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.     

一种HIV抗体化学发光诊断试剂的临床评价

目的临床评价北京科美东雅生物技术有限公司HIV抗体化学发光诊断试剂。方法用HIV抗体化学发光诊断试剂对既往已知经确证检测结果为HIV-1抗体阳性者标本500份和用酶联免疫吸附（ELISA）试剂检测为HIV-1／2抗体阴性者标本1500份的血清样品进行检测，并对检测结果进行比较。结果HIV抗体化学发光诊断试剂盒的敏感性、特异性和功效率均为100％。结论HIV抗体化学发光诊断试剂盒具有良好的应用价值。     

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.     

Concomitant infection of HTLV-I and HIV-l: Prevalence of IgG and IgM antibodies in Washington,D.C. area

Serum samples collected from four groups of individuals in the Washington, D.C. area were examined for the presence of IgG and IgM classes of antibody reacting against HTLV-1 and HIV-1. These four groups were: (1) healthy adults with negative premarital VDRL test for syphilis (n=113), (2) miscellaneous common disease patients (n=155), (3) drug abusers (n=130), and (4) homosexual men (n=187). The former two groups are considered to be low-risk groups, and the latter two, high-risk groups. The prevalence of IgG antibody on ELISA/Western blot tests for these groups were respectively: (1) 5.3%/1.8%, (2) 5.2%/1.9%, (3) 13.9%/4.6%, and (4) 4.3%/1.6% for HTLV-1, and (1) 2.7%/0.9%, (2) 4.5%/0%, (3) 12.3%/5.4%, and (4) 8.0%/5.9% for HIV-1. Instances of possible concomitant infection as shown by the presence of antibodies against both HTLV-I and HIV-1 were found only in the latter two high-risk groups, i.e. two (1.5%) in group (3), and three (1.6%) in group (4) as confirmed by both Western blot and immunofluorescence tests. Out of 97 sera collected from drug abusers in 1985-86 which had IgG antibody by Western blot test against HIV-1, 23 (23.7%) were HTLV-I antibody positive by ELISA test (Group 5), and 8 of these were confirmed by Western blot test. Among these 8 persons, IgM antibody against HTLV-I was found in 2, while that against HIV-1 was positive in 7 persons. This fact suggests that the exposure to HIV-1 occurred more recently than that with HTLV-I in most of those persons who were dually infected. By cross-absorption studies, it was shown that the dual antibody reactivities were not due to cross-reactivity between HTLV-I and HIV-1.     

孕产妇HIV抗体筛查阳性与免疫印迹试验对比

目的探讨孕产妇人类免疫缺陷病毒（HIV）抗体筛查试验阳性与免疫印迹试验（WB）结果的关系。方法对33份孕产妇HIV抗体待复查样本,进行酶联免疫吸附试验（ELISA）及免疫印迹试验（WB）,对WB试验结果不确定者进行3个月、6个月随访检测,6个月随访样本补充HIV-1病毒载量检测,分析ELISA检测与WB试验检测结果。结果 33份样本ELISA复检均呈阳性,免疫印迹试验（WB）中20份确认为HIV-1抗体阳性,ELISA检测与WB试验阳性符合率为60.61%（20/33）;S/CO值〉8的20份样本,WB试验结果均为HIV-1抗体阳性,1〈S/CO值〈8的13份样本,WB试验5份为HIV抗体阴性,8份为HIV抗体不确定;6个月随访样本HIV-1病毒载量检测,结果均小于最低检测限（50 IU/ml）。结论孕产妇HIV抗体筛查（ELISA）假阳性较高,假阳性样本存在于WB试验抗体阴性和不确定结果之中;随着ELISA试验S/CO值增高,ELISA检测与WB试验的阳性符合率随之增高。     

蛋白免疫印迹法试验结果与HIV感染关系的探讨

目的通过对蛋白免疫印迹法(WB)试验结果的观察，确定个体是否感染HIV以及HIV感染状况。方法对50份抗-HIV初筛阳性血清使用WB法进行确认实验。结果在被检测样品中，HIV-1型确认试验阳性45例，占90％；HIV-1型确认试验阳性，且提示HIV-2阳性感染1例，占2％；HIV-1型确认试验弱阳性(不确定)2例，占4％；HIV-1型确认试验阴性2例，占4％。结论WB法试验为确定个体有无HIV感染以及HIV感染状况提供依据。     

