酶联免疫吸附试验和直接免疫荧光检测沙眼衣原体的方法学比较

目的：评价酶联免疫吸附试验（ELISA）和直接免疫荧光（DFA）法检测沙眼衣原体（CT）的灵敏度和特异性。方法：分别采用CT抗原DFA和ELISA法检测泌尿生殖道CT,两法结果不一致时采用荧光定量PCR确证。以DFA和ELISA法均阳性或经PCR确证阳性的结果作为真阳性,分别计算DFA和ELISA法的灵敏度、特异性、阳性预测值和阴性预测值。结果：共检测222份女性宫颈拭子和69份男性尿道拭子,真阳性66例,真阴性225例,其中DFA和ELISA检测结果均阳性63例,另10例两法结果不符的样本经PCR检测阳性3例。ELISA法的灵敏度、特异性、阳性预测值和阴性预测值分别为97．0％、98．7％、95．5％和99．1％,而DFA分别为98．5％,98．2％,94．2％,99．5％。两种方法检测结果符合率为96．6％。结论：ELISA和DFA法检测CT有较高的灵敏度和特异性,均可为临床治疗和性病监测工作提供可靠依据。     

四种检测泌尿生殖道沙眼衣原体方法的比较与评价

目的对胶体金免疫层析、酶免疫(EIA)、直接荧光抗体测定(DFA)和细胞培养四种检测泌尿生殖道沙眼衣原体的方法进行比较与评价。方法分别应用胶体金,EIA,DFA和细胞培养四种方法检测不同稀释倍数的沙眼衣原体E型标准株。35例临床疑为泌尿生殖道沙眼衣原体感染患者的宫颈或尿道拭子分别应用胶体金,EIA,DFA进行检测。结果能测出沙眼衣原体E型标准株为阳性的最大稀释倍数在胶体金,EIA,DFA和细胞培养法中分别为:104,106,108和104倍;35例临床标本的阳性率在胶体金,EIA和DFA法中分别为:11.43%,25.71%和40.00%,胶体金和DFA法之间差异有统计学意义(P<0.05),敏感性最高的为DFA法。结论 DFA法检测泌尿生殖道沙眼衣原体的敏感性较胶体金、EIA和细胞培养方法高,临床上可提倡应用。     

沙眼衣原体感染血清学筛查候选蛋白组合的优化

目的 优化适用于沙眼衣原体感染血清学筛查的候选抗原蛋白组合.方法 收集天津医科大学总医院性病门诊经胶体金法检测沙眼衣原体感染者的血清和泌尿生殖道分泌物拭子各50份,胶体金法检测沙眼衣原体未感染者的血清和泌尿生殖道分泌物拭子各30份,此30份血清微量免疫荧光(MIF)法检测为阴性.以沙眼衣原体蛋白Hsp60和MOMP为参照,选择沙眼衣原体Pgp3、CPAF、CT143、CT101、CT694、CT875、CT813、IncA共8种免疫优势蛋白为抗原,检测血清中的相应抗体,将该结果与血清MIF检测和泌尿生殖道分泌物沙眼衣原体细胞培养两种传统金标准作比较,确定具有最高敏感性和特异性的抗原蛋白组合.结果 50份胶体金法阳性标本中,MIF检测阳性44份,阴性6份;细胞培养阳性14份,阴性36份.沙眼衣原体Pgp3、CT694和CT875这3种免疫优势蛋白组合的血清学实验结果与MIF阳性符合率达到97.73％(43/44).30份胶体金法检测沙眼衣原体阴性标本中,30份血清标本经MIF检测全为阴性,也未检出上述3种蛋白抗体.结论 Pgp3、CT694与CT875免疫优势蛋白组合用于沙眼衣原体感染的血清学初筛具有很好的敏感性和特异性,且操作简单,易于推广.     

沙眼衣原体酶免疫法和细胞培养法的比较

目的　评价一种改进的沙眼衣原体酶免疫法 (ELISA)诊断沙眼衣原体感染的临床应用价值。方法　 2 0 0例性病门诊有泌尿生殖道症状的患者采用ELISA和细胞培养法检测泌尿生殖道标本中的沙眼衣原体 ,两种试验结果不符合者采用PCR检测。结果　 2 0 0例受检者中 ,ELISA阳性 19例 ,细胞培养阳性 2 0例。与“扩大金标准”比较 ,ELISA法和细胞培养的敏感性分别为 82 .68%和 68.96% ,特异性均为 10 0 % ,阳性预期值均为 10 0 %。结论　ELISA法检测泌尿生殖道沙眼衣原体感染 ,其敏感性和特异性高 ,且方便、快速 ,尤其适合大批量样本的检测 ,值得在临床应用。     

