玻片凝集试验和间接血凝试验诊断钩端螺旋体病比较

目的：探索间接血凝试验(血凝)和TR／Patocl抗原玻片法凝集试验(玻凝)在钩体病血清学诊断方面的应用效果。方法：采用血凝法、玻凝法检测不同人群血清并与显凝法作比较。结果：对30例钩体病患者早期血清检测结果显示：3种试验方法阳性率分别为：玻凝法86．7％，血凝法73．3％，而显凝法仅30．0%，显凝与玻凝、显凝与血凝间有显著性差异，而玻凝与血凝间无显著性差异。对90例非钩体病人3种方法检测结果：玻凝法检出3份阳性，血凝法检出4份阳性，其特异性分别达96．67％和95．56％。对131例钩体病疑似患者血清抗体检测结果：3种方法阳性率分别为显凝40．5％，玻凝35．9％，血凝25．2％。显凝与玻凝总符合率达84．0％，与血凝总符合率达69．2％，3法无显著性差异。对钩体流行地区95份人群血清及60份鼠、57份猪血清检测结果显示：玻凝与血凝试验阳检率低，而显凝试验阳性率显著高于玻凝和血凝两者。结论：玻凝试验和血凝试验早期诊断钩体病都具有高度的敏感性和特异性，明显优于显凝试验，但在应用方面，玻凝试验方法更简便快速，数分钟即出结果，值得基层医疗单位推广。     

钩端螺旋体疫苗的研究现状

钩端螺旋体(Leptospira interrogans，简称钩体)引起的钩体病是一种常见的人兽共患传染病，严重地危害人类健康；其广泛分布于世界各地，已有77个国家和地区报告有钩体病。我国目前已发现18个血清群75个血清型，31个省份报告有病例或带菌动物，病死率约1％。；通过钩体疫苗的应用，该病已得到有效控制。钩体疫苗的发展比较快，尤其是随着分子生物学技术的发展，     

钩端螺旋体外膜疫苗的研究进展

钩端螺旋体(钩体)病是一种人畜共患的急性传染病,我国目前发现有18个血清群75个血清型,31个省份报告有病人或带菌动物,危害较大.数十年来通过钩体全菌体疫苗的应用,对控制该病起到了重要作用.20世纪70年代至今,我国已研制成功双价及多价钩体外膜疫苗.着重介绍了钩体外膜疫苗外膜抗原的性质及其提纯、免疫原性、疫苗制备、疫苗的反应性、血清学抗体效果和现场流行病学保护效果,还对疫苗大规模预防接种的可行性及其免疫策略提出了建议.     

钩端螺旋体外膜菌苗免疫效果的研究

钩端螺旋体 (简称钩体 )病主要在我国长江流域的省市流行 ,从 2 0世纪 6 0年代发现钩体病以来 ,累计发病近 15万例 ,病死近 2 5 0 0例 ,发病率和病死率都较高 ,危害性极大〔1〕。现使用的钩体浓缩菌苗 ,接种后对控制钩体病流行起到了重要作用 ,但该菌苗副反应较大 ,免疫效果不够理想 ,国内外学者均致力于新钩体菌苗研究〔2 ,3〕。目前 ,上海生物制品研究所已研制出钩体外膜菌苗 ,为了证实钩体外膜菌苗血清学免疫效果 ,由湖北省卫生防疫站牵头组成协作组 ,选择湖北省荆州市荆州区接种钩体外膜菌苗 ,进行现场观察 ,结果报告如下。1　对象和方…     

钩端螺旋体病显微镜凝集试验影响因素的控制及结果分析

钩端螺旋体病(Leptosp irosis,简称钩体病)是致病性钩端螺旋体(Leptosp ira interrogans,简称钩体)引起的一种分布广泛的人畜共患病。我国是受钩体病危害严重的国家之一[1]。我国曾发生过几十次大规模钩体病流行,发病率在10/10万以上的有10次,而9次是洪涝之年[1]。20世纪90年代     

钩端螺旋体外膜疫苗免疫效果进一步观察

为了对钩端螺旋体(钩体)外膜疫苗的大规模人群使用进行免疫学效果的进一步观察,采集观察对象(6～12岁小学生)免疫前和免疫后1个月、6个月、1年的4份血清,用显微镜凝集试验(MAT)测定抗体.以抗体滴度≥110为阳性判别标准.黄疸出血群的赖型免疫前抗体阴性者和七日热群的七日热型免疫前抗体阴性者接种疫苗后血清抗体阳转率和几何平均滴度(GMT),均在免疫后6个月左右达到高峰,其阳转率分别为96.2%和95.7%,血清抗体GMT分别为187.7和147.48%.免疫后1年的血清抗体阳转率分别为53.9%和29.0%,血清抗体GMT分别为126.43和119.03.钩体外膜疫苗接种1针可至少维持1年,第2年是否加强接种仍需进一步研究.     

