(1,3)-β-D葡聚糖和半乳甘露聚糖联合检测在侵袭性真菌感染诊断中的应用

目的 评价(1,3)-β-D葡聚糖检测(G试验)联合半乳甘露聚糖检测(GM试验)在侵袭性真菌病(IFD)诊断中的价值.方法 回顾性分析我院2013年12月至2016年2月门诊及住院疑似IFD的患者,根据诊断标准分为临床诊断IFD145例,非IFD 476例,检测分析G试验、GM试验及联合检测的灵敏度(Sen)、特异性(Spe)、阳性预测值(PPV)、阴性预测值(NPV)及Youden指数.结果 以临床诊断为IFD的为真阳性组,以非IFD为真阴性组.G试验的Sen、Spe、PPV、NPV、Youden指数分别为89.66％、86.76％、67.36％、96.50％、0.7642;GM试验的Sen、Spe、PPV、NPV、Youden指数分别为60.00％、88.45％、61.27％、88.45％、0.485;G试验的Sen显著高于GM试验,差异有统计学意义(P＜0.05);G试验与GM试验并联检测Sen、Spe、PPV、NPV、Youden指数分别为98.62％、79.83％、65.30％、99.50％、0.7845,其Sen、NPV均高于G试验、GM试验单独检测,差异有统计学意义(P＜0.05).结论 G试验和GM试验联合检测,能提高IFD的诊断敏感性,减少假阴性的发生,对IFD的早期快速诊断比单独检测更有价值.     

化学发光法检测受血者梅毒螺旋体特异性抗体的方法学评价

目的 通过与梅毒螺旋体微量血凝试验(TPHA)和蛋白印迹试验法(WB)比较评估梅毒血清学筛查法化学发光法(CLIA)的性能.方法 回顾性研究18 494例受血者血清标本CLIA和TPHA检测梅毒螺旋体特异性抗体结果,对CLIA和(或)TPHA结果阳性177例标本用WB检测确认.同时用CLIA、TPHA和WB检测了81例各期梅毒患者血清、55例有潜在干扰的患者血清和250例阴性对照血清梅毒抗体.结果 以WB检测结果为金标准,CLIA方法的灵敏度为98.4％,显著高于TPHA(94.4％)(x2=5.76,P＜0.05);CLIA方法特异性为100％,高于TPHA方法特异性(99.7％),但差异无统计学意义(x2=1.0,P＞0.05).结论 CLIA法具有高度敏感性和特异性,适合于临床实验室进行梅毒筛查.     

微丝蚴固相抗原酶免疫试验诊断丝虫病的初步报告

以微丝蚴固相抗原酶免疫试验法,检查了101例微丝蚴血症患者和200例健康人。按本文拟订的标准判断阳性、可疑阳性、假阴性和假阳性率分别为:91.09％,7.92％,0.99％和1.5％。在与血吸虫、肺吸虫和钩虫病人血清作交叉试验中,仅发现与钩虫病人(1/10)有交叉阳性。用本法和厚血膜片法现场检查了480例,发现前者阳性20例,后者7例(其酶免疫试验均阳性)。初步认为,本法诊断丝虫病具有较好的敏感性、特异性和重现性,因而具有一定实用价值。     

新生儿溶血病红细胞血型免疫性抗体的特异性分析

目的:观察母婴血型不合新生儿溶血病(HDN)红细胞血型免疫性抗体的检出率及其特异性.方法:采用试管法和微柱凝胶法对母婴血标本进行ABO、Rh血型鉴定及不规则抗体筛查,对有黄疸症状的新生儿血标本进行直接抗人球蛋白试验、抗体游离试验、抗体放散试验、抗体特异性鉴定及其效价测定.结果:在298例由红细胞血型免疫性抗体引起的HDN患儿中,检出抗A 62例(20.8％),抗B 65例(21.8％),抗A+抗AB 87例(29.2％),抗B+抗AB 6例(2.0％);抗M4例(1.3％),抗N1例(0.3％);抗D4例(1.3％),抗E7例(2.3％),抗cE 3例(1.0％).由ABO及MN血型免疫性抗体引起HDN者,直接抗人球蛋白试验多为弱阳性,由Rh血型免疫性抗体引起HDN者,直接抗人球蛋白试验多为强阳性;微柱凝胶法的凝集强度高于试管法;HDN患儿出生后24 h内阳性检出率为91.5％.结论:HDN血型免疫性抗体的特异性主要为ABO系统的抗A、抗B、抗AB,其次为Rh系统的抗E、抗D、抗cE及MN系统的抗M、抗N.     

