CLINICAL EVALUATION OF FOUR RECOMBINANT TREPONEMA PALLIDUM ANTIGEN-BASED RAPID TESTS IN THE DIAGNOSIS OF SYPHILIS

Objective To assess the sensitivity, specificity, and feasibility of 4 recombinant Treponema pallidum antigenbased rapid tests in the diagnosis of syphilis. Methods A total of 970 outpatients were selected from the Sexually Transmitted Diseases Centre of Peking Union Medical College Hospital. Venous blood was collected and serum was extracted. T. paUidum antibodies in whole blood, anticoagulant whole blood, and serum were detected using 4 recombinant T. pallidum antigen-based rapid tests. T. pallidum haemagglutination test （TPHA） was considered as the gold standard for the detection of T. pallidum specific antibodies in serum. The sensitivities and specificities of four methods were analyzed. Results The sensitivities and specificities of Abbott Determine Syphilis TP test, SD-BIOLINE Syphilis 3.0 test, VISITECT-SYPHILIS test, and Syphicheck-WB test for serum specimens were 100% and 98. 9%, 95.7% and 98.0%, 94.6% and 98.2%, 68.1% and 98.9% ; for whole blood were 74. 1% and 99. 5%, 87.9% and 99.4% , 73.2% and 99.7%, 64. 7% and 99.7%. The observed sensitivities of the 4 rapid diagnosis tests were not significantly different with TPHA （ P 〉 0.05 ）. Conclusions The 4 rapid tests show good performance and characteristics in the diagnosis of syphilis. Furthermore, they are more sensitive for serum specimens than whole blood.

Clinical Value of the Fluorescent Quantitative Polymerase Chain Reaction in the Diagnosis of Primary Syphilis

Objective： To evaluate the clinical value of fluorescent quantitative polymerase chain reaction （FQ-PCR） in the diagnosis of primary syphilis. Methods： 68 swab specimens were collected from patients suspected of infecttion with primary syphilis attending two STD clinics （Guangzhou Institute of Dermatovenerology and the First People＇s Hospital of Guangzhou city）, from September 1998 to December 2000. Analysis： by FQ-PCR, darkfield microscopy （D-F） for Treponema pallidum （TP）, and serologic testing for syphilis （STS）. Results： Of 68 patients, 30 （44.12%） were positive for TP by QF-PCR assay, 19 （27.94%） were positive for TP by D-F, 33 （48.53%） were positive for TP-IgG antibody by RPR, and 42 （61.76%） were positive for TP-IgG antibody by TPHA. There are significant differences in detection between D-F and TPHA （P〈0.05）, but there is no difference with RPR （P〉0.1）. Conclusion： This data shows that QF-PCR is a convenient, reliable and rapid method for diagnosis of primary syphilis, and may be an effective clinical assay in the detection of TP.

The Difficulties of Congenital Syphilis Diagnosis about 3 Cases at Libreville, Gabon

First described embryo fetopathy, congenital syphilis remains a public health problem mostly in developing countries. The diagnosis mainly based on bacteriological and immunological evidence of mother-child couple is not always easy, as it is shown in our three clinical cases. Those three clinical observations demonstrate the difficulties encountered in the diagnosis of congenital syphilis in our country where only the TPHA (Treponema Pallidum Haemaglutination Assay) and VDRL (Venereal Disease Research Laboratory) tests are the only ones to be routinely carried out. Actually, these tests can be negative at the earliest stage of the syphilis or in case of zonal phenomenon. In addition, maternal antibodies could be found in child blood, even if the baby is in good health. At last, the child could have been contaminated belatedly while tests were negative at the third month of pregnancy. Congenital syphilis still exists in our developing countries and, in order to better manage this pathology, a proposition of an efficient algorithm is submitted.