钩端螺旋体不同型别外膜菌苗人体免疫效果观察

我国 6 0年代研制成功的钩端螺旋体全菌体菌苗 (简称菌体苗 ) ,一直沿用至今 ,对控制钩端螺旋体病 (简称钩体病 )流行起到重要作用。然而菌体苗接种次数多 ,反应较大 ,免疫效果不太理想。为了提高钩体菌苗接种后的免疫效果 ,80年代 ,卫生部上海生物制品研究所张锦麟等通过改进制备工艺 ,研制成了钩端螺旋体外膜菌苗 (简称外膜苗 ) ,通过实验室小量人体试验 ,具有较好的免疫效果。在进一步完善各项质控指标和改进生产工艺的同时 ,通过多年努力 ,先后研制成了二型、三型与五型钩体外膜苗。通过 2次小剂量人体接种反应观察 ,证明外膜苗全身和局…     

“浙江丁型”钩端螺旋体菌苗接种后反应与免疫效果的现场研究

对人群接种不同剂量的“浙江丁型”钩体菌苗后,两剂量组(1ml、2ml)均未出现全身反应。局部反应,2ml组的中、重反应高于1ml组。免疫后一个月,2ml组抗体高于1ml组;免疫后三个月,七日热型1ml组抗体高于2ml组。1ml组黄疸出血型免后一、三个月抗体GMT≥4价普通菌苗和4价纯化外膜菌苗。阳转率免疫后一个月,黄疸出血型1ml组为73.08%,2ml组为86.10%,七日热型分别为58.55%和67.46%。免后三个月两组均有一定数量的人体抗体阴转,但无显著性差异。菌苗接种与否与发病关系:无接种史的发病率为226.70/10万(9/3970),2ml组为160.00/10万(1/625),1ml组免疫人群无病例发生,认为用1ml免疫人群可获得相同的保护作用。     

胶乳凝集反应法测定糖化血红蛋白的方法学评价

目的：对胶乳凝集反应法测定糖化血红蛋白A1c（HbA1c）进行方法学评价。方法：用该法测定HbA1c,并对其精密度、准确度、线性范围、干扰因素和相关性加以评价。结果：该法正常值和高值总CV〈5.00%;平均回收率为96.5%;线性范围为2.0%～14.0%;884umol/L胆红素和0.5g/L维生素C均无显著干扰（P〉0.05）;与胶乳凝集抑制法测定结果有极显著的差异（P〈0.01）,但两种方法测定结果有良好的相关性（r=0.9798）。结论：胶乳凝集反应法测定HbA1c的技术性能符合临床要求,并且操作简便、检测快速;因此在具备自动生化分析仪的临床实验室可推广使用。     

Negative effect on immune response of repeated influenza vaccination and waning effectiveness in interseason for elderly people