应用MAC-ELISA方法检测呼吸道合胞病毒IgM抗体

建立酶联免疫吸附试验(MAC-ELISA)检测呼吸道合胞(RS)病毒特异性IgM抗体方法,并与中和试验(NT)进行对比。 取35例患毛细支气管炎婴幼儿的急性期及恢复期双份血清共70份标本进行研究。MAC-ELISA测得急性期血清中RS病毒特异性IgM抗体的阳性率为27/35(77.14％),而恢复期血清中和抗体呈≥4倍升高者为23/35(65.71％)。凡NT阳性病例,MAC-ELISA也呈阳性;凡MAC-ELISA阴性病例,NT也呈阴性。另4例NT阴性而MAC-ELISA呈阳性。两者阳性符合率为88.57％。 本研究也观察了IgM抗体与年龄的关系。在6个月龄以前,MAC-ELISA的阳性率远远高于NT。 实验说明采用MAC-ELISA检测RS病毒特异性IgM是可靠的快速诊断方法。     

113例情感性障碍家系遗传学调查

本文通过113例情感性障碍家系遗传学调查表明,病例组阳性家族史率为46.02％,其中同病阳性家族史率为34.51％,均高于对照组(7.97％)。病例组各级亲属患病率均高于对照组。并提示与患者血缘关系越近的亲属患病率越高,特别是亲属同病患病率的高低,与血缘关系近远显著相关。其遗传方式既不符合常染色体显性和隐性遗传,也不符合伴性遗传,而与多基因遗传相符。遗传率分别为84.8％和72.4％。     

抗生殖免疫抗体与不明原因反复自然流产的关系

目的：为探讨抗生殖免疫抗体与不明原因反复自然流产的关系。方法：采用ELISA法检测52例不明原因反复自然流产(流产组)血清抗精子抗体(AsAb)、抗子宫内膜抗体(EmAb)、抗卵巢抗体(AovAb)、抗心磷脂抗体(AcAb)和抗绒毛膜促性腺激素抗体(AhcGAb)的含量。结果：流产组AsAb阳性26．92％,EmAb阳性42．30％,AovAb阳性30．76％,AcA阳性46．15％和AhcGAb阳性48．07％;流产组的各项抗生殖免疫抗体检出率均明显高于对照组。结论：以上5种抗生殖免疫抗体可干扰卵的发育成熟、排卵、受精、胚泡着床和胚胎发育等过程。抗生殖免疫抗体与不明原因反复自然流产关系十分密切。     

36854例普通住院患者梅毒血清学抗体阳性率及其分布状况调查

目的 了解住院患者梅毒(TP)血清抗体阳性率及其分布状况,为梅毒的预防工作提供参考依据.方法 采用酶联免疫吸附试验(ELISA)法对我院2012年1月至2014年10月共36854例普通住院患者血清进行梅毒抗体筛查,阳性标本用双孔复检后再用金标法进行确认试验,两种方法均为阳性病例列为本次统计范围,回顾性分析各科室、各年度及各年龄段阳性率.结果 在36854例住院患者血清中共检出639例梅毒抗体阳性,总体阳性率为1.73％,男性阳性率(2.10％,365/17402)显著高于女性(1.41％,274/19452)(P＜0.05);2012年至2014年年度检出率分别为1.78％、1.77％及1.66％,年度检出率无明显差异(P＞0.05),但呈下降趋势.在科室分布上,检出率排名前五位的科室分别为肿瘤内科(4.64％)、放疗科(3.9％)、内分泌科(3.03％)、心内科(2.86％)及泌尿外科(2.68％),其中肿瘤内科、内分泌科、心内科、泌尿外科及消化内科阳性率均高于总体阳性率(P＜0.05),产科阳性率(0.73％)低于总体阳性率(P＜0.05);各年龄组＜20、20～29、30～ 39、40～49、50 ～ 59、60～ 69、70～79及≥80岁的阳性率分别为:0.14％、0.68％、1.13％、2.14％、2.14％、2.15％、2.22％、3.42％,随着年龄的增加,阳性率呈上升趋势,其中≥40岁各年龄组均显著高于总体阳性率(P＜0.05).结论 三年来梅毒检出率未见上升趋势,梅毒血清抗体阳性在临床上占一定的比例,几乎分布各个科室,常规对住院患者进行梅毒血清学筛查很有必要,对保护医务工作者、减少医源性感染和传播、预防交叉感染以及避免不必要的医疗纠纷有着重要意义.     

