就医人群HIV1/2抗体检测的结果分析

目的探讨门诊就诊者HIV1/2抗体筛查检测的效果及其分布特点。方法用第四代酶联免疫吸附试验(ELISA)试剂检测HIV1/2的抗原及抗体,阳性的样本经复检后仍为阳性即送杭州市疾病预防控制中心进行免疫印迹(Western blot)确证试验。结果 147 229份血液标本初筛阳性165例,检出率0.11%,确证阳性90例,阳性率0.07%,两者符合率为54.55%。确证阳性样本,筛查检测S/CO平均值为19.34;不确定人数6例,占3.64%,在追踪观察中2例患者2个月后确证为阳性。确证阳性样本逐年上升,且以19~45岁男性居多。结论第四代酶联免疫吸附试验(ELISA)试剂检测HIV1/2抗原及抗体的检测具有很高的敏感性;本地区就诊者中HIV1/2抗体阳性者主要集中在19~45岁男性,应引起相关部门的重视。     

影响HIV抗体初筛检测质控因素的分析

目的为提高AIDS初筛实验室检测质量,最大限度地减少HIV抗体检测可能出现的错误和误差。方法采用双抗原夹心酶联免疫法(ELISA)和免疫层析快速诊断试剂(金标法)测定血清中的HIV抗体。结果经重复试验和确诊试验,其假阳性率分别为30.0%和22.2%。结论需严格控制实验条件,提高实验准确率。     

南京市6774份HIV抗体初筛阳性标本复检与确证结果分析

目的：分析南京市2012-2017年6774份HIV抗体初筛、复检与确证实验的准确性。方法：对2012年1月－2017年12月该市艾滋病筛查实验室初筛阳性送检样本6774份,采用两种酶标法和金标法进行复检,复检阳性可疑标本进行免疫印迹法(WB) 确证检测。结果：6774 份初筛阳性标本经金标和酶标复检,复检双阳4821份,其中确证阳性4736份,确证阴性3份,不确定82份。金标和酶标复检单阳97份,其中确证阴性51份,阳性3份,不确定43份。2012-2017年HIV不确定率分别为1.5%,1.8%,1.9%,2.2%,2.3%,2.6%。结论：HIV初筛假阳性增多现象应引起重视;随着HIV不确定率逐年增多,需要找到快速鉴别HIV抗体的方法。     

2017年—2019年松江区人类免疫缺陷病毒抗体筛查阳性标本的确证假阳性结果分析

目的 了解上海市松江区的人类免疫缺陷病毒(HIV)感染状况,探索HIV抗体确证假阳性结果的影响因素,为制定针对性的艾滋病(AIDS)防治措施提供科学依据。方法 收集2017年—2019年上海市松江区各医疗机构送检的HIV抗体初筛阳性标本,对相关数据进行整理分析,采用Logistic回归模型分析确证假阳性的相关影响因素。结果 2017年—2019年松江区HIV初筛检测标本共656 955份,其中阳性934份,初筛阳性率为1.42‰。将其中526份初筛阳性标本进行确证试验,发现假阳性170份。多因素Logistic回归分析结果显示：女性(OR=7.804,95%CI:4.540～13.783)、≥60岁(OR=2.671,95%CI:1.267～5.740)、上海户籍(OR=3.532,95%CI:1.935～6.658)、已婚/离异(OR=2.263,95%CI:1.487～3.494)、医疗机构送检(OR=4.552,95%CI:1.321～17.081)和被动检测(OR=3.788,95%CI:1.408～11.437)是确证假阳性的主要影响因素。结论 应加强AIDS的健康宣教,动员...     

