五种艾滋病病毒抗体诊断试剂临床质量比较

目的：为掌握中国市售艾滋病病毒（HIV）抗体诊断试剂的实际应用状况，方法：对4种国产HIV抗体酶了免疫吸附试验（ELISA）诊断试剂（其中3种为国产双抗原夹法试剂）和美国AbbottHIV快速法诊断试剂用200份血清盘样品进行了统一测试。200份血清盘标本包括100份经过确认的HIV抗体阳性、弱阳性、阴性标本和100份高危人群的血清标本。初筛阳性和可疑样品再用蛋白印迹法（WB）做确认对比分析。结果：5种试剂的敏感性为90．7％－98．9％，特异性为93．0％－99．1％，假阳性率为0．9％－7．0％，假阴性率为1．2％－9．3％，总符合率为94．5％－97．5％，约登指数为89．5％－95．4％，阳性预示值（PPV）为91．2％－98．7％，阴性预法值（NPV）为93．4％－99．1％，结论：随着中国双抗原ELISA试剂的研制和市场投放使用，HIV抗体诊断试剂内 在质量指标虽有所提高，但其漏检率仍需进一步改进。     

五种艾滋病病毒抗体诊断试剂临床质量比较

目的 为掌握中国市售艾滋病病毒(HIV)抗体诊断试剂的实际应用状况。方法 对4种国产HIV抗体酶联免疫吸附试验(ELISA)诊断试剂(其中3种为国产双抗原夹心法试剂)和美国Abbott HIV快速法诊断试剂用200份血清盘样品进行了统一测试。200份血清盘标本包括100份经过确认的HIV抗体阳性、弱阳性、阴性标本和100份高危人群的血清标本。初筛阳性和可疑样品再用蛋白印迹法(WB)做确认对比分析。结果 5种试剂的敏感性为90.7％～98.9％,特异性为93.0％～99.1％,假阳性率为0.9％～7.0％,假阴性率为1.2％～9.3％,总符合率为94.5％～97.5％,约登指数为89.5％～95.4％,阳性预示值(PPV)为91.2％～98.7％,阴性预示值(NPV)为93.4％～99.1％。结论 随着中国双抗原ELISA试剂的研制和市场投放使用,HIV抗体诊断试剂内在质量指标虽有所提高,但其漏检率仍需进一步改进。     

GENSCREENULTRA HIV抗原抗体酶联免疫诊断试剂盒的敏感性评价

目的评价BIO-RAD公司开发研制的人类免疫缺陷病毒（HIV1＋2）抗原抗体酶联免疫诊断试剂盒（GENSCREEN~ ULTRA HIVAg-Ab）,对不同来源样本检测的敏感性。方法以法国生物梅里埃公司生产的HIV1＋2抗原/抗体ELISA检测试剂为参比试剂,分别使用评价试剂和参比试剂检测621例样本,分析两种试剂检测HIV抗原/抗体的敏感性。结果评价试剂和参比试剂检测502份HIV感染者/AIDS患者临床血浆标本均为阳性,符合率为100%,敏感性为100%。评价试剂和参比试剂检测92份HIV分离培养上清液,评价试剂检出89份阳性、参比试剂检出31份阳性,表明评价试剂检测HIV-1p24抗原的敏感性高于参比试剂。另外,又检测了27份HIV抗原系列稀释样本,计算出评价试剂检测HIV抗原的敏感性是参比试剂的4～8倍。结论评价试剂检测HIV抗体的效果与参比试剂相同,检测HIV-1p24抗原的敏感性高于参比试剂。     

