomiasis infection rate trends. 2180 serum samples of serum pool were detected, the positive rate in 2012 was the highest in 2015 37.38% serum, the lowest was 7.36%, in 2012 after the serum positive rate through trend analysis Decreased year by year, there was a statistically significant difference between the positive rate of serological detection (P=0.0001, P0.05) to estimate the population during.5 infection rates were 1.288%, 1.456%, 1.032%, 1.485% and 1.358%, in different years estimated infection rate difference was statistically difference (P=0.998, P0.05), suggesting that the risk factors of schistosomiasis transmission in 2011-2015 years may still exist schistosomiasis, need to continue to strengthen risk monitoring, to further strengthen the prevention and control work required. In short, ELISA detection method has high diagnostic efficiency; between different age groups and gender groups the sensitivity and specificity of significant differences; schistosomiasis serological Bayesian model can effectively estimate the infection rate of schistosomiasis, for schistosomiasis epidemic situation assessment.

【學(xué)位授予單位】：江蘇省血吸蟲病防治研究所
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R532.21

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