2003-2006年北京市各类艾滋病抗体检测筛查实验室确认符合率对比分析

目的通过分析2003-2006年北京市各类艾滋病抗体检测筛查实验室送检样本的确认符合率，为制定适合北京市艾滋病防治工作需要的抗体检测策略提供科学依据。方法北京市艾滋病确证中心实验室收到的HIV抗体筛查实验室送检的样本，首先同时用两种酶联试剂筛查，其一为阳性或两者均阳性的样本在本次研究中定义为“筛查阳性”，并进行蛋白免疫印迹（WB）方法确认。将北京市的所有艾滋病抗体检测筛查实验室分为5类，通过比较各类筛查实验室2003-2006年的“筛查阳性”样本的确认阳性率、确认阴性率、确认可疑率，制定出针对不同筛查实验室的抗体检测策略。结果监管系统和定点医院的筛查阳性样本确认阳性率最高，而血液系统的确认可疑率最高。结论目前北京市虽然属于艾滋病低流行地区，但在监管系统和定点医院（性病、艾滋病治疗定点医院、戒毒治疗定点医院）存在相对集中的高危人群。监管系统和定点医院的艾滋病抗体筛查阳性受检人群，适用于《全国艾滋病检测技术规范（2004年）》的WB替代检测策略Ⅱ。普通医院和疾控系统的受检人群属一般人群，仍然坚持采用常规HIV抗体检测策略。血液系统应该采取严谨规范的检测策略，应引入病毒载量检测技术提高HIV抗体检测中的不确定样本的鉴别诊断水平。     

2012 - 2017年武汉市HIV抗体确证检测结果分析

目的 对2012 - 2017年武汉市HIV初筛阳性样本的检测结果进行分析,了解武汉市HIV抗体确证情况。方法 依据《全国艾滋病检测技术规范（2009年版、2015年修订版）》对各筛查机构HIV筛查阳性反应的样本进行酶联免疫复核和免疫印迹确证试验。结果 2012 - 2017年武汉市艾滋病确证实验室共收到11 749份初筛阳性样本,经复核和确证试验,7 433份（63.26%）诊断为HIV - 1抗体阳性,3 780份（32.17%）为HIV - 1抗体阴性,536份（4.56%）为HIV - 1抗体不确定。阳性病例最多的年龄段为16 ～30岁。536例不确定样本中有156例（30.41%）进行了随访,120例（76.92%）确证为阳性,13例（8.33%）确证为阴性,23例（14.74%）仍为不确定。结论 2012 - 2017年武汉市HIV - 1抗体阳性数增长趋势明显,应进一步加强急性期和不确定结果病人的管理,做到早发现、早治疗。     

一种血液艾滋病病毒抗体免疫印迹试剂的现场评估

目的对Cambridge血液艾滋病病毒（HIV）-1抗体免疫印迹（WB）试剂进行现场评估并考核其在不同的HIV感染状态的人群中确认试验检测的敏感性和特异性.方法选取不同的现场,分别采集不同的HIV感染状态人群的血液样品,共计645份.经酶联免疫吸附试验（ELISA）检测后,分别使用Cambridge血液HIV-1抗体WB试剂盒和HIV blot 2.2 HIV-1/2型WB确认试剂盒进行平行对比试验.结果在已知既往HIV感染者中,Cambridge血液WB与Genelabs WB检测结果均为阳性,在此人群中上述2种确认试剂的敏感性均为100%.在398例HIV抗体ELISA检测为阴性的人群中,Cambridge血液WB试验23例为不确定;Genelabs血液WB试验86例为不确定,在此类人群中上述2种确认试剂的特异性分别为94.22%（375/398）和78.39%（312/398）.结论Cambridge血液HIV-1抗体WB试剂盒与Genelabs诊断公司的HIV blot 2.2 HIV-1/2型WB试剂盒的试验结果对比,在特异性方面前者优于后者.     