GENSCREEN~ULTRA HIV抗原抗体酶联免疫诊断试剂盒的敏感性评价

目的评价BIO-RAD公司开发研制的人类免疫缺陷病毒(HIV1+2)抗原抗体酶联免疫诊断试剂盒(GENSCREEN~ ULTRA HIVAg-Ab),对不同来源样本检测的敏感性。方法以法国生物梅里埃公司生产的HIV1+2抗原/抗体ELISA检测试剂为参比试剂,分别使用评价试剂和参比试剂检测621例样本,分析两种试剂检测HIV抗原/抗体的敏感性。结果评价试剂和参比试剂检测502份HIV感染者/AIDS患者临床血浆标本均为阳性,符合率为100%,敏感性为100%。评价试剂和参比试剂检测92份HIV分离培养上清液,评价试剂检出89份阳性、参比试剂检出31份阳性,表明评价试剂检测HIV-1p24抗原的敏感性高于参比试剂。另外,又检测了27份HIV抗原系列稀释样本,计算出评价试剂检测HIV抗原的敏感性是参比试剂的4～8倍。结论评价试剂检测HIV抗体的效果与参比试剂相同,检测HIV-1p24抗原的敏感性高于参比试剂。     

适合VCT的HIV抗体检测替代策略研究

目的 探求适合在艾滋病自愿咨询检测(VCT)点应用的检测艾滋病病毒(HIV)抗体的替代策略.方法 从河南、安徽和山西省的27个VCT检测点日常工作中采集样品10 310份,离心分离血浆后,全部用HIV快速检测试剂1(RT1)和HIV快速检测试剂2(RT2)进行检测,其中任何一种试剂的检测.结果 为阳性时,分别用酶联免疫吸附试验(ELISA)试剂和免疫印迹试验(WB)试剂复检.当两种快速检测均为阴性时,保留血浆,集中用ELISA试剂复检,复检为阳性者,进一步用WB确认检测.结果 RT1检测为阳性的样品418份,WB确认阳性的样品386份;RT2检测为阳性的样品427份,WB确认阳性的样品388份;RT1和RT2均为阳性的样品391份,WB确认阳性的样品386份.RT1和RT2检测.结果 不一致的样品共63份,57份为ELISA阴性,6份为ELISA阳性.结论 使用任何一种HIV快速检测试剂可以筛查出99%以上的阴性样品;两种HIV快速检测试剂的检测.结果 均为阳性时,可以筛查出98%以上的阳性样品;两种HIV快速检测试剂的检测.结果 不一致时,ELISA复检为阴性的样品可按HIV抗体阴性咨询,ELISA复检为阳性的样品应进一步做WB确认检测.使用RT1 RT2 ELISA策略,可以替代98.54%的WB确认检测,并且与WB确认检测.结果 的符合率为99.94%,因而可以在保证检测.结果 质量的同时,大大减少检测费用,提高检测效率和成本效益.     

抗-HIV快速检测试剂质量考查

目前国内检测艾滋病病毒(HIV)抗体(抗-HIV)最常用的试剂有酶联免疫吸附试验(ELISA)试剂和快速法(RT)试剂。RT试剂使用的最大优点是操作简便，可单份检测，报告结果快(可在滴加血清样品后3～30分钟观察到结果)。2003年8～12月，本所受中国疾病预防控制中心(CDC)艾滋病(AIDS)参比实验室委托，对国内销售的Abbott公司的快速试剂进行质量考查，现将结果报告如下。     

三种类型HIV抗体检测技术的方法学评价

目的对不同原理的艾滋病病毒(HIV)抗体诊断方法进行评价,了解现有HIV抗体诊断试剂的敏感性、特异性等性能。方法应用6种血清盘[即基础血清盘、干扰样本血清盘、线性稀释系列血清盘、精密度血清盘、美国病理学家协会(CAP)能力验证血清盘以及商业阳转血清盘]对三种类型HIV抗体检测方法[HIV快速检测方法、HIV酶联免疫吸附试验(ELISA)、蛋白印迹试验(WB)]的诊断试剂的敏感性、特异性、分析灵敏度、分析特异性及精密度等指标进行评价。结果 1)A(国产抗体)、B(国产抗体)、C(国产抗原抗体)、D(进口抗原抗体)、E(国产胶体金法)、F(进口胶体硒法)6种试剂应用基础血清盘评估,敏感性均为100%(40/40),特异性均97.5%(39/40)。2)A-D ELISA检测试剂板内精密度值介于4.40%~24.98%之间。3)用商业阳转血清盘评价,A-F试剂阳性率分别为18.2%、16.7%、33.3%、37.9%、19.7%、18.2%,并且差异有统计学意义(P0.05);各试剂检测结果相比核酸检测的延长天数介于7~10.8天,D(进口抗原抗体)最短,WB试剂最长;重组免疫印迹试验(RIBA)与WB试剂检测结果进行配对差异有统计学意义(χ2检验,P0.05)。结论参与评价的ELISA诊断试剂与快速诊断试剂均有较高的敏感性和特异性,抗原抗体检测试剂敏感性相对较高,适合作为抗体筛查试剂。4种ELISA试剂板内精密度差别较大。作为抗体确证试剂,RIBA与WB相比敏感性较高,不确定率低,从而发现早期感染的检验效能较高,减少了由于不确定带来的随访率。     