ClearView CT快速诊断女性生殖道沙眼衣原体感染的评价

目的:对C learV iew CT快速诊断试剂盒检测女性生殖道的沙眼衣原体进行方法学评价。方法:采集每名受试者宫颈分泌物拭子2份,将之随机分为2组,以荧光定量PCR为参比试验,评价C lear-V iew CT快速诊断试剂盒在女性生殖道沙眼衣原体感染的应用性能。结果:设置荧光定量PCR为参比试验,C learV iew快速诊断试剂盒检测女性生殖道衣原体的敏感性为32.73%,特异性为88.52%,约登指数为0.2125。在感染率为28.95%的性服务工作者人群中应用该试剂盒检测生殖道沙眼衣原体时,其验后概率为53.74%。结论:C learV iew CT快速试剂盒的特异性尚可,但其敏感性差;在感染率达28.95%的女性性服务工作者人群应用C learV iew快速试剂盒检测生殖道衣原体感染,检测阳性者来诊断衣原体感染的把握度为53.74%。     

用细胞培养和酶免疫法检测泌尿生殖道标本中沙眼衣原体的研究

用细胞培养和酶免疫法对１００例性病门诊病人的泌尿生殖道标本作了沙眼衣原体检测。在细胞培养法阳性的２２价标本中，用酶免疫法检测阳性的为２１份，在细胞培养阴性的７８份标本中，用酶免疫法检出阳性的１份。与细胞培养法比较，酶免疫法检测沙眼衣原体的敏感性为９５．５％，特异性为９８．７％。结果表明，酶免疫法不失为一种快速诊断泌尿生殖道沙眼衣原体感染的方法。     

汕头性病门诊患者泌尿生殖道沙眼衣原体检测

目的：了解2011-2017年本院11584例性病门诊患者泌尿生殖道沙眼衣原体感染特征。方法：对就诊患者的临床资料进行回顾性分析。结果：（1）11584例患者中沙眼衣原体阳性1480例,阳性率12.78%。6886例男性患者中泌尿生殖道沙眼衣原体感染1023例,阳性率14.86%,4698例女性患者中沙眼衣原体阳性457例,阳性率9.73%,男女患者阳性率比较有显著统计学差异;（2）感染率最高和最低的年龄段为≤19岁和≥60岁的患者,感染率分别为 28.29%（71/251）和9.16%（34/371）;（3）1480例泌尿生殖道沙眼衣原体阳性患者中有991例无症状的体检者（66.96 %）。结论：2011-2017年本院性病门诊患者泌尿生殖道沙眼衣原体感染率较高,泌尿生殖道沙眼衣原体阳性感染者中无症状感染者占比较高。     

三种方法检测泌尿生殖道沙眼衣原体的比较

目的用三种方法检测泌尿生殖道沙眼衣原体,评价其方法的敏感性和特异性.方法采用C-C快速法、PCR和VIDAS CHL三种方法检测150例尿道或宫颈分泌物标本.结果在150例患者中,阳性患者43例,阳性率为28.67％,C-C快速法检测的敏感性与特异性为97.67％和100％,PCR检测的敏感性和特异性为100％和98.13％,VIDAS CHL检测的敏感性和特异性为97.67％和97.20％.结论三种方法检测泌尿生殖道沙眼衣原体的敏感性和特异性无显著性差异(P＞0.05).     

淋球菌、沙眼衣原体、解脲脲原体联合检测基因芯片临床应用评价

目的评价基因芯片在检测淋球菌（NG）、沙眼衣原体（CT）和解脲脲原体（UU）中的应用价值。方法697例NG检测样本、663例CT检测样本及653例UU检测样本均用现有临床常规检测（培养法检测NG及UU，免疫层析法检测CT）、PCR检测及基因芯片检测。以临床常规检测为参照，分析基因芯片检测与临床常规检测结果的符合情况；以临床常规检测和PCR检测为参照，分析基因芯片检测的敏感性及特异性。结果基因芯片检测结果与临床常规方法的符合率为：NG阳性符合率为99．2％，阴性符合率为97．9％；CT阳性符合率为100％，阴性符合率为97．2％；UU阳性符合率为84．5％，阴性符合率为97．1％。基因芯片检测NG的敏感性为99．1％，特异性为99．3％；基因芯片检测CT的敏感性为98．9％，特异性为99．5％；基因芯片检测UU的敏感性为98．5％，特异性为99．5％。结论基因芯片检测泌尿生殖道NG、UU及CT的特异性和敏感性均较高，在泌尿生殖道病原学诊断中有很好的临床应用价值。     