2013年HIV抗体免疫印迹试验确证不确定结果分析

摘要:目的　分析人类免疫缺陷病毒（HIV）抗体免疫印迹试验（WB）确证不确定结果的血清学特点及临床意义,探讨导致电化学发光法筛查假阳性且免疫印迹试验（WB）确证不确定的临床原因。方法　对四川大学华西医院2013年HIV抗体WB确证结果为不确定的107例患者的带型及其临床资料进行分析,其中有WB随访结果的患者47例以WB随访结果进行判断,无WB随访结果的患者60例,结合核酸（HIV-1 RNA）或HIV-1 P24抗原定量测定结果进行综合判断。结果　107例WB确证不确定患者共有16种带型,p24比例最高,占51.4%,其次是gp160+p24,占15.89%。env类、pol类、gag类分别占28.97%、6.54%、64.49%。在env类中,阳性患者的出现率最高,为67.74%,pol类和gag类分别为14.29%、2.90%。16例HIV抗体ELISA法和电化学发光法同时筛查阳性的患者,其最终结果为阳性的发生率为93.75%。83例最终确证结果为阴性的患者中,肿瘤患者的构成比最高,占27.71%。结论　在HIV抗体WB确证不确定的结果当中,env类提示HIV感染的作用最大;gag类大部分为非特异性反应。ELISA法和电化学发光法同时阳性时提示HIV阳性的可能性较大。疾病因素与HIV抗体WB不确定的发生相关。     

An alternative approach to confirming anti-HIV reactivity: a multi-country collaborative study.

The confirmation of positive screening assay reactions for antibodies to human immunodeficiency virus type 1 (anti-HIV-1) by Western blot is expensive and often gives indeterminate results. We therefore carried out a collaborative study to investigate the confirmation of screening assay reactions using a second screening assay. For this purpose, seven laboratories prospectively tested sequential specimens, using at least one additional screening assay, until about 50 confirmed anti-HIV-1-positive specimens had been identified in each test centre. The reactions of 16 assays were analysed in pairs (assay A and assay B), using assay B on specimens reactive in assay A: A+/B+ reactions were considered positive and A-, negative anti-HIV results. These outcomes were compared with those obtained using confirmatory Western blot. In all, 7950 specimens were tested, and 359 were reported as positive by the laboratories. Within the test centres, eight screening assay pairings gave rise to no false-positive or false-negative results, and these combinations were at least as accurate as a single screening assay followed by Western blot. From 6.3% to 8.3% of the Western blot results were indeterminate. The number of specimens examined was too small to justify recommending for general use named pairs of screening assays; the choice of these would, in any case, depend on local conditions. However, individual laboratory managers may wish to investigate the large potential savings to be made by confirming HIV infection using a second screening assay on initially reactive specimens. If the more sensitive screening assay is used first, the sensitivity of this approach may be improved by further investigation of specimens that react as A+B-.     

Successful use of pooled sera to estimate HIV antibody seroprevalence and eliminate all positive cases.

Pooling specimens when testing them in large numbers can save scarce resources and several earlier reports have indicated this to be a feasible strategy. In an HIV antibody mass screening test carried out in our laboratory, we used Dorfman's two-stage model. We sought to establish the optimal number of specimens in a pool, and to achieve maximum efficiency while maintaining both sensitivity and specificity. Before testing for HIV antibody, five positive samples were placed in a set of 1012 sera in a double blind manner, one positive sample into a second set of 1012 sera and none in a third set. The positive rate was assumed to be 0.2% for each set of 1012 sera. As indicated by our model, 22 individual serum samples were placed into each of 46 pools which, when tested by particle agglutination assays, lead to the identification of all positive samples. We concluded that the prevalence rate can be estimated in the first stage, 95% confidence intervals were given, and the efficiency rate could be calculated for the identification of all infected specimens in a large number of samples showing low prevalence rates.     

The use of saliva for the detection of IgG and anti-bodies against rubella virus: comparison of indirect ELISA and antibody capture immunoassay.