免疫胶体金与酶免疫检测HIV抗体和梅毒螺旋体抗体对照实验

目的采用免疫胶体金技术(DIGFA)检测试卡和酶免疫(EIA)检测试剂，检测艾滋病病毒抗体(抗-HIV1／2)和梅毒螺旋体特异性抗体(抗-TP)，对DIGFA技术参数进行评估。方法对多份质控血清和5863份患者血清或血浆，分别采用DIGFA试卡和EIA试剂进行检测，以EIA检测结果为参照，对DIGFA检测试卡的灵敏度、特异性、检测效能和物理性能等参数进行评价。结果多份质控血清抗-TP和抗-HIV1／2 DIGFA试卡检测特异性均为100％；抗-TP、抗-HIV1／2DIGFA试卡检测的灵敏度分别为80．00％和93．33％；检测效率分别为88．44％和96．97％。5863份患者血清(血浆)的抗-TP和抗-HIV1／2DIGFA试卡检测特异性分别为99．86％和99．76％；灵敏度分别为50．94％和77．78％；检测效率分别为99．42％和99．69％。结论DIGFA试卡检测灵敏度比较低，花费成本较大，不适宜献血员筛选试验。如果应用到街头(采血车)献血员快速筛选，必须和EIA联合应用。     

大规模普查时不同HIV抗体筛查方法的比较

目的 在对既往有偿献血者艾滋病病毒(HIV)抗体筛查工作中，寻找一种适合于大批量标本检测，而且敏感性、特异性都比较强、成本较低的HIV抗体筛查方法。方法 用国产酶联免疫吸附试验(ELISA)试剂做筛查，分别选用不同厂家试剂和方法做复查。结果 筛查选用国产ELISA试剂 进口快速试剂准确率为97．83％；选用国产和进口ELISA试剂准确率为96．57％。选用两种国产ELISA试剂准确率为82．5％。结论 筛查选用国产和进口ELISA试剂效果较好。     

两代酶联免疫试剂在男男性行为人群HIV检测中的应用

目的通过使用第四代与第三代艾滋病病毒(HIV)抗体酶联免疫试剂检测结果及核酸检测结果的比较,评估其在天津市男性性行为人群(MSM)HIV感染筛查中的应用效果。方法对天津市某区自愿咨询检测点进行咨询检测的男男性行为人群用EDTA抗凝管采集血液样品,同时使用两代HIV抗体筛查试剂进行检测,阳性者进行确证检测,两种筛查试剂检测结果均为阴性的样品,采用集合核酸检测方法进行检测。结果共计检测MSM人群血液样本2 065份,共对87份样品进行了确证试验,1 978份HIV抗体筛查阴性样品经核酸检测,有1份集合样品呈阳性。HIV抗体确证试验为阴性和不确定的6份样品,进行单份核酸检测,有4份HIV-1RNA阳性,病毒载量检测结果均符合HIV急性感染特征。此次研究中的MSM人群HIV感染率为4.16%(86/2 065),95%可信区间3.34%～5.12%。发现5例HIV急性感染者,估计该人群年发病率为3.16%,95%可信区间1.01%～7.35%。使用第三代抗体试剂进行筛查时,总费用为148 360元,其敏感性为94.2%(81/86)、特异性为100%,发现HIV感染者的单位成本为1 832.6元。使用第四代抗体试剂进行筛查时,总费用为166 080元,其敏感性为98.8%(85/86)、特异性为99.9%(1 977/1 979),发现HIV感染者的单位成本为1 953.9元。结论此次研究估测该人群的HIV感染年发病率为1.01%～7.35%,提示其高危性行为程度较高。在该人群中,使用第四代试剂筛查时,HIV感染者发现数比使用第三代试剂增加4.9%,发现HIV感染者的单位成本增加6.2%,提示具有推广应用价值。     

