免疫比浊法测定糖化血红蛋白的方法评价

对免疫比浊法测定糖化血红蛋白(HbAlc)的精密度、线性、干扰因素及与高效液相色谱测定法相关性比较,评价免疫比浊法测定HbAlc方法的可靠性.结果表明:免疫比浊法批内CV为1.3～2.1%、批间CV为1.9～2.3%;黄疸、脂血及类风湿因子对本法无明显干扰;相关系数R2=0.9934(P<0.010).直线回归方程为Y...     

视黄醇结合蛋白两种测定方法的可比性与不同真空采血管间干扰性评价

目的观察视黄醇结合蛋白(RBP)免疫比浊法(340nm波长)和胶乳增强免疫比浊法(600nm波长)两种检测方法的可比性,以及不同采血管的影响差异。方法用三种采血管,随机抽取40例样本,由同一操作者在同一生化仪上,用两种不同方法学的RBP试剂进行检测。并用SPSS17.O统计软件进行处理,以P<0.05为有统计学意义。结果普通无抗凝剂采血管用两种方法测定比较,P>0.05无显著性差异;免疫比浊法用肝素抗凝采血管与普通无抗凝剂管相比,有显著性差异(P<0.05);胶乳增强免疫比浊法用分离胶采血管与普通无抗凝剂管相比,有显著性差异(P<0.05)。结论视黄醇结合蛋白(RBP)两种检测方法的检测结果具有可比性,可应用于临床;免疫比浊法(340nm波长)受肝素抗凝管干扰影响结果 ;胶乳增强免疫比浊法(600nm波长)受分离胶采血管干扰影响结果 。     

化学发光免疫分析法检测黄体生成素和癌胚抗原的性能评价

目的评价化学发光免疫分析法检测黄体生成素和癌胚抗原.方法通过对不同浓度样品黄体生成素(LH)、癌胚抗原(CEA)含量的测定,进行精密度、灵敏度、干扰、回收试验.结果批内CV均小于5%,批间CV均小于6.5%;LH、CEA回收率分别为97.9%～102.2%、98.9%～102.4%,灵敏度分别达到2.4IU/L、2.6ng/ml;无吸样间的交叉污染.结论该方法各项指标结果准确,精密度好、灵敏度高、干扰小,具有广泛的应用前景.     

铁蛋白时间分辨荧光免疫层析法的建立及临床应用

建立铁蛋白(FER)时间分辨荧光免疫层析检测法(TRFIA-POCT)并进行临床应用。将FER抗体和兔IgG包被在硝酸纤维素膜(NC膜)上,以荧光微球标记抗FER单克隆抗体及兔IgG分别作为检测线和质控线制备荧光免疫层析试纸条。FER-TRFIA-POCT的灵敏度为0.5ng/ml;批内CV为3.2%~4.6%,批间CV为3.8%~5.2%;平均回收率为100.5%;热稳定性好;与电化学发光分析技术(ECLIA)比对,相关系数达0.8898。正常参考值范围男性为90~350ng/ml,女性为30~260ng/ml。本法建立的FER-TRFIA-POCT是一个快速高灵敏和可靠的检测。     

免疫散射比浊法测定CRP

目的本文对比浊法测定血清CRP(C-反应蛋白)进行方法学评价。方法采用免疫散射比浊法检测100例患者和30例健康正常人血清CRP含量，同时与乳胶凝集法结果对比。结果批内、批问变异系数分别为1．41％和4．66％，定量检测具有满意的线性响应(r=0．987)，免疫比浊法阳性率为35％，乳胶法为18％，比浊法阳性率明显高于乳胶法。结论本方法的重复性、准确性、稳定性、特异性均较好，脂血、黄疸无明显影响，具有较高的临床推广价值。     