Serum and saliva specimens, collected simultaneously from 26 normal adult females, were tested for IgG and IgA antibodies to rubella virus by indirect ELISA and antibody capture assays. Antibody capture assays were found to be more sensitive than indirect ELISA for the detection of IgG and IgA antibodies in saliva samples whereas both assays were similar in sensitivity for the detection of IgG and IgA antibodies in serum samples. Comparison of the results obtained from serum and saliva samples showed that by an indirect ELISA test 13 out of the 22 seropositive subjects were also positive for antibodies in their saliva. So this test had 9 false negative results, whereas by an antibody capture assay 18 out of 22 seropositive subjects were also positive for antibody in saliva. Thus there were only 4 false negative results. Further comparison of results derived from testing serum and saliva are needed before recommending the use of saliva alone for detection of antibodies to rubella virus.     

南通市HIV抗体筛查阳性标本的确认结果分析

目的:通过对HIV抗体筛查(ELISA)阳性标本进行确认试验(WB),分析两者之间的关系。方法:按照《全国艾滋病检测技术规范》(2009版)的检测方法和要求,对南通市250例HIV抗体ELISA标本采用WB进行确认。结果:250例HIV抗体筛查阳性标本中,221例(88.4%)确认为HIV-1抗体阳性,22例(8.8%)为HIV抗体不确定,7例(2.8%)为HIV抗体阴性。阳性确认标本中,gp160、gp120、p66、p51、gp41、p31、p24的出现率均在90%以上,p55、p39和p17的出现率相对较低,分别为41.63%、37.56%、83.26%;不确定标本中,p24的出现率最高,为77.27%,其次是p160,为63.64%。结论:S/CO值越高,阳性确认率亦相应升高,但不能以此作为判别阳性的依据。对于不确定标本,除了加强随访外,还应积极寻求一种新的替代确认策略。     

Evaluation of a panel of commercial kits for the detection of serum HIV-specific antibodies, and choice of alternative strategies for the serological diagnosis in Libreville (Gabon)

Nine commercially available kits for the screening of serum antibodies to the human immunodeficiency virus (HIV) were evaluated with a panel of 170 serum samples from adults in Gabon. The reference procedures showed that 96 samples had no antibodies, while 74 produced antibodies to HIV-1 (n=72) or HIV-2 (n=2). The sensitivity for 2 kits was less than 99% and the specificity of 3 less than 95%. Based on the panel of Gabonese serum samples, 4 of the 9 kits met the World Health Organization (WHO) acceptability criteria: sensitivity greater than 99% and specificity greater than 95%. Three kits available in Gabon that met these criteria were finally retained: Determine HIV-1/2, Genscreen Plus HIV Ag-Ab, and Immunocomb II HIV1&2 BiSpot. Of 18 configurations of alternative diagnosis strategies for HIV infection with these three kits, some WHO strategy II configurations (2 sequential assays) and all the WHO strategy III configurations (3 sequential assays) provided the maximum accuracy in diagnosing HIV infection in Gabon (sensitivity, specificity, positive predictive value, negative predictive value of 100%). The configuration using the Determine HIV-1/2 kit as first screening assay, followed by Genscreen Plus HIV Ag-Ab as a confirmatory assay, and finally, Immunocomb II HIV1&2 BiSpot as the third assay to discriminate samples discordant with the two first assays, was best, with high accuracy and less expense. The configuration of the two sequential rapid assays, Immunocomb II HIV1&2 BiSpot followed by Determine HIV-1/2, was also very accurate and reliable, as well as easiest to carry out (no need for ELISA technology), but it was twice as expensive as the first configuration with three sequential kits. In conclusion, when the laboratory facilities are available, the sequential diagnostic strategy of two rapid assays and a combined ELISA assay constitutes the best configuration, in terms of both accuracy and cost. When laboratory facilities are unavailable, sequential use of two rapid assays constitutes a convenient and accurate configuration, but is much more expensive.     