Seroprevalence and Risk Factors of Syphilis Infection among Antiretroviral Therapy Naive HIV Patients at the Cape Coast Teaching Hospital, Ghana

Diagnosis of sexually transmitted infections is very important considering the spread of HIV and the extensive use of highly active antiretroviral therapy worldwide. This will assist in planning of treatment schedule in controlling these infections. The study therefore aimed at determining the prevalence of syphilis in HIV positive antiretroviral therapy naive patients in Cape Coast and the associated risk factors involved in infection. A cross-sectional study was carried out using initial HIV rapid and confirmation tests, and then Venereal Disease Research Laboratory test with the Ultra Rapid Test Kits for syphilis. Demographic data, risky sexual behaviours capable of co-transmission of both HIV and Syphilis, were also collected through the use of questionnaires. In all, 150 HIV positive antiretroviral naive subjects were studied and 15 (10%) were positive for VDRL test, with females (6.00%) and males (4.00%), who were mainly within the age group of 20 - 39 years. A significant number of males (p = 0.019) and females (p = 0.015) participants were not smoking with a fewer number of the females (p = 0.002) having multiple sexual partners. Also a smaller number of those who were infected with the bacteria (p = 0.004) did not support the control of sexually transmitted infection (p = 0.022). The result showed that co-infection of Syphilis in HIV positive antiretroviral therapy naive patients persists in the Cape Coast Metropolis, which is an indication of prominence of STIs that require further study on a larger scale to ascertain the extent of co-infection and to formulate policy for treatment to help minimize the rate of infection.

Circulating MicroRNAs as Potential Biomarkers in the Diagnosis of Neurosyphilis: A Case Control Study

Objective:Laboratory diagnosis of neurosyphilis(NS)remains a great challenge.This study was the aimed to identify miRNA candidates as biomarkers to distinguish between NS,non-neurosyphilis,and healthy controls(HCs).Methods:We analyzed miRNA expression profiles in peripheral blood mononuclear cells(PBMCs)from six patients with NS,eight patients with secondary syphilis(SS),and five HCs using microarray technology.The differentially expressed miRNAs were validated in 33 NS samples,31 SS samples,and 30 HC samples using TaqMan miRNA real-time qPCR(qRT-PCR).Results:Thirty-nine miRNAs were differentially expressed in SS and NS patients compared with HCs.Thirteen miRNAs were randomly selected to validate their expression levels in the same samples used in microarray assay by qRT-PCR.All miRNAs were upregulated in SS and NS samples compared with HC.qRT-PCR analysis of the expression of the 13 miRNAs in a second cohort(76 samples)showed that the average expression levels of nine miRNAs were higher in SS than in NS(SS:0.185,NS:0.136,P=3.8E-10),while the expressions of the other four miRNAs were lower in SS than in NS(SS:0.000757,NS:0.000873,P=0.022).ROC curve analysis of the 13 miRNAs showed the area under the curve value to be 1.00 for distinguishing SS patients from HCs,1.00 for distinguishing NS patients from HCs,1.00 for distinguishing SS and NS patients from HCs,and 0.968 for distinguishing NS from SS patients.Conclusion:The present study is the first one that identified differentially expressed miRNAs in PBMCs from patients with NS.Our results suggest that the 13 candidate miRNAs in PBMCs may be novel noninvasive biomarkers for NS diagnosis.

Usefulness of Positron Emission Tomography in Patients with Syphilis： A Systematic Review of Observational Studies

