快速免疫色谱测定在骨关节结核诊断及鉴别诊断中的价值

目的 探讨快速免疫色谱对活动骨关节结核的诊断价值。方法 采用快速免疫色谱测定法检测７５例活动性骨关节结核，６９例以肿瘤为主的骨病患者及７２例正常人血清中的抗体，结果 骨关节结核组阳性率为８０．０％，其中脊柱结核阳性率为９０．４％，脊柱以外的关节结核阳性率为６０．８％，合并其它部位结核阳性率为７６％，骨病组３例阳性，正常组２例阳性，假阳性率分别为４．３％和２．８％。结论：ＩＣＴ快速免疫色谱测定骨关节     

不同结核分支杆菌抗原对结核病的诊断价值

目的　研究不同结核分支杆菌单体蛋白抗原在结核病体液免疫诊断中的价值。方法以快速免疫色谱法（ＩＣＴＴＢ卡） 检测结核分支杆菌５ 种单体蛋白的抗原性，观察其在结核病诊断中的敏感性和特异性，并与ＰＰＤ 皮试及脂阿拉伯糖甘露糖（ＬＡＭ） 相比较。结果　ＩＣＴＴＢ 卡、ＬＡＭ 及ＰＰＤ皮试诊断结核病的敏感性分别为５５．９％ 、５２．６％ 、７５．０％ ，后者与前二者间差异均有显著意义（ Ｐ＜０ ．０５）；ＩＣＴＴＢ卡、ＬＡＭ、ＰＰＤ皮试诊断肺结核的特异性为８７ ．６％ 、６２．９％ 、６８．９％ ，前者与后二者间差异均有非常显著意义（ Ｐ＜ ０．０１）；ＩＣＴＴＢ卡诊断肺结核病的临床阳性预计值为８８ ．５％ ，临床阴性预计值为５３ ．８ ％ ；非结核病例中的ＩＣＴＴＢ阳性主要由抗原４、５ 阳性所致，如果去除抗原４ 、５，那么ＩＣＴＴＢ诊断结核病的特异性将提高到９８．９％ 。结论　血清结核分支杆菌单体蛋白抗原性的测定是肺结核病一项有用的辅助诊断手段。     

ICT-TB卡快速检测肺结核患者血清中五种抗结核抗体的效果

目的：对ＩＣＴ－ＴＢ卡快速联合检测５种抗结核抗体技术用于肺结核诊断的价值进行评估。方法：９６例肺结核患者和３５例健康对照者血汗用ＩＣＴ－ＴＢ卡定性检测５种特异性抗体（包括抗３８ＫＤａ抗体），肺结核患者痰结核菌抗酸染色涂片检查和分离培养按常规操作。结果：９６例肺结核ＩＣＴ－ＴＢ卡检测的敏感性为５３．１％，其中痰涂片阳性组和阴性组的敏感性分别为７５％和３１．３％，特异性为９７．１％；ＩＣＴ－ＴＢ卡检查可在２０分钟内得到结果。结论：ＩＣＴ－ＴＢ卡快速检测技术对肺结核的诊断是快速、方便、敏感及特异性的，可用作排菌肪结核的特异诊断方法。     

快速ELISA检测血清抗PPD-IgG对肺结核的诊断价值

目的评价抗PPD－IgG检测对活动性肺结核的诊断价值。方法采用快速酶联免疫吸附法(ELISA)检测340例活动性肺结核、56例非活动性肺结核、88例非结核性病人血清中的抗PPD－IgG。结果活动性肺结核组抗PPD－IgG阳性率为83．8％,其中痰涂片(＋)组为92．2％,涂片(－)组为78．7％。非活动性肺结核组3例阳性,非结核组5例阳性,假阳性率分别为7．1％和5．7％。本法敏感性为83．8％,特异性为93．8％,准确性为86．8％,阳性预测值为96．9％,阴性预测值71．1％。结论。提示血清抗PPD－IgG测定是肺结核病人一项有用的辅助诊断手段。     