赣州市569份HIV抗体初筛阳性标本复检与确证结果分析

目的了解赣州市不同人群HIV抗体感染状况,探讨HIV抗体初筛、复检与确证实验的准确性,为指导与提高各筛查实验室的检测水平提供依据。方法对2002年1月-2009年12月该市艾滋病筛查实验室经酶联免疫吸附试验初筛阳性送检样本569份,采用两种ELISA试剂和金标法进行复检,复检阳性可疑标本进行免疫印迹法(WB)确证检测,并对其结果进行回顾性分析。结果 569份初筛阳性标本复检总符合率为38.84%(221/569),确证阳性符合率为68.33%(151/221)。确证阴性59份,不确定11份。不确定中出现gp160+p24条带5份;p24单条带3份;gp160和p17单条带各1份;p39+p24条带1份。ELISA法复检符合率为61.54%(24/39),确证阳性符合率50.00%(12/24)。ELISA法和金标法复检符合率为34.34%(182/530),确证阳性符合率为98.58%(139/141)。在确证的151份HIV阳性感染者中,男性100份(占66.23%),女性51份(占33.77%),两者差异有统计学意义(P<0.01)。HIV阳性感染者有年龄增长趋势,多为40~和50~年龄段。结论采用ELISA加金标试剂复核,可剔除筛查实验室假阳性标本,提高确证的阳性符合率,降低检测成本。     

基层医院梅毒螺旋体抗体筛查方法比较及筛查流程探讨

目的:探讨基层医院梅毒螺旋检测的筛查方法及流程。方法:对9169份标本分别应用酶联免疫方法,胶乳凝集方法,血浆反应素卡试验进行梅毒螺旋体特异性抗体和非特异性抗体的检测,其结果与梅毒螺旋体抗体颗粒凝集试验确证方法的结果相比较。结果:9169份标本中,ELISA方法检测出的83例阳性标本经TPPA确证后79例阳性占95.18%;胶乳快速法检测出的96例阳性标本经TPPA确证76例阳性占79.17%;两种方法双阳性的77例标本经TPPA确证76例为阳性占98.70%。RPR法检测到37份阳性标本,经TPPA确证34份阳性占91.89%。初筛ELISA,胶乳快速法,RPR三种方法均阳性的34例,与经TPPA确证均为阳性为100%。结论:对于基层医院可以用ELISA方法进行筛查,用胶乳法复检,并用RPR法做传染性的检测,适当改进筛查流程确保梅毒螺旋体的检查。     

化学发光微粒子免疫分析检测HIV抗体的高灵敏度及低值阳性结果分析与处理

目的分析化学发光微粒子免疫分析(CMIA)在人类免疫缺陷病毒(HIV)筛查检测中的高灵敏度,统计低值阳性结果,分析原因及提出处理措施。方法对医院门诊和住院部2016年1月-2018年8月需要HIV筛查的患者,通过CMIA法进行检测,采用化学发光免疫分析(CLIA)、胶体金、胶体硒方法复检,初筛两种方法阳性标本进行确证试验。结果 254 035例患者血清标本共筛查出阳性样本2 976例,其中低值阳性796例。确证试验结果为阳性及不确定标本共2 180例,其中低值阳性中检出HIV确证阳性7例,不确定57例。CMIA法检测阳性结果中与WB结果比较假阳性率为26.75%,低值阳性时(1S/CO值100)假阳性率高,且假阳性率随S/CO值增大而降低(P0.05)。三种方法复检:CMIA法检测低值阳性结果,阳性符合率随S/CO值增大而增加(P0.05)。结论 CMIA法检测HIV抗体的灵敏度高于CLIA法、胶体金、胶体硒方法,但同时也增加了假阳性率,在CMIA法低值阳性结果时应采用多种方法复检,并结合临床资料及确证试验结果综合判断。     

第四代电化学发光HIV筛查试剂在AIDS诊断中的应用探讨

目的对比人类免疫缺陷病毒(HIV)抗体第四代电化学发光免疫分析(ECLIA)试剂筛查结果与免疫印迹试验(WB)结果,评估ECLIA法HIV筛查在艾滋病诊断中的临床价值。方法 ECLIA法对2016年1月-2019年8月本院109 649例患者进行HIV抗体初筛检测,复核阳性标本用WB法确证,记录结果并进行对比分析。结果 ECLIA法初筛阳性217例,WB确证阳性45例,ECLIA初筛方法确证阳性率为20.74%。WB确证阳性患者ECLIA法S/CO值为367.70(160.60,790.80),与确证阴性患者S/CO值[2.1(1.45,3.96)]和确证不确定患者S/CO值[1.84(1.31,3.83)]差异有统计学意义(P0.05)。比较1S/CO≤10、10S/CO≤50及S/CO50三组,WB法获得的阳性率的差异有统计学意义(P0.05)。结论 ECLIA法筛查HIV抗体灵敏度较高,但存在较高的假阳性率,尤其是低S/CO值的标本。较高的S/CO值的患者HIV感染的风险较大,但是高S/CO值并不代表HIV感染,应进一步推进诊断试剂的研发和改进进程,助力临床精准医疗,减轻AIDS公共管理负担。     

