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%.

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HIV-1/2抗体快速检测试剂性能影响因素的实验研究

目的 探讨无创法快速检测(简称快检)人类免疫缺陷病毒(HIV)-1/2抗体试剂性能的影响因素。方法 选取2016年12月至2018年12月无锡市第五人民医院传染病门诊收治的317例HIV-1感染者(疾控中心已确证,实验组)和32例未感染者(对照组)作为研究对象。另从从实验组和对照组中分别选择46例未出现假阴性的感染者和21例未感染者。采集其的口腔黏膜渗出液和血清样本,分析人口学信息、饮水、进食、病毒载量、CD4⁺T淋巴细胞计数(CD4)和服用抗逆转录病毒药物对口腔黏膜渗出液假阴性率的影响,通过酶联免疫吸附试验法进行校验,计算口腔黏膜渗出液与血清免疫球蛋白G(IgG)的浓度关系,比较四种样品缓冲液对检测性能的影响。结果 317例HIV-1感染者口腔黏膜渗出液快检的假阴性率为15.46%,以20～34岁为主,男性假阴性率是女性的1.73倍,实验组低病毒载量、CD4<200个/μL和服抗逆转录病毒药的抗体滴度与对照组比较,差异具有统计学意义(P<0.05);饮水、进食0h及1h后,未见实验组出现假阴性,未见对照组出现假阳性;口腔黏膜渗出液IgG抗体浓度约为血...     

第4代HIV ELISA诊断试剂在性病门诊筛查中的评价

目的:评价第4代HIV ELISA诊断试剂在STD人群中的应用价值.方法:采用第3代和第4代HIV ELISA试剂对982份STD人群样本同时进行检测,用蛋白印迹(WB)试验确认检测阳性标本,RT-PCR法检测抗体阴性或疑似标本.结果:以WB及核酸检测结果为参照,第3代和第4代试剂的特异性为98.81%,97.51%;敏感性为93.10%,100%.结论:第4代试剂可作为STD门诊HIV感染的筛查试剂.     

广西壮族自治区性病门诊就诊的人类免疫缺陷病毒Ⅰ型感染者丙型肝炎病毒感染的调查

目的 了解广西壮族自治区性病门诊就诊的人类免疫缺陷病毒I型(HIV-1)感染者中丙型肝炎病毒(HCV)感染情况.方法 对11 553份性病门诊就诊者血浆标本进行HIV抗体筛查、确证,并采用病例对照研究方法,按年龄、婚姻状况和1∶2的比例,140份HIV-1抗体确证阳性标本配对282份HIV-1抗体阴性标本.422份标本采用酶联免疫吸附试验(ELISA)进行HCV抗体检测.利用卡方检验对HIV-1抗体阳性者及HIV-1抗体阴性者HCV抗体阳性率进行比较,采用Logistic回归对HCV和HIV合并感染进行危险性分析.结果 HIV-1抗体阳性标本HCV抗体阳性率为33.57％(47/140),HIV-1抗体阴性标本为1.06％(3/282),后者显著低于前者(x2=94.66,P＜0.05).危险因素分析显示,多个性伴合并感染HCV和HIV的概率高于单个性伴[OR=2.4,95％CI(1.0～5.6),P=0.05],静脉吸毒者合并感染HCV和HIV的概率高于非静脉吸毒者[OR=20.8,95％ CI (5.7～76.5),P＜ 0.05].结论 HCV感染与HIV感染相关,对HIV-1就诊者进行综合干预能降低HCV的传播.     

免疫缺陷性皮肤病

20061911HIV抗体筛查试剂联合检测替代免疫印迹法的对比分析/梁姝(四川大学公共卫生学院),秦光明,郑国英∥中国艾滋病性病.-2006,12(2).-108~1109种艾滋病病毒(HIV)初筛试剂对50份HIV免疫印迹法(WB)阳性样本和150份高危人群样本检测结果表明:两次酶联免疫法(ELISA)检测中,只要有1次S/CO值>6或两种快速检测均阳性反应者,WB确认阳性率为100%;两次ELISA检测S/CO值均<6或仅1种快速检测为阳性者,可能出现不确定或阴性WB检测结果。认为出现两次ELISA阴性(其中1次S/CO值>6),或两次快速检测均为阳性,或1种ELISA和1种快速检测结果…     

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。     

HIV快速检测法在性病门诊艾滋筛查中应用探讨

目的探讨快速法(RT)在HIV抗体检测中与ELISA和WB法相比,敏感性和特异性是否有差异。方法门诊检测HIV抗体的血样,采取快速法和ELISA法两种方法平行检测,结果双阳或一阴一阳,复检后,血样送泰州疾控艾滋确证实验室确证。结果门诊4 568例血样中,HIV抗体检测快速法检出26例阳性,检出率0.57%,ELISA法检出23例,检出率0.5%,WB法确证21例,检出率0.46%。与金标准WB法相比,快速法的敏感度100%、特异度99.89%、阳性预测值80.77%、阴性预测值100%;ELISA的敏感度100%、特异度99.96%、阳性预测值91.30%、阴性预测值100%。结论快速法在敏感度和特异度上与ELISA相当,可以在门诊筛查、急诊、基层、咨询检测等场合应用于HIV抗体检测,进行快速筛查。     