快速免疫色谱测试法诊断恶性疟的初步观察

目的：评价快速免疫色谱测试法（ＩＣＴ）在我国疟区门诊疟疾的适用性。方法：以镜检结果为对照，用ＩＣＴ方法检测门诊“四热”病人中的恶性疟。结果：ＩＣＴ检测恶性疟的敏感性和特异性分别为９４．７％和９０．３％，与间日疟无交叉，检测不同性别和民族人群阳性率间的差别无显著意义。结论：ＩＣＴ较镜检诊断恶性疟更为快速且简便，更适于在疟区门诊应用。     

快速免疫色谱测试法诊断恶性疟的初步观察

目的：评价快速免疫色谱测试法（ＩＣＴ）在我国疟区门诊疟疾的适用性。方法：以镜检结果为对照，用ＩＣＴ方法检测门诊“四热”病人中的恶性疟。结果：ＩＣＴ检测恶性疟的敏感性和特异性分别为９４．７％和９０．３％，与间日疟无交叉，检测不同性别和民族人群阳性率间的差别无显著意义。结论：ＩＣＴ较镜检诊断恶性疟更为快速且简便，更适于在疟区门诊应用。     

免疫色谱技术用于班氏丝虫病诊断及丝虫病防治后期监测的实验研究

目的：评价免疫色谱技术（ＩＣＴ）用于班氏丝虫病诊断及丝虫病防治后期监测的效果。方法：丝虫病ＩＣＴ系采用单克隆抗体检测血中班氏丝虫抗原。结果：在１１６例班氏微丝蚴血症者中有１１１例ＩＣＴ阳性，敏感性为９５．７％。１２例马来微丝蚴血症者、３３例蛔虫感染者、２０例血吸虫感染者及６例旋毛虫感染者血清，ＩＣＴ均为阴性，表明其特异性强；７３例晚期丝虫病患者有１８例ＩＣＴ阳性，为活动性感染，其中１６例伴有微丝蚴血症；用伊维菌素治疗３０例班氏微丝蚴血症者，治疗前ＩＣＴ阳性２９例（９６．７％）。治疗后８ｄ—１４ｄ微丝蚴全部转阴，追踪观察６个月及１２个月，分别有５例及７例微丝蚴复现，治疗后６个月用ＩＣＴ测试，除５例ＩＣＴ和微丝蚴均阳性外，８例微丝蚴阴性ＩＣＴ阳性者于疗后１２个月有５例查见微丝蚴；ＩＣＴ及常规血检法同步用于河南省柘城县候大村丝虫病防治后期监测，血检１３２人，９例微丝蚴阳性者ＩＣＴ均为阳性，血检阴性的１２３人中ＩＣＴ阳性者１例。结论：实验研究证实，ＩＣＴ法快速、简便、敏感性高和特异性强，可用于班氏丝虫病诊断、疗效考核及丝虫病防治后期监测。     

免疫色谱技术用于班式丝虫病诊断及丝虫病防治后期监测的实验研究

目的：评价免疫色谱技术（ＩＣＴ）用于班氏丝虫病诊断及丝虫病防治后期监测的效果。方法：丝虫病ＩＣＴ系采用单克隆抗体检测血中班氏丝虫抗原。结果：在１１６例班氏微丝蚴血症者中有１１１例ＩＣＴ阳性，敏感性为９５．７％。1２例马来微丝蚴血症者、３３例蛔虫感染者、２０例血吸虫感染者及６例旋毛虫感染者血清，ＩＣＴ均为阴性，表明其特异性 强；７３例晚期丝虫病患者有１８例ＩＣＴ阳性，为活动性感染，其中１６例伴有微丝蚴血症；用伊维菌素治疗３０例班氏微丝蚴血症者，治疗前ＩＣＴ阳性２９例（９６．７％）。治疗后８ｄ—１４ｄ微丝蚴全部转阴，追踪观察６个月及１２个月，分别有５例及７例微丝蚴复现，治疗后６个月用ＩＣＴ测试，除５例ＩＣＴ和微丝蚴均阳性外，８例微丝蚴阴性ＩＣＴ阳性者于疗后１２个月有５例查见微丝蚴；ＩＣＴ及常规血检法同步用于河南省柘城县候大村丝虫病防治后期监测，血检１３２人，９例微丝蚴阳性者ＩＣＴ均为阳性，血检阴性的１２３人中ＩＣＴ阳性者１例。结论：实验研究证实，ＩＣＴ法快速、简便、敏感性高和特异性强，可用于班氏丝虫病诊断、疗效考核及丝虫病防治后期监测。     