肠道病毒71型强神经毒分离株VP1蛋白的表达鉴定

目的利用大肠杆菌原核表达系统表达肠道病毒71型强神经毒分离株VP1蛋白,为抗体制备和病毒诊断试剂盒的开发奠定基础。方法利用一步法RT-PCR扩增出病毒VP1基因,构建重组原核表达质粒,IPTG诱导后经SDS-PAGE和Western blot验证蛋白表达的特异性。结果重组质粒在1 mmol/L的IPTG 37℃诱导6 h后可诱导表达得到约33 KD的蛋白,且表达的蛋白主要以不溶性的包涵体形式存在。VP1蛋白特异性单抗和His蛋白单抗验证了蛋白表达的特异性。结论获得特异性的EV71病毒河南分离株VP1蛋白,可用于开发病毒诊断试剂盒。     

一种口腔渗出液中HIV抗体检测试剂的试验研究

目的:对一种口腔黏膜渗出液HIV(1/2)抗体检测试剂盒进行试验研究,评价其检测敏感性、特异性和功效率。方法:采集400名吸毒人群的口腔黏膜渗出液样本,现场使用成都协和生物技术中心生产的口腔黏膜渗出液HIV(1/2)抗体检测试剂盒进行检测,平行采集受试者的血液样本,用北京华大吉比爱生物技术有限公司生产的人类免疫缺陷病毒(HIV)1+2型抗体酶联免疫法诊断试剂盒进行对比测试。结果:口腔黏膜渗出液HIV(1/2)抗体检测试剂盒的敏感性为97.44%,特异性为100%,功效率为99.75%。结论:这种口腔黏膜渗出液HIV(1/2)抗体检测试剂是一种比较可靠的快速检测试剂。     

Testing for AIDS on samples of dried blood prepared on filter papers

A substantial rise in the number of AIDS cases has been observed during the past year in many African countries, and HIV-2 indigenous transmission and increased disease have since gained importance in Senegal¹. Both for HIV-1 and HIV-2 diagnosis, ELISA positivity is followed by a Western blot test for specific antibodies. The serum samples are stored at sub-zero temperatures both during shipment and storage while awaiting serological testing. Attempts have been made to use dried blood on filter papers for AIDS diagnosis, in 35 samples from Africa and 10 from USA, along with corresponding serum samples². The concordance has been good with an almost invariable ELISA confirmation on Western blot, no selective loss in any of the bands in Western blot and the Pearson coefficient value for ELISA testing on serum and dried blood lots of 0.85. Based on the data obtained during the intentional exposure of blood-impregnated filter papers, from nine HIV-positive and one HIV-negative patient from the USA, to varying temperatures and humidity for different intervals, blood collection on filter paper would appear to have emerged as a satisfactory procedure for HIV seroepidemiological studies.     

HIV感染者窗口期的实验诊断

目的筛查高危人群和一般人群中HIV窗口期感染者,并评估各实验方法的检测性能。方法使用第四代抗原/抗体联合检测,HIV-1P24抗原检测,以50:1、10:1、1:1三级集合HIV RNA RT-PCR和流式细胞术对1383例高危人群和2249例一般人群血清进行筛查。结果分别自高危人群和一般人群中筛查出1例HIV窗口期感染者,其中高危人群中的1例抗体和P24抗原检测均为阳性,病毒载量HIV-1RNA拷贝每毫升为51万,并且CD4+/CD8+T细胞的比值小于0.9;在一般人群中所发现的1例P24抗原检测为阳性,HIV-1RNA拷贝数为每毫米32万,CD4+/CD8+T细胞比值0.92,追踪采样抗体检测结果为前阳后阴再阳。结论①第四代抗原/抗体联合检测,病毒载量HIV-1RNAP24抗原和流式细胞术检测具有良好的实验性能,可用于HIV感染者窗口期筛查。②关注第二窗口期的出现。     