丙型肝炎病毒抗体诊断试剂质量评估

目的对国内外不同厂家的丙型肝炎(丙肝)病毒的15种酶联免疫吸附法(ELISA)诊断试剂及8种胶体金法诊断试剂的质量进行评价。方法使用国家艾滋病参比室基础血清盘、参比室干扰血清盘、商业阳转血清盘,以阳性符合率、阴性符合率等指标评价试剂的质量。结果共检测80份样本,15种丙肝ELISA试剂的阳性符合率、阴性符合率均≥97.5%(39/40);8种丙肝胶体金试剂阳性符合率为82.5%～100%(33/40～40/40),阴性符合率均≥97.5%(39/40)。对阳转血清盘检测,ELISA试剂的平均延长天数分布于8-19天之间。丙肝ELISA和胶体金试剂的分析特异性均为100%。结论参评的ELISA试剂具有较高的阳性符合率和阴性符合率。胶体金试剂的阴性符合率较高、阳性符合率有差异。丙肝ELISA试剂适合于中国一般人群的筛查检测。丙肝胶体金试剂的敏感性有待于进一步提高。     

Evaluation of an HIV screening assay kit for the combined detection of anti-HIV-1/2 antibodies and HIV p24 antigen]

We have evaluated a new HIV screening assay kit (Genscreen HIV Ag-Ab) for the HIV antigen-antibody combined test by comparing with two HIV antigen-antibody combined assay kits (VIDAS HIV DUO, Enzygnost HIV integral). Genscreen HIV Ag-Ab is a microwell plate enzyme immunoassay for the detection of HIV infection, based on the detection of anti-HIV-1/2 antibodies and HIV p24 antigen in human serum or plasma. In this study, 90 samples of HIV-1 antibody positive sera and 670 samples of HIV negative sera were examined. The sensitivity was 100% and the specificity was 99.7%. All of HIV-1 group M sera (subtypes A to G and B/D), HIV-1 group O sera and HIV-2 sera in worldwide HIV performance panel-302 were positive with Genscreen HIV Ag-Ab. Ten commercially available HIV-1 seroconversion panels were tested to evaluate sensitivity of three HIV antigen-antibody combined assay kits. Genscreen HIV Ag-Ab detected infection at the same bleeds as VIDAS HIV DUO in 8 of 10 seroconversion panels and 1 to 2 bleeds earlier than Enzygnost HIV integral in 5 of 10 seroconversion panels. However, VIDAS HIV DUO indicated false negative on 5th bleed in panel BB (PRA952). The result of the specimen was positive on 3rd bleed, equivocal on 4th bleed, negative on 5th bleed and again positive on 6th bleed. All of these specimens were positive by Genscreen HIV Ag-Ab. Therefore, Genscreen HIV Ag-Ab that shorten the window period is a useful and reliable for HIV screening test, especially in case of primary infection.     