快速血清学诊断方法联合检测对结核病诊断和鉴别诊断价值的评价

目前，尽管结核病的诊断仍主要靠细菌学、组织病理学、影像学等手段，但在传统血清学方法基础上建立起来的快速血清学检测方法有了很大的改进和发展。临床应用已有报道［１、２、３］为了横向比较各种方法的敏感性和特异性，评估其联合应用的诊断效果，我们同时用ＭｙｃｏＤｏｔ（结明试验）、ＩＣＴ－ＴＢ卡，ＴＢ卡（结核快速卡）和ＦＤ（斑点免疫渗滤试验）快速检测了血清中结核特异性抗体，现将结果报告如下。对象和方法１观察对象１．１肺结核组：共８０例，均为我院结核科住院的肺结核患者。其中涂阳６２例，涂阴１１８例。诊断依据：…     

糖脂抗原和包膜抗原血清学检测活动性结核IgG抗体价值评估

目的评估脂阿拉伯甘露糖─ＩｇＧ（ＬＡＭ－ＩｇＧ）和包膜蛋白─ＩｇＧ对活动性结核的诊断价值。方法两种抗原分别采用快速和常规酶朕免疫吸附法（ＥＬＩＳＡ）进行检测。选择１０８例活动性结核（其中９７例活动性肺结核、１１例肺外结核），６９例非结核肺部疾患（其中肺癌１６例，其它肺部疾患５３例）血清平行检测结核分支杆菌ＩｇＧ抗体。结果９７例活动性肺结核涂阳敏感性分别为７１．８％（２８／３９）和９２．３％（３６／３９），涂阴为６０．３％（３５／５８）和７７．６％（４５／５８）。６９例非结核肺部疾患组两法阳性分别为４例和１４例，假阳性率分别为５．８％（４／６９）和２０．３％（１４／６９）；特异性分别为９４．２％（６５／６９）和７９．７％（５５／６９）。结论提示快速ＥＬＩＳＡ血清ＬＡＭ－ＩｇＧ测定操作简便、快速、不需任何仪器设备且特异性较高，对活动性结核病有较高的临床辅助诊断价值。     

血清抗脂阿拉伯甘露糖及38kD抗体检测对涂阴肺结核及肺外结核诊断价值

目的　评估血清抗脂阿拉伯甘露糖及38kDa抗体 (LAM38kD IgG)检测对涂阴肺结核和肺外结核的诊断价值。方法 采用斑点免疫金渗滤法 (dotimmunogoldfiltrationassay，DIGFA)检测57例涂阴肺结核，52例肺外结核，32例涂阳肺结核，29例肺癌患者及33例正常人血清中LAM38kD IgG。 结果 涂阴肺结核组LAM38kD IgG阳性率为73.7%，其中痰结核菌涂 (-)培 (+)组为84 .6%，涂 (-)培 (-)组为70 .5%。肺外结核组阳性率为71.2%，涂 (+)肺结核组阳性率93.8%，肺癌组假阳性率31%，健康组假阳性率9.1%。结论 血清LAM38kD IgG检测对涂阴肺结核和肺外结核有一定的辅助诊断价值。     

