梅毒非特异性类脂质反应素抗体试验操作的改进及应用评价

目的探讨标准化操作对梅毒非特异性类脂质反应素抗体试验的使用价值.方法上海市9个医院实验室按照统一的操作程序、使用相同试剂和水平反应装置,在检测系统受控情况下,对未知靶值(盲样)的梅毒血清质控品进行连续检测.在实施新操作方案前后,用一套靶值范围覆盖从阴性到1∶128的7份新鲜血清样品各进行一次室间质量评价.统计反馈结果,分析误差产生的原因.结果 9个实验室共计进行了388次肓样检测,结果分布在1∶8、1∶16和1∶32分别是40.2%、49.2%和3.6%,总合格率为93.0%,没有高于合格标准的正向偏倚结果.两次室间质量评价的合格率经统计学分析,差异有统计学意义(x2=4.17,P<0.05).结论改进的非梅毒螺旋体抗原试验程序有助于减少试验误差,为建立标准化操作和开展室内质控提供了基础.

Abstract：

Objective To estimate the application value of a standard operating procedure (SOP) in the detection of syphilitic anticardiolipin reagin. Methods Clinical laboratories from 9 local hospitals in Shanghai participated the program. Quality control samples with unknown target value were qualitatively and quantitatively examined according to the uniform SOP in these laboratories with the same reagent and facility of horizontal reaction. External quality assessment (EQA) was carried out by using seven serum samples with no, or low (1∶ 128 dilution) to high (1∶1 dilution) concentrations of target before and after the implementation of SOP. The test results were statistically analyzed and the reasons for the detecting error were assessed. Results A total of 388 tests were performed in the 9 clinical laboratories. The total accuracy rate was 93.0%, including 40.2% in the detection of samples with 1 ∶ 8 dilution of target, 49.2% in the detection of samples with 1 ∶ 16 dilution of target, and 3.6% in the detection of samples with 1 ∶ 32 dilution of target. No forward bias was observed in these tests. There was a significant difference in the accuracy rate between the two times of EQA before and after the implementation of SOP (x2 = 4.17, P < 0.05). Conclusions The improved standard procedure for nontreponemal antigen test is beneficial to the decrease of testing error, and may provide a basis for the establishment of SOP and implementation of internal quality assessment.     

梅毒非特异性类脂质反应素抗体试验操作的改进及应用评价

Objective To estimate the application value of a standard operating procedure (SOP) in the detection of syphilitic anticardiolipin reagin. Methods Clinical laboratories from 9 local hospitals in Shanghai participated the program. Quality control samples with unknown target value were qualitatively and quantitatively examined according to the uniform SOP in these laboratories with the same reagent and facility of horizontal reaction. External quality assessment (EQA) was carried out by using seven serum samples with no, or low (1∶ 128 dilution) to high (1∶1 dilution) concentrations of target before and after the implementation of SOP. The test results were statistically analyzed and the reasons for the detecting error were assessed. Results A total of 388 tests were performed in the 9 clinical laboratories. The total accuracy rate was 93.0%, including 40.2% in the detection of samples with 1 ∶ 8 dilution of target, 49.2% in the detection of samples with 1 ∶ 16 dilution of target, and 3.6% in the detection of samples with 1 ∶ 32 dilution of target. No forward bias was observed in these tests. There was a significant difference in the accuracy rate between the two times of EQA before and after the implementation of SOP (x2 = 4.17, P < 0.05). Conclusions The improved standard procedure for nontreponemal antigen test is beneficial to the decrease of testing error, and may provide a basis for the establishment of SOP and implementation of internal quality assessment.     