艾滋病筛查阳性标本复检与确认试验结果的对比分析

目的通过HIV抗体酶联免疫吸附（ELISA）初筛试验与蛋白印迹（WB）确认试验结果的比对,探讨目前艾滋病检测存在的问题。方法对芜湖市2011年艾滋病筛查阳性标本复检与确证实验结果进行比对,并分析WB确认试验带型及感染者基本信息。结果 119份HIV抗体初筛阳性血清经WB确认80份阳性,23份阴性,16份不确定。其中,两种初筛试剂测试结果均阳性的93份标本经WB确认80份阳性,7份阴性,6份不确定;两种初筛试剂测试结果一阴一阳的26份血样经WB确认16份阴性,10份不确定。在80份HIV-1确认阳性标本中,P55条带出现次数最少,仅为50.00%。在16份不确定标本中,Gp160条带出现频率最高,占总不确定标本的62.50%。结论筛查弱阳性的标本尽量用筛查试剂排除,从而减少＂HIV抗体不确定＂结果。不确定结果与WB试验的假阳性有关,可结合流行病学资料对结果进行准确解释。     

人血液和尿液样本HIV-1抗体的ELISA 检测比较

目的 比较人的血液和尿液样本中HIV-1抗体的一致性。方法 在广东省两所劳动教养所收集346名HIV高危的血液和尿液样本，分别用血液和尿液ELISA初筛试剂检测HIV-1抗体。结果 346份血液和尿液样本各18份阳性，其中有17人的血液和尿液平行样本均为HIV—1抗体阳性，血液和尿液样本HIV-1抗体检测的一致性为99．4％。结论 在采集血液样本不便的情况下，可利用尿液ELISA初筛诊断试剂进行HIV感染的筛查和监测。     

Comparison between self-reported hepatitis B, hepatitis C, and HIV antibody status and oral fluid assay results in Irish prisoners

Self-reported hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV infection status was compared with the results of oral fluid assays of antibodies to these viruses in prisoners from nine of the 15 prisons in the Republic of Ireland. A total of 1205 out of 1366 prisoners completed a confidential questionnaire and 1193 provided analysable oral fluid specimens for testing for antibodies to HBV core antigen (anti-HBc), HCV (anti-HCV), and HIV (anti-HIV). The self-reported prevalence of hepatitis infection (hepatitis B: 5%; hepatitis C: 19%) was lower than that derived from oral fluid assays (anti-HBc: 9%; anti-HCV: 37%). The self-reported prevalence of HIV infection was similar to that found by oral fluid assay (2%). Many discrepancies were found between self-reported results and the results of oral fluid assays. Of those who reported being positive for HBV, HCV, or HIV, 48%, 5%, and 58%, respectively, tested negative on the oral fluid assay. Of those who reported a previous negative test result for HBV, HCV, or HIV, 10%, 37%, and 2%, respectively, had positive oral fluid assays. Self-reports of hepatitis and HIV infection status are unreliable and should not be used as a basis for planning preventive and treatment services for prisoners. All prisoners should have the opportunity to be tested for HBV, HCV, and HIV infection.     