Antibodies to HTLV-1–2, HIV-1 and HIV-2 in syphilitic patients

Antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) and to human T-cell leukemia virus (HTLV-1) were investigated by ELISA, Western blot and radioimmunoprecipitation (RIPA) assay in 318 sera (191 males and 127 females) obtained from syphilitic patients. The sera from 10% of the males and 3.1% of the females were positive for HIV-1. None of the sera contained antibodies to HIV-2. Antibodies to HTLV-1–2 were present in the sera of 7.1% of the males and 4.8% of the females who were seronegative for HIV. Five out of 24 (20.8%) HIV-1 positive subjects had antibodies to HTLV-1–2 as well.Sera from another group of 58 syphilitic patients (38 males and 20 females in the Anti-Venereal Disease Department), seronegative for HIV-1 and HIV-2, who denied both i.v. drug abuse and blood transfusion, were investigated in the same manner. None of the males had antibodies to HTLV-1–2, while 2 females (10%) were positive.     

Seroprevalence of HIV-1 and HIV-2 infection among children diagnosed with protein-calorie malnutrition in Nigeria.

Excessive weight loss due to protein calorie malnutrition (PCM) is a significant problem in Nigerian children. This syndrome may be difficult to differentiate from the wasting disease caused by human immunodeficiency virus type 1 (HIV-1) infection. We studied 70 children admitted to the Baptist Medical Center in Ogbomosho, Nigeria in 1990 with PCM for prevalence of antibodies to HIV-1 and HIV-2. The cohort was from low-risk mothers and had a median age of 25 months (range, 4 months-9 years) with a weight deficit of at least 20% of the theoretical weight for age. Two sera were positive for anti-HIV-1 by both ELISA and Western blot (WB). A high prevalence of samples negative for HIV-1 antibody by ELISA were repeatedly reactive (11%, 8/70) or indeterminate (46%, 32/70) by WB. None of the sera was positive for antibody to HIV-2. There was no correlation of ELISA positivity or extent of WB banding with successful recovery from malnutrition. These results indicate a relatively low but significant prevalence of HIV-1 infection in Nigerian children with PCM. The high prevalence of indeterminate reactions in WB assays for HIV-1 suggests that other procedures may be necessary for confirmatory diagnosis of HIV-1 infection in this African population.     

Seroprevalence of HIV-type 1 in a northern California health plan population: an unlinked survey.

We conducted an unlinked seroprevalence survey for human immunodeficiency virus-type 1 (HIV-1) of 9821 persons who had a routine personal health appraisal examination in 1989 while members of the Kaiser Permanente Medical Care Program in northern California. An outside laboratory performed enzyme immunoassay (EIA) analyses, and the California Viral and Rickettsial Diseases Laboratory confirmed EIA-reactive samples by immunofluorescent assay and Western blot assay. Only 20 specimens (0.2%) were confirmed as positive, and 18 were from men. These data suggest that, at the time of this survey, HIV-1 infection was not widespread in the northern California population represented by this health plan membership.     

Detection of HIV antigen and cDNA among antibody-negative blood samples in Nigeria

In developing countries as many as 50% of patients for whom a transfusion is indicated are at risk of dying immediately if transfusion is withheld. It is therefore important that blood transfusion is made as safe as possible. This study was designed to assess the safety of blood transfusion in two large blood banks in Ibadan, Nigeria. Aliquots of 250 samples already screened and passed as negative for HIV-1 and -2 were collected from each of the blood banks. Samples were tested for the presence of HIV-1 antigen (ELAVIA Ag I) and the antigen-positive samples tested for the presence of specific HIV-1 antibodies by Western blot (BioRad, France). All antigen-positive samples were also subjected to PCR. HIV-1 antigen was detected in 6 (1.2%) of the 500 samples, of which 4 (0.8%) and 3 (0.6%) were Western blot-indeterminate and PCR-positive, respectively. Transfusion of HIV-contaminated blood may be contributing significantly to the spread of the virus in Nigeria. There is therefore an urgent need for an organized blood-banking system with facilities for more sensitive assays for the detection of HIV in blood to prevent transmission through transfusion.     

Distribution of HIV type 1 infection in childbearing women in California.

The incidence of acquired immunodeficiency syndrome (AIDS) is increasing among California heterosexuals and children. To assess human immunodeficiency virus (HIV)-1 infection in childbearing women, we conducted a blinded serosurvey of newborns. Dried blood specimens taken from 99% of California births during the third quarter of 1988 (n = 135,808) and linked only to maternal demographic categories were tested for HIV-1 antibody by enzyme immunoassay and confirmed by Western blot. Period prevalence of HIV-1 infection was 7.4 per 10,000 childbearing women. Prevalence was highest for Black women and was also elevated for Hispanic and San Francisco Bay Area women. Findings suggest that California Hispanic women will make up an increasing proportion of new AIDS cases.     