金华市HIV抗体筛查试验阳性样本确证结果分析

目的了解HIV抗体筛查阳性结果与确证结果之间的关系,为HIV感染诊断提供科学依据。方法采用酶联免疫法和胶体硒法对样本进行HIV抗体筛查,筛查阳性样本进行确证试验(WB),对筛查结果和确证结果进行比较分析。结果 708份HIV抗体筛查阳性样本,确证试验HIV-1抗体阳性629份,占88.84%;不确定57份,占8.05%;阴性22份,占3.11%;629份确证阳性样本中,626份ELISA法S/CO值6,占99.52%,S/CO值1确证结果无阳性;确证阳性样本抗env基因编码蛋白阳性率最高,gp160和gp120的阳性率均为100%;不确定样本中,gp160和p24出现的几率最高,分别为77.19%和68.42%。结论 HIV抗体筛查试验存在一定的假阳性,S/CO值6的样本确证阳性的几率较高;对同时出现gp160和p24的不确定样本应予以重视。     

白念珠菌芽管特异性抗原快速检测方法的建立和初步评价北大核心CSCD

目的建立白念珠菌芽管特异性抗原快速检测系统,探讨其特异性和敏感性。方法以单克隆抗体McAb03．2C1-C2作为一抗,辣根过氧化物酶标记McAb03．2C1-C2为二抗,建立双抗体夹心ELISA实验方法并检测6只动物模型和5例系统性白念珠菌感染患者的血清标本。结果筛选出McAb03．2C1-C2最佳稀释度和检测包被抗原浓度分别为l：4000和1．25-40μg,／ml;双抗体夹心ELISA检测动物模型的特异性和敏感性分别为95％、92％,其对阳性临床标本的检测结果与常规鉴定方法一致。结论初步建立白念珠菌芽管特异性抗原的双抗体ELISA快速检测系统,动物模型实验证实该系统有较好的特异性和敏感性。     

Syphilis serology and HIV infection in Harare, Zimbabwe

OBJECTIVE: To determine the reliability of serological tests in detecting syphilis in a factory worker cohort and examine the impact of concurrent HIV infection on serological tests for syphilis. METHOD: Reactions to non-treponemal and treponemal antigens were tested using sera from a cohort of 3401 factory workers in Harare, Zimbabwe. The participants consented to regular testing for syphilis, by VDRL, and HIV using two ELISAs. All sera from men who were VDRL positive, and a random sample of VDRL negative sera, were tested by RPR, TPHA, and where appropriate FTA-Abs. From the results, men were defined as having no syphilis, active syphilis, incident syphilis, historic syphilis, or giving biological false positive reactions. RESULTS: 709 sera were examined from 580 men. There were 78 cases of active syphilis in the cohort, giving a prevalence of 2.3%, and the seroincidence was 0.25 per 100 person years of follow up. The prevalence of HIV in the cohort was 19.8%. There was a strong association between syphilis, whether active, incident or historic, and HIV seropositivity. With both HIV positive and negative sera the negative predictive values of VDRL and RPR were > 99.9% while the positive predictive value for VDRL (30%) was lower than for RPR (39%). Biological false positive reactions were detected in 0.5% of the cohort, with in most cases a transient rise in VDRL titres up to < 1/16. Higher false positive titres occurred in five men, each of whom was HIV positive. CONCLUSIONS: The VDRL is reliable in detecting possible cases of syphilis even in a community with a high prevalence of heterosexually transmitted HIV. There is need, however, for confirmatory tests. The prevalence of syphilis in this cohort is very low in comparison with other countries in southern Africa, but is consistent with recent data from Harare. Despite a strong association between syphilis and HIV it was clear that syphilis could not be counted as a major factor fueling the HIV epidemic in Zimbabwe.     