三种HIV抗体确证试剂盒检测早期感染的比较

目的 比较3种HIV抗体确证试剂盒检测HIV早期感染的性能.方法 对5份HIV抗体阳性血浆样品进行10倍系列稀释,然后用ELISA检测.对检测结果呈阳性反应的稀释样品分别用3种HIV抗体确证试剂盒进行检测以测试其灵敏度,所用试剂盒包括北京万泰公司的HIV 1+2型抗体检测试剂盒(万泰RIBA)、新加坡MP公司的HIV 1+2型抗体检测试剂盒(MP-WB)和比利时Innogenetics公司的INNO-LIA TM HIV Ⅰ/ⅡScore(INNO-LIA).用这些试剂盒检测11套HIV抗体阳转血清盘中ELISA试验呈阳性反应的样品(共48份).结果 对HIV抗体阳性稀释样品的检测结果显示,当5份样品在稀释100倍时,万泰RIBA均检测出阳性结果.在ELISA试验呈阳性反应的48份HIV抗体阳转血清盘样品中,万泰RIBA、MP-WB和INNO-LIA的确证阳性率分别为97.92%(47/48)、81.25%(39/48)和91.67%(44/48).万泰RIBA与MP-WB之间差异有统计学意义(χ2=6.13,P＜0.05),INNO-LIA与MP-WB之间差异有统计学意义(χ2=5.48,P＜0.05),而万泰RIBA与INNO-LIA之间差异无统计学意义(χ2=1.33,P＞0.05).对于含有HIV抗体检测结果不确定样品的6套阳转血清盘,用万泰RIBA、MP-WB和INNO-LIA检测的平均阳转时间分别为0.7、13.3、3.7 d.结论 与我国目前常用的MP-WB相比,万泰RIBA和INNO-LIA可以缩短HIV抗体确证的窗口期.

Abstract：

Objective This study was to compare the performance of three HIV antibody confirmatory assay kits in confirming early HIV infection. Methods Five HIV antibody-positive plasma specimens were ten-fold serially diluted and then detected by ELISA. The above diluted specimens were detected with the following three HIV antibody coufirmatory assay kits to analyze their sensitivity, including Wantai-RIBA ( Recombinant immunoblot assay, Beijing Wantai Biological Pharmacy, China), MP-WB ( HIV Blot 2. 2 WB,MP Biomedicals Asia Pacific Pte. Ltd. ,Singapore) and INNO-LIA ( INNO-LIATM HIV Ⅰ/Ⅱ Score, Innogenetics N. V. , Belgium), respectively. These kits were further used to detect 48 ELISA-reactive specimens from 11 sets of HIV seroconversion specimens (a total of 48 sanples ) which were previously detected as HIV antibody-positive by ELISA. Results When 5 samples were diluted to 100 fold,Wantai-RIBA still can detect them positive. Among the 48 HIV antibody-positive specimens detected with ELISA,the confirmation positive rate for Wantai-RIBA, MP-WB and INNO-LIA were 97.92% (47/48),81.25 % ( 39/48 ) and 91.67% ( 44/48 ), respectively. There was statistically significant difference between the confirmatory results of Wantai-RIBA and MP-WB ( χ2 = 6. 13, P ＜ 0. 05 ), as well as between those of INNO-LIA and MP-WB ( χ2 = 5.48, P ＜ 0. 05 ); however, there was no statistically significant difference between those of Wantai-RIBA and INNO-LIA ( χ2 = 1.33, P ＞ 0. 05 ). For other six HIV seroconversion panels containing indeterminate specimens, the average seroconversion period of time for Wantai-RIBA,MP-WB and INNO-LIA were 0. 7,13.3 and 3.7 days, respectively. Conclusion Compared with MP-WB,Wantai-RIBA and INNO-LIA could reduce the window period to confirm early HIV infection.     

Influence of infection with non-filarial helminths on the specificity of serological assays for antifilarial immunoglobulin G4

Serological assays based on the detection of immunoglobulin (Ig) G4 antibodies to crude filarial extracts are widely used for epidemiological and diagnostic purposes. We tested 195 samples collected in 1998 from an area of Brazil where filariasis is not endemic and 13 (6.7%) had levels of antifilarial IgG4 antibodies that were defined as positive. Both Strongyloides infection and the presence of Strongyloides antibody responses were associated with higher antifilarial antibody responses. None of the specimens had a positive response to the Brugia malayi recombinant antigen (Bm14). These data suggest that serodiagnostic assays based on the use of crude filarial antigens should be interpreted with caution because of the potential for cross-reactivity with Strongyloides.     

Comparative evaluation of 36 commercial assays for detecting antibodies to HIV.