Background： Diagnosis of syphilis is difficult. Follow-up and therapy evaluation of syphilitic patients are poor. Little is known about positron emission tomography （PET） in syphilis. This review was to systematically review usefulness of PET for diagnosis, disease extent evaluation, follow-up, and treatment response assessment in patients with syphilis. Methods： We searched PubMed, EMBASE, SCOPUS, Cochrane Library, Web of Science, ClinicalTrials.gov, and three Chinese databases （SinoMed, Wanfang, and CNKI） for English and Chinese language articles from inception to September 2016. We also collected potentially relevant studies and reviews using a manual search. The search keywords included the combined text and MeSH terms ＂syphilis＂ and ＂positron emission tomography＂. We included studies that reporting syphilis with a PET scan before and/or after antibiotic treatment. The diagnosis of syphilis was based on serological criteria or dark field microscopy. Outcomes include pre- and post-treatment PET scan, pre- and post-treatment computed tomography, and pre- and post-treatment magnetic resonance imaging. We excluded the articles not published in English or Chinese or not involving humans. Results： Of 258 identified articles, 34 observational studies were included. Thirty-three studies were single-patient case reports and one study was a small case series. All patients were adults. The mean age of patients was 48.3 ~ 12.1 years. In primary syphilis, increased fluorodeoxyglucose （FDG） accumulation could be seen at the site of inoculation or in the regional lymph nodes. In secondary syphilis with lung, bone, gastrointestinal involvement, or generalized lymphadenopathy, increased FDG uptake was the most commonly detected changes. In tertiary＇ syphilis, increased glucose metabolic activity, hypometabolic lesions, or normal glucose uptake might be seen on PET. There were five types of PET scans in neurosyphilis. A repeated PET scan after treatment revealed apparent or complete resolution of the asymmetry of radiotracer uptake. Conclusion： PET is helpful in targeting diagnostic interventions, characterizing disease extent, assessing nodal involvement, and treatment efficacy for syphilis.

两种梅毒抗体检测方法在梅毒早期诊断中的应用

目的分析梅毒早期诊断中两种梅毒抗体检测方法的应用效果。方法从梅毒螺旋体明胶颗粒凝集试验为阳性患者中选择117例,另选择健康体检者113例,所有研究对象均接受梅毒螺旋体明胶颗粒凝集试验和甲苯胺红不加热血清试验进行检验,以梅毒螺旋体明胶颗粒凝集试验结果为金标准,分析甲苯胺红不加热血清试验的检查结果及诊断敏感性和特异性。结果梅毒螺旋体明胶颗粒凝集试验检出阳性117例,阴性113例。以梅毒螺旋体明胶颗粒凝集试验结果为金标准,甲苯胺红不加热血清试验检出阳性患者99例、占比43.04%,阴性患者131例、占比56.96%,诊断敏感性、特异性分别为84.62%(99/117)和100.00%(113/113)。结论梅毒传染性较强,对身体危害大,因此需尽早筛查尽早治疗,避免延误治疗时机。梅毒螺旋体明胶颗粒凝集试验灵敏性较高,可以提升诊断质量,减少误诊,但该检测方式费用更高,操作较为复杂,因此在实际检测过程中可以使用甲苯胺红不加热血清试验进行筛查,联合两种检测方式效果更优。

神经梅毒的诊疗进展

21世纪以来,全球范围内梅毒的发病率和患病率均在逐年升高,因梅毒的特殊传播途径使其成为严重的社会公共健康问题。与此同时,神经梅毒的发病率也随之不断升高,梅毒螺旋体对神经系统的损伤表现多种多样,感染早期更是缺乏临床特异性,如诊治不及时,将对神经系统结构和功能造成不可逆性损害,严重者甚至会失能失智。目前对神经梅毒的分类可以根据是否存在临床症状分为有症状性神经梅毒和无症状性神经梅毒;根据感染的时间分为早期神经梅毒和晚期神经梅毒,对神经梅毒的确诊主要依据脑脊液的实验室检查结果。本文着重对近年来神经梅毒的流行病学、临床表现、诊断和治疗进展等进行归纳总结,以提高临床医生对该病的诊治水平。