人巨细胞病毒对药疹病情发生发展的影响

目的 探究人巨细胞病毒对药疹病情发生发展的影响.方法 选取2012年9月-2014年6月在我院就诊的50例药疹患者作为观察组,同期选取50例体检健康者作为对照组,采用Taqman实时荧光定量PCR检测外周血单一核细胞中巨细胞病毒(CMV) DNA阳性率及载量,用酶联免疫吸附试验(ELISA)检测血清中CMV IgM阳性率,对结果进行对比分析.结果 观察组中出现32例CMV DNA阳性患者,阳性率为64％.对照组中出现13例CMV DNA阳性患者,阳性率为26％,两者相比.观察组阳性率显著高于对照组,其差异具有统计学意义(P＜0.05);观察组中CMV DNA载量为28188.824±19525.632拷贝,对照组中CMV DNA载量为3018.9532±1 761.958拷贝,观察组显与对照组比较差异显著,具有统计学意义(P＜0.05);观察组中出现11例CMV IgM阳性患者,阳性率为22％,对照组中出现5例阳性患者,阳性率为10％,两者相比.观察组CMV IgM阳性率显著高于对照组,差异具有统计学意义(P＜0.05).结论 药疹患者中存在CMV感染,其在药疹的发生和发展过程中可能起到一定的促进作用,是药疹发病的因素之一.     

黄疸患儿血清学检测时间对诊断新生儿溶血病的影响

目的对黄疸患儿进行血型血清学检测分析,并探讨血清学检测时间对诊断新生儿溶血病的影响。方法选择2014年1月~5月临床送检母亲为O型、出生1~10d的高胆红素血症黄疸患儿血标本212例,进行患儿红细胞直接抗人球蛋白试验、血清游离抗体试验、红细胞抗体放散试验。结果 212例患儿中,直接抗人球蛋白试验阳性4例(1.9%),游离抗体试验阳性24例(11.3%),放散试验阳性33例(15.6%),未检出ABO以外抗体;出生1~3d、4~7d的新生儿血清学检测阳性率明显高于7d以上的阳性率,放散试验阳性患儿总胆红素明显高于阴性患儿,差异有统计学意义(P0.05)。结论黄疸患儿血清学检测时间与新生儿溶血病检出率密切相关,早期检测,早期确诊,能够为新生儿溶血病的治疗争取时间,对防止胆红素脑病、减低新生儿溶血病后遗症的发生具有重要意义。     

Diagnostic and prognostic potential of a competitive enzyme-linked immunosorbent assay for leishmaniasis in India.

A Leishmania donovani species-specific monoclonal antibody (monoclonal antibody D2) was evaluated for its diagnostic and prognostic potential by a competitive enzyme-linked immunosorbent assay (C-ELISA) in sera from Indian patients with visceral leishmaniasis (VL) and seven patients with post-kala-azar dermal leishmaniasis (PKDL). These results were compared with those obtained by microscopy with Giemsa-stained tissue smears and a direct enzyme-linked immunosorbent assay (direct ELISA) with crude parasite antigen. Of 121 patients with clinically diagnosed VL examined, 103 (85.1%) were positive and 11 (9.1%) were negative by all three methods. An additional 7 (5.8%) who were negative by microscopy were positive by both C-ELISA and direct ELISA. Seven PKDL patients were also examined and were found to be positive by all three methods. Analysis of the chemotherapeutic response to sodium antimony gluconate of these 110 serologically positive VL patients showed that 57 (51.8%) were drug responsive and 53 (48.2%) were drug resistant. The C-ELISA with sera from 20 longitudinally monitored VL patients before and after chemotherapy showed a significant decrease in percent inhibition of monoclonal antibody D2 in drug-responsive patients. However, in drug-unresponsive patients, the percent inhibition of D2 was unchanged or was slightly increased. Our results therefore indicate (i) the applicability of L. donovani species-specific monoclonal antibody D2 for sensitive and specific serodiagnosis by C-ELISA, (ii) that the C-ELISA is more sensitive than microscopy, especially for early diagnosis, (iii) that L. donovani is still the main causative agent of VL, irrespective of the chemotherapeutic response, and (iv) that the C-ELISA can be used to evaluate the success of drug treatment.     