Summarized are the results of an assessment of the major operational characteristics of 36 commercially available assays for detection of antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2). For this purpose, 20 enzyme-linked immunosorbent assays (ELISAs), 11 simple immunoassays with visual reading, four supplemental assays, and one discriminatory assay were assessed using a panel of 537 sera (65% of which were of African, 26% of European, and 9% of South American origin); the prevalence of HIV-1 was 39.1% and of HIV-2, 15.7%. The following operational parameters of the assays were investigated: ease of performance; suitability for use in small blood collection centres; sensitivity and specificity; positive predictive values at different prevalences; inter-reader variability for simple assays whose results were read visually; the proportion of indeterminate results; and, for some of the ELISA assays, delta-values, as quantitative measures of sensitivity and specificity. The results will be of use to health policy decision-makers, managers of national AIDS prevention and control programmes, directors of blood banks, and laboratory specialists in the selection of appropriate HIV antibody assays.     

Assessment of serological assays for the diagnosis of HIV-1 infections.

Many serologic techniques are available for the detection of HIV-1 infection, but their diagnostic performances have been reported to vary depending on the testing situations. We evaluated eight different serologic assays for detecting HIV-1 antibody in sera from suspected high risk groups in North and East Africa. These included: one ELISA bead assay, three indirect ELISAs, two competitive ELISA assays, one gelatin agglutination assay and a recombinant dot-blot assay. A panel of 38 HIV-1 antibody confirmed positive human sera and a panel of 60 HIV negative sera were tested. All sera yielding discordant results were retested for verification of reactivity. Among the different assays evaluated for detecting HIV-1 antibody, sensitivities ranged from 0.919 to 0.974 and test efficiencies ranged from 94.2-98.9%. All assays failed to detect at least one western blot confirmed positive serum; three tests (Organon, DuPont recombinant and Serodia) produced only one false-negative result. Five of the eight assays did not produce any false-positive results. The Organon viral lysate and the DuPont recombinant ELISAs exhibited the best overall performance (test efficiency = 98.9%).     

同时检测4种传染病病原体的蛋白质微阵列研究

[目的]建立1种用蛋白质微阵列法可同时检测血清中艾滋病病毒（HIV）抗体、丙型肝炎病毒（HCV）抗体、梅毒螺旋体（TP）抗体和乙型肝炎病毒表面抗原的方法。[方法]将基因工程HIV、HCV、TP重组抗原和乙肝病毒单克隆抗体共价结合于固相载体玻片上，制成蛋白质微阵列。血清样本经稀释、加样、孵育、洗涤后，加上Cy3荧光标记物，用激光芯片扫描系统对蛋白质微阵列进行扫描成像。将获得的图像用Imagene专用分析软件进行分析，所获数据根据cutoff值自动生成判断结果。用此蛋白微阵列系统检测了100份4个项目皆阴性的血清标本，确定了其cutoff值。检测了经酶联免疫吸附试验（EUSA）筛选出4个项目皆阴性的标本40例；艾滋病病毒抗体阳性标本30例；乙肝表面抗原、丙肝抗体、梅毒特异性抗体阳性血清各100份。[结果]蛋白质微阵列法检测艾滋病病毒抗体、丙肝抗体和乙型肝炎表面抗原的阳性和阴性标本的符合率皆为100％，梅毒特异性抗体阳性符合率为97％，阴性符合率为100％。[结论]蛋白质微阵列法检测HIV、HCV、TP和HBsAg与EUSA法检测结果具有高度的符合率。该法具有高通量、快速、特异性强、操作简便等特点，适用于大规模样本的分析，在卫生检疫传染病检测方面具有应用和推广价值。     

Testing for antibodies to human immunodeficiency virus type 2 in the United States.