结核菌特异性IFN-γ Elispot检测在活动性结核病和结核感染诊断中的应用

目的评价早期建立的结核菌特异性IFN-γ Elispot检测在活动性结核病和结核感染诊断中的应用价值。方法应用Elispot技术对1 154例结核病患者,52例非结核病肺部疾病对照,384例新发痰菌阳性结核患者的密切接触者,422例健康对照进行外周血结核菌特异性IFN-γ水平检测。对健康对照和密切接触者同时还进行平行的PPD皮试。结果结核患者Elispot检测的阳性率显著高于对照人群及结核病密切接触者。其中,血行播散性结核、继发性肺结核、结核性胸膜炎、结核性脑膜炎和其他肺外结核患者Elispot阳性率分别为91.3%,81.7%,86.5%,66.2%,89.8%。非结核病肺部疾病对照、健康对照和新发结核病人密切接触者Elispot阳性率分别为13.5%,15.4%和35.4%。在密切接触者筛查中,发现活动性结核病人17例,其中Elispot阳性14例(82.4%),PPD强阳性5人(29.4%);两者阳性率差异有统计学意义。结论在结合结核病史、结核病接触史以及临床表现的基础上,结核菌特异性IFN-γ的检测对活动性结核病诊断有一定的辅助诊断价值。通过检测结核高危人群结核菌特异性IFN-γ的水平,对早期发现活动...     

Clinical evaluation of a rapid immunochromatographic assay based on the 38 kda antigen of Mycobacterium tuberculosis on patients with pulmonary tuberculosis in China

Setting: A rapid membrane-based antibody assay capable of diagnosing pulmonary tuberculosis within 15 min has been developed using the 38 kDa antigen from Mycobacterium tuberculosis.Objective: To determine the specificity and sensitivity of this assay and evaluate its usefulness in a clinical setting.Design: Sera from patients with active pulmonary tuberculosis were obtained from three hospitals in China. The control groups consisted of patients who were diagnosed with lung diseases other than tuberculosis and healthy subjects.Results: Antibody was detected in 54 of 61 (89%) sputum positive patients and 67 of 91 (74%) sputum negative patients who had been clinically diagnosed as having active pulmonary tuberculosis. Five out of 56 (9%) patients with respiratory diseases other than tuberculosis and 1 out of 30 (3%) healthy controls had a positive antibody response. The overall specificity of the assay was 93% and the positive predictive value was 95%. We conclude that this assay is rapid, sensitive and specific and will be a valuable aid in the clinical diagnosis of pulmonary tuberculosis.     

ELISPOT检测在老年肺结核诊断中的应用价值

目的评价结核分枝杆菌特异性IFN-γ酶联免疫斑点(Elispot)检测技术对老年人肺结核的诊断价值。方法对46例老年肺结核、85例中青年肺结核、22例老年非肺结核、97例健康对照,进行Elispot检测并分析该技术诊断老年肺结核的可靠性。结果老年和中青年肺结核Elispot检测的敏感度分别为76.19%和87.5%,特异度分别为84.47%和85.29%。中青年和老年肺结核组Elispot检测阳性率显著高于其它两组(P<0.05)。结论 Elispot检测技术在诊断老年肺结核中显示出较好的敏感性和特异性,阳性率高,可用作老年肺结核的辅助诊断。     

Diagnostic role of fiberoptic bronchoscopy for mycobacterial diseases--serological diagnosis]

Detection of IgG antibodies against purified cord factor (trehalose-6, 6'-dimycolate) prepared from Mycobacterium tuberculosis H37Rv was carried out by the method of enzyme-linked immunosorbent assay (ELISA) and its diagnostic usefulness was also evaluated in this study. Sera from 65 patients with active pulmonary tuberculosis, 58 patients with inactive pulmonary tuberculosis, 36 patients with diseases other than tuberculosis and 66 healthy adults were examined. Patients with active pulmonary tuberculosis showed significantly higher titers of IgG antibodies against cord factor than other groups (p < 0.001). Patients with inactive pulmonary tuberculosis also showed significantly higher titers of IgG antibodies against cord factor than patients with diseases other than tuberculosis and healthy adults (p < 0.001). An antibody titers of greater than 0.29 were established as a positive ELISA test. For patients with active pulmonary tuberculosis, the ELISA had a sensitivity of 85% and a specificity of 96%. From these results, it is concluded that the detection of IgG antibodies against cord factor is useful for the serodiagnosis of active or inactive pulmonary tuberculosis.     