梅毒非特异性类脂质反应素抗体试验操作的改进及应用评价

Objective To estimate the application value of a standard operating procedure (SOP) in the detection of syphilitic anticardiolipin reagin. Methods Clinical laboratories from 9 local hospitals in Shanghai participated the program. Quality control samples with unknown target value were qualitatively and quantitatively examined according to the uniform SOP in these laboratories with the same reagent and facility of horizontal reaction. External quality assessment (EQA) was carried out by using seven serum samples with no, or low (1∶ 128 dilution) to high (1∶1 dilution) concentrations of target before and after the implementation of SOP. The test results were statistically analyzed and the reasons for the detecting error were assessed. Results A total of 388 tests were performed in the 9 clinical laboratories. The total accuracy rate was 93.0%, including 40.2% in the detection of samples with 1 ∶ 8 dilution of target, 49.2% in the detection of samples with 1 ∶ 16 dilution of target, and 3.6% in the detection of samples with 1 ∶ 32 dilution of target. No forward bias was observed in these tests. There was a significant difference in the accuracy rate between the two times of EQA before and after the implementation of SOP (x2 = 4.17, P < 0.05). Conclusions The improved standard procedure for nontreponemal antigen test is beneficial to the decrease of testing error, and may provide a basis for the establishment of SOP and implementation of internal quality assessment.     

梅毒血清反应及梅毒螺旋体IgM抗体的临床意义

<正> 在梅毒的诊断治疗过程中,经常能够遇到使医生棘手,病人困惑的梅毒血清反应问题。下面就三点加以分析。梅毒血清反应的分类     

梅毒非特异性抗体与特异性抗体血清学检测的临床应用评价

目的 评价梅毒血清学检测中非特异性抗体的甲苯胺红未加热血清试验(TRUST)和特异性抗体的梅毒螺旋体抗体酶联免疫吸附试验(TP-ELISA)、梅毒螺旋体颗粒凝集试验(TPPA)3种方法对梅毒诊断的临床应用.方法 对340份血清样本分别采用上述3种方法进行梅毒抗体检测,以TPPA为对照,比较TRUST、TP-ELISA对...     

非梅毒螺旋体血清学试验持续阳性梅毒患者神经梅毒发生情况及影响因素分析

目的 探讨正规治疗后非梅毒螺旋体（Tp）血清学试验持续阳性梅毒患者的神经梅毒发生情况及相关危险因素。 方法 回顾性分析248例正规治疗后非Tp血清学试验持续阳性梅毒患者的临床资料。用单因素分析、多因素logistic回归分析及ROC曲线法检测可用于预测神经梅毒的临床指标。 结果 248例患者中25例（10.1%）诊断为神经梅毒。单因素分析显示,血甲苯胺红不加热血清试验（TRUST）下降程度（χ2 = 20.663,P < 0.05）、血TRUST持续阳性滴度（Z = -7.021,P < 0.05）与神经梅毒发生有关,而性别、年龄、梅毒分期、治疗方案、初次就诊时血TRUST滴度、有无神经系统症状与神经梅毒无显著相关性（均P > 0.05）。多因素logistic回归分析显示,血TRUST持续阳性滴度是神经梅毒的相关危险因素（OR = 4.685,95% CI = 2.552 ～ 8.601,P < 0.05）。绘制血TRUST持续阳性滴度的ROC曲线下面积为0.907,最佳临界滴度为1 ∶ 8。 结论 正规治疗后,血清TRUST滴度对于预测神经梅毒有一定意义。     

梅毒特异性抗体的ELISA法对梅毒实验诊断的评价

目的：为评价梅毒特异性抗体的ELISA法对梅毒的诊断价值。方法：分别用ELISA、TRUST、TPP三种方法检测临床疑似梅毒病人36名。结果：ELISA法检测呈阳性18例,阴性18例;用TRUST法,呈阳性12例,阴性24例;再用TPPA进行确证试验,呈阳性18例,呈阴性18例。结论：ELISA法对比TRUST,TRUST的假阴性6例,表明ELISA法的敏感性和特异性均高于TRUST法。     