TgAb时间分辨荧光免疫分析间接测定法的建立及临床应用

目的建立甲状腺球蛋白抗体(TgAb)时间分辨荧光免疫分析(TRFIA)间接检测法。方法用Tg抗原包板,用铕(Eu3+)标记兔抗人IgG做标记物,间接法TRFIA检测人血清中的TgAb。结果 TgAb-TRFIA的灵敏度为1.0 IU/ml;批内变异系数(CV)为3.1%～3.6%,批间CV为3.3%～3.6%;平均回收率为101.6%;热稳定性好;与电化学发光分析技术(ECLIA)比对,相关系数达0.8945;与临床结果高度相关。结论本法建立的TgAb-TRFIA是一个高灵敏和可靠的检测,有助于甲状腺疾病的临床诊断。     

甲状腺过氧化物酶抗体TRFIA技术的建立及临床应用

目的:建立甲状腺过氧化物酶抗体(TPOAb)时间分辨荧光免疫分析(TRFIA)竞争检测法。方法:用TPO抗原包板,用Eu3+标记羊抗鼠IgG做标记物,TRFIA检测人血清中的TPOAb。结果:TPOAb-TRFIA的灵敏度为1.0IU/ml;批内CV为3.2%～5.3%,批间CV为3.6%～5.6%;平均回收率为97.95%;热稳定性好;与电化学发光分析技术(ECLIA)比对,相关系数达0.9861;女性TPOAb测定值显著高于男性(P<0.01),且人群中TPOAb的阳性率女性也显著高于男性;TPOAb的正常值范围为≤32.6IU/ml。结论:本法建立的TPOAb-TRFIA是一个高灵敏和可靠的检测,有助于甲状腺疾病的临床诊断。     

顺磁性微粒子化学发光免疫分析法检测血清维生素B12的性能评价

目的:评估顺磁性微粒子化学发光免疫分析法(Chemiluminescence microparticle immunoassay,CMIA)检测血清维生素B12(Vitamin B12,VitB12)的分析性能。方法:应用美国临床和实验室标准化协会(CLSI)EP5-A2、EP15-A2、EP7-A2、EP6-A、C28-A3c方法评价CMIA检测VitB12的精密度、正确度、抗干扰性、分析测量范围(AMR)、临床可报告范围(CRR)、生物参考区间。采用美国国家标准技术研究所(National Institute of Standards and Technology,NIST)有证参考物质SRM 1955、美国病理学家协会(CAP)发放的室间质评物(K-C)、校准验证/线性评价物(LN5-B)评估CMIA系统检测VitB12正确度。结果:VitB12在108.84~874.43 pmol/L时,批内、批间精密度均小于厂家声明的标准。正确度验证显示测定有证参考物质NIST SRM1955,结果符合验证要求;检测CAP室间质评物(K-C)、校准验证/线性评价物(LN5-B)显示,结果均符合CAP校准验证/线性评价误差界限所规定的标准,VitB12浓度在89~1 057 pmol/L范围内通过线性验证,95%验证区间也包含其指定均值,相对偏差均小于卫生部临床检验中心室间质量评价标准(TEa:靶值±25%)。抗干扰性评估显示在TG≤20 mmol/L、Bil≤300μmol/L、Vit C≤1.5 g/L时对VitB12检测系统(CMIA)无显著干扰。AMR验证判断最佳拟合方程为二元一次多项式,VitB12浓度在0~1 107 pmol/L范围内存在线性关系。CRR上限为110 700 pmol/L,最大稀释倍数为100倍。生物参考区间验证显示本研究选择的参考个体VitB12水平符合厂家试剂说明书给定参考区间,女性略高于男性,但无显著差异。结论:CMIA检测血清VitB12的各项性能指标基本满足实验室要求,其可为实验室提供可靠的VitB12结果,为实验室评价人群VitB12营养状况提供信息。     