梅毒患者血清对HIV明胶颗粒凝集试验的影响

目的了解梅毒患者血清对艾滋病病毒(HIV)明胶颗粒凝集试验(PA)的影响。方法收集用甲苯胺红不加热试剂(TRUST)、梅毒螺旋体明胶颗粒凝集试剂(TPPA)确认为梅毒的患者血清225份和性病门诊非梅毒人群血清95份,同时用艾滋病病毒(HIV)明胶颗粒凝集试剂(PA)和两种不同厂家的酶联免疫吸附试剂(ELISA)筛查其艾滋病病毒抗体。结果第1次检测的225份梅毒患者血清中,37份HIV1/2-PA致敏颗粒和非致敏颗粒都凝集;10份HIV1/2-PA非致敏颗粒凝集,致敏颗粒孔未凝集;5份致敏颗粒凝集,呈弱阳性,非致敏颗粒未凝集,其它173份血清HIV1/2-PA检测结果都为阴性。对52份标本进行第2次复检,5份第1次检测致敏颗粒凝集的标本结果均为阴性,非致敏颗粒未凝集;其他标本检测结果与第1次一致。两种ELISA试剂检测结果均为阴性。对照组95份标本HIV1/2抗体检测结果均为阴性。结论梅毒患者血清用PA法检测HIV抗体时有干扰现象。     

四种梅毒血清学检测方法的比较

目的评价梅毒甲苯胺红不加热血清反应素试验(TRUST)、快速血浆反应素环状卡片试验(RPR)、梅毒酶联免疫吸附试验(TP-ELISA)和梅毒螺旋体明胶凝集试验(TPPA)在梅毒检测中的应用价值。方法同时用RPR、TRUST、TP-ELISA和TPPA法检测确诊为梅毒患者的血清87份、健康查体人员血清100份及非梅毒患者的血清50份,并评价TRUST、RPR、TP-ELISA和TPPA法检测结果的敏感性和特异性等。ELISA法结合TRUST法双法筛查梅毒抗体,阳性标本再用TPPA法甄别生物学假阳性。结果TRUST、RPR和TPPA法对87份TP-ELISA法检测为阳性标本的敏感性分别为75.86%,74.71%,98.90%,特异性为98.67%,98.67%和100.00%。RPR法与TRUST法、TPPA法与ELISA法比较差异均无显著性意义(P均>0.05);TRUST法与TPPA法、RPR法与TPPA法比较差异均有显著性意义(P均<0.01)。100份健康查体人员血清,RPR、TRUST、TP-ELISA和TPPA法检测均为阴性,50份非梅毒患者血清进行RPR和TRUST法检测,2份阳性。结论TP-ELISA可替代TPPA使用;RPR法和TRUST法存在不同程度的假阳性,TP-ELISA结合TRUST双法筛查血液,用TPPA报告确证试验阳性。     

Evaluation of the fluorescent treponemal antibody-absorption (FTA-Abs) test specificity.

Serum samples from 43 patients with positive test for syphilis only in the FTA-Abs test, were evaluated. Three had primary or treated syphilis. Twenty-one (49%) had clinical and/or serological signs of Lyme borreliosis as assessed by whole-cell sonicate Borrelia burgdorferi ELISA and Western blot techniques. Seven (16%) had genital Herpes simplex infection and the remaining 12 patients, miscellaneous disorders. In control sera from 30 patients with Lyme borreliosis an isolated positive FTA-Abs reaction was found in 13 patients (43%). Elevated Borrelia ELISA titres were found in nine of 30 (30%) syphilitic patient serum samples, whereas Western blots for Borrelia were negative. Six per cent of healthy blood donors were seropositive for Borrelia. Lyme borreliosis is an important cause of cross-reactions in the FTA-Abs test. Other serological tests for syphilis and Western blot for Borrelia are useful for discrimination.     

The testing of saliva samples for HIV-1 antibodies: reliability in a non-clinic setting.

AIMS--To assess the reliability of saliva samples as a means of testing for HIV-antibodies outside clinic settings. METHODS--Men taking part in a non-clinic longitudinal study of homosexually active men provided samples of saliva and blood. Sera were screened using a competitive ELISA (Wellcozyme) and positive sera were confirmed by an indirect ELISA (Abbott). Saliva samples were screened either using an IgG captive radioimmunoassay or an amplified ELISA. RESULTS--A total of 534 paired saliva and blood samples were tested. Overall sensitivity was 96.2% and specificity was 100%. None of the saliva tests were falsely positive for HIV-1 antibodies. CONCLUSIONS--HIV-1 saliva tests can reliably be used in a non-clinic or field setting. However, if results are to be given to respondents, it is necessary to offer adequate counselling and consider the mechanisms for referral and follow-up for those that are found to be HIV-1 antibody positive.     