梅毒螺旋体特异性抗体对梅毒早期诊断和治疗的评价

目的：为评价梅毒血清特异性抗体在梅毒早期诊断及治疗后的意义。方法：采用蛋白印迹法(Western blottinG,WB)、快速血浆反应素(RPR)试验、梅毒颗粒凝集试验(TPPA)3种方法．对67例梅毒及其中经治疗后随诊18～24个月的21例患者作血清检测。对5年来诊治的临床一期、二期梅毒血清抗体的变化进行分析。结果：20例一期梅毒WB检测出现不同抗体谱条带,其中均有相对分子质量为47000的条带,RPR试验及TPPA部分为阴性。经治疗后随诊18-24个月的21例梅毒患者．18个月内检测时WB9．52％阴转,24个月时28．57％阴转;TPPA阴转的情况同WB;RPR滴度随疗后时间的增加而逐渐下降．6个月内28．57％阴转,24个月85．71％阴转：结论：相对分子质量为47000、17000的条带对早期梅毒的诊断既敏感又特异：部分一期和二期梅毒患者在经过有效治疗后2年,梅毒抗体可以完全消失;RPR试验可用于梅毒治疗期间的疗效判定。     

梅毒螺旋体IgM抗体蛋白印迹试验诊断新生儿胎传梅毒的探讨

目的探讨梅毒螺旋体IgM抗体蛋白印迹试验(Treponema pallidum IgM Western blot，TP-IgM-WB)在新生儿胎传梅毒早期诊断中的价值。方法对8例胎传梅毒新生儿(其母亲均为梅毒)进行TRUST、TPPA，FTA-ABS-19S-IgM和TP-IgM-WB 4种梅毒血清学检查，并结合临床对结果进行比较。结果8例中3例出现胎传梅毒的典型临床表现，包括典型皮肤损害，梅毒新生儿肺炎，伴发心、脑、肝、肾多脏器衰竭；另外5例无胎传梅毒的临床表现。梅毒血清学试验结果：所有8例TP-IgM-WB均为阳性；除1例外，7例FTA-ABS-19S-IgM试验为阳性；3例有症状的胎传梅毒及3例胎传潜伏梅毒中4种梅毒血清学试验均为阳性；1例TRUST和TPPA均阴性，但FTA-ABS-19S-IgM和TP-IgM-WB均阳性；1例FTA-ABS-19S-IgM阴性，但TRUST滴度是母亲的4倍，TPPA和TP-IgM-WB均阳性。结论梅毒螺旋体IgM抗体蛋白印迹试验可作为一种确诊试验应用于新生儿胎传梅毒，尤其是胎传潜伏梅毒的早期诊断。     

梅毒孕妇分娩的新生儿血清学随访

目的 探讨梅毒孕妇分娩的新生儿血清学转归和治疗对未感染梅毒婴儿血清阴转时间的影响。 方法 梅毒孕妇分娩的新生儿115例,出生时进行甲苯胺红不加热血清试验（TRUST）、梅毒螺旋体明胶凝集试验（TPPA）、19S IgM-TPPA检测。在1、3、6、9、12、18、24月龄时进行TRUST和TPPA血清学监测和随访。当TRUST和TPPA均阴性时,终止随访。采用SPSS13.0软件进行Kaplan-Meiter生存分析和两独立样本比较的Wilcoxon秩和检验。结果 115例新生儿出生时TPPA均阳性;97例TRUST阳性,滴度从1 ∶ 1到1 ∶ 256不等;3例19S IgM-TPPA阳性。出生时确诊胎传梅毒3例,TRUST均在12 ～ 18月龄内转阴,2例24月龄时TPPA仍阳性,另1例20月龄时TPPA阳性,仍在随访中。112例疑似病例随访后均排除梅毒感染,90例TRUST在0 ～ 3、4 ～ 6、7 ～ 9月龄时的累计阴转率分别为82.2%、98.9%、100%。96例TPPA在0 ～ 3、4 ～ 6、7 ～ 9、10 ～ 12月龄时的累计阴转率分别为3.1%、30.2%、85.4%、100%。余16例缺部分复查,TRUST和TPPA在15月龄时均转阴。血清阳性未感染梅毒婴儿,出生后苄星青霉素G治疗组与未治疗组TRUST阴转时间差异无统计学意义（χ2 = 0.54,P ＞ 0.05）,TPPA阴转时间差异亦无统计学意义（χ2 = 2.41,P ＞ 0.05）。TRUST阴转时间显著早于TPPA阴转时间（Z = 10.45,P ＜ 0.01）。 结论 梅毒孕妇分娩的未感染梅毒婴儿,大多数婴儿TRUST在6月龄内转阴,TPPA在12月龄内转阴;TRUST阴转时间早于TPPA,治疗对TRUST和TPPA阴转时间无影响。     