Screening for toxoplasmosis in pregnancy.

The prevalence of antibody against Toxoplasma gondi in a population of 715 pregnant women has been evaluated by two methods: indirect haemagglutination antibody (IHA) and indirect fluorescent antibody (IFA) test and all positive sera were checked by the dye test. Five hundred of the study population were questioned on diet and on animal contact to elucidate a possible relation to the prevalence of antibody. Results are expressed in international units (IU) of antibody against T gondi. Of the 715 sera, 171 were positive by IHA and 173 by IFA. One hundred and sixty-seven sera were positive by both tests, ninety-eight (58%) correlating exactly, as to the concentration of antibody. The ten sera which were not positive by both tests all had detectable antibody at the minimum concentration only (12 IU). The dye test confirmed all sera positive by both tests with the exception of three. It also confirmed one of four sera positive by IHA antibody alone and two of six positive by IFA alone. All sera that proved dye test-negative had low antibody concentrations (12 IU) by IHA or IFA. The IHA test, which is commercially available in kit form, would be suitable for use as a screening test during pregnancy. The estimated annual rate of antibody acquisition over the age range 16-40 years is 1.2% per annum with the highest rate in the 36-40 age group (2.5% per annum) and the lowest in the 26-30 age group (0.4% per annum). The clinical history was not significantly different between those with and those without antibody against T gondi but significantly more women in the 36-40 age group had a history of animal contact than those in the 26-30 age group. No conclusive evidence of recent or current infection was found.     

TORCH-IgM捕获法ELISA试剂盒的研制和应用

目的 为了发展TORCH近期感染的IgM酶免疫诊断技术。方法 以抗人IgM McAb包板，加待检血清、TORCH抗原，接着加酶标记的抗TORCH—McAb，最后加3，3’，5，5’-四甲基联苯胺(TNB)显色。用这种自制的捕获法ELISA(C—ELISA)试剂盒和HOPE公司的间接法ELISA(I—ELISA)试剂盒平行检测1196份孕妇血清TORCH-IgM。结果C—ELISA试剂盒检出阳性血清67份，并经其他试验证实为阳性。其中4份用I—ELISA试剂盒检测为阴性。由乳胶凝集试验诊断为类风湿因子(RF)阳性的2份血清，经I—ELISA试剂盒检测为阳性，但经C—ELISA试剂盒检测为阴性。结论 在检测孕妇TORCH—IgM方面，C—ELISA比I-ELISA有更强的敏感性和更高的特异性。C—ELISA试剂盒是诊断TORCH近期感染的良好工具。     

Comparison of competitive and indirect enzyme-linked immunosorbent assays for detection of bluetongue virus antibodies in serum and whole blood.

An indirect (I) enzyme-linked immunosorbent assay (ELISA) and a competitive (C) ELISA, using a group-specific monoclonal antibody against bluetongue virus (BTV), are described for the detection of antibodies to BTV in cattle and sheep sera. The performance of these assays in detecting anti-BTV antibody in sequential serum samples and eluates from whole blood (WB) dried on filter paper from three calves and four sheep experimentally infected with type 10 BTV was evaluated. The C-ELISA was superior to the I-ELISA in the detection of anti-BTV antibody in the sera and WB samples from both cattle and sheep early after infection with BTV. BTV antibodies were demonstrable by C-ELISA in all the bovine and ovine sera and WB eluates by 9 days postinfection; whereas the I-ELISA results for sheep sera and WB eluates were similar, anti-BTV antibody was not detected in bovine serum and WB eluates until 26 and 14 days postinfection, respectively. While both ELISAs proved reliable, under the present test conditions involving detection of early postinfection reactions of experimentally infected animals, the C-ELISA was always as sensitive or more sensitive than the standard agar gel immunodiffusion test, the modified complement fixation test, and the plaque neutralization tests in the detection of anti-BTV antibodies. Unlike observations with the immunodiffusion test, no reaction was seen between BTV antigen and bovine epizootic hemorrhagic disease virus antiserum in either ELISA. The results suggest that either ELISA may be suitable for routine diagnostic testing and may have the potential to replace other tests for detection of anti-BTV group-specific antibodies and that the C-ELISA may have the most potential.     

Evaluation of methods to detect antibodies against Aspergillus fumigatus.