血清抗体ELISA、TPPA联合检测在梅毒诊断中的应用

目的探讨血清抗体酶联免疫吸附试验(ELISA)、明胶颗粒凝集试验(TPPA)联合检测对梅毒的诊断价值。方法选取126例我院2020年8月~2022年8月就诊的疑似梅毒患者,入院后均行血清抗体ELISA、TPPA检查,比较血清抗体ELISA、TPPA对梅毒的诊断结果、诊断效能,并比较其对不同梅毒分期的阳性检出率。结果经ELISA检测显示,阳性37例;TPPA检测显示,阳性38例;ELISA、TPPA联合诊断显示,阳性47例;与血清抗体ELISA、TPPA单独诊断比较,联合诊断灵敏度93.75%、准确率96.03%较高,漏诊率6.25%较低(P<0.05);血清抗体ELISA、TPPA联合诊断对梅毒一期阳性检出率高于单独诊断(P<0.05)。结论血清抗体ELISA、TPPA联合检测能提高梅毒诊断准确性,可用于临床早期筛查、病情分期中,为临床制定相应治疗方案提供依据。

梅毒诊断中三种梅毒血清学检测方法的对比分析

目的 分析对比梅毒诊断中三种梅毒血清学检测方法的结果及应用价值。方法 选取2021年12月—2022年12月本单位收集的200例梅毒血清样本进行对比分析,采用快速梅毒螺旋体抗体胶体金法、梅毒螺旋体明胶凝集试验(TPPA)以及甲苯胺红不加热血清反应素试验(TRUST)三种梅毒血清学检测方法,对200例样本进行对比分析,探讨其检测准确性。结果 ①TPPA与TRUST检测方法相对比,TPPA检出率显著增高(P<0.05);②TRUST与胶体金法检测方法相对比,胶体金法检测方法检出率更高(P<0.05);③TPPA与胶体金法检测方法相对比,检出准确率差异无统计学意义(P>0.05)。结论 在梅毒疾病的诊断过程中,采用胶体金法及梅毒螺旋体明胶凝集试验作为检测手段,能够有效地检测出梅毒疾病,展现出较高的检出率,因此具备显著的临床应用价值。

早期梅毒治疗前后血清学分析

用苄星青霉素治疗了２１０例早期梅毒，对其治疗效果及治疗前后的血清学结果进行了分析，结果发现：治疗前ＲＰＲ与ＴＰＨＡ滴度呈正相关，ＴＰＨＡ滴度的高低对治疗效果无影响。二期梅毒患者ＴＰＨＡ与ＲＰＲ两项滴度均高于一期梅毒及潜伏梅毒。

2015年美国疾病控制中心性传播疾病诊断和治疗指南(续)——梅毒的诊断和治疗指南

梅毒是梅毒螺旋体引起的系统性疾病。为指导治疗及随访,将梅毒分成三期：一期梅毒（如感染部位溃疡或硬下疳）、二期梅毒（包括但不仅限于皮疹、皮肤黏膜病变及淋巴结病变）和三期梅毒（如心脏病变或树胶肿）。缺乏临床表现,仅血清学检查阳性的梅毒螺旋体感染称潜伏梅毒,感染期在1年内称为早期潜伏梅毒,其余的称为晚期潜伏梅毒或分期未明的潜伏梅毒。神经梅毒可以出现在梅毒的各期。早期神经系统表现有颅神经功能障碍、脑膜炎、卒中、精神状态的急性改变及听力、视力异常。晚期神经系统表现（如三期梅毒）出现在感染后10~30年内。

先天性梅毒致继发性先天性肾病综合征5例

目的探讨先天性梅毒致继发性先天性肾病综合征(NS)的临床特点、诊断、治疗及预后。方法对本院2000～2006年收治5例先天性梅毒致继发性先天性NS患儿的临床表现、诊断及治疗、预后进行综合分析,并结合文献进行回顾性研究。结果发病年龄21d～5个月,平均2.8个月。均有梅毒接触史,临床以腹胀、水肿为主要表现,符合先天性NS的主要诊断标准。患者均伴肝脾大,4例有皮疹、脱皮及贫血。3例青霉素足量治疗,疗效较佳,不需激素治疗,预后良好;并肺部感染死亡、自动出院失访各1例。结论对于早期发生NS伴肝脾大、皮疹患儿应考虑到梅毒肾病可能,并对患儿父母进行梅毒血清学检查,注意鉴别诊断。治疗关键在于驱梅疗法,而非激素治疗。多数患儿早期经足量足疗程驱梅治疗症状消失,预后良好。