FDA approves urine-based Western blot test for HIV. Food and Drug Administration

The HIV-1 urine-based Western blot confirmatory test by Calypte Biomedical Corporation has been approved by the Food and Drug Administration (FDA). The new testing option will help make testing more attractive to those who fear needles and help expand clinic outreach services because the test no longer requires a trained phlebotomist to draw blood.     

Absence of antibodies to human herpesvirus-6 in patients with slowly-progressive human immunodeficiency virus type I infection

To evaluate a possible role for Human Herpesvirus-type 6 (HHV-6) coinfection as a co-factor in the progression of HIV-1 disease, we investigated the prevalence of seropositivity for HHV-6 in a cohort of HIV-1 infected patients. These patients were retrospectively divided into two groups according to the decline of CD4+ T cells during the follow up: 11 were classified as rapid decliners (< 400 CD4+/cmm within 1 year), and 38 as slow decliners (> 400 CD4+/cmm after at least 4 years' follow up). HHV-6 antibodies were detected by a commercial immunofluorescence assay and by a Western blotting assay developed in our laboratory. Our results show that Western blot appears to provide results satisfactorily free of false positivities. We found that the frequency of HHV-6 seropositivity was significantly lower in the group of slow decliners, compared both to rapid decliners and to the general population. These data suggest a role for HHV-6 co-infection in the progression of HIV-1 disease.     

血液唾液和尿液HIV抗体快速检测及免疫印迹试剂评估

目的对Calypte公司血液、唾液和尿液3种HIV-1／2抗体快速检测试剂与尿液和血液两种HIV-1抗体免疫印迹试剂进行评估,为引进检测性能良好的试剂提供参考。方法平行采集84位HIV阳性感染者指尖血、唾液、尿液和静脉血标本,分别用Calypte公司的3种快速试剂进行HIV-1／2抗体检测,并与梅里埃血液ELISA参比试剂检测结果比较;尿液和静脉血标本分别用Calypte公司的两种免疫印迹试剂进行检测,并与GerieLabs公司的血液免疫印迹参比试剂检测结果进行比较。结果血液、唾液和尿液快速检测试剂的敏感性分别为100％、100％和96．42％,3种快速试剂检测结果与梅里埃血液ELISA检测结果一致性分别为100％、100％和96．42％;血液和尿液HIV-1WB试剂检测结果与GeneLabs参比试剂的一致性为100％。结论Calypte公司3种HIV-1／2抗体快速检测试剂和两种HIV-1抗体免疫印迹试剂与相应的参比试剂有很好的一致性。     

Screening of African sera stored for more than 17 years for HIV antibodies by site-directed serology

Antibodies to Human Immunodeficiency Virus type 1 (HIV-1) and type 2 (HIV-2) were investigated, using site-directed enzyme immunoassay (ELISA), in 320 specimens obtained from three remote, African tribes during 1969–1971. Using HIV-1 E34/E32 ELISA and HIV-2 149 ELISA, assays were conducted on 101 serum specimens from the Korekore tribe of Zimbabwe, 93 specimens from the Mano tribe of Liberia, and 126 specimens from the Turkana tribe of Kenya; specimens which tested positive in ELISA were further tested by radioimmunoprecipation assay (RIPA) and Western blot (WB). Two serum specimens from the Mano tribe of Liberia gave OD 492 nm values greater than 0.2 in HIV E34/E32 ELISA in all three runs. These two specimens reacted with HIV-1 envelope proteins gp160 and gp120 and the internal protein p24 in RIPA and WB; however, the reactivity was uncostant. All other serum specimens were negative for HIV-1 and HIV-2 antibodies. Site directed ELISA serology for HIV-1 and HIV-2 gave very low rates of false positive reactivity. Thus, reaction with HIV-1 antigen was identified in two persons of one tribe in Liberia in 1971, but HIV-2 antibodies were not detected in this tribe; HIV-1 and HIV-2 antibodies were absent during the late 1960's and early 1970's from two African tribes resident in Zimbabwe and Kenya.Corresponding author.