细胞因子与梅毒免疫学研究进展

梅毒是由梅毒螺旋体引起的一种系统性的性传播疾病.感染梅毒后,机体对梅毒的免疫学反应复杂,多种细胞因子在梅毒的发病及病情进展中起重要作用.在梅毒早期,Th1型细胞因子介导的细胞免疫反应占优势,以利于机体清除梅毒螺旋体;随着病情进展,Th2型细胞因子介导的体液免疫反应逐渐增强,导致梅毒螺旋体的免疫逃逸.概述Th1型、Th2型、Th17型等7种细胞因子及一些趋化因子在梅毒发病过程中的作用.     

56例早期梅毒的临床分析及组织病理学检查

目的：通过临床分析及组织病理检查,探讨早期梅毒的诊断依据。方法：利用电镜,墨汁染色及W－F染色法观察病损组织液,淋巴结穿刺液及病理组织切片中的梅毒螺旋体,结果：5例组织液及肿大的淋巴结穿刺液涂片扫描电镜下发现梅毒螺旋体,42例肿大的淋巴结穿刺液及19例组织液涂片经墨汁染色等发现梅毒螺旋体。结论：在病损组织液,肿大的淋巴结穿刺液及病理切片中检出梅毒螺旋体可作为梅毒的重要诊断依据。     

头孢三嗪联合苄青霉素治疗妊娠期梅毒的临床效果及安全性评价

目的 分析头孢三嗪联合苄青霉素治疗妊娠期梅毒的临床效果及安全性评价.方法 选取2016年1月至2017年12月唐山市传染病医院收治的110例妊娠期梅毒患者作为研究对象.根据住院号采取随机原则分为观察组(n=55)和对照组(n=55).对照组采取苄青霉素治疗,观察组在对照组的基础上联合头孢三嗪治疗.比较两组的临床治疗总有...     

Premarket evaluation of Monofluor reagent for detecting Chlamydia trachomatis in adolescent outpatients.

A new direct fluorescent antibody reagent, Monofluor, was evaluated for detecting Chlamydia trachomatis in fresh specimens. Monofluor was compared with Micro Trak and with cultivation in McCoy cells. Both direct systems were slightly less sensitive than culture, but no significant differences in specificity or sensitivity were noted between culture, Monofluor, or Micro Trak results.     

An evaluation of near patient tests for detecting herpes simplex virus type-2 antibody

OBJECTIVES: To examine the "in use" test characteristics of the POCkit "near patient" HSV-2 rapid test for the detection of HSV-2 IgG antibodies for use in the clinic. This test relies on a visual interpretation of the result. METHODS: 2093 serum samples, 229 from UK and 919 from Italian genitourinary medicine clinic patients and 945 from obstetric and gynaecology clinic patients in Italy were tested. Tests were carried out according to manufacturers' protocol in the United Kingdom and Italy. Three readers independently recorded a score for each test carried out and the results were compared. RESULTS: In the UK study, the three readers disagreed on the result on 5.2% of tests. In the Italian study, there was disagreement in 10.2% of tests. CONCLUSIONS: This study has demonstrated a problem in the subjective nature of the interpretation of the POCkit HSV-2 test. It highlights the need for adequate training of clinic staff and the need for clinics to adopt policies of quality assurance and ongoing monitoring which will ensure the validity and accuracy of this clinic based test.