五种不同沙眼衣原体实验室筛查试剂检测性能评价

目的通过对不同商品化沙眼衣原体(CT)检测试剂的检测结果,与Roche Cobas Amplicor检测结果的分析比较,评价5种沙眼衣原体检测试剂的性能。方法采用分层按比例的方法抽取32家医疗机构,收集各抽样单位2009年9月至11月期间,皮肤(性病)科、妇产科、泌尿科门诊就诊者的泌尿生殖道标本1 986人份。比较各个医疗机构采用的检测方法与Roche Cobas Amplicor检测方法所得检测结果,分析各不同检测试剂的特异度和灵敏度。结果共对1 986例样本进行了Roche Cobas Amplicor沙眼衣原体核酸检测,沙眼衣原体阳性为367例(18.48%)。3种免疫层析法(ICA)检测试剂中,ICA1(国产)、ICA2(国产)、ICA3(进口)灵敏度分别为34.48%、15.22%、52.53%;特异度分别为99.45%、98.04%、98.93%;阳性预测值(Positive predictive value,PPV)分别为93.75%、63.64%、92.86%;阴性预测值(Negative predictive value,NPV)分别为86.36%、83.68%、88.73%。2种聚合酶链反应(PCR)法检测试剂中,PCR1(国产)、PCR2(国产)灵敏度分别为70.09%、96.43%;特异度分别为99.44%、100.00%;阳性预测值分别为96.15%、100.00%;阴性预测值分别为94.34%、99.31%。用免疫层析试剂检测的四种样本间的敏感性和特异性有明显差异;PCR检测方法中,各类型标本的评价相近。结论不同公司生产的免疫层析检测试剂的性能存在显著差异,且总体水平均低于PCR法检测试剂。另外,不同类型标本对沙眼衣原体的检测也有影响,免疫层析法检测试剂较适用于女性阴道拭子和宫颈拭子标本的检测。     

Staining for p53 and Ki-67 increases the sensitivity of EUS-FNA to detect pancreatic malignancy

AIM: To investigate whether tumor marker staining can improve the sensitivity of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to diagnose pancreatic malignancy.METHODS: Patients who underwent EUS-FNA were retrospectively identified. Each EUS-FNA specimen was evaluated by routine cytology and stained for tumor markers p53, Ki-67, carcinoembryonic antigen (CEA) and CA19-9. Sensitivity, specificity, positive and negative predictive values (PPV and NPV), and positive and negative likelihood ratios (PLR and NLR) were calculated in order to evaluate the performance of each test to detect malignancy.RESULTS: Sixty-one specimens had complete sets of stains, yielding 49 and 12 specimens from pancreatic adenocarcinomas and benign pancreatic lesions due to pancreatitis, respectively. Cytology alone had sensitivity and specificity of 41% and 100% to detect malignancy, respectively. In 46% of the specimens, routine cytology alone was deemed indeterminate. The addition of either p53 or Ki-67 increased the sensitivity to 51% and 53%, respectively, with perfect specificity, PPV and PLR (100%, 100% and infinite). Both stains in combination increased the sensitivity to 57%. While additional staining with CEA and CA19-9 further increased the sensitivity to 86%, the specificity, PPV and PLR were significantly reduced (at minimum 42%, 84% and 1, respectively). Markers in all combinations performed poorly as a negative test (NPV 26% to 47%, and NLR 0.27 and 0.70).CONCLUSION: Immunohistochemical staining for p53 and Ki-67 can improve the sensitivity of EUS-FNA to diagnose pancreatic adenocarcinoma.     

Differential Diagnosis of Tuberculous and Malignant Pleural Effusions: What is the Role of Adenosine Deaminase?

The objective of this study was to evaluate the utility of invasive and noninvasive diagnostic procedures in tuberculous pleurisy (TPE) in an area with intermediate incidence of tuberculosis. The aim was to determine the cutoff value for adenosine deaminase (ADA) and the sensitivity and specificity of ADA and evaluate pleural fluid cytology and pleural biopsy in the differential diagnosis of malignant and tuberculous pleurisy. The study included 121 patients. TPE was confirmed in 54 patients and malignant effusion in 67 patients. Criteria used for TPE diagnosis were positive cultures of effusion or biopsy specimen, tuberculous granulomas, or positive sputum cultures without other explanation for pleural effusion. Malignancy was diagnosed by either cytology or biopsy. The cutoff value of ADA in TPE was 49 U/L, sensitivity was 89.2%, specificity was 70.4%, positive predictive value (PPV) was 84.4%, and negative predictive value (NPV) was 78.4%. ADA activity below 16 U/L suggests that TPE is highly unlikely with sensitivity=38.5%, specificity=100%, PPV=100%, and NPV=57.4%. ADA effusion/serum ratio reached a cutoff in TPE of 1.7 (sensitivity=84.6%, specificity=72.2%, PPV=81.4%, NPV=71.4%). Sensitivity, specificity, PPV, and NPV of cytology evaluation for TPE are 72.2%, 70.1%, 66.1%, and 75.8%, respectively. Pleuroscopy-guided pleural biopsy had sensitivity=66.7%, specificity=100%, PPV=100%, and NPV=78.8%. In 27.8% of TPE cases, pleural fluid cultures were positive. There is no doubt that pleuroscopy-guided biopsy is of great value for TPE diagnosis; however, sensitivity and specificity of noninvasive tests, especially ADA, can help to distinguish between TB and malignancy.     