Clinical study of polymerase chain reaction technique in the diagnosis of bone tuberculosis]

OBJECTIVE: To evaluate the clinical value of polymerase chain reaction (PCR) technique in diagnosis of bone tuberculosis. METHODS: PCR, standard light-microscopy and standard culture technique were used to detect Mycobacterium tuberculosis in samples obtained from 60 patients with bone tuberculosis and 20 patients without bone tuberculosis. In the meantime, some factors affecting PCR result were analysed and methods to deal with them were discussed. RESULTS: In the group of 60 patients with bone tuberculosis, the positive rate was 83% in PCR technique, 3% in standard light-microscope technique and 7% in the standard culture technique. A statistically obvious difference was seen (P < 0.005). In the group of 20 patients without bone tuberculosis, 2 cases showed positive in PCR technique, none in the other methods. Specificity of PCR technique in a blind comparison study indicated 100%. The whole process of PCR amplification is fully automatic and can be finished within several hours, and the detection time is considerably reduced. CONCLUSIONS: PCR technique is a rapid, specific, sensitive and simple method for detection of mycobacterium tuberculosis in sample of bone tuberculosis, and it is of great value in the diagnosis of bone tuberculosis and differentiating bone tuberculosis from other bone diseases.     

Performance of recombinant K39 antigen in the diagnosis of Brazilian visceral leishmaniasis

This study evaluated the performance of recombinant K39 (rK39) antigen in a immunochromatographic format (strip test) and a crude antigen enzyme-linked immunosorbent assay in the diagnosis of Brazilian visceral leishmaniasis (VL) in 128 consecutive patients with parasitologically proven infections (by microscopy and/or culture). For each patient, a medical history was obtained and a complete physical examination was performed. Controls included 10 healthy volunteers and 50 patients with other diseases: malaria (10), leprosy (9), Chagas' disease (10), tuberculosis (10), and cutaneous leishmaniasis (11). The sensitivities of the rK39 antigen strip test and the ELISA were 90% and 89%, respectively, while the specificities were 100% and 98%, respectively. Our study confirms the accuracy of the rK39 antigen strip test in the diagnosis of VL in a high prevalence population.     

结核分枝杆菌IFN-γ酶联免疫斑点检测的建立和初步应用

目的建立结核分枝杆菌特异性IFN-γ酶联免疫斑点（Elispot）检测技术,初步评价其在诊断结核分枝杆菌感染的敏感性和特异性。方法采用以早期分泌抗原靶6kDa蛋白（ESAT-6）抗原为主的重组蛋白库、多肽库为抗原,建立结核分枝杆菌特异性IFN-γElispot检测技术（简称Elispot）;应用该技术对32例肺结核病患者、205例健康对照者和18例肺部其他疾病对照的外周血结核菌特异性IFN-γ水平进行检测;结核病人和部分健康对照同时采用全血干扰素试剂（Quantiferon-TB-Gold,QFT-G）进行平行检测。结果采用Elispot检测,结核患者的阳性率最高（75.0%）,显著高于健康对照（7.3％）和其他肺部疾病患者（11.1%）,结核患者反应水平与其他两组比较均差异有统计学意义（P<0.05,P<0.05）。采用QFT-G在结核病人中的IFN-γ应答阳性率为78.1%,与Elispot检测结果进行配对比较无显著性差别（χ²=1.6,P>0.05）。 结论建立了结核菌特异性IFN-γ Elispot检测技术,该技术在诊断结核菌感染的初步应用显示出较好的特异性和敏感性,但仍需进一步扩大样本数观察。     