胶乳增强免疫比浊法检测糖化血红蛋白的性能评价

目的 对应用胶乳增强免疫比浊法在日立7600-020全自动生化分析仪上检测糖化血红蛋白(HbA1c)的性能进行评价.方法 应用胶乳增强免疫比浊法在日立7600-020全自动生化分析仪上检测HbA1c,对其精密度、空白检测限、线性、携带污染率进行评价,并与BIO-RAD(D-1 0N)高效液相色谱法(HPLC)检测HbA1c进行相关性分析,同时对参考区间进行验证.结果 日立7600-020全自动生化分析仪上检测HbA1c的低高水平的CV％批内分别为1.6％、0.5％;CV％批间分别为2.6％、1.3％;CV％总分别为3.5％、2.6％.检测限为0.1％.在2.0％～17.6％范围内线性良好(y=1.0046X-0.0619,R2=0.9996).携带污染率为1.03％,样本间交叉污染小.日立7600-020分析仪与BIO-RAD(D-10N)分析仪检测HbA1c的结果呈明显相关(y=1.0064X-0.0769,R2 =0.9942),95％置信区间为(-0.41～0.52)且百分偏倚的绝对值均小于6％.20名健康人群的HbA1c测定结果为4.0％ ～5.5％,在厂家提供的参考区间内.结论 应用胶乳增强免疫比浊法在日立7600-020全自动生化分析仪上检测HbA1c的性能良好,可供临床使用.     

尿微量白蛋白检测试剂盒性能评价

目的评价北京九强生物免疫比浊法尿微量白蛋白检测试剂盒的性能。方法评价九强生物免疫比浊法检测尿微量白蛋白的精密度、准确度、线性范围、最大稀释倍数、前带性能以及特异性。结果精密度实验显示,日内不精密度高低浓度质控的变异系数(CV)分别为0.61%和0.70%,日间精密度高低浓度质控的CV分别为1.95%和2.83%;准确度实验结果显示,九强生物与罗氏尿微量白蛋白检测试剂盒的检测结果回归方程为Y=1.0169X+5.7251,相关系数(r)为0.9987;测量线性范围与厂家提供的范围一致;最大稀释倍数最大可达40倍;检测样本浓度43000mg/L时前带样本仍在可控范围;在厂家说明书标示的干扰物浓度范围内,对检测结果没有明显影响。结论九强生物的mALB检测试剂盒精密度好、准确度高、线性范围宽、前带性能好,性能完全能满足临床的使用要求。     

Renal dysplasia and asplenia in two sibs

A family is reported in which two sibs, one male and the other female, both died within 24 hours of birth with enlarged polycystic kidneys. Postmortem histology in the second child showed gross renal dysplasia. In both children the pancreas was enlarged, nodular and cystic but the liver appeared macroscopically normal. In the second child, histological examination confirmed pancreatic fibrosis with cystic dilation of ducts, but showed portal fibrosis with bile duct proliferation in the liver.
This combination of findings is very reminiscent of those in a girl and her brother reported by Ivemark et al. (1959). The children reported here also showed absence or hypoplasia of the spleen, cardiac anomalies and other features of the Ivemark syndrome (Ivemark 1955), a quite different, usually sporadic, congenital disorder. It is suggested that the children described here have a distinct lethal congenital disorder, probably inherited in an autosomal recessive manner.     

Schizophrenia in a North Swedish geographical isolate, 1900–1977. Epidemiology, genetics and biochemistry

Over 200 schizophrenic patients belonging to three major and interrelated pedigree complexes have been investigated over the past 30 years in a North Swedish geographically isolated population, presently numbering about 6,000. An intensive investigation of a number of biochemical correlates and genetic markers in a few selected families belonging to one of the major pedigrees has indicated new strategies for the current research program.
Schizophrenia, as defined operationally, is significantly associated with decreased activities of two enzymes (1) blood platelet monoamine oxidase, (2) plasma dopamine-β-hydroxylase, and (3) with the genetic marker Gc² (group specific antigen). Both enzymes are subject to genetic variation. A positive score for linkage between schizophrenia and low plasma DBH activity has been calculated, but, so far, available data are insufficient for discrimination between linkage and partial contribution of genetically controlled low plasma DBH to the pathogenesis of the disease. Alternatively, both mechanisms could be involved.
As a model for continued research, schizophrenia is explained as based on a double dominant-recessive genotype (Aabb), representing a vulnerability which in about 50 % of cases develops into clinical schizophrenia. It is suggested that the dominant mutation (A) operates on or affects MAO activity, and that the recessive genotype (bb) is instrumental in low variates of DBH activity and very likely such variates within the normal range of physiological variation. Moreover, it is suggested that the combined effects of MAO- and DBH-reduced efficiency on the metabolism of e.g. dopamine could be an essential pathogenic mechanism for the schizophrenic illness which is segregating in this population.     