An appraisal of enzyme linked immunosorbent assay (ELISA) and serum antibody competition test (SACT) in leprosy.

Seventy-eight untreated leprosy patients, 104 treated patients and 105 healthy contacts were tested using two serological tests, SACT (serum antibody competition test based on competitive inhibition of monoclonal antibody binding to the MY2a determinant of M. leprae) and ELISA (measurement of IgM antibodies to the neoglycoproteins D-BSA and ND-BSA representing the phenolic-glycolipid antigen of M. leprae). The controls included normal healthy individuals, patients with sputum positive pulmonary tuberculosis, and active cases of rheumatoid arthritis from the department of rheumatology. The specificity of SACT was found to be very high. ELISA was found to be positive in two patients with rheumatoid arthritis, one each for D-BSA and ND-BSA ELISA. Both tests had a high sensitivity in BL and lepromatous patients. The sensitivity to both tests was considerably lower in tuberculoid and BT patients i.e., below 40%. Therefore the diagnostic value of a negative test in suspected cases of leprosy was very low employing either of the two tests. A proportion of patients with paucibacillary tuberculoid and BT leprosy were positive after six months or longer after therapy. Similarly a large number of BL and lepromatous patients were positive after considerably longer periods of treatment. The use of either tests for determining the duration of therapy is therefore limited. SACT appears to be more sensitive than ELISA with ND-BSA in detecting subclinical infection. The cumulative positivity of the two tests may be used as a measure of the infectivity of the disease in the community and for evaluating disease control methods.     

手工洗板和机洗板对ELISA法检测HIV抗体结果的比较

目的:探讨手工洗板和洗板机洗板对酶联免疫吸附试验(ELISA)检测HIV抗体结果的影响。方法:通过用手工洗板和洗板机洗板方法对3000份艾滋病高危人群人员的血清样品进行HIV抗体初筛检测,对两种洗板方法的检测结果进行比较;将1 NCU/mL质控物分别经手工洗板和洗板机洗板检测10次所得结果进行比较。结果:手工洗板检测结果为阳性数47例,阴性数2953例,阳性率为1.57%;洗板机洗板检测结果为阳性50例,阴性2950例,阳性率为1.67%;洗板机洗板检测结果阳性而手工洗板检测结果阴性8例;洗板机洗板检测结果阴性而手工洗板检测结果阳性5例,经配对X2检验,洗板机洗板检测和手工洗板初筛检测HIV抗体的阳性率无统计学差异(P>0.05)。洗板机洗板和手工洗板两种检测方法初筛检测结果共同阳性42例,共同阴性2945例,总符合率为98.57%。1NCU/mL质控物分别经手工洗板后OD=0.681±0.02,经洗板机洗板后OD=0.675±0.01,经配对t检验,P>0.05,两者差异无统计学意义。结论:在ELISA方法检验当中,手工洗板和洗板机洗板没有本质上的差别,只要严格按照说明书进行规范操作,均能得到正确的结果。     

Sensitivity of indirect immunofluorescence and ELISA in detecting intercellular antibodies in endemic pemphigus foliaceus (Fogo Selvagem)