两种免疫试剂盒检测沙眼衣原体的评价

目的评估目前临床常用于检测泌尿生殖道标本中沙眼衣原体的两种免疫试剂盒的性能。方法以酶联免疫法作为对照,测定两种金标快速试剂盒的敏感性和特异性。结果两种金标类试剂检测结果差异无显著性,但与酶免法相比,其敏感性相对较低,尤其是对男性尿道拭子标本的漏检率较高。结论两种金标方法的特异性均较理想。     

Evaluation of a direct fluorescence assay as a screening method in asymptomatic young women.

The purpose of the study was to evaluate one rapid antigen test (DFA), in comparison to culture, for the detection of Chlamydia trachomatis in young, asymptomatic women. C. trachomatis was isolated from specimens of 8.6% of the patients studied, and 11.3% had 10 or more elementary bodies (EBs) in their specimens. A lowered cut-off point of the DFA did not affect the sensitivity of the method, but the predictive value of a positive test decreased markedly when the cut-off point was lowered. Patients with symptoms of genital infection, signs of genital infection, or both had a higher DFA sensitivity than those who were asymptomatic. Patients whose specimens yielded 1-9 EBs were reexamined three times, once every fourth week. We found little evidence that those patients should be regarded as falsely negative in culture, since most of them remained negative. In order to minimize the social consequences of a false positive test, the DFA method should not be substituted for culture as a diagnostic tool, especially for screening of asymptomatic groups with a low prevalence of C. trachomatis.     

Evaluation of Abbott Testpack Chlamydia for detection of Chlamydia trachomatis in patients attending sexually transmitted diseases clinics

This work compares a rapid solid-phase EIA (Abbott TestPack Chlamydia) to tissue culture and a direct fluorescent antibody test (Syva Microtrak) for detection of C. trachomatis in 436 patients attending two inner-city sexually transmitted diseases (STD) clinics. The prevalence of C. trachomatis by culture was 12% (5% in men, 15% in women). Overall sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TestPack compared to culture were 70%, 98%, 80%, and 96% respectively. In men, 12 specimens were positive by TestPack, while only eight specimens were positive by culture. Six TestPack-positive, culture-negative specimens were further evaluated by centrifugation of culture transport media and examination of the sediment for chlamydia elementary bodies (EBs) using fluorescent monoclonal antibodies to C. trachomatis. Using this procedure, five of six culture negative specimens contained EBs (revised sensitivity 85%, specificity 99%, PPV 92%, NPV 99%). In 285 women evaluable in culture and TestPack, 44 (15%) specimens were culture positive; TestPack was positive in 29 (sensitivity 66%) culture positive women. Of 241 culture negative patients, 238 had negative TestPack results (specificity 99%) and no EBs were detected in the culture-negative, TestPack-positive specimens. Twenty-three (8%) Microtrak specimens were unsatisfactory for testing; two of these were culture and TestPack positive. Therefore, of 263 specimens evaluable using Microtrak, 42 (16%) specimens were culture positive; Microtrak was positive in 32 (sensitivity 76%) culture-positive women. Abbott TestPack Chlamydia is a rapid (25 minute), visually read format requiring no specialized equipment for detection of chalmydia infections with a sensitivity comparable to that of Microtrak.     

Chlamydia trachomatis infection in women attending urban midwestern family planning and community health clinics: risk factors, selective screening, and evaluation of non-culture techniques

To determine prevalence and risk factors for endocervical Chlamydia trachomatis infection in an urban midwestern population and to evaluate two non-culture direct tests for C. trachomatis, we studied 849 women attending two family planning clinics and a community health clinic in Milwaukee, Wisconsin. Adequate endocervical specimens were obtained from 751 women for chlamydial isolation in tissue culture and antigen tests using direct fluorescence (DFA) and enzyme immunoassay (EIA); 93 (12.4%) patients had cultures positive for C. trachomatis. Compared to culture, the DFA test had a 77.4% sensitivity, 96.8% specificity, and a predictive value positive (PVP) of 77%. For the EIA, these values were 83.9%, 97.0%, and 80%, respectively. No single historical, clinical, or laboratory variable, including the previously described cervicitis index and specific cytologic findings on Pap smear, had sufficient predictive value to be used as the only criterion for selective screening in this population. Criteria for selective screening were proposed that would result in screening 43% of patients and would identify 71% of infections. PVP of both non-culture tests was 89% in persons identified by these criteria to be at increased risk of C. trachomatis infection.     