The Food and Drug Administration (FDA) has recommended that all donated blood be screened for antibodies to human immunodeficiency virus type 2 (HIV-2) beginning no later than June 1, 1992. This article provides CDC recommendations for the diagnosis of HIV-1 and HIV-2 infections in persons being tested in settings other than blood centers and CDC/FDA guidelines for serologic testing with combination HIV-1/HIV-2 screening enzyme immunoassays (EIAs). Epidemiologic data indicate that the prevalence of HIV-2 infections in persons in the United States is extremely low. Therefore, CDC does not recommend routine testing for HIV-2 in settings other than blood centers. However, when HIV testing is indicated, tests for antibodies to both HIV-1 and HIV-2 should be obtained if epidemiologic risk factors for HIV-2 infection are present, if clinical evidence exists for HIV disease in the absence of a positive test for antibodies to HIV-1, or if HIV-1 Western blot results exhibit the unusual indeterminate pattern of gag plus pol bands in the absence of env bands. The following procedures are recommended if testing for both HIV-1 and HIV-2 is performed by means of a combination HIV-1/HIV-2 EIA. A repeatedly reactive specimen by HIV-1/HIV-2 EIA should be tested by HIV-1 Western blot (or another licensed HIV-1 supplemental test). A positive result by HIV-1 Western blot confirms the presence of antibodies to HIV, and testing for HIV-2 is recommended only if HIV-2 risk factors are present. If the HIV-1 Western blot result is negative or indeterminate, an HIV-2 EIA should be performed. If the HIV-2 EIA is positive, an HIV-2 supplemental test should be performed.     

A comparative meta-analysis on the variability in test performance among FDA-licensed enzyme immunosorbent assays for HIV antibody testing

BACKGROUND: Although independently published studies have compared diagnostic test performance among various manufactured enzyme immunosorbent assays (EIAs) used in HIV antibody testing, none have attempted to formally synthesize such results through a comparative meta-analysis. In particular, no estimates of post-FDA approval test performance, in terms of sensitivity and specificity, and their associated variability within each manufacturer, has been reported in the literature, along with an analysis of the relative differences in manufacturer test performance in practice (after FDA approval). METHODS: Retrieval of studies was done using several searching strategies, while retrieval of manufacturer information was done through package inserts and direct contacts. Comparisons of HIV antibody test performance across manufacturers and within a single manufacturer were made based on 16 estimates (from 11 articles) and 33 estimates (from 19 articles), respectively. A generalized linear model, based upon Bayes estimates of sensitivity and specificity, was used to assess the impact of several study-level covariates on the performance of these EIAs, with overall estimates of manufacturer test performance and associated variability obtained based on generalized estimating equations. RESULTS: Estimates of test performance were obtained across studies, with a significant (P < 0.01) difference between manufacturers. The test performance of each manufacturer significantly interacted (P < 0.05) with the following study-level covariates: type of population screened, year of diagnostic testing and study quality. Among a single manufacturer, Abbott, significant improvement in estimates of test sensitivity (P < 0.01) and specificity (P < 0.01) was observed with each newly produced antibody kit. CONCLUSION: Estimates on the relative differences in test performance within each manufacturer may be used for guiding decisions on the choice of EIA test kit for HIV antibodies, given the type of population screened, as well as cost and time considerations. In addition, the results of this meta-analysis may be used in modeling HIV prevalence when used as prior information within a Bayesian framework or for standardizing test results among various manufacturers.     

人类免疫缺陷病毒抗体检测策略在不同人群中的应用研究

目的了解我国人类免疫缺陷病毒(HIV)检测技术规范在不同人群中的应用情况,对现行检测策略进行评价。方法 2007年组织14所武警艾滋病网络实验室收集数据,对临床就诊患者、新兵体检和HIV感染高危人群进行HIV抗体的横断面调查。结果新兵人群中HIV感染率最低,为0.0019%,临床就诊人群居中为0.089%,吸毒人群最高,达到4.1%;新兵人群和临床就诊人群的HIV不确定发生率显著不同(0.009%对0.038%,P0.05);确认效率在吸毒人群的最高,达到了100.0%明显高于临床就诊人群和新兵人群。结论我国现行的HIV抗体检测策略在不同人群中的应用效果不同,确认效率和检测者HIV高危行为有关。