The dominant diseases of modernized societies as omega-3 essential fatty acid deficiency syndrome: Substrate beriberi

About 1900, modern food selection and processing caused widespread $\text{epidemics}$ of the B vitamin deficiency diseases of beriberi and pellagra which, for genetic reasons, often expressed as different diseases ranging from bowel and heart disease to dermatoses and psychoses. But the B vitamins merely help convert essential fatty acids (EFA) into the prostaglandin (PG) tissue regulators and it now turns out that, through hydrogenation, milling and selection of w3-poor southern foods, we have also been systematically depleting, by as much as 90%, a newly discovered trace Nordic EFA (w3) of special importance to primates and sole precursor of the PG3(4) series, even as a concurrent fiber deficiency increases body demand for EFA. Since substrate EFA is processed by many B vitamin catalysts, an EFA deficiency will mimic a $\text{panh}$ypovitaminosis B, i.e., a mixture of $\text{substrate}$ beriberi and $\text{substrate}$ pellagra resembling vitamin beriberi and pellagra but exhibiting as even more diverse $\text{endemic}$ disease. This would consitute a second stage of the Modern Malnutrition and explain why some workers now hold the dominant diseases of modermized societies to be new, nutritionally based, pellagraform yet lipid-related and to range, once again, from heart disease to psychosis. It is an assumption that our dominant diseases are unrelated to each other or are merely revealed by our diagnostic acumen and therapeutic success; and that hydrogenating millions of tons of food oils annually, to destroy the rancidity producing w3-EFA, is safe for $\text{primates}$. Extensive beriberiform disease is reported here in 32 typical cases taken from medical practice which responds strikingly to linseed oil supplements (60% w3-EFA) in confirmation of identical results in Capuchins.     

What will studies of Fulani individuals naturally exposed to malaria teach us about protective immunity to malaria?

There are an estimated over 200 million yearly cases of malaria worldwide. Despite concerted international effort to combat the disease, it still causes approximately half a million deaths every year, the majority of which are young children with Plasmodium falciparum infection in sub-Saharan Africa. Successes are largely attributed to malaria prevention strategies, such as insecticide-treated mosquito nets and indoor spraying, as well as improved access to existing treatments. One important hurdle to new approaches for the treatment and prevention of malaria is our limited understanding of the biology of Plasmodium infection and its complex interaction with the immune system of its human host. Therefore, the elimination of malaria in Africa not only relies on existing tools to reduce malaria burden, but also requires fundamental research to develop innovative approaches. Here, we summarize our discoveries from investigations of ethnic groups of West Africa who have different susceptibility to malaria.     

'Very sore nights and days': the child's experience of illness in early modern England, c.1580-1720

Sick children were ubiquitous in early modern England, and yet they have received very little attention from historians. Taking the elusive perspective of the child, this article explores the physical, emotional, and spiritual experience of illness in England between approximately 1580 and 1720. What was it like being ill and suffering pain? How did the young respond emotionally to the anticipation of death? It is argued that children’s experiences were characterised by profound ambivalence: illness could be terrifying and distressing, but also a source of emotional and spiritual fulfilment and joy. This interpretation challenges the common assumption amongst medical historians that the experiences of early modern patients were utterly miserable. It also sheds light on children’s emotional feelings for their parents, a subject often overlooked in the historiography of childhood. The primary sources used in this article include diaries, autobiographies, letters, the biographies of pious children, printed possession cases, doctors’ casebooks, and theological treatises concerning the afterlife.     

