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 incre

德國Nova恰加斯(魯茲錐體)

我們不斷發(fā)展和改善我們的產(chǎn)品,以滿足我們客戶的需求。因此我們現(xiàn)在新的NovaLisa®恰加斯(魯茲錐體)免疫球蛋白ELISA,我們才能夠增加的敏感性(99%)和特異性(99%)。

魯茲錐體的病原體是恰加斯氏病(美洲錐蟲病),這是一種寄生蟲病,影響約800萬人,主要是在拉丁美洲。然而,在過去的幾十年中,已經(jīng)越來越多地發(fā)現(xiàn)在加拿大,美國和許多歐洲和西太平洋國家。

它是由原生動(dòng)物寄生蟲氏錐蟲鞭毛蟲引起的。恰加斯病?疾病傳播給動(dòng)物和人類吸血錐蝽昆蟲通過(?家庭Reduviidae親吻bug ?)。腸的向量,這些寄生蟲轉(zhuǎn)換為集中乘epimastigote階段,后來成trypomastigote形式發(fā)布的糞便當(dāng)錐蝽蟲血。

這些昆蟲為食時(shí)就會(huì)感染動(dòng)物的血作為水庫的寄生蟲。野生和家養(yǎng)的哺乳動(dòng)物包括人類、狗、貓、老鼠、負(fù)鼠、犰狳和魯茲錐體的蝙蝠是已知的水庫。獵蝽蟲巢,動(dòng)物的自然棲息地,和其他地方經(jīng)常光顧的脊椎動(dòng)物的血提供了他們的生計(jì)。一些種類的Reduviidae入侵國內(nèi)的棲息地。白天,錐蝽昆蟲躲在縫隙的墻壁和屋頂構(gòu)造不佳的住房在農(nóng)村地區(qū)。晚上蟲子出現(xiàn),當(dāng)居民睡覺。

trypomastigotes進(jìn)入人類宿主通過咬傷或完整的粘膜膜,如結(jié)膜。一旦進(jìn)入人體,寄生蟲被巨噬細(xì)胞吞噬或侵犯其他細(xì)胞,主要是肌肉細(xì)胞(心臟、骨骼或光滑的肌肉組織)以及神經(jīng)細(xì)胞。在細(xì)胞內(nèi),它們分化成無鞭毛體和繁殖。細(xì)胞充滿了多達(dá)500個(gè)寄生蟲叫什么?假性囊腫?。5天后寄生蟲轉(zhuǎn)換回trypomastigotes并返回到血液中。

恰加斯病?疾病急性期和長期潛伏階段。急性期,遵循7-30天的潛伏期,可能沒有或很輕微的癥狀。癥狀包括:發(fā)熱、水腫、淋巴結(jié)腫脹,肝腫大,脾腫大,心肌炎,減少頻繁,腦膜腦炎。zui*的感染急性恰加斯病的癥狀是與眼瞼水腫(結(jié)膜炎)和平標(biāo)志或chagoma(本地、炎癥性皮膚反應(yīng))。

開始大約8 - 10周后急性期感染變成一個(gè)隱性的階段。臨床表現(xiàn)的慢性階段,通常10 - 20年后急性期開始,心臟病、消化道損傷和疾病。

除了從媒介傳播恰加斯?疾病,魯茲錐體也可以通過輸血傳播,器官移植,經(jīng)胎盤或受污染的食物和飲料。

感染的診斷則需要通過:

顯微鏡:確定錐蟲在急性期血培養(yǎng)。

血清學(xué):特定抗體基于ELISA-technique的決心

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用于抗體的定性測定魯茲錐體在人類血清或血漿(檸檬酸)。

抗原:

魯茲錐體重組抗原(TcF)

特定的性能特點(diǎn)恰加斯(TRYP0570):

	Intraassay			Interassay			靈敏度%	特異性%
	n	的意思是	CV %	n	的意思是	CV %
恰加斯病ELISA (TRYP0570)	24 24	1.352 0.786	2.4 3.8	12 12	32.1 27.3	3.5 4.3	> 99	> 99

特定的性能特點(diǎn)恰加斯病免疫球蛋白(CHAG0560):

	Intraassay			Interassay			靈敏度%	特異性%
	n	的意思是	CV %	n	的意思是	CV %
恰加斯病ELISA (CHAG0560)	15	0.61	7.8	4 7	5.7 13.5	10.2 7.7	> 99	> 99

比較表

Novalisa®恰加斯(TRYP0570)
	老	新
診斷的敏感性	100%	> 99%
診斷特異性	98.9%	> 99%
NovaLisa®恰加斯(魯茲錐體)免疫球蛋白(CHAG0560)
	老	新
診斷的敏感性	99%	> 99%
診斷特異性	99%	> 99%

外部研究

摘要目的:探討商業(yè)套件的歧視性效率NovaLisa®恰加斯(魯茲錐體)IgG-ELISA在哥倫比亞的一群個(gè)體,使用間接免疫熒光抗體試驗(yàn)(IFAT)和酶免疫測定(ELISA)測試作為參考。

材料與方法:78慢性chagasic患者樣本(36無癥狀和42癥狀)和21健康對(duì)照組都包括在內(nèi)。十七個(gè)樣本未受感染的人恰加斯病流行病學(xué)的風(fēng)險(xiǎn),與利什曼病7或9 non-chagasic心肌病也進(jìn)行了分析。實(shí)時(shí)PCR進(jìn)行測試在4個(gè)人的結(jié)果不一。

圖1:不同群體之間的中位數(shù)OD值的比較評(píng)價(jià)。圖形的橫線代表的OD值的中值組

佐野=健康的病人;
SN反對(duì)危險(xiǎn)= -患者的危險(xiǎn)因素;
CD沒有infectados =心臟病患者感染;
利什曼蟲=利什曼蟲陽性的病人
Asintomaticos =無癥狀
Sintomaticos =癥狀

敏感性= 96.15%(96.15% CI:95% - 98.68%)
特異性= 96.55%(95% CI:82.82% - 99.39)
協(xié)議= 0.9074(95%置信區(qū)間CI:0.7181 - 1.097)

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

訂單信息:

ELISA	的數(shù)量決定	產(chǎn)品編號(hào)
恰加斯病ELISA	96年	TRYP0570
恰加斯 (魯茲錐體)免疫球蛋白	96年	CHAG0560

【公司名稱】 廣州健侖生物科技有限公司
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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):

	Intraassay			Interassay			Sensitivity %	Specificity %
	n	Mean	CV%	n	Mean	CV%
Chagas ELISA  (TRYP0570)	24 24	1.352 0.786	2.4 3.8	12 12	32.1 27.3	3.5 4.3	> 99	> 99

 

Specific performance characteristics Chagas IgG (CHAG0560):

	Intraassay			Interassay			Sensitivity %	Specificity %
	n	Mean	CV%	n	Mean	CV%
Chagas ELISA  (CHAG0560)	15	0.61	7.8	4 7	5.7 13.5	10.2 7.7	> 99	> 99

 

Comparison Table

Novalisa® Chagas (TRYP0570)
	Old	New
Diagnostic Sensitivity	100%	> 99%
Diagnostic Specificity	98.9%	> 99%
NovaLisa® Chagas (Trypanosoma cruzi) IgG (CHAG0560)
	Old	New
Diagnostic Sensitivity	99%	> 99%
Diagnostic Specificity	99%	> 99%

 

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

Order information:

ELISA	Number of Determinations	Product Number
Chagas ELISA	96	TRYP0570
Chagas  (Trypanosoma cruzi) IgG	96	CHAG0560