德国Nova恰加斯(鲁兹锥体)

我们不断发展和改善我们的产品,以满足我们客户的需求。因此我们现在新的NovaLisa®恰加斯(鲁兹锥体)免疫球蛋白ELISA,我们才能够增加的敏感性(99%)和特异性(99%)。

鲁兹锥体的病原体是恰加斯氏病(美洲锥虫病),这是一种寄生虫病,影响约800万人,主要是在拉丁美洲。然而,在过去的几十年中,已经越来越多地发现在加拿大,美国和许多欧洲和西太平洋国家。

它是由原生动物寄生虫氏锥虫鞭毛虫引起的。恰加斯病?疾病传播给动物和人类吸血锥蝽昆虫通过(?家庭Reduviidae亲吻bug ?)。肠的向量,这些寄生虫转换为集中乘epimastigote阶段,后来成trypomastigote形式发布的粪便当锥蝽虫血。

这些昆虫为食时就会感染动物的血作为水库的寄生虫。野生和家养的哺乳动物包括人类、狗、猫、老鼠、负鼠、犰狳和鲁兹锥体的蝙蝠是已知的水库。猎蝽虫巢,动物的自然栖息地,和其他地方经常光顾的脊椎动物的血提供了他们的生计。一些种类的Reduviidae入侵国内的栖息地。白天,锥蝽昆虫躲在缝隙的墙壁和屋顶构造不佳的住房在农村地区。晚上虫子出现,当居民睡觉。

trypomastigotes进入人类宿主通过咬伤或完整的粘膜膜,如结膜。一旦进入人体,寄生虫被巨噬细胞吞噬或侵犯其他细胞,主要是肌肉细胞(心脏、骨骼或光滑的肌肉组织)以及神经细胞。在细胞内,它们分化成无鞭毛体和繁殖。细胞充满了多达500个寄生虫叫什么?假性囊肿?。5天后寄生虫转换回trypomastigotes并返回到血液中。

恰加斯病?疾病急性期和长期潜伏阶段。急性期,遵循7-30天的潜伏期,可能没有或很轻微的症状。症状包括:发热、水肿、淋巴结肿胀,肝肿大,脾肿大,心肌炎,减少频繁,脑膜脑炎。zui*的感染急性恰加斯病的症状是与眼睑水肿(结膜炎)和平标志或chagoma(本地、炎症性皮肤反应)。

开始大约8 - 10周后急性期感染变成一个隐性的阶段。临床表现的慢性阶段,通常10 - 20年后急性期开始,心脏病、消化道损伤和疾病。

除了从媒介传播恰加斯?疾病,鲁兹锥体也可以通过输血传播,器官移植,经胎盘或受污染的食物和饮料。

感染的诊断则需要通过:

显微镜:确定锥虫在急性期血培养。

血清学:特定抗体基于ELISA-technique的决心

NovaLisa®恰加斯病ELISA / NovaLisa®恰加斯病免疫球蛋白ELISA:

的NovaLisa®恰加斯病ELISA和NovaLisa®免疫球蛋白ELISA用于抗体的定性测定鲁兹锥体在人类血清或血浆(柠檬酸)。

抗原:

鲁兹锥体重组抗原(TcF)

特定的性能特点恰加斯(TRYP0570):

特定的性能特点恰加斯病免疫球蛋白(CHAG0560):

比较表

外部研究

摘要目的:探讨商业套件的歧视性效率NovaLisa®恰加斯(鲁兹锥体)IgG-ELISA在哥伦比亚的一群个体,使用间接免疫荧光抗体试验(IFAT)和酶免疫测定(ELISA)测试作为参考。

材料与方法:78慢性chagasic患者样本(36无症状和42症状)和21健康对照组都包括在内。十七个样本未受感染的人恰加斯病流行病学的风险,与利什曼病7或9 non-chagasic心肌病也进行了分析。实时PCR进行测试在4个人的结果不一。

图1:不同群体之间的中位数OD值的比较评价。图形的横线代表的OD值的中值组

佐野=健康的病人;
SN反对危险= -患者的危险因素;
CD没有infectados =心脏病患者感染;
利什曼虫=利什曼虫阳性的病人
Asintomaticos =无症状
Sintomaticos =症状

敏感性= 96.15%(96.15% CI:95% - 98.68%)
特异性= 96.55%(95% CI:82.82% - 99.39)
协议= 0.9074(95%置信区间CI:0.7181 - 1.097)

请找到的*出版物:http://www.revistabiomedica。。ｏｒｇ/index.php/biomedica/article/view/1580/2313

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【公司名称】 广州健仑生物科技有限公司
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Chagas (Trypanosoma cruzi)

We are constantly developing and improving our products in order to meet our costumer's needs. As a result we present our new NovaLisa^® Chagas (Trypanosoma cruzi) IgG ELISA where we were able to increase both the sensitivity (99%) and specificity (99%).