4种以重组梅毒螺旋体抗原为基础的梅毒快速诊断试验的临床评价

目的:评估4种以重组梅毒螺旋体抗原为基础的梅毒快速诊断试剂盒的敏感性和特异性,及其在临床应用中的可操作性。方法:选择860例性传播疾病(STD)门诊患者,签署知情同意书并采集其静脉血。分别取全血和血清进行梅毒螺旋体血凝试验(TPHA)及4种试剂盒的检测。检测方法分别按照说明书进行。结果:以TPHA为标准,结果分别为:①AbbottDetermineSyphilisTPtest:血清敏感性为100%,特异性为98.9%;全血敏感性为81.9%,特异性为99.4%。②SDBIOLINESyphilis3.0test:血清敏感性为95.5%,特异性为97.9%;全血敏感性为87.6%,特异性为99.4%。③VISITECT-SYPHILIStest:血清敏感性为94.0%,特异性为98.1%;全血敏感性为73.5%,特异性为99.7%。④Syphicheck-WBtest:血清敏感性为67.4%,特异性为98.8%;全血敏感性为64.0%,特异性为99.7%。结论:4种试剂盒均具有优良的临床操作性能,适用于STD门诊的梅毒快速检测。而且这4种快速诊断试剂盒在血清中的检测比全血具有更高的敏感性。

TP-ELISA法在梅毒临床诊断中的应用

目的:评价梅毒螺旋体酶联免疫吸附试验(Enzyme-linked immunosorbent assay,TP-ELISA)检测梅毒螺旋体抗体IgG/IgM的临床意义。方法:收集经临床确诊的各期梅毒血清80份,自身免疫性疾病并排除梅毒的患者血清样本40份,以及100份献血员血清样本。全部血清标本分别进行RPR、TPPA和TP-ELISA试验,检测梅毒螺旋体抗体。结果:TP-ELSIA在梅毒患者组中的阳性率为100%(80//80),确证试验TPPA的阳性率为98.8%(79/80),两种方法的检测阳性率无统计学差异(P>0.05)。TP-ELSIA检测阳性率明显高于初筛试验RPR的检测阳性率87.5%(70/80)。在自身免疫性疾病组RPR试验出现假阳性,其他两种方法无假阳性出现。结论:TP-ELISA检测梅毒螺旋体特异性IgG/IgM抗体具有较高的敏感性和特异性,适用于临床大批量样本初筛和确诊,TP-ELISA试验阳性标本建议进一步作RPR试验。

鼻和口咽梅毒的临床病理特点

目的 非性病专业临床和病理医生对鼻、口咽部梅毒误诊率较高 ,探讨检测活体组织内梅毒螺旋体的方法 ,以提高鼻、口咽部梅毒检出率。方法 以 12例鼻、口咽部可疑梅毒螺旋体感染的活检黏膜为研究对象 ,用HE染色观察其病理学特点 ,用改良的Warthin Starry (W S)染色法检测病变组织及其渗出物涂片中的梅毒螺旋体。用性病研究实验室试验 (venerealdiseaseresearchlaboratory,VDRL)、快速血浆反应素试验 (rapidplasmareagincircletest,RPR)、荧光螺旋体抗体吸收试验 (fluorescenttrepnemalantibody absorptiontest,FTA ABS)、螺旋体血细胞凝集试验 (trepnemapallidumhemagglutinationtest,TPHA)加以证实。用国家颁布的驱梅方法进行治疗。结果 W S染色显示 12例切片黏膜上皮中及 6例渗出物涂片内见大量梅毒螺旋体 ,固有膜内螺旋体很少发现。血清学检查 :11例次VDRL( + + + + ) ,7例次RPR ( + ) ,1例次FTA ABS( + ) ,11例次TPHA( + )。 1例回当地治疗 ,未作血清学检查。 11例均临床治愈 ,血清学检查均转阴性。结论 用病理组织化学改良的W S染色方法 ,能直观地显示活检标本及渗出物涂片内梅毒螺旋体 ,结合临床及梅毒血清学检查 。