双抗原夹心胶体金免疫层析法快速检测结核分枝杆菌抗体的研究

目的 建立一种简易、快速和准确的双抗原夹心胶体金免疫层析法,用于检测结核病患者血清中的抗MTB抗体.方法 采用胶体金标记相对分子质量分别为6000、16 000和38 000的重组MTB早期分泌抗原靶蛋白(ESAT),成为重组MTB融合蛋白ESAT-16-38,研制出双抗原胶体金免疫层析检测卡,对浙江省德清县疾病预防控制中心2007-2009年临床确诊的结核病患者血清163份(其中肺结核痰MTB阳性57份、痰MTB阴性64份和肺外结核42份)和对照血清573份(其中体检者血清224份、急性肺炎和支气管炎患者血清217份、肺吸虫患者血清132份)样本进行检测,并与MTB蛋向芯片抗体法的检测结果进行比较.检出率的比较采用χ2检验.结果 双抗原法和蛋白芯片法检测结核病患者血清的阳性符合率分别为73.0%(120/163)和72.4%(118/163),差异无统计学意义(χ2=0.062,P＞0.05);检测对照血清的阴性检出率分别为93.9%(538/573)和92.0%(527/573),差异无统计学意义(χ2=0.635,P＞0.05);未见与肺吸虫患者血清有交叉反应,双抗原法对痰MTB阳性血清的检出率高达87.7%(50/57).结论 重组ESAT-6和ESAT-16双抗原胶体金免疫层析检测卡具有较高的敏感度和特异度,与蛋白芯片法的检测结果相似,且方法简便、快速,有很好的重现性和稳定性.

Abstract：

Objective To establish a simple,fast and accurate double antigen colloidal gold immunochromatographic technique for detecting Mycobacterium tuberculosis antibody from tuberculosis patients.Methods The fusion protein ESAT-6-16-38 was constructed by using gene cloning technique for the 6,16 and 38 kDa early secreted antigenic target from Mycobacterium tuberculosis.The ESAT-6-16-38 fusion protein was marked to colloidal gold to eatablish the double antigen colloidal gold immunochromatographie assay.Serum samples from 163 patients with tuberculosis,including 57 sputumpositive cases,64 sputum-negative cases,and 42 cases with extrapulmonary tuberculosis,were collected during 2007and 2009 from the Disease Prevention and Control Center of Deqing County.In addition,573 controls(224 healthy volunteers,217 patients with acute pneumonia and bronchitis,132 patients with paragonimiasis)were recruited for comparison.Mycobacterium tuberculosis specific antibodies were detected by using immunochromatographic and protein chip technique.Detection rate was compared with Chi-square test. Results Among the 163 tuberculosis patients,the positive rates of immunochmmatographic detection and protein chip were 73.0%(120/163)and 72.4%(118/163)respectively;the difference was not statistically significant(χ2=0.062,P＞0.05).Among the 573 controls,the negative rates of immunochromatographic detection and protein chip were 93.9%(538/573)and 92.0%(527/573)respectively;the difference was not statistically significant(χ2=0.635,P＞0.05).There was no cross reaction in the paragonimiasis patients.The positive rate of the immunoehromatographie assay was as high as 87.7%(50/57)in the sputmn-positive patients.Conclusions The double antigen immunoehromatographie technique is an easy to operate, rapid,highly sensitive, specific, and reproducible method for the detection of Mycobacterium tuberculosis antibodies.     

Serologic diagnosis of bone and joint tuberculosis by an enzyme-linked immunosorbent assay

Sera from patients receiving treatment for active bone and joint tuberculosis and sera from patients with inactive bone and joint tuberculosis were examined by an enzyme-linked immunosorbent assay for antibody to antigen 6, a homogeneous protein prepared from Mycobacterium tuberculosis strain H37Ra by immunosorbent affinity chromatography. Sera from 21 control subjects had a geometric mean titer of 1:6 with no difference between tuberculin purified protein derivative-positive and -negative patients. Sera from 20 patients with inactive disease had a geometric mean titer of 1:19. Fifteen patients receiving treatment for M. tuberculosis infection had a geometric mean titer of 1:179, which is significantly different from the geometric mean titers of both of the patients with inactive tuberculosis (P less than 0.001) and the control subjects (P less than 0.001). At a cut-off titer of 1:32, the sensitivity of the assay is 94% and the specificity for the control subjects and patients with inactive disease was 100%.