本文選題：限制性抗原親和力酶免法 + BED捕獲酶免法��； 參考：《中國疾病預(yù)防控制中心》2014年碩士論文

【摘要】：背景 準(zhǔn)確的實驗室HIV新發(fā)感染檢測方法對于獲得橫斷面人群的HIV發(fā)病率,掌握HIV的流行動態(tài)、發(fā)現(xiàn)高發(fā)病率地區(qū)和高危人群,評價干預(yù)措施實施的效果具有重要意義。新一代HIV新發(fā)感染檢測方法-限制性抗原親和力酶免法(Limiting antigen avidity enzyme immunoassay, LAg-avidity EIA)在準(zhǔn)確性方面較現(xiàn)在普遍應(yīng)用的BED捕獲酶免法(BED Capture enzyme immunoassay, BED CEIA)方法有較大改進,對既往感染者錯分率低,受疾病進展和抗逆轉(zhuǎn)錄病毒治療(Antiretroviral Treatment,ART)影響小,因此可以獲得更加準(zhǔn)確的HIV發(fā)病率。 目的 一、比較LAg與BED方法在我國哨點橫斷面人群中應(yīng)用結(jié)果,為該方法在我國的推廣應(yīng)用和可能存在的問題提供參考； 二、結(jié)合哨點流行病學(xué)信息,對2011年哨點HIV感染率最高的MSM人群的HIV感染狀況和行為因素進行分析,為今后在該人群中開展有效防治措施提供依據(jù)。 材料和方法 一、收集2011年14省市自治區(qū)國家級HIV監(jiān)測哨點MSM、DUS、FSW和STD四類高危人群的新發(fā)感染檢測樣本1442份,用LAg方法進行檢測,將LAg方法HIV新發(fā)感染判定結(jié)果與BED方法HIV新發(fā)感染判定結(jié)果進行比較(BED結(jié)果來自各省檢測結(jié)果),比較兩種方法HIV新發(fā)感染判定結(jié)果的一致性；按照WHO推薦的新發(fā)感染實驗室檢測方法HIV發(fā)病率計算公式,應(yīng)用國際發(fā)表的LAg方法校正系數(shù)和我國發(fā)表BED方法系數(shù)分別計算LAg方法和BED方法獲得四類人群的HIV發(fā)病率,比較兩種方法獲得HIV發(fā)病率是否存在差異； 二、應(yīng)用前期研究中獲得LAg方法不同校正系數(shù)計算四類人群的HIV發(fā)病率,探討發(fā)病率計算的影響因素。不同校正系數(shù)分別為LAg方法以不同ODn值為判定界值(cutoff值)時國際和我國研究數(shù)據(jù)(數(shù)據(jù)未發(fā)表)； 三、從“艾滋病綜合防治數(shù)據(jù)信息系統(tǒng)”下載13省市自治區(qū)2011年MSM哨點問卷信息19613份,對各省市MSM人群的人口學(xué)信息、行為因素和血清學(xué)檢測結(jié)果進行描述；分析人口行為因素及梅毒、HCV感染對BED和LAg判定結(jié)果的影響；對HIV感染和新發(fā)感染的相關(guān)因素進行多元Logistic回歸分析。 結(jié)果 一、1442份樣本,LAg判定新發(fā)感染312份,新發(fā)感染比例為21.6%；BED判定404份為新發(fā)感染,新發(fā)感染比例為28.0%,配對Χ2檢驗兩種方法判定結(jié)果存在差異,LAg判定新發(fā)感染比例低于BED。兩種方法判定結(jié)果一致率為89.9%, Kappa值0.73。LAg和BED方法對不同人群新發(fā)感染判定結(jié)果存在差異：HIV感染率較高的MSM和DUS人群,LAg和BED方法新發(fā)感染判定結(jié)果不一致,LAg判定新發(fā)感染比例低于BED。MSM人群檢測樣本795份,LAg判定新發(fā)感染261份,BED判定新發(fā)感染323份,新發(fā)感染比例分別為32.8%、40.6%；DUS人群檢測樣本468份,LAg和BED判定新發(fā)感染分別3.0%(14/468)和7.9%(37/468)。FSW和STD人群兩種方法新發(fā)感染判定結(jié)果沒有統(tǒng)計學(xué)差異,可能與這類人群HIV感染率低,納入新發(fā)感染檢測樣本數(shù)量少有關(guān)。87份FSW樣本,LAg和BED判定新發(fā)感染樣本數(shù)分別為10份和14份；92份STD樣本兩種方法判定新發(fā)感染樣本數(shù)分別為27和30份。 二、LAg和BED方法獲得的四類人群HIV發(fā)病率沒有統(tǒng)計學(xué)差異,MSM、 DUS、FSW和STD人群,LAg獲得HIV發(fā)病率分別為3.94%(95%CI:3.32-4.56)、0.07%(95%CI:-0.01-0.15%)、0.06%(95%CI:0.02-0.09%)和0.17%(95%CI:0.10-0.24%); BED獲得HIV發(fā)病率分別為3.49%(95%CI:2.99-3.99%)、0.04%(95%CI:-0.01-0.15%)、0.04%(95%CI:0.01-0.07%)和0.12%(95%CI：0.07-0.18%)。 三、LAg方法不同國際校正系數(shù)計算獲得HIV發(fā)病率沒有統(tǒng)計學(xué)差異,LAg方法分別以1.0、1.5、1.75為cutoff值對應(yīng)國際系數(shù)計算四類人群HIV發(fā)病率結(jié)果：MSM人群HIV發(fā)病率分別為4.18%(95%CI：3.45-4.91%)、3.94%(95%CI：3.32-4.56%)和3.76%(95%CI:3.22-4.31%); DUS人群獲得的發(fā)病率分別為0.02%(95%CI：-0.04-0.08%)、0.07%(95%CI：-0.01-0.15%)和0.07%(95%CI:-0.01-0.14%); FSW人群發(fā)病率分別為：0.03%(95%CI：0-0.07%)、0.06%(95%CI：0.02-0.09%)和0.05%(95%CI：0.02-0.09%),STD人群不同cutoff值獲得HIV-1發(fā)病率均為0.17%。LAg分別以O(shè)Dn值1.0、1.5為cutoff值對應(yīng)我國校正系數(shù)計算獲得MSM HIV發(fā)病率2.97%(95%CI：2.54-3.41%)和2.92(95%CI:2.54-3.29%), DUS、FSW和STD人群HIV發(fā)病率分別為0.02%(95%CI:-0.02-0.07%)/0.03%(95%CI:-0.03-0.09%).0.02%(95%CI:0-0.05%)/0.04%(95%CI：0.01-0.07%)和0.12%(95%CI：0.06-0.18%)/0.13%(95%CI：0.08-0.18%),各人群LAg方法不同cutoff值對應(yīng)我國系數(shù)計算HIV發(fā)病率基本一致。LAg方法cutoff值為1.0和1.5時,我國系數(shù)計算MSM人群HIV發(fā)病率低于相同cutoff值國際系數(shù)計算結(jié)果,差異有統(tǒng)計學(xué)意義；其余人群我國和國際系數(shù)計算結(jié)果沒有統(tǒng)計學(xué)差異。 四、13省市哨點MSM調(diào)查對象HIV抗體陽性率為5.01%,平均年齡29.3歲,52.5%為21～30歲人群,62.1%未婚；漢族占95.8%,高中及以上文化程度占76.9%,艾滋病知識知曉率為91.3%。近6個月,同性性行為、同性商業(yè)性行為和異性性行為發(fā)生率分別為84.1%、8.0%和31.3%,梅毒感染率為8.1%。不同地區(qū)調(diào)查對象人口學(xué)特征和行為因素分布具有不同質(zhì)性。 五、13省市哨點MSM人群LAg判定新發(fā)感染217人,平均年齡30.2歲；BED檢測判定新發(fā)感染277人,平均年齡30.3歲。兩種方法判定HIV新發(fā)感染者在年齡、婚姻、戶籍、民族、文化程度、行為因素、梅毒、HCV感染等因素的分布沒有統(tǒng)計學(xué)差異。HIV新發(fā)人群50.0%以上年齡在21～30歲；與異性的婚姻狀況61.0%未婚；70.0%為以上為本地戶籍；90.0%以上為漢族。BED和LAg判定新發(fā)感染人群近6個月同性性行為、同性商業(yè)性行為和異性性行為發(fā)生率分別為87.4%/89.4%、7.6%/6.9%和27.8%/29.0%。BED判定HIV新發(fā)感染人群中梅毒陽性率為20.9%,LAg為19.4%。