A critical evaluation of commercial immunoassays for antineutrophil cytoplasmic antibodies directed against proteinase 3 and myeloperoxidase in Wegener's granulomatosis and microscopic polyangiitis

OBJECTIVE: To evaluate the performance of 11 commercial enzyme-linked immunosorbent assay (ELISA) kits for the detection of antineutrophil cytoplasmic antibodies (ANCA) directed against proteinase 3 (PR3) and myeloperoxidase (MPO) in patients with Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). METHODS: Serum samples were taken from 92 patients with a histological and clinical diagnosis of WG (n=50) or MPA (n=42) and from 30 disease controls (systemic lupus erythematosus, n=15; rheumatoid arthritis, n=15) and 30 healthy controls. Each of the sera was tested for the presence of ANCA directed against PR3 and MPO using 11 commercially available direct ELISA kits, our in-house PR3- and MPO-ANCA capture ELISAs, and the indirect immunofluorescence technique (IFT). RESULTS: In tests for WG using PR3-ANCA, the commercial direct ELISA kits differed widely in their sensitivity (from 22 to 70%) and negative predictive value (NPV) (from 43 to 70%), but only moderately in their specificity (from 93 to 100%) and positive predictive value (PPV) (from 93 to 100%). The highest sensitivity (74%) and specificity (100%) for PR3-ANCA were obtained with the in-house capture ELISA. Similar differences and trends were noted for MPO-ANCA assays. Diagnostic sensitivity was more than 60% for four and at least 50% for six of the 11 ELISA kits. The PPV varied from 84 to 100% and the NPV from 58 to 70%. In tests for MPA, the MPO-ANCA ELISA kit designated F and the in-house capture ELISA were best (both had sensitivity 62% and specificity 100%). For both WG and MPA, maximum sensitivity for ANCA was obtained with IFT (80 and 70% respectively). CONCLUSION: Determination of PR3-ANCA and MPO-ANCA with the commercial direct ELISA kits achieved poor sensitivity for both WG and MPA. The in-house PR3 and MPO-ANCA capture ELISAs performed better than the commercial ELISAs, combining higher specificity with similar sensitivity. IFT remains the best method for ANCA detection in both diseases.     

Evaluation of Wondfo influenza A&B fast test based on immunochromatography assay for rapid diagnosis of influenza A H1N1

Influenza viruses cause significant morbidity and mortality in both children and adults during local outbreaks or epidemics. Therefore, a rapid test for influenza A&B would be useful. This study was conducted to evaluate the clinical performance of the Wondfo influenza A&B test for rapid diagnosis of influenza A H1N1 Infection. The rapid testing assay could distinguish infection of influenza A and B virus. The reference viral strains were cultured in MDCK cells while TCID50 if the viruses were determined. The analytical sensitivity of the Wondfo kit was 100 TCID50/ml. The Wondfo kit did not show cross reactivity with other common viruses. 1928 suspected cases of influenza A (H1N1) virus infection were analyzed in the Wondfo influenza A&B test and other commercially available products. Inconsistent results were further confirmed by virus isolation in cell culture. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 100%, 98.23%, 92.45%, and 100% for flu A, and 96.39%, 99.95%, 98.77%, and 99.84% for flu B respectively. 766 suspected cases of influenza A (H1N1) virus infection were analyzed in the Wondfo influenza A&B test and RT-PCR. The sensitivity, specificity, PPV and NPV were 56.5%, 99.75%, 99.52% and 71.04% for flu A, 25.45%, 99.86%, 93.33% and 94.54% for flu B respectively. These results indicate that the Wondfo influenza A&B test has high positive and negative detection rates. One hundred fifty-six specimens of influenza A (H1N1) confirmed by RT-PCR were analyzed by the Wondfo influenza A&B test and 66.67% were positive while only 18.59% were positive by the reference kit. These results indicate that our rapid diagnostic assay may be useful for analyzing influenza A H1N1 infections in patient specimen.     