Desmoglein 3-ELISA: a pemphigus vulgaris-specific diagnostic tool

BACKGROUND: Pemphigus vulgaris (PV) is an autoimmune-blistering disease of the skin and mucous membranes caused by autoantibodies against desmoglein 3 (Dsg3), an epidermal desmosomal adhesion protein of the cadherin family. Cloning of the Dsg3 gene and expression of the protein in a native conformation enabled the recent development of a specific and sensitive enzyme-linked immunosorbent assay (ELISA) for the detection of PV autoantibodies. OBJECTIVES: To evaluate serum samples from patients with PV and other dermatologic diseases for anti-Dsg3 antibodies. To compare ELISA values with autoantibody titers obtained by classic indirect immunofluorescence (IIF). DESIGN: Serum samples from patients with PV and various other bullous and nonbullous skin diseases were tested for anti-Dsg3 reactivity by ELISA. SETTING: Ambulatory and hospitalized patients from a university hospital. PATIENTS: Fifty-two serum samples from 11 patients with PV, and serum samples from 11 patients with bullous pemphigoid, 12 patients with other bullous diseases, 22 patients with various nonbullous skin disorders, and 10 healthy individuals were tested. RESULTS: Forty-seven (98%) of 48 serum samples from patients with PV that were positive by IIF on monkey esophagus were also reactive by Dsg3-ELISA, whereas 4 of 4 IIF-negative PV serum samples showed no reactivity by ELISA. In addition, negative ELISA results were obtained from 11 of 11 serum samples from patients with bullous pemphigoid, 10 of 12 serum samples from patients with other bullous skin disorders, 7 of 9 serum samples from patients with autoimmune-connective tissue diseases, and 13 of 13 serum samples from patients with other nonbullous skin diseases. Interestingly, 1 patient with paraneoplastic pemphigus had positive ELISA results. There was a positive correlation (r = 0.654) between ELISA values and IIF titers within the whole population with PV. In addition, when multiple serum samples from 1 patient with PV sampled over a 2-year period were tested, ELISA reactivity paralleled both the IIF titers and the clinical course. CONCLUSION: The Dsg3-ELISA is a sensitive, objective, and PV-specific test that should be considered as an adjunct test for the management of patients with PV.     

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。     

酶联免疫吸附法检测血清中抗解脲支原体抗体

ELISA间接法检测临床感染解脲支原体的患者血清抗体,与代谢抑制法相比,22例培养阳性的标本,其血清抗体检出率,ELISA法检出21例,代谢抑制法检出22例,其一致率为95%.在81例培养阳性的血清标本中,93.8%有IgG、30.8%有IgM,而在81例培养阴性的血清标本中,2.5%有IgG,3.7%有IgM.用ELISA不能检出型特异性抗体,这种交叉反应可能是由于在解脲支原体中有同源性抗原存在。     

Screening for treponemal infection by a new enzyme immunoassay.

A new enzyme immunoassay (EIA, Captia Syphilis-G) for detecting IgG antibodies against Treponema pallidum was evaluated as a screening test for syphilis. When serum samples were tested at a dilution of 1 in 20 (EIA20), the overall agreement between the IgG EIA and serological status based on the T pallidum haemagglutination assay (TPHA) and the fluorescent treponemal antibody absorption (FTA-ABS) test was 99.2% (1310/1321). The sensitivity of the EIA20 was 98.4% (60/61) and the specificity 99.3% (1251/1260). Discrimination between patients with and without treponemal infection was good: the mean EIA20 absorbance ratios (patient/mean low titre positive control results) were 0.49 for antibody negative patients, 3.30 for patients with positive Venereal Diseases Research Laboratory (VDRL) test and TPHA results, and 1.77 for patients with negative VDRL but positive TPHA results. The cut off point for excluding treponemal infection was taken as 0.9. Specimens with ratios of more than 0.9 should be confirmed by the FTA-ABS test and evaluated for specific IgM antibodies to treponemes. When serum samples were tested at a 1 in 50 dilution (EIA50) the sensitivity was lower (80.3%) but the specificity was absolute. The reduction in sensitivity correlated with low absorbance ratios in the patients who were VDRL negative and TPHA positive. The screening performance of the IgG EIA20 is thus comparable with that provided by a combination of the VDRL test and TPHA. The potential for automation makes the EIA an attractive alternative, particularly in larger centres. Alternatively, the test can be performed at a 1 in 50 dilution (EIA50), at which level it is ideally suited for confirming the treponemal status of antibodies in serum samples preselected by positive cardiolipin antigen screening test results.