BED和LAg方法判定HIV新發(fā)感染者HCV抗體陽性率均為1.4%。 六、多因素Logistic回歸分析結(jié)果,地區(qū)、26歲以上,外地戶籍,初中文化程度,近6個月與同性發(fā)生性行為,無保護性性行為以及梅毒感染7個因素是HIV感染的危險因素；居住時間是HIV感染的保護因素。地區(qū)、外地戶籍,近6個月與同性發(fā)生性行為,無保護性性行為以及梅毒感染是BED判定新發(fā)感染危險因素。地區(qū)、外地戶籍,初中文化,近6個月與同性發(fā)生性行為,無保護性性行為以及梅毒感染6個因素是LAg判定的HIV新發(fā)感染危險因素。 結(jié)論 一、BED和LAg方法對哨點橫斷面樣本的判定結(jié)果存在差異；LAg判定的新發(fā)感染樣本數(shù)少于BED,可能與LAg對既往感染者的誤判率低有關(guān)； 二、國際公布LAg方法校正系數(shù)計算我國哨點人群HIV發(fā)病率與我國人群BED校正系數(shù)計算我國哨點人群HIV發(fā)病率結(jié)果基本一致。 三、除LAg界值在1.0和1.5時我國系數(shù)獲得MSM HIV發(fā)病率顯著低于國際系數(shù)計算結(jié)果之外,其余人群不同界值我國系數(shù)和國際系數(shù)獲得HIV發(fā)病率無統(tǒng)計學(xué)差異,與BED結(jié)果也沒有統(tǒng)計學(xué)差異。仍需進一步獲得我國人群LAg方法的窗口期和FRR。 四、MSM人群HIV感染率較高,高危行為普遍存在,部分地區(qū)梅毒感染率處于較高水平,仍需進一步加強MSM人群的行為干預(yù)。人口行為因素及梅毒、HCV感染對BED和LAg判定結(jié)果無影響。HIV感染者和新發(fā)感染者在人口學(xué)特征上存在差異；LAg和BED方法判定HIV新發(fā)感染危險因素在人口學(xué)特征上也存在差異。
[Abstract]:background
HIV new infection detection method in the laboratory is very important to obtain the incidence of HIV in the cross section population, to grasp the epidemic trend of HIV, to find the high incidence area and high risk population, to evaluate the effect of the intervention measures. The new generation of HIV new infection detection method, the restriction antigen affinity enzyme immunoassay (Limiting antigen avidit) Y enzyme immunoassay, LAg-avidity EIA) has a greater improvement in accuracy than the commonly used BED capture enzyme immunoassay (BED Capture enzyme immunoassay, BED CEIA) method, which has a low error rate for previously infected persons, less affected by disease progression and antiretroviral therapy, and thus can be obtained more. Accurate incidence of HIV.
objective
First, compare the application results of LAg and BED in sentinel cross sectional population in China, and provide reference for the popularization and application of this method in China.
Two, in combination with sentinel epidemiological information, the HIV infection status and behavioral factors of the MSM population with the highest HIV infection rate in 2011 were analyzed to provide the basis for the effective prevention and control measures in the population in the future.
Materials and methods
First, we collected 1442 new infection detection samples from four high-risk groups of high risk groups in 14 provinces and municipalities of 2011 in 14 provinces and municipalities. LAg method was used to detect 1442 new infection samples. The LAg method HIV new infection determination results were compared with the BED method HIV new infection determination results (BED results came from the provincial test results), and two methods HI were compared. V is consistent with the results of new infection determination; according to the formula of the HIV incidence of the new infection laboratory detection method recommended by WHO, the international published LAg method correction coefficient and the BED method coefficient in our country, the HIV incidence of the four groups of people is calculated by the LAg method and the BED method respectively, and the two methods are compared to obtain the HIV incidence. There are differences.
Two, using different correction coefficients of LAg method to calculate the HIV incidence of the group of four groups in the previous study, and discuss the influencing factors of the incidence of the incidence. The different correction coefficients are the LAg method with different ODn values as the boundary value (cutoff value), and the research data of our country (the data are not published).