Guidelines for the Validation and Use of Immunoassays for Determination of Introduced Proteins in Biotechnology Enhanced Crops and Derived Food Ingredients

Recent advancements in agricultural biotechnology have created a need for analytical techniques to determine introduced proteins in crops enhanced through modern biotechnology techniques. These proteins are expressed in plant tissues and may be present in food ingredients. Immunoassays are ideally suited for protein detection and may be used as both quantitative and threshold methods. Microplate ELISA and lateral flow devices are two of the most commonly used immunoassay formats for agricultural biotechnology applications. This paper provides general background information and a discussion of criteria for the validation and application of immunochemical methods to the analysis of proteins introduced into plants and food ingredients using biotechnology methods. It is the result of a collaborative effort of members of the Analytical Environmental Immunochemical Consortium. This collaborative effort represents the combined expertise of several organizations to reach consensus on establishing guidelines for the validation and use of immunoassays. Further, the paper offers developers and users a consistent approach to adopting the technology as well as aid in producing accurate and meaningful results.     

HLA in North Colombia Chimila Amerindians

HLA-A,-B,-C,-DRB1 and -DQB1 alleles have been studied in Chimila Amerindians from Sabana de San Angel (North Colombian Coast) by using high resolution molecular typing. A frequent extended haplotype was found:HLA-A*24:02-B*51:10-C*15:02-BRB1*04:07-DQB1*03:02 (28.7%) which has also been described in Amerinndian Mayos Mexican population (Mexico, California Gulf, Pacific Ocean). Other haplotypes had already been found in Amerindians from Mexico (Pacific and Atlantic Coast), Peru (highlands and Amazon Basin), Bolivia and North USA. A geographic pattern according to HLA allele or haplotype frequencies is lacking in Amerindians, as already known. Also, five new extended haplotypes were found in Chimila Amerindians. Their HLA-A*24:02 high frequencies characteristic is shared with aboriginal populations of Taiwan; also, HLA-C*01:02 high frequencies are found in New Zealand Maoris, New Caledonians and Kimberly Aborigines from Australia. Finally, this study may show a model of evolutionary factors acting and rising one HLA allele frequency (-A*24:02), but not in others that belong to the same or different HLA loci.     

Ultracryotomy: development and application (with examples from the yeast cytology) (author's transl)

The preparation steps usually necessary for obtaining ultrathin frozen sections of biological material (chemical prefixation, enclosing, cryoprotective treatment, freezing, sectioning, and post-staining the sections for transmission electron microscopy) are submitted to a critical analysis. The application of cryo-ultramicrotomy, in particularly for cytochemical purposes, is reviewed. Fundamental considerations of chemical prefixation and poststaining are supported by examples from yeast cytology. Furthermore, the efficiency of the cryo-ultramicrotomy (electron optical resolution of ultrastructural details) is demonstrated on yeast cells and protoplasts.     

The universal muscular chamber. A basic unit of the genitourinary, cardiovascular, gastro-intestinal, skeletal, cutaneous, respiratory and other systems, endocameral hypertension; and spasm, the key to their idiopathic diseases and arthropathies

Starting with the integument, we see many organs are contractile sacs or multiples thereof, which tubes or bags constitute the major part of the entire body. Recognition of this basic unit and its characteristics sheds new light, individually and collectively, on many disorders previously considered unrelated. Muscular tears and perforations develop in the walls of these chambers, being no way peculiar to those organs, wherein, hydrochloric acid occurs. So, it is not necessary to explain the absence of excessive acid from patients who exhibit holes in the gastric, uterine, aortic, duodenal, rectal, pulmonary, retina, and other walls. Muscle, not acid is the great common factor relating idiopathic disorders in the gastrointestinal tract to each other and to similar diseases in other systems. When the units are linked together, the lesions tend to appear as arthropathies, i.e. at the joints. Rephrasing common-place observations, frees us from conventional, conceptual cul-de-sacs. An observation is only as good as its interpretation, so all possibilities must be considered, otherwise, we will remain blinded by our misconceptions.