BACKGROUND: Since 1967 dermatology has used the classic technique of indirect immunofluorescence (IFI) for the detection of autoantibodies against antigens of the skin in diseased people with endemic pemphigus foliaceus. Thirty years later enzyme-linked immunosorbent assays--ELISA (rDsg1 and rDsg3) appeared as a viable option. A group of highly recognized researchers have concluded that ELISA is a simple, sensitive and highly specific method, allowing for diagnostic differentiation between pemphigus vulgaris (PV) and endemic pemphigus foliaceus (EPF). Scientific literature certifies that both ELISA and IIF bear high sensitivity in spite of the fact that a direct comparison between the ELISA and IIF tests has never been performed. OBJECTIVES: This study was conducted to compare the sensitivity of these tests in detecting antibodies in the EPF. MATERIAL AND METHODS: Thirty-two serum samples were collected from patients with EPF. The control serum of 15 healthy individuals was tested to detect the presence of antibodies of EPF by indirect immunofluorescence and ELISA (rDsg1 and rDsg3). The IIF was performed, taking human skin as a substrate. RESULTS: Antibodies in patients with EPF were detected more commonly by the ELISA (rDsg1) (91%) compared with IIF (81%). CONCLUSIONS: The ELISA (rDsg1) is slightly more sensitive than IIF in detecting antibodies related to EPV. However, according to our results, we do not currently possess a test with 100% accuracy in differentiating EPF from PV. Although previous studies have associated Dsg3 with PV, the tests performed during this study showed that 12% (4/32) of patients with EPF (cutaneous diseases only) also had Dsg3 antibodies.     

口腔黏膜渗出液快速诊断试剂与血清ELISA试剂检测不同人群HIV-1抗体的评价

目的探讨口腔黏膜渗出液(OMT)快速诊断试剂与酶联免疫吸附试验(ELISA)试剂检测不同人群HIV-1抗体的一致性.方法对已经过生物梅里埃ELISA试剂检测血清HIV-1抗体阳性并经蛋白印迹(WB)试验确诊的HIV感染者200例(HIV阳性组),和经过生物梅里埃ELISA试剂检测血清HIV-1抗体阴性的健康人群600例(HIV阴性组)采集OMT标本,使用OMT快速诊断试剂进行HIV-1抗体检测.同时评价口腔黏膜渗出液快速诊断试剂在实际应用中的影响因素.结果 HIV阳性组200例中198例OMT标本检测为阳性,其中192例(96%)检测线清楚,易做阳性结果判断.4例(2%)"模糊",2例(1%)"很模糊",需经专业人员判断;2例(1%)检测线"看不见",为阴性.HIV阴性组600例OMT标本检测HIV抗体全为阴性.结论口腔黏膜渗出液快速诊断试剂与生物梅里埃血清ELISA诊断试剂检测HIV-1抗体相比,在HIV阳性标本中检测一致性为99.0%,在HIV阴性标本中检测一致性为100%,总体一致性为99.75%.

Abstract：

Objective To evaluate the consistence in the detection of antibodies against HIV-1 between a new rapid test using oral mucosal transudate (OMT) samples and ELISA using serum samples. Methods Two-hundred patients who were positive for anti-HIV-1 antibodies by serum ELISA and confirmed by Western blot to be infected with HIV, and 600 healthy human controls negative for anti-HIV-1 antibodies by serum ELISA, were eligible for this study. OMT samples were collected from these subjects and subjected to a rapid test for anti-HIV-1 antibodies. The factors influencing the performance of the rapid test were analyzed. Results Of the 200 OMT specimens from HIV-infected patients, 198 showed positive reaction, 2 showed negative reaction. Among the 198 positive reactions, 192 (96%) were "clear" and easy to make decisions, 4 (2%) were "faint", 2(1%) were "very faint" and required professionals to make decisions. The rapid test was negative in all the 600 OMT specimens from the control group. Conclusions The consistence in the detection of anti-HIV-1 antibodies between the OMT rapid test and serum ELISA was 99% in HIV-positive specimens, 100% in HIV-negative specimens, and 99.75% in all the specimens.     

