CAJ | 학술논문

目的评估集合核酸检测方法在男男性行为人群(MSM)中的应用,探索适合该人群的HIV早期感染检测策略及应用该方法估算新发感染率的可行性.方法本研究共采集4 856份2008年4月至2009 年9月我国黑龙江省(4 156份样品)和北京市(700份样品)MSM人群的样品.分别经三代ELISA、四代ELISA和WB检测后,HIV阴性样品进行集合核酸检测.样品集合采用三级集合策略.并计算和比较"三代ELISA检测+WB"、"四代ELISA检测+WB"、"三代ELISA检测+WB+集合核酸检测"和"四代ELISA检测+WB+集合核酸检测"的HIV检测阳性率.4 156份黑龙江省MSM人群样品中符合条件的WB确认阳性样品纳入BED-捕获酶联试验 (BED-CEIA),并应用BED方法和集合核酸检测方法进行新发感染率估算.结果 4 856份样品中共有143份被判定为HIV阳性,其中经三代和四代ELISA检测为阳性的样品均为130份,窗口期感染样品13份.常规ELISA检测加核酸检测能最有效检测出MSM人群窗口期感染者;4种检测策略的HIV检测阳性率分别为:2.68%(95%CI 为2.22%～3.14%)、2.82%(95%CI 为2.35%～3.29%)、2.94%(95%CI 为2.46%～3.42%)和2.94%(95%CI 为2.46%～3.42%),差异无统计学意义(χ2=0.854 3,P=0.836 4).4 156份黑龙江省样品中有88份纳入BED检测,41份样品被判为新近感染.应用BED检测方法和集合核酸检测方法估算的HIV发病率分别为2.36%(95%CI 为1.63%～3.08%)和2.92%(95%CI 为1.01%～4.83%).结论 HIV集合核酸检测技术能有效地筛查出窗口期感染者,可用于我国MSM人群窗口期检测.
목적 평고집합핵산검측방법재남남성행위인군(MSM)중적응용,탐색괄합해인군적HIV조기감염검측책략급응용해방법고산신발감염솔적가행성.방법 본연구공채집4 856빈2008년4월지2009 년9월아국흑룡강성(4 156빈양품)화북경시(700빈양품)MSM인군적양품.분별경삼대ELISA、사대ELISA화WB검측후,HIV음성양품진행집합핵산검측.양품집합채용삼급집합책략.병계산화비교"삼대ELISA검측+WB"、"사대ELISA검측+WB"、"삼대ELISA검측+WB+집합핵산검측"화"사대ELISA검측+WB+집합핵산검측"적HIV검측양성솔.4 156빈흑룡강성MSM인군양품중부합조건적WB학인양성양품납입BED-포획매련시험 (BED-CEIA),병응용BED방법화집합핵산검측방법진행신발감염솔고산.결과 4 856빈양품중공유143빈피판정위HIV양성,기중경삼대화사대ELISA검측위양성적양품균위130빈,창구기감염양품13빈.상규ELISA검측가핵산검측능최유효검측출MSM인군창구기감염자;4충검측책략적HIV검측양성솔분별위:2.68%(95%CI 위2.22%～3.14%)、2.82%(95%CI 위2.35%～3.29%)、2.94%(95%CI 위2.46%～3.42%)화2.94%(95%CI 위2.46%～3.42%),차이무통계학의의(χ2=0.854 3,P=0.836 4).4 156빈흑룡강성양품중유88빈납입BED검측,41빈양품피판위신근감염.응용BED검측방법화집합핵산검측방법고산적HIV발병솔분별위2.36%(95%CI 위1.63%～3.08%)화2.92%(95%CI 위1.01%～4.83%).결론 HIV집합핵산검측기술능유효지사사출창구기감염자,가용우아국MSM인군창구기검측.
Objective To evaluate the application of pooling HIV nucleic acid amplification testing (NAAT) among men who had sex with men (MSM) population, and to investigate suitable HIV screening strategy and the feasibility of calculation of HIV incidence using pooling NAAT among MSM population in China.Methods Four thousand eight hundred and fifty-six samples were collected from MSM population from April 2008 to September 2009 among with 4 156 were in Heilongjiang province and 700 were in Beijing in China. After standard testing with an HIV ELISA and WB confirmation testing, HIV antibody-negative samples were pooled and screened for HIV using NAAT.A three-stage pooling strategy was adopted.The HIV positive rate estimated by the four HIV screening strategies was calculated.In addition, 4 156 HIV positive specimens from Heilongjiang province were screened with the BED capture enzyme immunoassay (BED-CEIA).The HIV-1 incidences were estimated by BED-CEIA assay and pooling NAAT individually.ResultsOne hundred and forty-three of 4 856 subjects were HIV infected.130 were 3rd and 4th generation ELISA positive; 13 were antibody-negative but acutely HIV infected.According to the evaluation of four HIV screening strategies, routine HIV screening test together with pooling NAAT was more effective than other strategies for screening out window period generation ELISA+WB+pooling NAAT' were 2.68%(95% confidence interval CI=2.22%-3.14%), 2.82%(95%CI=2.35%-3.29%), 2.94%(95%CI=2.46%-3.42%) and 2.94%(95%CI=2.46%-3.42%), respectively.The differences were not significant (χ2=0.854 3, P=0.836 4).Of the 88 HIV positive samples from Heilongjiang province, 44 participants were tested as recent HIV infections by BED-CEIA assay. The estimated HIV-1 incidence was 2.36% (95%CI=1.63%-3.08%) and 2.92% (95%CI=1.01%-4.83%) based on BED-CEIA assay and pooling NAAT,respectively.Conclusions Pooling NAAT is a effective screening test in HIV negative population to detect window period infection among MSM population in China.