Three, from the "AIDS comprehensive prevention and control data information system" to download the 2011 MSM sentinel questionnaire information from 13 provinces and municipalities, to describe the demographic information, behavioral factors and serological results of MSM population in various provinces and cities, and to analyze the effects of population behavior factors and syphilis, HCV infection on the results of BED and LAg, and HIV infection and Multivariate Logistic regression analysis was used to identify the related factors of new infection.
Result
One, 1442 samples, LAg identified 312 new infection, 21.6% new hair infection, 404 new hair infection, 28% new hair infection, 2 test of 2 test, and two methods, LAg determined that the ratio of new infection was lower than that of BED. two, and the Kappa value 0.73.LAg and BED methods were not good. There were differences in the results of new infection determination in the same group: MSM and DUS with high HIV infection rate were not consistent with the new infection determination results of LAg and BED, LAg determined that the proportion of new infection was 795 lower than that of BED.MSM population, LAg determined new infection 261, BED determined 323 NEW hair infection, and the ratio of new hair infection was 32.8%, 40.6%; DUS respectively. There were 468 samples of population detection, LAg and BED determined that there were no statistical differences between the two new infection methods of new hair infection, 3% (14/468) and 7.9% (37/468).FSW and STD respectively. It may be low in HIV infection rate in this group, and the number of new infection samples is less related to.87 FSW samples, LAg and BED determine the number of new infection samples, respectively. The total number of new infections was 27 and 30, respectively, for 10 and 14 samples and 92 STD samples two methods.
Two, the incidence of HIV in four groups of people with LAg and BED was not statistically different. The incidence of HIV in MSM, DUS, FSW and STD groups was 3.94% (95%CI:3.32-4.56), 0.07% (95%CI:-0.01-0.15%), 0.06% (95%CI:0.02-0.09%) and 0.17%, respectively, 3.49% (0.04%), respectively. -0.15%), 0.04% (95%CI:0.01-0.07%) and 0.12% (95%CI:0.07-0.18%).
Three, there was no statistical difference in the incidence of HIV in the LAg method, and the incidence of HIV in the four groups was calculated with the LAg method corresponding to the international coefficient of cutoff. The incidence of HIV in the MSM population was 4.18% (95%CI:3.45-4.91%), 3.94% (95%CI:3.32-4.56%) and 3.76% (95%CI:3.22-4.31%), respectively; The incidence of the group was 0.02% (95%CI:-0.04-0.08%), 0.07% (95%CI:-0.01-0.15%) and 0.07% (95%CI:-0.01-0.14%), and the incidence of FSW in the population was 0.03% (95%CI:0-0.07%), 0.06% (95%CI:0.02-0.09%) and 0.05% (95%CI:0.02-0.09%). The incidence of HIV-1 in STD crowds was all 0.17%.LAg on ODn values, respectively. 5 the incidence of MSM HIV was 2.97% (95%CI:2.54-3.41%) and 2.92 (95%CI:2.54-3.29%), DUS, FSW and STD were 0.02% (95%CI:-0.02-0.07%) /0.03% (95%CI:-0.03-0.09%) and 0.12% (0.12%) for the calculation of the correction coefficient in China. 8-0.18%), different cutoff values of different population LAg corresponding to China's coefficient calculation HIV incidence rate basically consistent.LAg method cutoff value is 1 and 1.5, our country coefficient calculation MSM population HIV incidence rate is lower than the same cutoff international coefficient calculation result, the difference has statistical significance; the rest of the population of our country and international coefficient calculation results are not statistically significant Difference.