Seventy-five sera, including sera from 23 patients with aspergillosis, 17 with tuberculosis, asthma or carcinoma, and 35 normal controls, were studied for antibody activity against Aspergillus fumigatus by agar gel double diffusion (DD), counterimmunoelectrophoresis (CIE), indirect hemagglutination (IHA) and indirect immunofluorescence (IF). Metabolic antigens produced from a selected strain of A. fumigatus were used for DD, CIE and IHA, while slide cultures of the same organism were used for IF. The results indicated that sera from the patients with aspergillosis had high IHA and IF titers, while only 91 and 87% were positive for CIE and DD methods, respectively. IHA was more sensitive than DD and CIE, and IF was equally sensitive but had false-positive reactions. CIE was simple and fast, but had false-negative and occasionally false-positive results.     

Brucella melitensis cell envelope protein and lipopolysaccharide epitopes involved in humoral immune responses of naturally and experimentally infected sheep.

Cell envelope fraction (CEF) of Brucella melitensis B115 was used to investigate antibody responses of B. melitensis naturally and strain H38 experimentally infected sheep by immunoblotting, indirect enzyme-linked immunosorbent assay (ELISA) (I-ELISA), and competitive ELISA (C-ELISA) with monoclonal antibodies (MAbs). MAbs used were directed to outer membrane proteins with molecular masses of 10, 16.5, 19, 25 to 27, 31 to 34, 36 to 38, and 89 kDa; to the heat shock protein DnaK, to O-polysaccharide (O-PS) common (C) and M epitopes; and to rough lipopolysaccharide (R-LPS) epitopes. In immunoblotting, all infected sheep sera tested recognized a large number of protein bands, including the above-cited proteins and other proteins for which MAbs have not been defined. The antibody response pattern was different from one animal to another, even within the experimentally infected sheep which were infected under the same experimental conditions. A number of protein bands were recognized by the sheep sera prior to experimental infection and by other uninfected sheep sera. The antibody reactivity to these antigens and others might explain the nonspecific antibody reactivity of sera in I-ELISA with CEF. C-ELISA confirmed also the individual variability of the antibody responses of infected sheep to protein antigens. Antibody responses to O-PS C and M epitopes were detected in all experimentally infected sheep and in half of the naturally infected sheep, but these responses were also heterogeneous in relation to their intensities. Antibody responses to R-LPS epitopes detected by use of C-ELISA with the anti-R-LPS MAbs were low or negative in most of the infected animals. Despite antibody response heterogeneity for CEF antigens, immunoblot and C-ELISA results indicated that, among the CEF antigens, the O-PS epitopes (C and M epitopes) and epitopes of the major 25- to 27- and 31- to 34-kDa outer membrane proteins seem to be the most promising for detecting B. melitensis infection in sheep.     

Serological investigations on Indian kala-azar.

Detailed serological investigations were carried out in forty-nine active kala-azar (KA) cases in North Bihar, India. Various classes of immunoglobulin (IgG, IgA, and IgM) and third component of complement (C3) levels were determined in these sera and results were compared with those obtained in normal controls. Antibody titres were determined by the indirect haemagglutination (IHA) method using soluble Leishmania antigen. Immunoglobulin G and M class-specific antibody titres were also determined separately by the enzyme-linked immunosorbent assay (ELISA) method. Polyclonal hypergammaglobulinaemia with marked increase in serum IgG (and to a lesser extent in IgM) level was a rather common feature in the majority of these sera. Much of this immunoglobulin increase, however, appeared to be non-specific in nature and no absolute correlation could be noted between serum IgG or IgM levels and corresponding IgG or IgM antibody titres. Significant decrease in serum C3 level was observed in KA and this decrease was found to be independent of immunoglobulin levels or specific antibody titres. A fairly good correlation between aldehyde test and serum IgG level was evident from this study. Aldehyde-positive KA sera usually gave higher antibody titres than aldehyde-negative ones. Anti-leishmanial antibodies belonged mostly to IgG class although some IgM antibodies were also demonstrable. The latter class of antibodies probably appeared early in KA infection although their serological specificity was poorer to IgG antibodies. Out of forty-nine KA sera examined in this study thirty-six (73.5%) gave positive IHA titres while forty-six (93.9%) were positive by IgG-ELISA which appeared to be a highly specific and sensitive serodiagnostic method particularly for the early detection of KA cases.     