口腔黏膜渗出液快速诊断试剂与血清ELISA试剂检测不同人群HIV-1抗体的评价

目的探讨口腔黏膜渗出液(OMT)快速诊断试剂与酶联免疫吸附试验(ELISA)试剂检测不同人群HIV-1抗体的一致性.方法对已经过生物梅里埃ELISA试剂检测血清HIV-1抗体阳性并经蛋白印迹(WB)试验确诊的HIV感染者200例(HIV阳性组),和经过生物梅里埃ELISA试剂检测血清HIV-1抗体阴性的健康人群600例(HIV阴性组)采集OMT标本,使用OMT快速诊断试剂进行HIV-1抗体检测.同时评价口腔黏膜渗出液快速诊断试剂在实际应用中的影响因素.结果 HIV阳性组200例中198例OMT标本检测为阳性,其中192例(96%)检测线清楚,易做阳性结果判断.4例(2%)"模糊",2例(1%)"很模糊",需经专业人员判断;2例(1%)检测线"看不见",为阴性.HIV阴性组600例OMT标本检测HIV抗体全为阴性.结论口腔黏膜渗出液快速诊断试剂与生物梅里埃血清ELISA诊断试剂检测HIV-1抗体相比,在HIV阳性标本中检测一致性为99.0%,在HIV阴性标本中检测一致性为100%,总体一致性为99.75%.     

口腔黏膜渗出液快速诊断试剂与血清ELISA试剂检测不同人群HIV-1抗体的评价

目的探讨口腔黏膜渗出液(OMT)快速诊断试剂与酶联免疫吸附试验(ELISA)试剂检测不同人群HIV-1抗体的一致性.方法对已经过生物梅里埃ELISA试剂检测血清HIV-1抗体阳性并经蛋白印迹(WB)试验确诊的HIV感染者200例(HIV阳性组),和经过生物梅里埃ELISA试剂检测血清HIV-1抗体阴性的健康人群600例(HIV阴性组)采集OMT标本,使用OMT快速诊断试剂进行HIV-1抗体检测.同时评价口腔黏膜渗出液快速诊断试剂在实际应用中的影响因素.结果 HIV阳性组200例中198例OMT标本检测为阳性,其中192例(96%)检测线清楚,易做阳性结果判断.4例(2%)"模糊",2例(1%)"很模糊",需经专业人员判断;2例(1%)检测线"看不见",为阴性.HIV阴性组600例OMT标本检测HIV抗体全为阴性.结论口腔黏膜渗出液快速诊断试剂与生物梅里埃血清ELISA诊断试剂检测HIV-1抗体相比,在HIV阳性标本中检测一致性为99.0%,在HIV阴性标本中检测一致性为100%,总体一致性为99.75%.     

口腔黏膜渗出液快速诊断试剂与血清ELISA试剂检测不同人群HIV-1抗体的评价

目的探讨口腔黏膜渗出液(OMT)快速诊断试剂与酶联免疫吸附试验(ELISA)试剂检测不同人群HIV-1抗体的一致性.方法对已经过生物梅里埃ELISA试剂检测血清HIV-1抗体阳性并经蛋白印迹(WB)试验确诊的HIV感染者200例(HIV阳性组),和经过生物梅里埃ELISA试剂检测血清HIV-1抗体阴性的健康人群600例(HIV阴性组)采集OMT标本,使用OMT快速诊断试剂进行HIV-1抗体检测.同时评价口腔黏膜渗出液快速诊断试剂在实际应用中的影响因素.结果 HIV阳性组200例中198例OMT标本检测为阳性,其中192例(96%)检测线清楚,易做阳性结果判断.4例(2%)"模糊",2例(1%)"很模糊",需经专业人员判断;2例(1%)检测线"看不见",为阴性.HIV阴性组600例OMT标本检测HIV抗体全为阴性.结论口腔黏膜渗出液快速诊断试剂与生物梅里埃血清ELISA诊断试剂检测HIV-1抗体相比,在HIV阳性标本中检测一致性为99.0%,在HIV阴性标本中检测一致性为100%,总体一致性为99.75%.     

二期梅毒合并生殖器疱疹和HIV感染1例

患者女,27岁。全身暗褐色斑疹2个月,外阴溃疡1个月。皮肤科情况:面、胸、背、躯干及四肢可见圆形或椭圆型斑疹、斑丘疹及丘疹,外阴见两处溃疡,大、小阴唇明显肿大。肝、肾功能和心电图、胸部X线检查无异常。TPPA(+),CD4+/CD8+为0.207;Ⅱ型疱疹抗体IgG(+);Ⅱ型疱疹抗原(+)。HIV抗体确证试验(WB)阳性。诊断:二期梅毒;生殖器疱疹;HIV感染。