梅毒流行病学和诊疗现状分析

梅毒是由梅毒螺旋体感染引起的一种慢性传染病,主要传播方式为性接触、血液传播和垂直传播,危害性极大。近年来,梅毒疫情呈上升趋势,已成为我国发病率最高的性传播疾病。梅毒的发病率存在地区差异性,发病人群有从高危人群向普通人群扩大的趋势,尤其是农民工、老年患者发病率较高。目前,梅毒的实验室诊断主要有病原学诊断、血清学诊断、组织病理诊断、基因诊断和脑脊液检查。血清学检查因其简便、可靠,目前临床上应用最为广泛。梅毒的治疗应遵循早期、规范、足量的原则。青霉素是治疗梅毒的首选药。

妊娠梅毒患者围生结局和临床治疗分析

目的:探讨妊娠合并梅毒对围生结局的影响,分析临床治疗对改善其妊娠结局及围生儿预后的临床意义。方法:2009年12月—2012年12月在江阴市人民医院妇产科就诊的妊娠梅毒患者79例,根据在妊娠期梅毒治疗情况分为全程治疗组(32例)、非全程治疗组(30例)和未治疗组(17例),比较3组妊娠结局、围生儿预后及新生儿先天梅毒的发生情况。结果:3组足月分娩率差异有统计学意义(P<0.05),全程治疗组为93.8%,高于非全程治疗组(80.0%)及未治疗组(58.8%),但与非全程治疗组差异无统计学意义,与未治疗组差异有统计学意义(P<0.05);全程治疗组、非全程治疗组和未治疗组先天性梅毒儿发生例数分别为6,9,17例,发生率差异有统计学意义(P<0.05)。3组早产发生例数分别为2,4,4例,发生率差异无统计学意义(P>0.05)。3组死胎的发生例数分别为0,1,1例,发生率差异无统计学意义(P>0.05)。结论:应建议妊娠期开展梅毒血清学的筛查工作,尤其某些特殊人群,早期发现妊娠期梅毒并进行全程的抗梅毒治疗,可显著改善其围生结局,降低先天梅毒儿发生率。

VDRL和TRUST在梅毒实验室诊断中的应用比较

目的探讨性病实验室试验(VDRL)和甲苯胺红血清不加热试验(TRUST)试验在梅毒实验室诊断中的应用。方法采用VDRL和TRUST试验同时对梅毒患者和健康对照者的血清、血浆和脑脊液(CSF)进行检测。结果 TRUST和VDRL用于血清和CSF标本检测时,VDRL检测结果较TRUST普遍偏高1~2个滴度;用于血浆标本检测时,VDRL检测结果较TRUST普遍偏低1~2个滴度。VDRL在检测健康对照血清和血浆标本时均出现不同程度的假阳性,而在检测正常对照的CSF时,TRUST和VDRL结果一致。结论 TRUST更适用于血清和血浆标本检测,VDRL适用于CSF标本检测,但不适合血清和血浆检测。

32例早期先天梅毒的诊疗分析

目的探讨早期先天梅毒的临床表现及诊断治疗方法。方法回顾性分析中国医科大学附属二院2003～2005年收治的32例早期先天梅毒的临床表现及诊断治疗情况。结果100%患儿能够达到临床痊愈,血清学痊愈81.5%(22/27),血清学有效18.5%(5/27)。结论不伴有先天畸形的早期先天梅毒患儿给予正规的治疗预后良好,早期发现并给予及时正规的治疗是防止发展至晚期先天梅毒的有效措施。