Evaluation of a new chemiluminometric immunoassay, Magic Lite Chlamydia, for detecting Chlamydia trachomatis antigen from urogenital specimens.

The chemiluminometric sandwich immunoassay, Magic Lite Chlamydia by Ciba Corning (Medfield, MA), using one Chlamydia trachomatis-specific monoclonal antibody conjugated with acridinium ester and one polyclonal immobilized to magnetic particles, was compared to cell culture in 291 urogenital specimens from 92 men and 102 women tested both in the cervix and urethra. The proportion of patients with positive culture results ranged from 11.8% among the women to 15% among the men, using microculture plates and peroxidase-antiperoxidase staining procedure with genus-specific monoclonal antibody (Orthodiagnostics, Raritan, NJ). The chemiluminometric method for detecting Chlamydia trachomatis antigen showed an overall sensitivity of 72.4%, specificity of 97.7%, positive predictive value of 77.7%, and negative predictive value of 96.9%. A higher sensitivity of Magic Lite was found in clinical specimens yielding more than 10 inclusions by well in cell culture. The newly developed chemiluminometric test, easy to perform, had the same limits in terms of sensitivity and positive predictive value than the other widely-used existing tests for detecting Chlamydia trachomatis antigen from urogenital specimens.     

Diagnostic efficacy of chlamydial antibodies in cervical secretions from pregnant women and adolescent girls.

OBJECTIVE--To assess the prevalence of cervical antibodies to Chlamydia trachomatis in two different populations and to correlate the findings to culture, direct fluorescent antibody test (DFA) and serum antibodies. SETTING--Antenatal clinics and clinic for teenage counselling in Gävle. PATIENTS--1078 pregnant women attending for routine follow up in the third trimester of pregnancy and 256 teenage girls. OUTCOME MEASURES--Cervical IgG and IgA antibodies to Chlamydia trachomatis. Cervical cultures for chlamydia. Serum IgG antibodies. DFA tests were used only in the teenage group. RESULTS--The prevalence of positive culture was 2.0% in pregnant women and 8.6% in teenage girls. In pregnant women cervical IgG > or = 8 and IgA > or = 8 were found in 7.2% and 5.8% respectively and in teenage girls in 6.6% and 2.0% respectively. The agreement between cervical IgG > or = 8 and humoral IgG > or = 32 was 0.76 in the pregnant group and 0.95 in the teenage group. The sensitivity, specificity and positive predictive value (PPV) for cervix IgG > or = 8 to predict a positive culture was 0.64, 0.94 and 0.18 respectively in pregnant women and 0.41, 0.97, 0.53 respectively in teenage girls. Of 31 teenage girls with either positive culture or positive DFA 12 had cervical IgG > or = 8 while five of 225 with negative chlamydia tests had cervical IgG > or = 8 (sensitivity 0.40 and PPV of 0.71). Cervical IgG > or = 16 was found in eight of 31 with positive chlamydia tests and in one of 225 with negative tests (sensitivity 0.26 and PPV 0.89). CONCLUSIONS--The finding of cervical IgG > or = 16 predicts current chlamydia (culture or DFA) in nearly 90% in a teenage population. It might indicate current infection in spite of negative culture in some cases. For low titres and in a low prevalence pregnant population cervical IgG are not useful for the diagnosis of chlamydia. As the sensitivity is low cervical antibodies cannot be used for screening purposes.     

Evaluation of the Amplicor Chlamydia trachomatis test versus culture in genital samples in various prevalence populations.

OBJECTIVE--To evaluate a newly developed polymerase chain reaction (PCR) assay, Amplicor C trachomatis for the detection of C trachomatis in genital samples using cell culture for comparison. SUBJECTS--501 patients (431 women and 70 men) attending an STD clinic in Hôpital Pellegrin (high-risk population) and gynaecological clinics (low-risk population) in Bordeaux, France. METHODS--The genital samples (cervical and urethral) were tested for the presence of C trachomatis using the Amplicor test and using standard cell culture identified by the immunofluorescence test using a monoclonal antibody to C trachomatis. Discrepancies between the results of culture and Amplicor were further analysed by major outer membrane protein gene (omp1)-PCR of the specimens taken in transport media and by direct fluorescent antibody (DFA) staining of elementary bodies in culture transport tubes. RESULTS--After analysis of discrepancies, the revised sensitivity and specificity of PCR were 95.3% and 100% and the positive and negative predictive values were 100% and 99.5%, respectively. CONCLUSION--The present results indicate that the Amplicor assay is rapid, specific and more sensitive than the culture method. This test provides an excellent non-culture method for the detection of C trachomatis in various prevalence populations.     