BackgroundThrough test negative designs for visiting a doctor because of influenza-like illness, many studies have found decreasing efficacy of repeated vaccination. Furthermore, waning effectiveness during interseason periods has been reported. This study was conducted to confirm negative effects of repeated vaccination in individuals with the same vaccine strain and to measure waning effects.MethodsOur cohort includes 66 participants older than 65 years old recruited from an outpatient department of one hospital. All were vaccinated, with hemagglutination inhibition (HI) antibody titers measured from 2001/02 season through the 2003/04 season. HI antibody titers were measured three times in one season: pre-vaccination, post-vaccination, and post-epidemic. To test negative effects of immune response to the repeated vaccination, differences between protection rates and differences between response rates were analyzed for individuals in the two consecutive seasons. For the test of waning effectiveness, we measured the difference in geometric mean titers of HI antibody between post-epidemic results and pre-vaccination results obtained in the following season.ResultsProtection rates were 40–55% in A/New Caledonia/20/99 and ≥75% in A/Panama/2007/99 by repeated vaccination. In A/New Caledonia/20/99 and A/Panama/2007/99 in the 2003/04 season, significant decreases were found in protection rates from the earlier seasons, although the rate for A/Panama/2007/99 in the 2002/03 season increased significantly from that of the prior season. The respective response rates in the 2003/04 season in A/New Caledonia/20/99, and in the 2002/03 and 2003/04 seasons in A/Panama/2007/99 decreased significantly from those of earlier seasons. Regarding waning effectiveness, antibody titers for A/New Caledonia/20/99 in 2003/04 season, and A/Panama/2007/99 in 2002/03 and 2003/04 seasons decreased significantly to 37.0–66.7%.ConclusionResults show significant negative effects of immune response by repeated vaccination and show significant waning effectiveness during the interseason for individuals with the same strain of influenza type A. The proportion of elderly people with HI antibody titers of ≥1:40 might be maintained by repeated influenza vaccination.     

No effect of oral polio vaccine administered at birth on mortality and immune response to BCG. A natural experiment

Background

WHO recommends oral polio vaccine at birth (OPV0) in polio endemic countries. During a period without OPV in Guinea-Bissau in 2004, we observed that not receiving OPV0 was associated with significantly decreased mortality in boys and better immune response to BCG vaccination. In 2007, whilst conducting a trial of BCG and vitamin A supplementation (VAS) at birth to low birthweight (LBW) children, OPV was again lacking for a short period. We used this natural experiment to test the previous observations.

Methods

In the trial LBW infants were randomised to early or delayed BCG and VAS or placebo at birth. We noted whether the children received OPV0 or not. We compared children who received No OPV0 with those who received OPV0 in the 2 months before and the 2 months after the period without OPV. Mortality was compared in Cox regression models providing adjusted hazard ratios (aHR); the immune response to BCG was assessed in Poisson models providing adjusted prevalence ratios (aPR).

Results

Ninety-nine children received No OPV0 and were compared with 243 children who received OPV0. No OPV0 was associated with insignificantly higher mortality during the first year of life, the aHR being 1.83 (95% CI: 0.93–3.61). The effect was similar in boys and girls. Overall, there was no significant association between No OPV0 and having a positive PPD response (aPR = 1.33 (0.64–2.78)) or a scar (aPR = 1.02 (0.93–1.11)) after BCG vaccination, though No OPV0 boys were more likely to develop a scar (aPR: 1.10 (1.01–1.20)).

Conclusions

The findings did not support our previous observation that not receiving OPV0 was associated with reduced mortality in boys. The findings weakly supported that OPV0 leads to a dampened response to simultaneously administered BCG vaccine in boys.     

Evaluation of the monocyte activation test for the safety testing of meningococcal B vaccine Bexsero: A collaborative study

The aim of this collaborative study was to evaluate the robustness of the monocyte activation test (MAT) for quantifying the pyrogenic content in the outer membrane vesicle (OMV)-containing vaccine Bexsero: the first meningococcal B vaccine to be licenced. We analysed datasets from 9 laboratories covering 15 test systems for 3 batches of Bexsero with higher, equivalent and lower activity relative to a reference lot in the MAT. Activity was measured in terms of relative pyrogen units (RPU) based on European Pharmacopoeia (Ph. Eur.) MAT Chapter 2.6.30 Method C: Reference Lot Comparison Test. We report that all 15 test systems were consistent in that they showed sample A to be the most active in the MAT; that 13 of 15 test systems had an accuracy of more than 80% and an overall geometric mean RPU of 1.03 with lower and upper 95% confidence limits of 0.97 and 1.09 respectively for a sample with an expected value of 1.00 RPU. We also report larger variability in the results for test systems involving cells from individual blood donations for sample A suggesting that there could be donor to donor differences in sensitivity to the vaccine constituents responsible for the higher activity of this batch. Overall, the consistency and accuracy of the MAT was remarkable given the range of test systems used by participants, all of which are permitted by the Ph. Eur. General MAT Chapter. This is important given the limitations of the rabbit pyrogen test for the control of pyrogenicity in general and particularly with products with intrinsic pyrogenicity such as Bexsero.