Four, the positive rate of HIV antibody was 5.01%, the average age was 5.01%, the average age was 29.3, 52.5% was 21~30 years old, 62.1% was unmarried, the Han nationality accounted for 95.8%, the high school and above was 76.9%, the awareness rate of AIDS knowledge was nearly 6 months, homosexual sex, sex commercial sex and sex behavior were 84.1%, 8%, respectively, 8%. And 31.3%, syphilis infection rate was 8.1%.. The distribution of demographic characteristics and behavioral factors in different regions had different quality.
Five, 13 provinces and cities sentinel MSM population LAg determine 217 new infection, the average age of 30.2 years, BED detection and determination of new infection 277 people, the average age of 30.3 years. Two methods to determine the HIV new hair infection in the age, marriage, household registration, ethnic, cultural, behavioral factors, syphilis, HCV infection and other factors, there are no statistical differences in the distribution of.HIV new population 50 More than 21~30 years of age were in the age of 21~30; 61% were unmarried with the opposite sex marriage status; 70% was the local domicile; more than 90% of the Han.BED and LAg determined the sex behavior of the newly infected people for nearly 6 months, and the rate of sexual commercial sex and heterosexual behavior was 87.4%/89.4%, 7.6%/6.9% and 27.8%/29.0%.BED determined the new infection of the people. The positive rate of syphilis in the group was 20.9%, LAg was 19.4%.BED and LAg method. The positive rate of HCV antibody in new HIV infection was 1.4%..
Six, multiple factor Logistic regression analysis results, areas over 26 years old, foreign domicile, junior high school education, nearly 6 months with sex sex, unprotected sex and 7 factors of syphilis infection are risk factors for HIV infection; residence time is the protective factor of HIV infection. Unprotected sex and syphilis infection are the risk factors for BED to determine new infection. Region, local household registration, junior high school culture, sexual behavior of the same sex in the last 6 months, unprotected sex and 6 factors of syphilis infection are the risk factors for the new infection of HIV determined by LAg.
conclusion
First, there is a difference between the BED and LAg methods for sentinel cross sectional samples; the number of new infection samples determined by LAg is less than that of BED, which may be related to the low miscarriage rate of LAg to the previous infection.
Two, the correction coefficient of LAg method was published internationally to calculate the incidence of HIV in Chinese sentinel population and the BED correction coefficient of Chinese population to calculate the incidence of HIV in Chinese sentinel population.
Three, in addition to the LAg boundary value of 1 and 1.5, the incidence of MSM HIV in China is significantly lower than that of the international coefficient calculation. There is no statistical difference in the incidence of HIV in the other population values and international coefficients in the rest of the population, and there is no statistical difference from the BED results. It is still necessary to further obtain the window period and FRR. of the LAg method in the population of our country.
Four, the rate of HIV infection in the MSM population is high, high risk behavior is prevalent, and the rate of syphilis infection is at a high level in some areas. It is still necessary to further strengthen the behavioral intervention of the MSM population. Population behavior factors and syphilis, HCV infection has no influence on the.HIV infection and the new hair Dyer in the demographic characteristics of the BED and LAg determinant; LAg and BED square There were differences in demographic characteristics between HIV and new risk factors.
【學(xué)位授予單位】：中國疾病預(yù)防控制中心
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R512.91