Evaluation of an enzyme immunoassay for the combined detection of antibodies to HIV-1, HIV-2, HTLV-I and HTLV-II.

OBJECTIVE: To assess the sensitivity and specificity of a newly-developed assay (Bioelisa HIV-1 + 2, HTLV-1 + 2) for the simultaneous detection of HIV-1, HIV-2, HTLV-I and HTLV-II antibodies in human serum or plasma specimens. METHODS: A panel of 775 well characterized serum or plasma samples was studied. This included samples confirmed to contain antibodies to HIV-1 (n = 46), HIV-2 (n = 19), HTLV-I (n = 49) and HTLV-II (n = 12), samples containing low titres of anti-HIV antibody (n = 14) and samples collected during HIV seroconversion (n = 36). Eighty-three sera samples which were reactive in one or more HIV or HTLV screening assays, but which could not be confirmed to contain anti-HIV-1/2 or anti-HTLV-I/II antibodies, were also examined. RESULTS: Excluding the seroconversion samples and those selected on the basis of false reactivity in other screening assays, the Bioelisa kit had a sensitivity of 100% for antibody to all four viruses and a specificity of 98.8%. The ability of the kit to detect anti-HIV during seroconversion was similar to that of several other synthetic HIV-antigen-based screening kits currently in use. CONCLUSIONS: Our findings indicate that the Bioelisa kit is sufficiently accurate to screen for both HIV and HTLV infections and that it warrants larger scale trials. Its use might allow blood donor screening for HTLV infection to be introduced more widely at modest extra cost [corrected].     

Performance of the integrated management of childhood illness algorithm for diagnosis of HIV-1 infection among African infants

OBJECTIVES:: Early infant HIV-1 diagnosis and treatment substantially improve survival. Where virologic HIV-1 testing is unavailable, integrated management of childhood illness (IMCI) clinical algorithms may be used for infant HIV-1 screening. We evaluated the performance of the 2008 WHO IMCI HIV algorithm in a cohort of HIV-exposed Kenyan infants. METHODS:: From 1999 to 2003, 444 infants had monthly clinical assessments and quarterly virologic HIV-1 testing. Using archived clinical data, IMCI sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated using virologic testing as a gold standard. Linear regression and survival analyses were used to determine the effect of age on IMCI performance and timing of diagnosis. RESULTS:: Overall IMCI sensitivity, specificity, PPV, and NPV value were 58, 87, 52, and 90%, respectively. Sensitivity (1.4%) and PPV (14%) were lowest at 1 month of age, when 81% of HIV infections already had occurred. Sensitivity increased with age (P?相似文献   

ELISA法检测尿液中HIV-1抗体的研究分析

目的 探讨艾滋病病毒(HIV)感染者晨尿、非晨尿和血液中HIV-1抗体检测结果的一致性，引进尿液HIV-1抗体检测方法。方法 平行采集吸毒人员血液和尿液标本，分别用血液和尿液酶联免疫吸附试验(ELISA)法检测HIV抗体，阳性血清标本送云南省疾病预防控制中心确认。结果 检测483人，血检阳性91人，晨尿检测阳性96人，两种方法一致性98．96％。对应晨尿阳性者采集非晨尿和阴性对照尿液标本各91份(其中血液标本检测HIV抗体阳性者86份)，检出阳性86份，阴性5份，非晨尿标本与血液标本检测结果一致。以血液标本检测结果为准，晨尿标本检测HIV-1抗体的灵敏度100％，特异度98．72％；非晨尿标本检测HIV-1抗体的灵敏度和特异度均为100％。结论 尿液ELISA法检测HIV-1抗体结果可靠，非晨尿可代替晨尿作HIV-1抗体筛查。