Evaluation of a microdot immunofluorescent antigen detection test for Chlamydia trachomatis.

OBJECTIVE--To evaluate a centrifuge enhanced direct immunofluorescent antigen test (MD test), compared with conventional culture and ELISA testing in the diagnosis of Chlamydia trachomatis infection. SETTING--A District General Hospital situated 30 miles from a University Department of Medical Microbiology. SUBJECT AND METHOD--A prospective study on specimens from 638 patients. Culture was performed on 348 specimens from genitourinary medicine patients and ELISA testing was carried out on 272 specimens from Gynaecology patients. RESULTS--When compared with culture the MD test had a sensitivity of 90.6%, specificity of 96.8%, positive predictive value of 74.3% and a negative predictive value of 99%. When compared with confirmed ELISA results the MD test had a sensitivity of 100%, specificity of 98.8%, positive predictive value of 78.5% and negative predictive value of 100%. CONCLUSION--The MD test compares favourably with other chlamydial diagnostic techniques and in our setting is preferable to sending specimens for chlamydial culture. It is not suitable as the sole diagnostic method for screening large numbers of specimens but is a cost effective confirmatory test for positive ELISA results.     

Comparison of the Amplicor Chlamydia trachomatis test and cell culture for the detection of urogenital chlamydial infections.

OBJECTIVE--To compare the polymerase chain reaction (PCR) Amplicor Chlamydia trachomatis test with the cell culture method, in diagnosing urogenital chlamydial infections. SUBJECTS--439 patients (327 women and 112 men) attending one STD clinic and Family Planning and Gynaecological Clinics in Lisbon, Portugal, between November 1993 and March 1994. METHODS--In women, two endocervical swab samples were collected: one for PCR Amplicor and one for standard culture technique. Men were asked to submit 20 ml of urine (first pass urine) for PCR Amplicor and one urethral specimen was taken for culture. The order of collection of the specimens was rotated every 50 patients. Discrepant results were further analysed by a second PCR with primers directed against the C trachomatis major outer membrane protein (MOMP) and by direct fluorescent antibody (DFA). RESULTS--After analysis of discrepancies, the adjusted sensitivity and specificity of PCR on endocervical specimens were 92.9% and 100% and the positive and negative predictive values were 100% and 99.7% respectively; on the urine samples these values were 100%, 99.1%, 100% and 99.1%, respectively. CONCLUSION--These results indicate that the PCR Amplicor test is a rapid sensitive and specific assay for the detection of C trachomatis in urogenital infections and provides a non-invasive technique for screening chlamydia infection in men.     

299例泌尿生殖道沙眼衣原体的检测及药物敏感性分析

目的:检测近4年来天津地区泌尿生殖道沙眼衣原体对阿奇霉素、米诺环素、莫西沙星3种临床常用抗生素体外药物敏感性,并评价药敏结果与临床疗效的关系.方法:将采集到的符合要求的299例临床标本及E型标准株破壁、离心后接种于细胞培养板的McCoy细胞,培养60～72 h后碘染观察衣原体包涵体.原代培养阴性或阳性的标本均进行传代培养.阴性标本均传代培养至第5代,阳性标本传代培养至感染率达90%以上,收集标本进行3种常用抗生素的药敏试验.结果:共培养出沙眼衣原体阳性株104株,阳性率为34.78%.其中McCoy细胞感染率达90%以上的菌株共94株,药敏(最低抑菌浓度,MIC)结果分别为阿奇霉素(0.063～1.000 mg/L),米诺环素0.004～0.128 mg/L,莫西沙星0.030～0.240 mg/L.应用阿奇霉素、莫西沙星、米诺环素治疗后的沙眼衣原体总体阴转率分别为44.44%、63.46%、88.89%.结论:随着时间的推移和抗生素的广泛应用,抗生素的敏感性呈不同程度的下降,米诺环素抗衣原体活性相对较强.整体评价临床各类药物治疗效果与时间变化趋势分析,药敏结果与临床疗效之间明显相关.