【參考文獻】

相關(guān)期刊論文 前5條

1 楊東智;吳忠蘭;趙立華;關(guān)光玉;;BED發(fā)病捕獲酶聯(lián)法檢測寧夏男男性行為人群HIV新發(fā)感染[J];寧夏醫(yī)學(xué)雜志;2012年07期

2 梁姝;魏東兵;曾亞莉;胡瑩;馮燎;袁丹;劉紅露;余佳;;BED HIV-1發(fā)病捕獲酶免疫測定法檢測四川省2006年吸毒哨點HIV新發(fā)感染[J];中國艾滋病性病;2008年02期

3 楊莉;方清艷;馬艷玲;楊志芳;陳玲;陳會超;施玉華;賈曼紅;;自愿咨詢檢測人群艾滋病新發(fā)感染危險因素分析[J];中國公共衛(wèi)生;2012年10期

4 馬志凌;馬名駒;衛(wèi)大英;邊仕超;馬兆瑾;劉茜;廖強;梁姝;于海英;裴曉方;;涼山州2006～2011年吸毒哨點人群HIV-1新發(fā)感染研究[J];現(xiàn)代預(yù)防醫(yī)學(xué);2013年08期

5 于海英;葉藝;張娜;顏浩;邱茂鋒;王宇;蔣巖;;檢測HIV-1新發(fā)感染的限制性抗原親和力方法的重復(fù)性與穩(wěn)定性評價[J];中國艾滋病性病;2013年05期

，

本文編號：2072514