Evidence of Burkholderia pseudomallei-specific immunity in patient sera persistently nonreactive by the indirect hemagglutination assay

The indirect hemagglutination assay (IHA) is the most frequently used serological test to confirm exposure to Burkholderia pseudomallei. Patients with culture-confirmed disease often have a nonreactive IHA at presentation and occasionally fail to seroconvert on serial testing. We investigated whether using antigens derived from the cultured isolates of persistently IHA-nonreactive patient sera improved the sensitivity of the IHA. In addition, we assessed the antigen-specific lymphocyte response in this group of patients to a panel of B. pseudomallei antigens, including those derived from their own cultured isolates. Eleven patients with culture-proven melioidosis were identified as having persistently IHA-nonreactive sera. A modified IHA using erythrocytes sensitized with patient isolate-derived antigen tested against convalescent-phase serum was performed. The majority (82%) of sera showed a negative (≤ 1:5) result, one was borderline (1:20), and one was positive at the cutoff value (1:40). IHA-nonreactive sera were also tested by enzyme immunoassay (EIA), with 73% (8/11) demonstrating IgG positivity. In addition, lymphocytes isolated from persistently IHA-nonreactive patient sera demonstrated significantly increased proliferation in response to B. pseudomallei antigens compared to controls. These studies demonstrate the presence of B. pseudomallei-specific antibody by EIA and B. pseudomallei-specific lymphocytes in patient sera categorized as persistently nonreactive according to the IHA. New immunoassays are required and should incorporate B. pseudomallei antigens that are immunoreactive for this subset of IHA-nonreactive patient sera.     

Diagnostic and Prognostic Potential of a Competitive Enzyme-Linked Immunosorbent Assay for Leishmaniasis in India

A Leishmania donovani species-specific monoclonal antibody (monoclonal antibody D2) was evaluated for its diagnostic and prognostic potential by a competitive enzyme-linked immunosorbent assay (C-ELISA) in sera from Indian patients with visceral leishmaniasis (VL) and seven patients with post-kala-azar dermal leishmaniasis (PKDL). These results were compared with those obtained by microscopy with Giemsa-stained tissue smears and a direct enzyme-linked immunosorbent assay (direct ELISA) with crude parasite antigen. Of 121 patients with clinically diagnosed VL examined, 103 (85.1%) were positive and 11 (9.1%) were negative by all three methods. An additional 7 (5.8%) who were negative by microscopy were positive by both C-ELISA and direct ELISA. Seven PKDL patients were also examined and were found to be positive by all three methods. Analysis of the chemotherapeutic response to sodium antimony gluconate of these 110 serologically positive VL patients showed that 57 (51.8%) were drug responsive and 53 (48.2%) were drug resistant. The C-ELISA with sera from 20 longitudinally monitored VL patients before and after chemotherapy showed a significant decrease in percent inhibition of monoclonal antibody D2 in drug-responsive patients. However, in drug-unresponsive patients, the percent inhibition of D2 was unchanged or was slightly increased. Our results therefore indicate (i) the applicability of L. donovani species-specific monoclonal antibody D2 for sensitive and specific serodiagnosis by C-ELISA, (ii) that the C-ELISA is more sensitive than microscopy, especially for early diagnosis, (iii) that L. donovani is still the main causative agent of VL, irrespective of the chemotherapeutic response, and (iv) that the C-ELISA can be used to evaluate the success of drug treatment.     

Comparison of an enzyme-linked immunoassay with an indirect hemagglutination assay for the detection of antibodies to cytomegalovirus

Because of the morbidity associated with cytomegalovirus (CMV) infections in neonates, immunosuppressed and transplant patients, there is a need for a rapid, sensitive, and reliable assay for the presence of antibody to CMV. Such an assay would permit the identification of CMV antibody negative blood or plasma for transfusion into these high-risk patients. The indirect hemagglutination assay (IHA) is often employed to detect antibodies to CMV, but results must be interpreted subjectively. Thus, an indirect enzyme immunoassay (EIA) was developed to detect antibodies to CMV, and was compared to IHA. 531 sera from a population of healthy blood donors were assayed by both methods. Compared with IHA the sensitivity of the indirect EIA was 98.5% (267/271) and the specificity was 93.1% (242/260). Antibodies to Epstein-Barr, herpes-zoster, or herpes simplex viruses did not react in the EIA. The EIA and IHA correlated well in the detection of antibodies to CMV in sera from acute CMV infections. The presence of rheumatoid factor did not interfere with the EIA or IHA results. This indirect EIA is a rapid, simple, and reproducible method to identify seronegative sera or plasma.