Trypanosoma cruzi is the causative agent of the Chagas' disease (American trypanosomosis), which is a parasitic disease that affects about 7 to 8 million people worldwide, mostly in Latin America. However, in the past decades, it has been increasingly detected in Canada, USA and many European and Western Pacific countries.

It is caused by the flagellate protozoan parasite Trypanosoma cruzi. Chagas? disease is transmitted to animals and humans by blood-sucking triatomine insects (?kissing bugs?) in the family Reduviidae. In the intestine of the vector, the parasites convert into intensively multiplying epimastigote stages, and later into trypomastigote forms that are released with the feces when the triatomine insect takes a blood meal.

These insects become infected when they feed on the blood of animals that serve as reservoirs for the parasite. Wild and domestic mammals including humans, dogs, cats, rodents, opossums, armadillos and bats are known reservoirs of Trypanosoma cruzi. The natural habitats of reduviid bugs are nests, animal dens, and other places frequented by vertebrate animals whose blood provides their sustenance. Some species of Reduviidae have invaded domestic habitats. During the day, triatomine insects hide in crevices in the walls and roofs of poorly constructed housing in rural areas. The bugs emerge at night, when the inhabitants are sleeping.

The trypomastigotes enter the human host through the bite wound or through intact mucosal membranes, such as the conjunctiva. Once in the human body, the parasites are phagocytosed by macrophages or invade other cells, mainly muscle cells (heart, skeletal, or smooth musculature) as well as neurological cells. Within the cells, they differentiate into amastigotes and multiply. Cells filled with up to 500 parasites are called ?pseudocysts?. After 5 days the parasites convert back to trypomastigotes and return to the bloodstream.

Chagas? disease has an acute phase and a chronic latent stage. The acute phase, which follows an incubation period of 7-30 days, may have no or very mild symptoms. Symptoms include: fever, edema, lymph node swelling, hepatomegaly, splenomegaly, myocarditis and less frequently, meningoencephalitis. The most recognized symptoms of acute Chagas infection are the Romaña sign (conjunctivitis with eyelid edema) or the chagoma (local, inflammatory dermal reaction).

Beginning about 8-10 weeks after the acute phase the infection turns to an inapparent phase. Clinical manifestations of the chronic phase, often starting 10-20 years after the acute phase, are cardiopathy, digestive tract damage and neuropathies.

Besides from vector-borne Chagas? disease, Trypanosoma cruzi can also be transmitted through blood transfusions, organ transplants, transplacentally, or contaminated food and drink.

Infections may be diagnosed by:

Microscopy: Determination of trypanosomes in the acute phase in blood cultures.

Serology: Determination of specific antibodies based on the ELISA-technique

NovaLisa^® Chagas ELISA / NovaLisa^® Chagas IgG ELISA:

The NovaLisa^® Chagas ELISA and NovaLisa^® IgG ELISA are intended for the qualitative determination of antibodies against Trypanosoma cruzi in human serum or plasma (citrate).

Antigens:

Recombinant Trypanosoma cruzi antigens (TcF) 

Specific performance characteristics Chagas (TRYP0570):

Specific performance characteristics Chagas IgG (CHAG0560):

Comparison Table

External Study

Objective: To evaluate the discriminatory efficiency of the commercial kit NovaLisa® Chagas (Trypanosoma cruzi) IgG-ELISA in a group of Colombian individuals, using the indirect immunofluorescence antibody testing (IFAT) and enzyme immunoassay (ELISA) tests as references.

Materials and methods: 78 samples from chronic chagasic patients (36 asymptomatic and 42 symptomatic) and 21 healthy controls were included. Seventeen samples from non-infected people with Chagas disease epidemiological risk, 7 with leishmaniasis or 9 with non-chagasic cardiomyopathy were also analyzed. Real time PCR was performed in 4 individuals whose results differed among tests.

 
Figure 1: Comparison of the medians OD values between the different groups in evaluated. The horizontal lines in the graphic represent the median of the OD values of the groups

Sanos = healthy patients; 
SN con riesgo = negative patients with risk factor;
CD no infectados = patients with cardiopathy not infected;
Leishmania = patients positive for Leishmania 
Asintomaticos = asymptomatic
Sintomaticos = symptomatic

Sensitivity = 96.15% (95% CI: 89.29% - 98.68%)
Specificity = 96.55% (95% CI: 82.82% - 99.39)
Agreement = 0.9074 (95% CI: 0.7181 to 1.097) 

Please find the official publication at:http://www.revistabiomedica。。ｏｒｇ/index.php/biomedica/article/view/1580/2313

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